TDAP Vaccine During Pregnancy Prevents Whooping Cough In Young Babies

MedicalResearch.com Interview with:
Tami H Skoff Centers for Disease Control and Prevention Atlanta, Georgia
Tami H Skoff
Centers for Disease Control and Prevention
Atlanta, Georgia

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Infants are at greatest risk for severe pertussis (whooping cough) morbidity and mortality, especially during the first months of life before infant immunizations begin.  CDC and the Advisory Committee on Immunization Practices (ACIP) currently recommend that women receive a dose of Tdap during the third trimester of each pregnancy.  This recommendation has been in place since 2012.  By getting Tdap, pregnant women pass critical short-term protection to their unborn babies. This helps protect babies until they are old enough to start getting their own whooping cough vaccines at 2 months of age.

The purpose of our study was to evaluate the effectiveness of maternal Tdap during pregnancy at preventing whooping cough in infants <2 months of age.

In our evaluation, Tdap administration during the third trimester of pregnancy prevented more than 3 in 4 (78%) infant cases.  Additionally, Tdap vaccination during pregnancy was even more effective (90%) at preventing whooping cough serious enough that the baby had to get treatment in a hospital.

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Third Dose of MMR Vaccine Reduced Risk of Mumps in University Students

MedicalResearch.com Interview with:

Cristina V. Cardemil, M.D., M.P.H. Pediatrics, Primary Care, Public Health Centers for Disease Control and Prevention Atlanta, GA 30333

Dr. Cardemil

Cristina V. Cardemil, M.D., M.P.H.
Pediatrics, Primary Care, Public Health
Centers for Disease Control and Prevention
Atlanta, GA 30333 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The effect of a third dose of the measles–mumps–rubella (MMR) vaccine in stemming a mumps outbreak is unknown. During an outbreak among vaccinated students at the University of Iowa, health officials implemented a widespread MMR vaccine campaign. We evaluated the effectiveness of a third dose of MMR vaccine in preventing mumps cases during the outbreak, and assessed for waning immunity.

Of 20,496 university students enrolled in the 2015-16 academic year, 259 developed mumps. Prior to the outbreak, 98.1% of students had received two or more doses of MMR vaccine. During the outbreak, 4,783 students received a third dose.

The attack rate was lower among students who received a third dose of MMR vs. 2-dose recipients (6.7 vs. 14.5 per 1,000, respectively). Students had at least nine times greater risk of getting mumps if they received their second dose of MMR 13 years or more prior to the outbreak. Individuals who received a third MMR vaccine dose had a 78% lower risk for mumps than individuals who had received only two doses. This study demonstrates a lower risk of mumps in 3-dose MMR vaccine recipients, suggesting the MMR vaccine dose campaign prevented cases and may have helped stop the spread of the outbreak. Waning immunity likely contributed to the spread of the outbreak.

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Increase in HPV+ Oropharyngeal Cancers Suggests Both Sexes Should Be Vaccinated

MedicalResearch.com Interview with:

Steven Habbous MSc, PhD candidate Ontario Cancer Institute Scarborough, Ontario, Canada

Steven Habbous

Steven Habbous MSc, PhD candidate
Ontario Cancer Institute
Scarborough, Ontario, Canada

MedicalResearch.com: What is the background for this study?

Response: Human papillomavirus (HPV) is a strong risk factor for oropharyngeal cancers (a subset of head and neck cancers). Because HPV-related oropharyngeal cancers generally respond well to treatment and may be prevented through HPV vaccination, it is critical to be able to accurately estimate the incidence and prevalence of this disease. Only recently, however, has testing for HPV become routine at most cancer centres across Canada.  As a result, attempts to estimate the growth of HPV-related oropharyngeal cancer over time may be inaccurate.

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Nasal Spray Flu Vaccine Ineffective and Not Recommended

MedicalResearch.com Interview with:

Michael Jackson  PhD, MPH Kaiser Permanente Washington Health Research Institute (KPWHRI) principal investigator for the United States Influenza Vaccine Effectiveness Network

Dr. Jackson

Michael Jackson  PhD, MPH
Kaiser Permanente Washington Health Research Institute (KPWHRI) principal investigator for the United States Influenza Vaccine Effectiveness Network 

MedicalResearch.com: What is the background for this study?

  • Response: Each year, Kaiser Permanente Washington is one of five sites across the country that participate in the United States Influenza Vaccine Effectiveness Network. The Network reports its early interim results in the MMWRand presents additional interim results to the Advisory Committee on Immunization Practices (ACIP)This New England Journal of Medicine publication is an update of those interim results.
  • The findings in this New England Journal of Medicine are special because prior randomized controlled trials indicated that the nasal spray vaccine (FluMist)—also called live attenuated influenza vaccine (LAIV)—would work well to protect children and teens from the flu, whereas in actual practice we found that the flu shot worked much better, particularly against the predominant strain, A(H1N1)pdm09.
  • The nasal spray vaccine was first seen to be less effective for young children than the flu shot in 2013-2014 for the A(H1N1)pdm09 virus strain. In response, the A(H1N1)pdm09 virus strain used in the nasal spray vaccine was changed for the 2015-2016 influenza season. The 2016/17 season was the first since 2015-2016 to be dominated by the A(H1N1)pdm09 virus, making this our first opportunity to evaluate the updated nasal spray vaccine.
  • The Influenza Vaccine Effectiveness Network evaluated the impact of this change as part of our estimates of influenza vaccine effectiveness in 2015-2016. Preliminary findings from this study were presented to the ACIP in June 2016, which led to the nasal spray vaccine not being recommended in 2016-2017 in the US, although the nasal spray vaccine remains licensed in the US. In 2016-2017, the LAIV A(H1N1)pdm09 vaccine strain was unchanged from 2015-2016.

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American Academy of Family Physicians Foundation Launches Highlight on VACCINATIONS 4 TEENS to Help Address Teen Under-Vaccination

 

MedicalResearch.com Interview with:

Hughes Melton, MD, MBA, FAAFP AAFP Foundation president

Dr. Melton

S. Hughes Melton, MD, MBA, FAAFP
AAFP Foundation president

MedicalResearch: What is the background for this initiative? What are the main vaccinations that teens should have?

 Response: The Centers for Disease Control and Prevention (CDC) recommends adolescents receive four immunizations – two of which are administered as multi-dose series – to help protect against meningococcal meningitis caused by serogroups A, C, W and Y; human papillomavirus (HPV); tetanus, diphtheria and pertussis (Tdap); and influenza (flu).1 Despite these recommendations, millions of teens remain vulnerable to serious infectious disease.2,3

Family physicians are well equipped to immunize their patients against a host of common infectious diseases and improve public health. However, discussing teen vaccinations during annual appointments may present challenges due to other issues teens and their parents/guardians may be focused on at this age. The American Academy of Family Physicians Foundation (AAFP Foundation) launched Highlight on VACCINATIONS 4 TEENS to help remind family physicians and their care teams to make immunization a priority at these key appointments for teens.

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Could Vaccine Against Meningococcus Help Protect Against Gonorrhea?

MedicalResearch.com Interview with:
Helen Petousis-Harris. BSc, PhD

Senior Lecturer, Dept General Practice and Primary Health Care
Academic Head, Immunisation Research and Vaccinology
Immunisation Advisory Centre
School of Population Health, Faculty of Medical and Health Sciences
University of Auckland

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Early thinking came from two quarters. One, the observation that the NZ OMV vaccine appeared broadly protective – beyond the clone it was based on and two, the observation of graphs depicting annual number of cases from both Cuba and NZ. There is nothing to suggest other types of meningococcal vaccine have had any effect on gonorrhoea so we are interested in the OMV vaccines. This led to the hypothesis that as these two Neisseria species are related the meningococcal OMV in the form of a vaccine may offer some kind of cross protection.

To explore this possibility we conducted a case-control study that compared the vaccination status of cases (gonorrhoea) and controls (Clamydia). We found that the cases with gonorrhoea were less likely to be vaccinated than the controls and after we controlled for confounders – ethnicity, SE deprivation, age we found a vaccine effectiveness of 31%.

