Author Interviews, Infections, Pediatrics, Vaccine Studies / 23.02.2018

MedicalResearch.com Interview with: Professor Julie Bines Inaugural Victor and Loti Smorgon Professor of Paediatrics and Deputy Head of Department of Paediatrics University of Melbourne. Murdoch Childrens Research Institute  MedicalResearch.com: What is the background for this study? Would you briefly explain the significance of Rotavirus infections? Diarrhoea is one of the leading causes of child illness and death, and rotavirus is the most common cause of severe diarrhoea. Globally rotaviruses cause approximately 215,000 deaths in children under five years. This disease doesn’t discriminate – it infects children worldwide under the age of five – irrespective of what environment you live in. The rotavirus vaccines that are currently available work very well in places like Australia, the US and Europe but they don’t seem to work as well in low income settings in Africa and Asia where severe gastroenteritis is common and many children die. In a world-first clinical trial conducted in Indonesia, the oral RV3-BB vaccine was administered to babies within their first five days of life. Current rotavirus vaccines can only be administered to children older than six weeks, which leaves newborn babies particularly vulnerable to rotavirus infection. In lower resource settings, birth is often the best contact between mother, baby and health services. The oral RV3-BB vaccine was developed from the human neonatal rotavirus strain RV3 identified in the stool of healthy newborn babies. It does not naturally cause diarrhoea like other rotaviruses. The RV3-BB vaccine program aims to take advantage of the characteristics of this novel strain to target a birth dose vaccination strategy.  (more…)
Addiction, Author Interviews, Opiods, Vaccine Studies / 22.02.2018

MedicalResearch.com Interview with: “Syringe and Vaccine” by NIAID is licensed under CC BY 2.0Candy Hwang, Ph.D. The Scripps Research Institute La Jolla, CA 92037 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Our heroin vaccine is designed to stimulate antibodies to recognize and bind heroin, preventing passage of drug molecules to the brain. By essentially blocking the “high” from heroin, we believe this will assist recovering addicts from relapsing. Last year, we reported a heroin vaccine that was shown to be effective in both mouse and non-human primate models. In this current study, we were interested in enhancing our heroin vaccine by exploring different vaccine components and dosages. Once we discovered the most promising vaccine formulations, we wanted to see if our vaccines would be stable under different storage conditions. We found that our heroin vaccine was shelf stable under different temperatures and as a powder or in liquid form, meaning that the vaccine will remain stable for transport and storage. The best vaccine formulation from these studies showed protection against lethal doses of heroin. (more…)
Author Interviews, Flu - Influenza, Vaccine Studies / 12.02.2018

MedicalResearch.com Interview with: “#influenza” by J.S. Zolliker is licensed under CC BY 2.0Dr. Vittorio Demicheli Servizio Regionale di Riferimento per l'Epidemiologia SSEpi-SeREMI, Azienda Sanitaria Locale ASL AL Alessandria, Piemonte, Italy MedicalResearch.com: What is the background for this study? What are the main findings?  Response: The consequences of influenza in adults are mainly time off work. Only vaccination of pregnant women is recommended internationally, while mass vaccination of healthy adults is still matter of debate. The aim of this Cochrane Review is to assist informed decision making summarizing research that looks at the effects of immunizing healthy adults with influenza vaccines during influenza seasons. The review process found 52 clinical trials of over 80,000 adults. Only around 15% of the included studies were well designed and conducted. We focused on reporting of results from 25 studies that looked at inactivated vaccines. Injected influenza vaccines probably have a small protective effect against influenza and influenza-like illness (ILI_ (moderate-certainty evidence), as 71 people would need to be vaccinated to avoid one influenza case, and 29 would need to be vaccinated to avoid one case of ILI. Vaccination may have little or no appreciable effect on hospitalizations (low-certainty evidence) or number of working days lost. (more…)
Author Interviews, Infections, Vaccine Studies / 08.02.2018

