Author Interviews, OBGYNE, Pediatrics, Vaccine Studies / 05.06.2016

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. (more…)
Author Interviews, Flu - Influenza, OBGYNE, Pediatrics, Vaccine Studies / 09.05.2016

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  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. (more…)
Author Interviews, Columbia, Pediatrics, Vaccine Studies / 06.05.2016

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  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. (more…)
Author Interviews, HPV, Kidney Disease, Transplantation, Vaccine Studies / 15.04.2016

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, Hepatitis - Liver Disease, HIV, JAMA, Vaccine Studies / 13.04.2016

MedicalResearch.com Interview with: 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 (more…)
Author Interviews, CDC, HPV, Pediatrics, Vaccine Studies / 07.04.2016

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. (more…)
Author Interviews, Herpes Viruses, Vaccine Studies / 28.03.2016

MedicalResearch.com Interview with: 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. (more…)
Annals Internal Medicine, Author Interviews, Flu - Influenza, Kaiser Permanente, Surgical Research, Vaccine Studies / 16.03.2016

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, CDC, Flu - Influenza, OBGYNE, Vaccine Studies / 04.02.2016

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.
(more…)
Author Interviews, Herpes Viruses, Ophthalmology, Vaccine Studies / 30.01.2016

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. (more…)
Author Interviews, CDC, Cost of Health Care, HPV, Vaccine Studies / 30.10.2015

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. (more…)
Author Interviews, CDC, JAMA, OBGYNE, Vaccine Studies / 21.10.2015

MedicalResearch.com Interview with: Dr.Lakshmi Sukumaran MD, MPH Immunization Safety Office, Centers for Disease Control and Prevention Department of Pediatrics, Emory University School of Medicine Atlanta, Georgia Medical Research: What is the background for this study? What are the main findings? Dr. Sukumaran: Pertussis (whooping cough) is a vaccine-preventable disease that has been increasing in incidence over the past decade in the United States. Newborns and infants are at increased risk of pertussis-related hospitalization and death compared with older children and adults. The Advisory Committee on Immunization Practices (ACIP) recommends that pregnant women receive a tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Tdap) during each pregnancy to protect her infant from pertussis disease, regardless of prior immunization status. However, there is limited data on the safety of repeated Tdap vaccines in pregnant women. Our study evaluated medically attended (associated with doctor visit or hospitalization) adverse events in mothers, such as fever, allergy and local reactions, and adverse birth outcomes, such as prematurity and low birth weight in newborns, in women receiving Tdap in pregnancy who had received a prior tetanus-containing vaccine. We found no significant differences in rates of these adverse outcomes in women who received Tdap in pregnancy following a prior tetanus-containing vaccine less than 2 years before, 2 to 5 years before, and more than 5 years before. (more…)
Author Interviews, Infections, Respiratory, Vaccine Studies, Vanderbilt / 11.10.2015

Annabelle de St. Maurice MD, MPH Pediatric Infectious Disease Fellow Vanderbilt Children's HospitaMedicalResearch.com Interview with: Annabelle de St. Maurice MD, MPH Pediatric Infectious Disease Fellow Vanderbilt Children's Hospital  Medical Research: What is the background for this study? What are the main findings? Dr. de St. Maurice: Susceptibility to certain infectious diseases appears to vary by gender. For example, males may be at increased risk of certain infections in childhood, including lower respiratory tract infections such as RSV, however females may have more severe infections, such as influenza, during pregnancy. Some early studies have suggested that males may be at increased risk of pneumococcal infections but this has not been confirmed. Furthermore, whether those potential gender differences remain after introduction of pneumococcal conjugate vaccines is unknown. Invasive pneumococcal disease, which includes meningitis, bacteremic pneumonia and bacteremia/septicemia, is a significant cause of morbidity and mortality in the United States in children and adults. The 7-valent pneumococcal conjugate vaccine (PCV7) and the 13-valent pneumococcal conjugate vaccine (PCV13) led to declines in invasive pneumococcal disease rates as well as eliminated racial disparities in regards to invasive pneumococcal disease rates. Our study sought to identify potential gender differences in the incidence of invasive pneumococcal disease, and to determine the impact of vaccines on gender differences in the susceptibility to these diseases. We conducted a large study that used data from a population-based surveillance system of invasive pneumococcal diseases in Tennessee. This is part of a large CDC funded network of surveillance sites for these diseases. For our study, we identified patients with laboratory-confirmed invasive pneumococcal disease, and calculated the incidence of invasive pneumococcal diseases from 1998-2013 by gender. We also stratified the calculations by age groups and race, both well-known factors that affect the occurrence of invasive pneumococcal disease. Our study found that males had generally higher rates of invasive pneumococcal disease than females across age groups, regardless of race. Although introduction of the pneumococcal conjugate vaccines led to a significant decrease in invasive pneumococcal disease rates, males continued to have higher rates than females in several age groups. (more…)
Allergies, Author Interviews, CDC, Pharmacology, Vaccine Studies / 07.10.2015