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Dissolvable Microneedle Patches Can Be Vaccination Game Changer

MedicalResearch.com Interview with:
Dr Nadine G Rouphael MD
Associate Professor of Medicine, Emory University
Director of the VTEU and HIPC networks at the
Hope Clinic of the Emory Vaccine Center
Decatur GA 30030, USA

MedicalResearch.com: What is the background for this new technology and study? What are the main findings?

Response: Different groups including a group of researchers at Georgia Tech have been working on the microneedle technology for more than 20 years. The dissolvable microneedle patches are already used in several cosmetic products and drugs. However, vaccination with microneedle patches has been studied mostly in animals.

Our phase 1 trial published this week in The Lancet showed that vaccination with the microneedle patches was safe, with no related serious adverse events reported. Local skin reactions to the patches were mostly mild itching and faint redness that lasted two to three days. No new chronic medical illnesses or influenza-like illnesses were reported with either the patch or the injection groups. Antibody responses generated by the vaccine, as measured through analysis of blood samples, were similar in the groups vaccinated using patches and those receiving intramuscular injection, and these immune responses were still present after six months. When asked after immunization, more than 70 percent of patch recipients reported they would prefer patch vaccination over injection or intranasal vaccination for future vaccinations.

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Efficacy of Recombinant Flu Vaccine in Adults 50 Years of Age or Older 

MedicalResearch.com Interview with:

Lisa M. Dunkle, M.D. Chief Medical Officer Protein Sciences Corporation 1000 Research Parkway Meriden, CT 

Dr. Dunkle

Lisa M. Dunkle, M.D.
Chief Medical Officer
Protein Sciences Corporation
1000 Research Parkway
Meriden, CT

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The first and only recombinant protein influenza vaccine (RIV, Flublok) was approved in 2013 as a trivalent formulation for use in adults 18 years of age and older. This approval was based on demonstration of clinical efficacy (full approval) in adults 18-49 years of age and accelerated approval was granted for adults 50 years of age and older. Two clinical trials were conducted in 2014-2015 with RIV4 (Flublok Quadrivalent), of which the trial reported in the current NEJM is one.

These studies supported full approval of Flublok in adults 50 years of age and older and approval of Flublok Quadrivalent in all adults 18 years of age and older. The second trial of immunogenicity of Flublok Quadrivalent in adults 18-49 years of age will be the subject of another publication in the near future.

The main findings of the current trial are well summarized in the Conclusion of the Abstract: “RIV4 provided better protection than standard-dose IIV4 against confirmed influenza-like illness in older adults.”

Additionally, the recombinant vaccine (RIV4, Flublok Quadrivalent) demonstrated significantly less injection site pain and tenderness following vaccination. Based on the characteristics of the study participants, one can conclude that RIV4 is safe and effective in most individuals with underlying chronic diseases

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Clinical Trial Uses Patient’s Own Tumor To Manufacture Anti-Cancer Vaccine

MedicalResearch.com Interview with:
Chrisann Kyi, MD
Fellow, Division of Hematology and Medical Oncology
Icahn School of Medicine at Mount Sinai
One Gustave L. Levy Place, Box 1079
New York, NY 10029

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Mutation-derived tumor antigens (MTAs or neoantigens) arise as a direct result of somatic mutations, including nucleotide substitutions, insertions, and deletions that occur during carcinogenesis. These somatic variations can be characterized via genetic sequencing and used to identify MTAs with predictive computational genomics and algorithms. To be a good candidate for a cancer vaccine, a mutated cancer protein must be visible and recognized by T cells, the soldiers of the immune system, so that they in turn can be educated to seek out and destroy cancer cells that bear the mutated protein.

At annual ASCO conference this year, we are presenting an exciting clinical trial investigating the feasibility, safety, and immunogenicity of a personalized MTA-based multi-peptide vaccine in the adjuvant treatment for multiple solid tumors.

In this trial, the patient’s own tumor is used to manufacture a cancer vaccine according to the mutations in their individual tumor. This vaccine is then given back to the patient in the adjuvant setting. The clinical trial is currently open and accruing at Tisch Cancer Center at Mount Sinai Hospital, NY

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Study Finds No Link Between First Trimester Influenza Vaccination and Major Structural Birth Defects

MedicalResearch.com Interview with:

Dr. Elyse Olshen Kharbanda, MD MPH HealthPartners Institute Minneapolis, MN

Dr. Kharbanda

Dr. Elyse Olshen Kharbanda, MD MPH

HealthPartners Institute
Minneapolis, MN

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Pregnant women who get the flu are at an increased risk for severe illness. To protect pregnant women, the Advisory Committee on Immunization Practices recommends women receive inactivated influenza vaccine (IIV) during any trimester of their pregnancy.

This study used data from the Vaccine Safety Datalink to evaluate if there was an increased risk for selected major structural birth defects for infants whose mothers received IIV in the first trimester of pregnancy versus infants who were unexposed to IIV. Among over 425,000 live births, including 52,856 whose mothers received IIV during first trimester, we evaluated risks for major structural birth defects.  In this large observational study, we did not observe increased risks for major structural birth defects in offspring following first trimester maternal inactivated influenza vaccine exposure.

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Most Health Care Personnel Not Getting Tdap Vaccination

MedicalResearch.com Interview with:
Anup Srivastav, DVM, MPVM, PhD

National Center for Immunization and Respiratory Diseases (NCIRD)
Centers for Disease Control and Prevention
Atlanta GA

MedicalResearch.com: What is the background for this study?

Response: Healthcare personnel (HCP) are at risk for being exposed to pertussis (whooping cough) and spreading the disease to patients in their work settings. CDC recommends tetanus, diphtheria, acellular pertussis (Tdap) vaccination for healthcare personnel to reduce their risk of getting the disease and spreading it to patients. This is the first report of Tdap vaccination coverage among healthcare personnel by occupational setting.

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Toward A Real Cure for HIV: Abivax’s ABX464 Reduced HIV Reservoir in Phase 2 Trial

MedicalResearch.com Interview with:
AbivaxJean-Marc Steens, M.D.

Chief Medical Officer of Abivax

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Antiretroviral therapy (ART) has had an enormous impact on the HIV pandemic since its introduction almost 20 years ago. Most patients treated with ART achieve undetectable or near undetectable plasma levels of the virus. This means that although HIV is controlled, it is not completely eliminated. The virus remains in the body, usually contained in dormant cells (known as the HIV reservoir) that are widely distributed, including to the central nervous system, the gut mucosa, the lymph nodes and other sites. If ART is stopped, the virus rebounds. The goal of any curative therapy would be to eliminate the virus or ensure there is sustained remission in the absence of ART, which until now have been unsuccessful.

Abivax’s Phase 2 clinical study with ABX464 demonstrated, for the first time, a reduction in HIV reservoirs in chronically infected HIV patients as measured by total HIV DNA detected in peripheral blood mononuclear cells (PBMCs).

In the ABX464-004 trial, 30 HIV patients received either ABX464 or matching placebo in addition to their current antiretroviral treatment over 28 days. The viral load at the start of the study was well controlled with boosted darunavir. After the 28-day treatment period, all treatments were interrupted until viral load rebound. Baseline and day 28 blood samples were taken to assess the potential effect of ABX464 on the HIV reservoir in PBMCs.

Safety was the primary endpoint in the trial. ABX464 was well tolerated, with no severe adverse events in the treatment group. Amongst evaluable patients (4 placebo and 14 ABX464-treated patients), a reduction in viral DNA copies/mPBMCs was observed in 7/14 treated patients (mean change of -40%, ranging from -27% to -67%) and no responders were observed in the placebo group. Responders were defined as patients who had a decrease greater than 25% in total HIV DNA in PBMCs and a reduction of at least 50 copies.

Total HIV DNA in PBMC has been validated as a widely accepted biomarker for measuring the HIV reservoir. Specifically, in untreated patients, total HIV DNA load influences the course of the infection and is therefore clinically relevant. In addition, a correlation exists between the pool of HIV-1 DNA and the replication-competent reservoir.