MedicalResearch.com Interview with: Dr. Daihai He Assistant Professor Department of Applied Mathematics Hong Kong Polytechnic University  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Yellow fever (YF) is a life-threatening mosquito-borne infection. The 2016-2017 Yellow fever outbreak in Angola, Democratic Republic of the Congo (DRC) and Uganda is the largest YF outbreak in decades. Vaccination is an effective measure to mitigate the YF outbreak. As a result, 30 million people have been vaccinated in DRC and Angola. 962 cases and 137 deaths were confirmed in these two countries. Suspected cases and deaths are 7334 and 498 respectively. The true effect of this large-scale vaccination campaign is unclear. Using mathematical modeling and statistical inference, we found that if the vaccination campaign was not implemented, the size of the outbreaks (in term of cases and deaths) could be 5-6 fold higher in Luanda province Angola, the hit-hardest region. (more…)
Author Interviews, Flu - Influenza, Nature, Vaccine Studies / 26.01.2018

MedicalResearch.com Interview with: “Syringe and Vaccine” by NIAID is licensed under CC BY 2.0Dr. Lei Deng PhD Postdoctoral researcher Institute for Biomedical Sciences at Georgia State University MedicalResearch.com: What is the background for this study? What are the main findings? Response: Influenza A viruses evade human herd immunity by genetic hypervariation. Annual influenza epidemics are estimated to cause about 3 to 5 million cases of severe illness, and about 290,000 to 650,000 deaths. Vaccination is still the most effective way to prevent diseases, but current influenza vaccines provide limited protections against mismatched circulating virus strains. This drives scientists to develop universal influenza vaccines that can induce broad immune responses against all influenza A virus infections. We used biochemistry and nanotechnology to generate a double-layered protein nanoparticle universal influenza vaccine. The layered nanoparticle contains genetically modified influenza virus components without irrelevant carry/structural proteins and chemicals and confers strong and long-lasting immunity in laboratory mice against H1N1, H3N2, H5N1 and H7N9 infections. We also explain the protection mechanism of antibody dependent cell-mediated cytotoxicity (ADCC) and antibody dependent cell-mediated phagocytosis (ADCP) play the main role in the immune protection.  (more…)
Author Interviews, Infections, Pfizer, Vaccine Studies / 22.12.2017

MedicalResearch.com Interview with: Judith Absalon, M.D., M.P.H Senior Director, Vaccines Clinical Research Pfizer Pharmaceuticals MedicalResearch.com: What is the background for these two studies? Response: Invasive serogroup B meningococcal disease (MenB) is uncommon, yet serious, is unpredictable and can strike at any age, including healthy teenagers and young adults, with potentially long-lasting and devastating consequences, including death. The data from these two Phase 3 studies, one in adolescents (Study 1009) and one young adults (Study 1016), highlight that Trumenba can help protect teens and young adults against meningococcal group B disease. Additionally, these two large Phase 3 studies confirmed the results of earlier studies and supported the transition from Accelerated to Traditional Approval in the US; were pivotal for approvals in Europe, Australia, and Canada earlier this year; and add to the growing portfolio of research for TRUMENBA. (more…)
Author Interviews, CDC, Vaccine Studies / 29.11.2017

MedicalResearch.com Interview with: “Syringe and Vaccine” by NIAID is licensed under CC BY 2.0Alissa C. O’Halloran, MSPH Immunization Services Division National Center for Immunization and Respiratory Diseases Centers for Disease Control and Prevention Atlanta GA 30329  MedicalResearch.com: What is the background for this study? Response: Outbreaks of pertussis (whooping cough) can occur in healthcare settings. Vaccinating healthcare personnel (HCP) may be helpful in protecting HCP from pertussis and potentially limiting spread to others in healthcare settings. The Advisory Committee on Immunization Practices (ACIP) recommends a single dose of tetanus, diphtheria, and acellular pertussis (Tdap) vaccine for all adults, including pregnant women during each pregnancy, to protect themselves and reduce the risk for transmitting pertussis to infants too young to be vaccinated. To assure high Tdap coverage and disease prevention among HCP, patients, and others, ACIP recommends that healthcare employers provide Tdap vaccination to HCP and use approaches that maximize vaccination rates. In this study, we assessed Tdap vaccination coverage among healthcare personnel  by occupation, industry, demographics, access-to-care characteristics, and by the 21 states in the study. (more…)
Author Interviews, Dengue, Lancet, Vaccine Studies / 29.11.2017