MedicalResearch.com Interview with: Michael M. McNeil, MD, MPH Centers for Disease Control and Prevention Atlanta, GA Medical Research: What is the background for this study? What are the main findings? Dr. McNeil : Anaphylaxis is an uncommon potentially life-threatening allergic reaction which can occur immediately (usually within minutes) after exposures to food, drugs, venom and vaccines. More than 100 million people in the U.S. receive vaccinations each year. Most vaccines have the potential to trigger anaphylaxis, but the rates at which it occurs after vaccination are not well known. The CDC study examined data from the Vaccine Safety Datalink (VSD), a collaborative project between CDC and 9 integrated healthcare organizations, which contains vaccination records on more than 9 million patients. The study sought to determine the rates of anaphylaxis after all vaccines combined and some individual vaccines including seasonal influenza vaccines given to children and adults.  Patients studied received vaccinations between January 1, 2009 – December 31, 2011.  Electronic medical record data was screened for patients with specific diagnostic codes for anaphylaxis or who had received epinephrine prescriptions as a treatment for potential anaphylaxis. Researchers were able to look at data from 25,173,965 vaccinations during 17,606,500 visits to healthcare providers. The researchers identified 33 confirmed vaccine-triggered anaphylaxis cases that occurred after more than 25 million vaccine doses. The rate of anaphylaxis was calculated at 1.31 per million doses for all vaccines, and 1.35 per million for seasonal inactivated influenza vaccines. Patients ranged in age from 4 to 65 with a median age of 17. None of the patients with anaphylaxis were below the age of 4 years old. Only one of the 33 patients was hospitalized, and none died as a result of anaphylaxis. A majority (85%) of the case-patients had pre-existing atopic disease including previous anaphylaxis, asthma, and allergies. (more…)
Author Interviews, Cleveland Clinic, Cost of Health Care, Herpes Viruses, Vaccine Studies / 24.09.2015

Phuc Le, Ph.D., M.P.H. Center for Value-Based Care Research, Medicine Institute Cleveland, OHMedicalResearch.com Interview with: Phuc Le, Ph.D., M.P.H. Center for Value-Based Care Research, Medicine Institute Cleveland, OH  Medical Research: What is the background for this study? What are the main findings? Dr. Phuc Le: The live attenuated herpes zoster vaccine is approved by the FDA for persons aged 50 years and above. However, the Advisory Committee on Immunization Practices recommends it for only persons aged 60 years and older. Therefore, we aimed to analyze the vaccine’s cost-effectiveness among persons aged 50-59 years to see if ACIP’s recommendation is reasonable. We found that the vaccine is not cost-effective among people at aged 50 years, having an incremental costs of $323,000 per QALY gained, which is 3 times more than a commonly accepted threshold ($100,000/QALY). (more…)
Author Interviews, Cleveland Clinic, Flu - Influenza, Vaccine Studies / 11.09.2015

Dr. Glen Taksler, PhD Medicine Institute Cleveland Clinic Main CampusMedicalResearch.com Interview with: Dr. Glen Taksler, PhD Medicine Institute Cleveland Clinic Main Campus Medical Research: What is the background for this study? What are the main findings? Dr. Taksler: Although young, healthy adults who develop influenza are usually able to recover, they may spread the flu to other people in the community who have a higher risk of hospitalization or other serious complications. These higher-risk people have a limited ability to protect themselves from influenza, because flu vaccines are less effective in the elderly and in people with weakened immune systems. To better understand whether young, healthy adults could help the community-at-large by getting a flu vaccine, we looked at data on more than 3 million Medicare beneficiaries across 8 influenza seasons. We found that the elderly had 21% lower odds of developing influenza if they lived in areas where more nonelderly adults (people aged 18-64 years old) got a flu vaccine. Importantly, we found these benefits even in elderly adults who obtained an influenza vaccine, perhaps because flu vaccines are less effective in the elderly.  This means that elderly adults who were proactive to try to prevent influenza still benefited from communitywide vaccination. (more…)
Author Interviews, CDC, Vaccine Studies / 04.09.2015