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First Report Of A Therapeutic Vaccine For Gluten Sensitive Celiac Disease

MedicalResearch.com Interview with:
Leslie Williams, BS, RN, MBA</strong> Director, Founder, President and Chief Executive Officer <strong>Dr Robert P Anderson MBChB BMedSc PhD FRACP</strong> Chief Scientific Officer ImmusanT Cambridge, MALeslie Williams, BS, RN, MBA

Director, Founder, President and
Chief Executive Officer and

Dr Robert P Anderson MBChB BMedSc PhD FRACP
Chief Scientific Officer
ImmusanT, Cambridge, MA

MedicalResearch.com: What is the background for this study?

Response: The 2 Phase 1 trials were randomized, double-blind, placebo-controlled, multi-center studies evaluating the safety, tolerability, and relevant bioactivity of Nexvax2 in HLA-DQ2.5+ patients with celiac disease. In one study, patients received three fixed doses of Nexvax2 or placebo once per week over a three-week period. In the other study, patients received 16 fixed doses of Nexvax2 or placebo twice per week over an eight-week period. Both studies evaluated a range of fixed, intradermal dose administrations in a series of ascending dose cohorts, which included a crossover, double-blind, placebo-controlled oral gluten challenge in the screening and post-treatment periods. The primary outcome measures were the number and percentage of adverse events in the treatment period.

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PaxVax Commences Trial to Modernize Adenovirus Vaccine

MedicalResearch.com Interview with:

Nima Farzan Chief Executive Officer & President of PaxVax

Nima Farzan

Nima Farzan
Chief Executive Officer & President of PaxVax

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: PaxVax is developing a new and improved version of the vaccine, known as the Modernized Production Adenovirus Vaccine (MPAV) Prototype A. The Company was chosen as the Small Business Innovation Research and Regulatory Sponsor for the development of the Modernized Production Adenovirus Vaccine (MPAV) Prototype A due to the company’s prior experience working with multiple strains of Adenovirus. An Investigational New Drug (IND) application for MPACV was submitted to the U.S. Food and Drug Administration (FDA) on January 30, 2017. The Phase I clinical trial has been initiated and will be conducted at the Larner College of Medicine at the University of Vermont and Cincinnati Children’s Hospital. PaxVax expects to see results of the Phase I clinical trial in early 2018.

Complications of adenovirus 4/7 can include headache, pneumonia, sore throat and eye infections. In severe cases, adenovirus can lead to acute respiratory distress syndrome and other serious complications related to organ system damage (including GI tract and bladder) that can result in death, if left untreated.

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Phase 2 Trial of Takeda’s Dengue Vaccine Demonstrates Immune Response Against All 4 Strains

MedicalResearch.com Interview with:

Dr Vianney Tricou DPhil Takeda Vaccines Singapore

Dr. Vianney Tricou

Dr Vianney Tricou DPhil
Takeda Vaccines
Singapore

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Dengue fever is a painful, debilitating mosquito-borne disease caused by any one of four closely related dengue virus serotypes, and persons living in dengue endemic regions may be affected by dengue more than once in their lifetime. Some individuals with dengue fever are hospitalized and may need intensive therapy to prevent shock and death, and severe dengue is a leading cause of hospitalization and death among children and adults in some Asian and Latin American countries. About half of the world’s population lives under the threat of dengue and the disease has a significant medical and economic impact in the tropical and subtropical regions of the world where dengue is endemic.

Takeda is committed to improving global public health and to developing a life-saving dengue vaccine candidate for people around the world. Takeda’s tetravalent dengue vaccine candidate (TAK-003) is based on a live-attenuated dengue serotype 2 virus (DENV-2), which provides the genetic ‘backbone’ for all four attenuated dengue virus serotypes present in the vaccine. Takeda’s Phase 1 and Phase 2 clinical study program includes 8 studies to date that assess the safety and/or immunogenicity of this candidate, before moving into Phase 3.

Takeda’s ongoing Phase 2 DEN-204 study is designed to assess the safety and immunogenicity of one- and two-dose schedules of TAK-003 in 1,794 healthy children and adolescents ages two through 17 years living in dengue-endemic countries in Latin America and Asia.

As published in The Lancet Infectious Diseases in March 2017, an interim analysis of DEN-204 data indicated that TAK-003 elicited antibody responses to all four dengue serotypes in the population studied, regardless of whether they had previous dengue exposure.

A second TDV dose improved antibody responses against DENV-3 and DENV-4 in children who were seronegative before vaccination. In this study, the safety profile was consistent with that observed in earlier Phase 1 and 2 studies.
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Most Newly Arrived Refugees Have Overseas Vaccination Documentation

MedicalResearch.com Interview with:
Deborah Lee, MPH

Division of Global Migration and Quarantine
Centers for Disease Control and Prevention, Atlanta, GA

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: We wanted to assess whether documentation for vaccines provided to refugees overseas was received by clinicians in the US and if doses of measles-mumps-rubella (MMR) vaccine were integrated into the vaccine schedule as recommended for adults and children by the US Advisory Committee on Immunization Practices.

CDC recommends that US-bound refugees receive vaccinations prior to arrival in the United States. Vaccinations are documented on the Vaccination Documentation Worksheet (DS-3025), which refugees bring with them to the United States, and made available to state and local refugee health programs through CDC’s Electronic Disease Notification (EDN) system. Thirty to 90 days after arrival, most refugees have a post-arrival health assessment performed by clinicians affiliated with the state and local refugee health programs.

Our assessment indicated that most refugees had overseas vaccination documentation available at the post-arrival health assessments (87%), and that MMR vaccine was given when needed (83%). Furthermore, many refugees (90%) in our assessment did not require an additional MMR dose because they had received vaccination before entering the United States.

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Quadrivalent HPV Vaccination and the Risk of Adverse Pregnancy Outcomes

MedicalResearch.com Interview with:
Anders Hviid

Senior Investigator, M.Sc.,Dr.Med.Sci.
Department of Epidemiology Research
Division of National Health Surveillance & Research

MedicalResearch.com: What is the background for this study?

Response: HPV vaccination targeting girls and young women has been introduced in many countries throughout the world. HPV vaccines are not recommended for use in pregnancy, but given the target group, inadvertent exposure will occur in early unrecognized pregnancies. However, data on the safety of HPV vaccination in pregnancy is lacking.
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Safety and Immunogenicity of the Tau Vaccine AADvac1 in Patients with Alzheimer’s Disease

MedicalResearch.com Interview with:

Petr Novak, MD, PhD AXON Neuroscience Bratislava, Slovakia

Dr. Petr Novak

Petr Novak, MD, PhD
AXON Neuroscience
Bratislava, Slovakia

MedicalResearch.com: What is the background for this study?

Response: Alzheimer’s disease is a complex, multifactorial disorder, with many-faceted neuropathology. A hallmark finding is the co-existence of neurofibrillary pathology (such as neurofibrillary tangles) composed of tau protein, and amyloid-β pathology (plaques) [1].

Neurofibrillary pathology is closely correlated with cognitive impairment in Alzheimer’s disease [2], while support for the role amyloid in the disease pathogenesis comes from the ability of certain mutations to induce AD in an autosomal-dominant fashion [3].

The field has explored various anti-amyloid therapies to great extent, and continues to do so with undiminished effort [4]; meanwhile, there is a noticeable paucity of investigated therapies aimed at neurofibrillary tau protein pathology, despite the ability of tau protein dysfunction to cause a multitude of neurodegenerative disorders, collectively named “tauopathies” [5].

AADvac1 is the first tau-targeted immunotherapy investigated in humans [6], a pioneering effort to target the component of AD neuropathology that is proximal to neuronal damage and cognitive loss, and thus to halt or slow the progression of Alzheimer’s disease.

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Quadracel™ DTaP-IPV Vaccine Now Available in US

MedicalResearch.com Interview with:

Dr. David Greenberg MD Vice President, Scientific & Medical Affairs and Chief Medical Officer Sanofi Pasteur U.S.

Dr. David Greenberg

Dr. David Greenberg MD
Vice President, Scientific & Medical Affairs
and Chief Medical Officer
Sanofi Pasteur U.S. 