MedicalResearch.com Interview with: Vianney Tricou DPhil Takeda Vaccines Pte Ltd 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 the four closely related dengue virus serotypes. Forty percent of the world’s population lives under the threat of dengue, with approximately 390 million infections and 20,000 deaths occurring globally each year. Dengue virus can infect people of all ages and is a leading cause of serious illness among children in some countries in Latin America and Asia. Takeda is developing a dengue vaccine candidate to safely protect children and adults living in, or traveling to, endemic areas against all four dengue virus serotypes, regardless of previous dengue virus exposure.  Takeda’s tetravalent dengue vaccine candidate (TAK-003) is based on a live, attenuated dengue serotype 2 virus, which provides the genetic ‘backbone’ for all four vaccine viruses. Takeda’s ongoing Phase 2 DEN-204 study was designed to assess the safety and immunogenicity of different dose schedules of TAK-003 in approximately 1,800 healthy children and adolescents ages two through 17 years living in dengue-endemic countries in Latin America and Asia. Participants of the DEN-204 trial received either one primary dose of TAK-003, two primary doses of TAK-003 administered three months apart, one primary dose of TAK-003 followed by a booster dose one year later, or a placebo. Eighteen-month interim data showed that that TAK-003 is associated with a reduction in the incidence of dengue in the study participants. Data also showed that TAK-003 induced sustained antibody responses against all four serotypes of dengue virus, regardless of previous dengue exposure and dosing schedule. (more…)
Author Interviews, Infections, OBGYNE, Pediatrics, Vaccine Studies / 03.10.2017

MedicalResearch.com Interview with: Tami H Skoff Centers for Disease Control and Prevention Atlanta, GeorgiaTami 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. (more…)
Author Interviews, CDC, Infections, Vaccine Studies / 08.09.2017

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  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. (more…)
Author Interviews, Cancer Research, CMAJ, HPV, Vaccine Studies / 14.08.2017

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, Flu - Influenza, Kaiser Permanente, Merck, NEJM, Vaccine Studies / 10.08.2017

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  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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Author Interviews, Pediatrics, Primary Care, Vaccine Studies / 14.07.2017

  MedicalResearch.com Interview with: 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. (more…)
Author Interviews, Infections, Lancet, STD, Vaccine Studies / 11.07.2017

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%. (more…)
Author Interviews, Emory, Flu - Influenza, Lancet, Technology, Vaccine Studies / 28.06.2017

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. (more…)
Author Interviews, Flu - Influenza, NEJM, Vaccine Studies / 22.06.2017

MedicalResearch.com Interview with: 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 (more…)
ASCO, Author Interviews, Cancer Research, Vaccine Studies / 12.06.2017

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 (more…)
Author Interviews, CDC, Flu - Influenza, OBGYNE, Vaccine Studies / 31.05.2017

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, CDC, Occupational Health, Vaccine Studies / 26.05.2017

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. (more…)
Author Interviews, Infections, Vaccine Studies / 15.05.2017

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. (more…)
Author Interviews, Gastrointestinal Disease, Lancet, Vaccine Studies / 13.05.2017

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. (more…)
Author Interviews, Infections, Respiratory, Vaccine Studies / 12.05.2017

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, Dengue, Vaccine Studies / 04.05.2017

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, CDC, Global Health, Vaccine Studies / 10.04.2017

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. (more…)
Author Interviews, HPV, NEJM, OBGYNE, Vaccine Studies / 30.03.2017

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. (more…)
Alzheimer's - Dementia, Author Interviews, Lancet, Vaccine Studies / 01.03.2017

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, Pediatrics, Vaccine Studies / 13.02.2017

MedicalResearch.com Interview with: 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 (more…)
Author Interviews, Pain Research, Pediatrics, Vaccine Studies / 13.12.2016

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 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. (more…)
Author Interviews, Herpes Viruses, Vaccine Studies / 21.11.2016

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. (more…)
Allergies, Asthma, Author Interviews, Flu - Influenza, Pediatrics, Vaccine Studies / 14.11.2016

MedicalResearch.com Interview with: 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%. (more…)