MedicalResearch.com Interview with: Holly A. Hill, MD, PhD Immunization Services Division National Center for Immunization and Respiratory Diseases CDC Medical Research: What is the background for this study? What are the main findings? Response: The National Immunization Survey involves random digit-dialing – both landlines and cell phones – to generate a large national sample we use to assess vaccination coverage.  The phone survey is followed by a mail survey sent to the children’s vaccination providers to obtain vaccination histories. This 2014 NIS report is based on 14,893 children 19-35 months of age with provider- reported vaccination records. According to the 2014 NIS, the majority of parents are vaccinating their children against potentially serious diseases. Nationally, there were no significant decreases in vaccination coverage among children 19-35 months for routinely recommended childhood vaccines in 2014. As in past years, lower coverage for vaccines recommended during the second year of life were observed.  We still have opportunities for improvement. While national coverage was high for most vaccines routinely recommended for young children, vaccination coverage does vary by state and poverty status. High coverage rates for childhood vaccines explain why most vaccine-preventable diseases are at record low levels. However, it is crucial to maintain these rates in order to keep outbreaks from happening. (more…)
Author Interviews, PLoS, Vaccine Studies / 28.08.2015

Dr Javier Martin PhD Principal Scientist Division of Virology National Institute for Biological Standards and Control (NIBSC) Medicines and Healthcare products Regulatory Agency (MHRA) Blanche Lane, South Mimms, Potters Bar United KingdomMedicalResearch.com Interview with: Dr Javier Martin PhD Principal Scientist Division of Virology National Institute for Biological Standards and Control (NIBSC) Medicines and Healthcare products Regulatory Agency (MHRA) United Kingdom Medical Research: What is the background for this study? Dr. Martin: The global eradication of polio appears to be within reach.  There has been no case of poliomyelitis caused by circulating wild type 2 poliovirus since 1999, no case of type 3 since November 2012 and the last case of type 1 in Africa was in August 2014, leaving some areas of Pakistan and Afghanistan as the main remaining reservoirs of circulating wild type 1 poliovirus. Poliovirus strains in the live-attenuated oral polio vaccine (OPV) are known to quickly revert to neurovirulent phenotype following replication in humans after immunisation. These vaccine-derived poliovirus (VDPV) strains can transmit from person to person in populations with low immunity potentially leading to poliomyelitis outbreaks. (more…)
Author Interviews, Infections, University of Pennsylvania, Vaccine Studies / 22.08.2015

David B. Weiner, Ph.D. Professor, Department of Pathology and Laboratory Medicine Chair, Gene Therapy and Vaccine Program, CAMB Co-Leader Tumor Virology Program, Abramson Cancer Program University of Pennsylvania, Perelman School of MedicineMedicalResearch.com Interview with: David B. Weiner, Ph.D. Professor, Department of Pathology and Laboratory Medicine Chair, Gene Therapy and Vaccine Program, CAMB Co-Leader Tumor Virology Program, Abramson Cancer Program University of Pennsylvania, Perelman School of Medicine Medical Research: What is the background for this study? What are the main findings? Dr. Weiner: MERS, like the Severe Acute Respiratory Syndrome (SARS), is characterized by high fever and severe cough from pneumonia. MERS is caused by an emerging human coronavirus, which is distinct from the SARS coronavirus. Since its identification in 2012, MERS has been linked to over 1,300 infections and close to 400 deaths. It has occurred in the Arabian Peninsula, Europe, and in the US and in Asia. It can be spread in a hospital setting. Scientists now report that a novel synthetic DNA vaccine can, for the first time, induce protective immunity against the Middle EastRespiratory Syndrome (MERS) coronavirus in animal species.   Researchers from the Perelman School of Medicine at the University of Pennsylvania. The NIH, the Public Health agency of Canada, and from a leading company in the development of synthetic DNA vaccine technology, Inovio described the results in a paper  published their work in Science Translational Medicine (STM) this week.  The experimental, preventive vaccine, given six weeks before exposure to the MERS virus, fully protects rhesus macaques from disease. The vaccine also generated potentially protective antibodies in blood drawn from camels, the purported source of MERS transmission in the Middle East. (more…)
Author Interviews, Pediatrics, Vaccine Studies / 21.08.2015