MedicalResearch.com: What is the importance of improved vaccination rates in light of recent outbreaks of vaccine-preventable diseases?

Response: It’s imperative. Too many children remain under-vaccinated against serious infectious diseases, and as the CDC reminds us – in addition to our country’s most credible medical associations – immunization is key in helping prevent both sporadic and outbreak-related cases of these diseases.1 In 2015, the CDC reported 6,448 new cases of pertussis in kids younger than 7 years of age, some of which could have potentially been avoided if vaccination completion was better. 2

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Topical Anesthetic Creams Work Best To Reduce Pain From Childhood Vaccination

MedicalResearch.com Interview with:

Dr. Anna Taddio PhD Professor in the Leslie Dan Faculty of Pharmacy University of Toronto Adjunct senior scientist and clinical pharmacist at SickKids

Dr. Anna Taddio

Dr. Anna Taddio PhD
Professor in the Leslie Dan Faculty of Pharmacy
University of Toronto
Adjunct senior scientist and clinical pharmacist at SickKids

MedicalResearch.com: What is the background for this study?
Response: We do not know enough about how well different pain interventions work over time and when combined together. In this study, we compared the effectiveness of interventions when layered together, starting from simplest to most complicated in terms of implementation, in the first year of life in infants undergoing routine vaccinations.

We compared 4 different treatments:
1. placebo (sham),
2. Educational video for parents about how to soothe their infants,
3) video and sucrose (sugar water),
4) video and sucrose and liposomal lidocaine cream.

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NYU Study To Evaluate Long-Term Treatment of Painful Shingles of the Eye

MedicalResearch.com Interview with:
Elisabeth J. Cohen, MD
NYU Langone Medical Center

MedicalResearch.com Editor’s note: Elisabeth J. Cohen, MD, of NYU Langone Medical Center, will head a five year study to evaluate new treatment protocols for herpes zoster ophthalmicus (HZO).
Herpes zoster ophthalmicus is a form of shingles that can cause prolonged pain and permanently damage the eye. Dr Cohen and NYU have received a grant from the National Institutes of Health to investigate the longer-term use of suppressive antiviral medication to reduce complications of HZO,

MedicalResearch.com: What is the background for this study? Can you tell us a little about herpes zoster/shingles?

Response: The rationale for the study is two-fold:

First: the accumulating evidence that zoster is followed by chronic active infection caused by the varicella zoster virus (VZV) that contributes to complications including vision threatening eye disease and life threatening stroke.

Second: the proven efficacy of suppressive antiviral treatment in reducing recurrent herpes simplex virus eye disease, caused by a different herpes virus, but with similar disease manifestations.

Zoster/shingles is caused by localized, unilateral reactivation of varicella zoster virus (VZV) in people who have had varicella/chicken pox resulting in a painful blistering rash that can be followed by chronic pain/postherpetic neuralgia. There are over one million new cases of zoster per year, and the incidence has increased over the past 6 decades for unknown reasons. Although the rate of zoster increases with age, the largest number of cases occur in people in their fifties.

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Many Children With Asthma Still Not Receiving Flu Vaccine

MedicalResearch.com Interview with:

Deepa Patadia, MD Wexner Medical Center The Ohio State University

Dr. Deepa Patadia

Deepa Patadia, MD
Wexner Medical Center
The Ohio State University

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Influenza vaccination is recommended every autumn for all children 6 months of age and older. It is particularly important for children with asthma, who are at high risk of hospitalization or severe illness if they contract influenza infection. The rates of influenza vaccination in children with asthma have not previously been well studied, but Healthy People 2020 has set a target goal to vaccinate 70% of all children for influenza. We found that rates of vaccination in our large primary care population was much lower than the target rate, with less than 50% of all children receiving the vaccine each year over a 5 year period; however rates were higher in children with asthma, albeit still only at 55%.

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Imugene Building Pipeline of B Cell Peptide Cancer Vaccines

MedicalResearch.com Interview with:

Leslie Chong Imugene Chief Operating Officer Armadale, Australia

Leslie Chong
Imugene
Chief Operating Officer
Armadale, Australia

 

MedicalResearch.com: What is the background for this study? How does HER-Vaxx work?

• The technology originates from the Medical University of Vienna, one of Europe’s leading cancer institutes and was identified in 2012 by Dr Axel Hoos (Currently Sr. Vice President of Oncology R&D at GlaxoSmithKline, previous Clinical Lead on Ipilumimab at Bristol-Myers Squibb, a director at Imugene; his only Board seat worldwide)
• HER-Vaxx is a peptide vaccine designed to treat tumours that over-express the HER2/neu receptor, such as gastric, breast, ovarian, lung and pancreatic cancers. The vaccine is constructed from various B Cell epitopes of HER2/neu. It has been shown in pre-clinical work and in a Phase 1 study to stimulate a potent polyclonal antibody response to HER2/neu, a commercially and clinically validated cancer target. HER-Vaxx’s successful Phase 1 study was in patients with metastatic breast cancer and the next stage of development will be a Phase 1b/2 study in patients with gastric cancer initiating in 2016.

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No Congenital Defects Found With TDAP Vaccine During Pregnancy

MedicalResearch.com Interview with:

Malini B. DeSilva, MD, MPH Clinician Investigator HealthPartners Institute

Dr. Malini B. DeSilva

Malini B. DeSilva, MD, MPH
Clinician Investigator
HealthPartners Institute

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: This is a retrospective study of more than 324,000 live births at seven Vaccine Safety Datalink sites between 2007 and 2013 which showed that the Tdap vaccine in pregnant mothers was not associated with increased risk for microcephaly or other major birth defects in their offspring.

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First Steps Toward Breast Cancer Vaccine Using HER-2 Mimotope

MedicalResearch.com Interview with:

Josef Singer MD, PhD Comparative Medicine Messerli Research Institute of the University of Veterinary Medicine Medical University Vienna University Vienna, Austria & Department for Comparative Immunology and Oncology Institute of Pathophysiology and Allergy Research Medical University Department of Internal Medicine II University Hospital Krems Karl Landsteiner University of Health Sciences Krems, Austria

Dr. Josef Singer

Josef Singer MD, PhD Comparative Medicine
Messerli Research Institute of the University of Veterinary Medicine
Medical University Vienna
University Vienna, Austria & Department for Comparative Immunology and Oncology Institute of Pathophysiology and Allergy Research Medical University
Department of Internal Medicine II University Hospital Krems Karl Landsteiner
University of Health Sciences Krems, Austria 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Immunotherapy of cancer has gained increasing interest in treatment of oncologic patients. Especially passive immunotherapy with monoclonal antibodies against tumor-associated antigens has been very successful due to good response rates with relatively moderate side effects compared to conventional chemotherapy.

Trastuzumab, an antibody against the human epidermal growth-factor receptor-2 (HER-2), is widely applied for the treatment of metastatic breast cancer. Trastuzumab leads to longer progression-free and overall survival in patients with HER-2 positive disease. However, monoclonal antibody therapies have to be repetitively applied, which represents a risk for infusion-related side effects and, due to the high costs, a massive burden for social security systems.

Our aim was to replace the passive immunotherapy by a vaccine actively inducing patients´ own antibodies with the same specificity as trastuzumab. A novel mimotope library platform enabled the development of a HER2-specific cancer vaccine: Mimotopes are small peptides that are able to mimic antibody epitopes on tumor-associated antigens, in our case the trastuzumab antigen on HER-2.

We use Adeno-associated-viruses (AAV) as carriers for our HER2 vaccine as they are highly immunogenic and safe. We could demonstrate that this HER-2 mimotope AAV-vaccine induced antibodies against human HER- 2 similar to the clinically used trastuzumab. In a mouse tumor model the HER-2 mimotope AAV vaccine was able to delay the growth of tumors significantly.