Gary S. Marshall, M.D. Professor of Pediatrics Chief, Division of Pediatric Infectious Diseases Director, Pediatric Clinical Trials Unit University of Louisville School of Medicine MedicalResearch.com Interview with: Gary S. Marshall, M.D. Professor of Pediatrics Chief, Division of Pediatric Infectious Diseases Director, Pediatric Clinical Trials Unit University of Louisville School of Medicine     Medical Research: What is the background for this study? What are the main findings? Dr. Marshall: The infant immunization schedule has become crowded. That’s great news, in a sense, because it means that our children have become better protected against more diseases. At the same time, this has led to well child visits during which many shots are recommended, and some parents want to limit the number of injections their children receive at one time. This leads to deferrals, poor timeliness and decreased coverage rates, all of which could impair protection. This study shows that a hexavalent vaccine—one that combines diphtheria, tetanus, pertussis, polio, Haemophilus influenzae type b, and hepatitis B vaccines in one syringe—is safe and just as immunogenic as the currently used component vaccines.  (more…)
Author Interviews / 18.08.2015

MedicalResearch.com Interview with: Jessica Leung, MPH and Rafael Harpaz, MD, MPH Division of Viral Diseases, National Center for Immunization and Respiratory Diseases (NCIRD) Centers for Disease Control and Prevention (CDC) MedicalResearch: What is the background for this study? Authors’ Response: Prior to the introduction of varicella (chickenpox) vaccination in the U.S., there were millions of cases, tens of thousands of hospitalizations, and hundreds of deaths due to varicella. One-dose of varicella vaccination was recommended in 1995, and two-doses in 2006. Since 1995, there have been substantial declines in varicella disease. In a previously published paper by authors Zhou et al (JAMA. 2005 Aug 17;294(7):797-802), they found an 88% decrease in varicella-related hospitalizations and a 59% decrease in outpatient visits during 1994-2002, a period after the one-dose program began in the U.S. but before the two-dose program started. We wanted to update the prior analyses with an additional 10 years of data to describe the impact of the varicella vaccination program during a period of high 1-dose coverage and increasing levels of 2-dose coverage. We looked at claims data during the 1994-2012 period using the Truven Health MarketScan® databases. (more…)
Author Interviews, HIV, NIH, Pediatrics, Vaccine Studies / 15.08.2015

George K Siberry, MD, MPH, Medical Officer Maternal and Pediatric Infectious Disease (MPID) Branch Eunice Kennedy Shriver National Institute of Child Health and Human Development National Institutes of Health Bethesda, MDMedicalResearch.com Interview with: George K Siberry, MD, MPH, Medical Officer Maternal and Pediatric Infectious Disease (MPID) Branch Eunice Kennedy Shriver National Institute of Child Health and Human Development National Institutes of Health Bethesda, MD Medical Research: What is the background for this study? Dr. Siberry:  Vaccines may not work as reliably in children with HIV infection, especially when their HIV is not under effective treatment. Today, most children in the United States who were born with HIV infection are receiving effective HIV treatment and have reached school age or even young adulthood. However, many received their childhood vaccines before they got started on their HIV treatment (because modern HIV treatments weren’t available when they were very young or their HIV infection was diagnosed late). So we wanted to see if these older children still had immunity from the vaccines they received when they were much younger. Medical Research:  What are the main findings? Dr. Siberry: We looked specifically at whether older children with HIV since birth were protected against measles, mumps, and rubella, the three viral infections covered by the measles-mumps-rubella (or MMR) vaccine. We found that 1/3 up to almost 1/2 of these children were not protected against these viruses, even though nearly all of the children had received at least 2 MMR doses, as recommended. And even if their HIV was currently under excellent control.  When we analyzed factors that were linked to being protected, we found that one of the most important factors was whether you got your MMR vaccine doses after you got on good treatment for your HIV infection.  For instance, over 85% of children who had gotten at least 2 MMR vaccine doses after being on effective HIV treatment were protected against measles compared to less than half of those who didn’t get both of their MMR vaccine doses while on effective HIV treatment. (more…)
Author Interviews, Cancer Research, HPV, OBGYNE, Vaccine Studies / 18.06.2015