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Breast Feeding Educates Baby’s Immune System

MedicalResearch.com Interview with:
Ameae M. Walker
Vice Provost for Academic Personnel
Distinguished Teaching Professor
Biomedical Sciences
School of Medicine
University of California, Riverside

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: There has previously been some evidence that immune cells in breast milk could pass through the wall of the immature gut, but if active they, like antibodies in milk, were considered likely a form of passive immunity. We now show that in addition to some maternal cells being active in the newborn (i.e. that they do contribute to passive cellular immunity), there are, more importantly, others that go to the thymus where they participate in selection of the neonate’s T cells. In this fashion, the neonate develops cells that recognize antigens against which the mother has been vaccinated – a process we have dubbed maternal educational immunity.

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Widespread Rotavirus Vaccination Has Greatly Reduced Infections in Children

MedicalResearch.com Interview with:
Harvey Kaufman MD
Quest Diagnostics
Madison, New Jersey

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Quest Diagnostics is the leading provider of diagnostic information services, meaning we provide information and insights from our laboratory test services. This includes analyzing results of our laboratory test data in order to provide insights into health, wellness and disease to help providers, patients and health plans make better healthcare decisions.

A Quest Diagnostics Health Trends™ study published in the Pediatrics evaluated 276,949 de-identified test results from children ages infant through 9 years over an 11-year period to determine trends in laboratory rotavirus detection and the impact of the rotavirus vaccine on rotavirus detection. Vaccination is recommended for infants. In the study, two patients groups were evaluated for rotavirus vaccine – likely vaccinated (children who were infants after vaccine availability) and unlikely vaccinated (children who were infants prior to vaccine availability).

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Immunity to the Acellular Whooping Cough Vaccine Wanes With Time

MedicalResearch.com Interview with:
Dr. Kevin Schwartz, MD MSc
Infection Prevention and Control Physician
Infection Prevention and Control
Public Health Ontario | Santé publique Ontario

MedicalResearch.com: What is the background for this study?

Response: There has been a resurgence of pertussis, or ‘whooping cough’, in several countries and regions since the introduction of the new “acellular” pertussis vaccine in the 1990s to replace the older “whole cell” vaccine. In Ontario, we have not seen large increases but observed a small outbreak in 2012 that affected both unvaccinated people, as well as in those who have been vaccinated against pertussis. Our objective was to evaluate the effectiveness of the current acellular vaccine used in Ontario. We wanted to find out whether immunity wanes with time in the same way as had been previously observed during a large outbreak in California. We also wanted to study the impact of receiving the older ‘whole cell’ vaccine, which we used in Ontario until 1997.

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Live Nasal and Injectable Flu Vaccines Had Similar Effectiveness in Pediatric Study

MedicalResearch.com Interview with:

Dr. Mark Loeb BSc (McGill), MD (McGill), MSc (McMaster), FRCPC Professor, Department of Pathology and Molecular Medicine Joint Member, Dept of Clinical Epidemiology & Biostatistics Division Director, Infectious Diseases, McMaster University

Dr. Mark Loeb

Dr. Mark Loeb
BSc (McGill), MD (McGill), MSc (McMaster), FRCPC
Professor, Department of Pathology and Molecular Medicine
Joint Member, Dept of Clinical Epidemiology & Biostatistics
Division Director, Infectious Diseases, McMaster University

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The background for this study is that in the U.S, the Advisory Committee on Immunization Practices (ACIP), the committee that advises the CDC on vaccination policy, decided this June not to recommend LAIV (nasal live vaccine) for children. This is because of non-randomized studies conducted in the U.S suggesting that the vaccine was ineffective. This was an unprecedented decision in influenza vaccine policy making for children.

Our study, a randomized, blinded, controlled trial, which is the most rigorous type of study design, conducted over 3 years (2012-13, 2013-2014, 2014-2015 influenza seasons), showed in fact very similar protection for children and their communities for the live and inactivated vaccines. We conducted the study in the Hutterite community of Western Canada which allowed us to compare the effect of the vaccines in entire communities. That is, we were able to study the direct effect and the indirect effect of these vaccines.

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Meningococcal B Vaccine Tested During University Outbreak of Meningitis

MedicalResearch.com Interview with:

Nicole E. Basta, PhD MPhil Assistant Professor Division of Epidemiology and Community Health School of Public Health University of Minnesota

Dr. Nicole Basta

Nicole E. Basta, PhD MPhil
Assistant Professor
Division of Epidemiology and Community Health
School of Public Health
University of Minnesota

MedicalResearch.com: What is the background for this study?

Response: Meningococcal disease is a serious and often life-threatening condition.

In the past several years, multiple outbreaks caused by meningococcal serogroup B (MenB) have occurred on college campuses in the US. Recently, a new meningococcal B vaccine known as 4CMenB or Bexsero was developed. The FDA granted special approval to use the vaccine to control an outbreak at a University in New Jersey prior to its licensure.

We took advantage of this unique opportunity to investigate the impact of Bexsero during the outbreak. In doing so, we conducted the first clinical study of Bexsero among teens and young adults in the US.

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HPV-Related Cancers Continue to Risk, Most Preventable With Vaccine

MedicalResearch.com Interview with:
Laura J. Viens, MD
Division of cancer prevention and control
CDC

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: We analyzed the most recent available data from 2008–2012 from CDC’s National Program of Cancer Registries (NPCR) and the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) program for HPV-associated cancers.

  • These data cover 99% of the US population.
  • These data represent the official federal statistics on cancer incidence (new cases).
  • Every year between 2008 and 2012, about 39,000 men and women were diagnosed with cancers associated with HPV, an overall increase when compared with the 33,000 cancers associated with HPV between 2004 and 2008.
  • 23,000 (13.5 per 100,000 population) among females and 15,793 (9.7 per 100,000 population) among males.

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Flu Vaccination During Pregnancy Protects Mother and Infant

MedicalResearch.com Interview with:

Marta C. Nunes, PhD DST/NRF:Vaccine Preventable Diseases Respiratory and Meningeal Pathogens Research Unit University of Witwatersrand Chris Hani Baragwanath Academic Hospital Soweto, South Africa

Dr. Marta Nunes

Marta C. Nunes, PhD
DST/NRF:Vaccine Preventable Diseases
Respiratory and Meningeal Pathogens Research Unit
University of Witwatersrand
Chris Hani Baragwanath Academic Hospital
Soweto, South Africa

MedicalResearch.com: What is the background for this study?

Response: Young infants are at increased risk for influenza infection and hospitalizations associated with influenza infection. While active annual influenza vaccination is the most efficient mode for the prevention of influenza infection, current vaccines are poorly immunogenic and not licensed for use in infants

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This Generation of Malaria Vaccine Not Perfect But Can Still Save Lives

MedicalResearch.com Interview with:

Philip Bejon, Ph.D. Professor of Tropical Medicine, Director of the Wellcome-KEMRI-Oxford Collaborative Research Programme, Group Head / PI, Consultant Physician and Unit Director Kilifi, Kenya

Dr. Philip Bejon

Philip Bejon, Ph.D.
Professor of Tropical Medicine, Director of the Wellcome-KEMRI-Oxford Collaborative Research Programme, Group Head / PI, Consultant Physician and Unit Director
Kilifi, Kenya

MedicalResearch.com: What is the background for this study?

Response: According to the latest World Health Organisation (WHO) estimates more than 400,000 people died from malaria in 2015, with over 90% of these deaths occurring in sub-Saharan Africa. The vast majority who die are children under 5, and almost all cases are caused by the P. falciparum strain of malaria transmitted by female Anopheles mosquitoes.

RTS,S, which protects only against P. falciparum, was developed by GlaxoSmithKline with support from the PATH Malaria Vaccine Initiative (MVI) and with grant funds from the Bill & Melinda Gates Foundation to MVI. In July 2015, it received a positive opinion from the European Medicines Agency.

Earlier this year, the WHO recommended further evaluation of the four-dose regimen of RTS,S in a pilot implementation programme in sub-Saharan Africa, to address several knowledge gaps before the vaccine might be rolled out more widely.

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Two New Vaccines Provide Protection Against Zika in Mice

MedicalResearch.com Interview with:

Dan Barouch, M.D., Ph.D. Professor of Medicine Harvard Medical School Ragon Institute of MGH, MIT, and Harvard Director, Center for Virology and Vaccine Research Beth Israel Deaconess Medical Center

Dr. Dan Barouch

Dan Barouch, M.D., Ph.D.
Professor of Medicine
Harvard Medical School
Ragon Institute of MGH, MIT, and Harvard
Director, Center for Virology and Vaccine Research
Beth Israel Deaconess Medical Center

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: We showed that two vaccines, a DNA vaccine and a purified inactivated virus vaccine, both provided complete protection against Zika virus challenge in mice. To the best of our knowledge, this is the first demonstration of Zika vaccine protection in any animal model.

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Premature Infants May Have Some Infection Protection from Vaccinated Mothers

MedicalResearch.com Interview with:
Dr Paul T Heath MB BS, FRACP, FRCPCH Reader / Honorary Consultant Paediatric Infectious Diseases St George’s, University of London and Vaccine Institute London, United KingdomDr Paul T Heath MB BS, FRACP, FRCPCH
Reader / Honorary Consultant
Paediatric Infectious Diseases
St George’s, University of London and Vaccine Institute
London, United Kingdom

MedicalResearch.com: What is the background for this study? What are the main findings?

Dr. Heath: Vaccinating pregnant women is an important and proven strategy for protecting young infants against tetanus, influenza and pertussis. Among the infants at highest risk for complications of these infections are infants born prematurely but it is generally believed that because antibody transfer from mother to baby is maximal in the 3rd trimester, babies born prematurely may miss out on the benefits of maternal vaccination.

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Flu Vaccination During Pregnancy Protects Both Mother and Baby

MedicalResearch.com Interview with:

Julie H. Shakib, DO, MS, MPH Assistant Professor of Pediatrics | University of Utah Medical Director | Well Baby and Intermediate Nursery Salt Lake City

Dr. Julie Shakib

Julie H. Shakib, DO, MS, MPH
Assistant Professor of Pediatrics | University of Utah
Medical Director | Well Baby and Intermediate Nursery
Salt Lake City 

MedicalResearch.com: What is the background for this study? What are the main findings?

Dr. Shakib: Immunization against influenza in the first six months of life is ineffective  due to an immature immune response. Passive protection via maternal immunization offers an alternative but only a few studies have evaluated the efficacy of this immunization strategy. We found that in infants born to women immunized against influenza during pregnancy, the risk of laboratory-confirmed influenza and influenza-related hospitalization were reduced by 70% and 81% in their first 6 months of life, respectively.This large study provides more evidence that when women are immunized against influenza during pregnancy, their infants are much less likely to be diagnosed with influenza in their first 6 months.

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Data Exchange Between Public Health Records and Pediatricians’ EHRs Improves Vaccine Rates

MedicalResearch.com Interview with:

Melissa Stockwell, MD, MPH, FAAP Florence Irving Associate Professor of Pediatrics and Population and Family Health Columbia University - College of Physicians & Surgeons and Mailman School of Public Health Medical Director, New York-Presbyterian Hospital Immunization Registry (EzVac) Co-Director, Primary Care Clinician Research Fellowship in Community Health New York, NY 10032

Dr. Melissa Stockwell

Melissa Stockwell, MD, MPH, FAAP
Florence Irving Associate Professor of Pediatrics and
Population and Family Health
Columbia University – College of Physicians & Surgeons and
Mailman School of Public Health
Medical Director, New York-Presbyterian Hospital Immunization Registry (EzVac)
Co-Director, Primary Care Clinician Research Fellowship in Community Health
New York, NY 10032 

MedicalResearch.com: What is the background for this study? What are the main findings?

Dr. Stockwell: Fragmentation of immunization records place children at risk for underimmunization and overimmunization. Nearly all 50 states, 5 cities, and the District of Columbia operate an immunization information system, which is a system that collects and centralizes immunization data for children and adolescents from immunization providers at a regional or state level. More than 75% of US office-based physicians have adopted an electronic health record (EHR), but until recently, clinicians wanting to access patient immunization information in an IIS generally had to manually look up the patient data on a state or local IIS website, that data was not available to them within their own EHR. In this study, we demonstrated that exchange of immunization information between an immunization information system (IIS) and an EHR at point of care had a significant impact on up-to-date rates, overimmunization, and immunization record completeness for low-income, urban children and adolescents.

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Morning Flu Vaccinations May Be More Effective

MedicalResearch.com Interview with:

Dr Anna C. Phillips PhD CPsychol AFBPsS Reader in Behavioural Medicine School of Sport, Exercise & Rehabilitation Sciences University of Birmingham Edgbaston Birmingham

Dr. Anna Phillips

Dr Anna C. Phillips PhD CPsychol AFBPsS
Reader in Behavioural Medicine
School of Sport, Exercise & Rehabilitation Sciences
University of Birmingham
Edgbaston Birmingham

MedicalResearch.com: What is the background for this study? What are the main findings?

Dr. Phillips: We know that various factors can affect the response to vaccination and that older adults have a poorer response than younger people, i.e. they produce fewer antibodies.  We also know that many immune messengers and important hormones have daily rhythms in their levels and wanted to test whether the antibody response to vaccination might also be affected by time of day.  We randomised surgeries to giving morning or afternoon vaccinations and tested before and one month after the vaccination for levels of antibodies.

Two of the three flu strains (viruses) contained in the vaccine showed a higher antibody response in the morning than in the afternoon, up to 4 x higher to one of the strains (A/California) and 1.5 x higher to the B strain. None of the potential mechanisms we measured (immune messengers, hormones) seemed to be driving this effect.

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Kidney Transplant Patients May Not Be Protected From HPV Strains in Vaccines

MedicalResearch.com Interview with:

Dr. Delphine Robotham MD Division of Pediatric Nephrology Johns Hopkins University School of Medicine Baltimore, Maryland

Dr. Robotham

Dr. Delphine Robotham MD
Division of Pediatric Nephrology
Johns Hopkins University School of Medicine
Baltimore, Maryland

Medical Research: What is the background for this study? What are the main findings?

Response: Cervical cancer is the second most common cancer in women worldwide and is almost entirely caused by high risk HPV genotypes.  Vaccines to high risk HPV genotypes have shown great success in protecting healthy women from the sequelae of infection, including cervical cancer and genital warts. Young women with a kidney transplant as well as those with chronic kidney disease have abnormal immune systems and as a result have a significantly increased burden of HPV-related disease making the potential health benefits of the HPV vaccine substantial in this particularly vulnerable population.  This study examined the immune response to the HPV vaccine among girls and young women with kidney disease.

The goal of this research was to determine if girls and young women with chronic kidney disease (abnormal kidney function, on dialysis, or post kidney transplant) showed evidence of immune response to the quadrivalent HPV vaccine.  Immune response was determined by measuring the amount of antibody made by the patients against each of the 4 HPV genotypes included in the vaccine.  There are established thresholds of antibody above which patients are believed to have protection from infection.  We found that study participants with chronic kidney disease and those on dialysis had antibody levels above the threshold, indicating the vaccine should be effective in protecting them from HPV related disease.  A significant proportion of patients with kidney transplants showed evidence of inadequate antibody response.  This is important information as it means patients with a kidney transplant, whom we know are at increased risk of developing cervical cancer from HPV infection, may not be protected from HPV infections from the HPV genotypes included in the vaccine.
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4-Dose Hepatitis B Vaccine Schedule For HIV Patients Induces Longer Protection

MedicalResearch.com Interview with:

Odile Launay MD, PhD Paris Descartes University Assistance Publique Hôpitaux de Paris, Cochin Hospital

Dr. Odile Launay

Odile Launay MD, PhD
Paris Descartes University
Assistance Publique Hôpitaux de Paris, Cochin Hospital 

MedicalResearch.com: What is the background for this study? What are the main findings?

Dr. Launay: In patients with HIV infection, responses to standard HBV vaccination regimens remain suboptimal compared with responses in HIV seonegative individuals. We previously reported that alternative regimens (a 4 injection IMdouble dose regimen and a 4 injection intradermal low dose regimen) improve antibody response compared with the standard HBV vaccination regimen (ANRS HB03 VIHVAC-B study). Further precision on the duration of response achieved with alternative HBV vaccination regimes was needed.

We report in this paper the results from the follow-up of the study.

The results of this study show that the 4 dose IM regimen induces higher seroconversion rate but also higher long term seroprotection in HIV infected patients

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No Causal Association Found Between Vaccines and Deaths in Young People

MedicalResearch.com Interview with:
Natalie L. McCarthy, MPH

Centers for Disease Control and Prevention
Atlanta, Georgia

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Recently, deaths immediately following 4vHPV vaccination have garnered intense media attention.  Often, these media stories do not take into account the background rates of death in older children and young adults or disclose the potential for non-vaccine related causes of death.  The publicity surrounding deaths temporally associated with HPV and the paucity of studies examining deaths in adolescents following vaccination, was the basis for our evaluation of deaths following vaccines administered to individuals 9 through 26 years of age in the Vaccine Safety Datalink (VSD). The VSD is a collaborative project between the Centers for Disease Control and Prevention and several integrated healthcare systems, which monitors the safety of vaccines in the U.S.

This study assessed the risk of death in the first 30 days following vaccination, described the causes of death, and included an evaluation of the potential association of vaccination and death among older children and young adults. The risk of death was not increased during the 30 days following vaccination, and no deaths were found to be causally associated with vaccination. The causes of death were consistent with what would be expected for this age group.

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Ear Infections Decreasing in Babies Due to Breastfeeding and Vaccines

MedicalResearch.com Interview with:

Tasnee Chonmaitree, M.D. Professor, Pediatrics and Pathology Division of Pediatric Infectious Diseases Department of Pediatrics University of Texas Medical Branch Galveston, TX 77555-0371

Dr. Tasnee Chonmaitree

Tasnee Chonmaitree, M.D.
Professor, Pediatrics and Pathology
Division of Pediatric Infectious Diseases
Department of Pediatrics
University of Texas Medical Branch
Galveston, TX 77555-0371

MedicalResearch.com: What is the background for this study?

Dr. Chonmaitree: Respiratory infections are common in infants and young children; they are caused by viruses and/or bacteria. Viral upper respiratory tract infection or the common cold is exceedingly common and leads to bacterial complications such as ear infection, which the leading cause of antibiotic prescription in the US and the most common reason children undergo surgery (ear tube placement). In the past few decades, some bacterial and viral vaccines have become available aiming to reduce respiratory infections in children.

MedicalResearch.com: What are the main findings?

Dr. Chonmaitree: Our study looked to update information on how often infants in the first year of life acquired the common cold, and ear infection in the new vaccine era. The study was performed between 2009 and 2014 and included 367 infants followed closely from near birth up to one year of age. We found that on average, an infant had about 3 colds in the first year of life, and almost half of infants had ear infection by age 1 year. This was less than what happened in the past few decades. The reduction of ear infection may have been the result of many factors from bacterial and viral vaccine use, to increased breastfeeding rate and reduction in household smoking. Risk factors for ear infection included carriage of bacteria in the nose, frequencies of common cold and lack of breastfeeding.

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First Therapeutic Vaccine For Genital Herpes Shows Promise

MedicalResearch.com Interview with:

Zeena Y. Nawas, MD Clinical Research Fellow Center for Clinical Studies Houston, TX, 77004

Dr. Zeena Nawas

Zeena Y. Nawas, MD
Clinical Research Fellow
Center for Clinical Studies
Houston, TX, 77004

MedicalResearch.com: What is the background for this study? What are the main findings?

Dr. Nawas: T cell immunity is believed to be particularly critical to the control of genital herpes, an incurable, lifelong sexually transmitted disease that affects roughly 500 million people worldwide. Genital herpes is characterized by recurrent, painful genital lesions and can be transmitted to sexual partners, even when there is no visible sign of the infection. Current genital herpes therapies only partially control the infection in some patients. These individuals continue to experience clinical symptoms and viral shedding, which drives disease transmission. Incomplete control of genital lesions and transmission risk, and the inconvenience of taking a daily medication are hurdles for effective long-term disease management.

GEN-003, is a first-in-class immunotherapy developed by Genocea Biosciences and is intended to treat genital herpes by inducing both a T cell and B cell (antibody) immune response. GEN-003 has demonstrated promising results to date by showing statistically significant reductions in the clinical signs of genital herpes and viral shedding, as well as safety and tolerability in its Phase 1/2 and Phase 2 clinical studies.

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Hospital Stays Provide Opportunity to Vaccinate High Risk Patients

MedicalResearch.com Interview with:

Sara Y. Tartof, PhD, MPH Kaiser Permanente Southern California Department of Research & Evaluation

Dr. Sarah Tartoff

Sara Y. Tartof, PhD, MPH
Kaiser Permanente Southern California Department of Research & Evaluation

MedicalResearch.com: What is the background for this study? What are the main findings?

Dr. Tartof: The flu is a highly contagious respiratory infection that can cause serious complications, hospitalizations and, in some cases, even death. Some people, such as older adults, young children and people with certain health conditions, are at high risk for serious complications. In addition to recommending annual flu vaccination for people 6 months of age and older, the Centers for Disease Control and Prevention recommends that hospitalized patients who are eligible receive the flu vaccine before discharge.

Historically, inpatient rates of vaccination have been low. There has been concern among surgeons that vaccinating patients while they are in the hospital can contribute to increased risk of vaccine-related fever or muscle pain, which might be incorrectly attributed to surgical complications. However, there have been no data to support that concern. The objective of this study was to provide clinical evidence that would either substantiate or refute concerns about the safety of perioperative vaccination.

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CMV Virus Based Vaccine Protects Non-Human Primates From Ebola

MedicalResearch.com Interview with:

Dr. Michael A. Jarvis, PhD Reader in Virology & Immunology Director of Graduate Studies, School of Biomedicine & Healthcare Science, University of Plymouth

Dr. Michael Jarvis

Dr. Michael A. Jarvis, PhD
Reader in Virology & Immunology
Director of Graduate Studies,
School of Biomedicine & Healthcare Science,
University of Plymouth 

Medical Research: What is the background for this study?
Dr. Jarvis: This study is the latest in a series from a collaborative team involving scientists from the National Institutes of Health, University of California, Riverside and Plymouth University in the UK, and is an example of how I think science works best – when individuals with complementing areas of expertise come together to address a problem.

Medical Research: What are the main findings?

Dr. Jarvis: A main finding of the study is that the protection against Ebola virus that we observed in earlier studies in the mouse model translates to the experimental non-human primate model. This is a critical step in development of a vaccine for use in humans and other apes. At the applied level, we are interested in further development of this vaccine in a number of directions.

  • First, in a replication-defective format for use in humans (other studies suggest that replication-defective versions of CMV maintain ability to induce immune responses).
  • Second, we are interested in developing CMV as a self-disseminating vaccine to protect inaccessible wild African ape populations against Ebola virus. Ebola has decimated wild apes and these animals also serve as a main source of transmission of the virus into the human population. This would be a win-win situation for both ape conservation and human health.An additional and unexpected finding was that expression of the Ebola virus target antigen (called glycoprotein, GP) corresponded to an anti-Ebola immune response heavily biased towards antibody production and away from T cells. This phenomenon, which we are in the process of examining further, has never been seen for any other primate herpesvirus-based vaccine. It was associated with expression of GP at later times in the replication cycle of the CMV vaccine. We are currently constructing additional versions of these vaccines that express their target proteins at different times to examine further the impact of time of antigen expression on antibody versus T cell bias. Clearly this ability to modulate the antibody: T cell bias of the adaptive immune response could have substantial importance for vaccination in general. This phenomenon is also mechanistically very interesting at a more basic scientific level.

In the absence of detectable T cells against Ebola glycoprotein, the data presents the depletion of antibodies following challenge gives a graphic visualization of the antibody mediated protection, with the only animal to succumb to Ebola virus being the one in which antibody levels dropped to below detectable levels.

Citation:

Andrea Marzi, Aisling A. Murphy, Friederike Feldmann, Christopher J. Parkins, Elaine Haddock, Patrick W. Hanley, Matthew J. Emery, Flora Engelmann, Ilhem Messaoudi, Heinz Feldmann, Michael A. Jarvis. Cytomegalovirus-based vaccine expressing Ebola virus glycoprotein protects nonhuman primates from Ebola virus infection.
Scientific Reports, 2016; 6: 21674 DOI: 10.1038/srep21674

Dr. Michael Jarvis (2016). CMV-Virus Based Vaccine Protects Non Human Primates From Ebola 

Pregnant Women With Flu At High Risk of Serious Illness and Complications

Ikwo Oboho, MD, ScMLCDR, United States Public Health Service Medical Epidemiologist, Centers for Disease Control and PreventionPriority Populations Treatment Team| HIV Care & Treatment Branch | Division of Global HIV/TB Atlanta, GA 30333

Dr. Ikwo Oboho

MedicalResearch.com Interview with:
Ikwo Oboho, MD, ScMLCDR

United States Public Health Service
Medical Epidemiologist, Centers for Disease Control and PreventionPriority Populations Treatment Team| HIV Care & Treatment Branch | Division of Global HIV/TB
Atlanta, GA 30333

MedicalResearch.com: What is the background for this study?

Dr. Oboho: ·Pregnant women with flu are at high risk of serious illness and complications, including death.

The study is based on data gathered from a nationwide flu surveillance network that includes 14 states. The analysis focused on pregnant women hospitalized with laboratory-confirmed flu over four recent flu seasons, from 2010 to 2014.

MedicalResearch.com: What are the main findings? 

Dr. Oboho: ·       During the study period, 865 pregnant women were hospitalized with flu. Sixty-three of these patients, or about 7 percent, had severe illness.

  • After adjusting for underlying medical conditions, vaccination status, and pregnancy trimester, we found that early treatment with the antiviral drug oseltamivir was associated with a shorter hospital stay.
  • Among pregnant women with severe flu illness who were treated early with oseltamivir — within two days of the start of symptoms — the median length of stay was about five days shorter compared to hospitalized pregnant women with severe flu illness who were treated later
  • Pregnant women who were hospitalized with severe cases of flu illness were half as likely to have been vaccinated as women with non-severe illness.

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Ocular Herpes Can Rarely Occur After Varicella Vaccine

Frederick W. Fraunfelder, MD MBA Chairman and Roy E. Mason and Elizabeth Patee Mason Distinguished ProfessorDepartment of Ophthalmology Missouri University School of Medicine Director of the Missouri University Health Care’s Mason Eye Institute

Dr. Rick Fraunfelder

MedicalResearch.com Interview with:
Frederick W. Fraunfelder, MD MBA
Chairman and Roy E. Mason and Elizabeth Patee Mason Distinguished ProfessorDepartment of Ophthalmology
Missouri University School of Medicine
Director of the Missouri University Health Care’s Mason Eye Institute

Medical Research: What is the background for this study? What are the main findings?

Dr. Fraunfelder: The background starts with a paper by Hwang et al (Cornea. 2013 Apr;32(4):508-9.Reactivation of herpes zoster keratitis in an adult after varicella zoster vaccination. Hwang CW Jr1Steigleman WASaucedo-Sanchez ETuli SS.) After reading this paper, I started keeping track of keratitis cases that were reported to my registry (www.eyedrugregistry.com) and also to the FDA and WHO spontaneous reporting databases. We found case reports in adults and children of keratitis occurring soon after vaccination, and we presented this at the American Academy of Ophthalmology’s annual meeting that we just held in Las Vegas in November 2015.

The main findings are that in rare instances, relatively speaking, herpes infection can occur in the cornea of the eye within days to weeks after vaccination. This may especially be true in adults who have had shingles in the past which caused a keratitis in the past. This keratitis may reoccur after the vaccination, and primary care providers should inquire about this past medical/ocular history and advise of the risk of recurrent keratitis after the vaccination for shingles.

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When Not Mandatory, Many Resident Physicians Did Not Get Flu Vaccine

Mubdiul Ali Imtiaz, MD Department of Internal Medicine Rutgers University, New Jersey Medical School Newark, NJ 07103.

Dr.  Mubdiul Ali Imtiaz

MedicalResearch.com Interview with:
Mubdiul Ali Imtiaz, MD

Department of Internal Medicine
Rutgers University, New Jersey Medical School
Newark, NJ 07103

Medical Research: What is the background for this study?

Response: Resident physicians (RPs) were defined to be all individuals enrolled in a graduate medical education training program in a healthcare setting. There were 611 resident physicians enrolled in 47 post-graduate residency and fellowship programs at RU-NJMS during the 2013-2014 academic year. Influenza immunization was strongly recommended, but not mandatory for Resident physicians during 2013-2014. A link to the online survey using a standardized, anonymous, self-administered questionnaire was emailed by the program-chiefs to their respective RPs to collect demographic characteristics, influenza immunization status during the 2013-2014 and the previous season, and reasons for non-vaccination.

Medical Research: What are the main findings?

Response: The overall self-reported immunization rate of  Resident physicians in 2013-2014 was 76.7%. The immunization rate did not differ by the location of medical school attended (P= 0.55) or sex (P= 0.69). Among the respondents, 95.8% had influenza vaccination in the past and 83.1% received influenza vaccine during 2012-2013 flu season. History of influenza vaccination ever and in 2012-2013 were both significantly associated with receiving the vaccine during the 2013-2014 season (P<0.01 for both). The most common reason for not being vaccinated (38.6%) was “lack of time to get immunized” (see Figure 1). The most common cited motivating factors to be vaccinated during the next influenza season among the NVRPs were “making vaccinations in the workplace at convenient locations and times” (43.2%), “availability of mobile flu vaccination carts in hospital floors” (40.9%), and “establishing mandatory flu vaccination for employment” (36.4%).

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Statins May Dampen Efficacy of Flu Vaccination

Saad Omer MBBS MPH PhD Associate Professor Emory Vaccine Center Associate Professor Global Health and Epidemiology Rollins School of Public Health Emory University

Dr. Saad Omer

MedicalResearch.com Interview with:
Saad Omer MBBS MPH PhD

Associate Professor Emory Vaccine Center
Associate Professor Global Health and Epidemiology
Rollins School of Public Health
Emory University

MedicalResearch: Can you give us a little background on this study?

Dr. Omer: My background is in global health, epidemiology and pediatrics and I have been fortunate to conduct field and clinical vaccine trials in a number of countries and with multiple infectious diseases including influenza, polio, measles and pneumococcal vaccines.

We were familiar with the data on investigating the potential effects of statins on other infections i.e. sepsis and community acquire pneumonia including

Dr. Vandermeer’s study in 2012 suggesting that “statin use may be associated with reduced mortality in patients hospitalized with influenza”.

Statins have lipid-lowering effects but they also exhibit anti-inflammatory and immunomodulatory properties. For lack of a better image, I think of statins as acting like a ‘big hammer made of Jell-O’: they have a broad, small dampening effect on immune response (as opposed to a narrow or deep effect).

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HPV Vaccination Rate Low for Girls Under Both Commercial and Medicaid Plans

Shannon Stokley, MPH Epidemiologist in the CDC Immunization Services Division

Shannon Stokley MPH

MedicalResearch.com Interview with:
Shannon Stokley, MPH

Epidemiologist in the
CDC Immunization Services Division

Medical Research: What is the background for this study? What are the main findings?

Response: To determine whether the recommended HPV vaccination series is currently being administered to adolescents with health insurance, CDC and the National Committee for Quality Assurance (NCQA) assessed 2013 data from the Healthcare Effectiveness Data and Information Set (HEDIS). The HEDIS HPV Vaccine for Female Adolescents performance measure evaluates the proportion of female adolescent members in commercial and Medicaid health plans who complete the recommended HPV vaccination series by age 13 years. In 2013, in the United States, the median HPV vaccination coverage level for female adolescents among commercial and Medicaid plans was 12% and 19%, respectively (ranges = 0%–34% for commercial plans, 5%–52% for Medicaid plans). The results of this study indicate that there are significant opportunities for improvement as HPV vaccination coverage among female adolescents was low for both commercial and Medicaid plans.

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