MedicalResearch.com Interview with: Ann Goding Sauer Epidemiologist, American Cancer Society, Inc. Atlanta, GA 30303 MedicalResearch: What is the background for this study? Response: Among US women, a positive association between Pap test uptake and HPV vaccination has been shown, though potential variation of the association by race/ethnicity had not been explored previously. The prevalence of some HPV types varies across different racial/ethnic groups so it is important to explore the association between Pap test uptake and HPV vaccination in detail. MedicalResearch: What are the main findings? Response: Pap test uptake was significantly lower among those who had not initiated HPV vaccination (81.0%) compared to women who had initiated vaccination (90.5%) (adjusted prevalence ratio = 0.93, 95% CI: 0.90–0.96). This result was seen across most of the sociodemographic factors examined, though not statistically significant for non-Hispanic blacks, Hispanics, those with lower levels of education, or those with higher levels of income. (more…)
Author Interviews, CDC, Gastrointestinal Disease, JAMA, Pediatrics, Vaccine Studies / 10.06.2015

Eyal Leshem, MD Division of Viral Diseases, US Centers for Disease Control and Prevention, Atlanta, GeorgiaMedicalResearch.com Interview with: Eyal Leshem, MD Division of Viral Diseases, US Centers for Disease Control and Prevention, Atlanta, Georgia Medical Research: What is the background for this study? What are the main findings? Response: Routine vaccination of US children to protect against rotavirus began in 2006. The purpose of this study was to examine the effect of implementation of rotavirus vaccine on gastroenteritis and rotavirus hospitalizations of children younger than 5 years old. The main finding from this study is that hospitalizations for diarrhea in U.S. children younger than 5 years old decreased dramatically during 2008 to 2012 following implementation of routine rotavirus vaccination in 2006. Additionally, seasonal peaks of hospitalizations for rotavirus illness were considerably reduced after the vaccine was implemented compared to years prior to rotavirus vaccination. By 2012, rates of rotavirus hospitalization declined by approximately 90% across all settings and age groups. Factors such as increasing vaccine coverage as well as herd immunity resulting in less transmission of rotavirus may be responsible for this large decrease. (more…)
Author Interviews, CDC, Vaccine Studies / 10.06.2015

MedicalResearch.com Interview with: Dr. Pedro Moro, MD, MPH Immunization Safety Office Division of Healthcare Quality Promotion Centers for Disease Control and Prevention Atlanta, GA 3033 Medical Research: What is the background for this study? What are the main findings? Response: The Vaccine Adverse Event Reporting System (VAERS) is a US national vaccine safety surveillance system, co-administered by the Centers for Disease Control and Prevention (CDC) and the US Food and Drug Administration (FDA). VAERS accepts reports of adverse events (possible side effects) following vaccination. Anyone can submit a report to VAERS. The study team searched VAERS for US reports of death after any vaccination from 7/1/1997 to 12/31/2013. During that time period, VAERS received 2,149 death reports, with most (68.4%) occurring in children. Among children, the most common causes of death were: o   sudden infant death syndrome (44%) o   asphyxia, or lack of oxygen to the brain (6%) o   septicemia, or blood poisoning from a bacterial infection (5%) o   pneumonia (5%) Among adults, the most common causes of death were: o   diseases of the circulatory system (47%) o   diseases of the respiratory system (15%) o   infections and parasitic diseases (12%) o   tumors (4%) The main causes of death seen in VAERS reports were consistent with the most common causes of death in the US population. When studied separately, none of these causes of death have found to be related to vaccines. This finding is reassuring, and consistent with previous research on vaccine safety. (more…)
Author Interviews, HPV, Vaccine Studies / 13.05.2015

Maria Blomberg Virus, Lifestyle & Genes Danish Cancer Society Research Centre Copenhagen, DenmarkMedicalResearch.com Interview with: Maria Blomberg Virus, Lifestyle & Genes Danish Cancer Society Research Centre Copenhagen, Denmark Medical Research: What is the background for this study? What are the main findings? Response: Two vaccines against human papillomavirus (HPV) were licensed almost one decade ago. Since then multiple countries have implemented HPV vaccination programs to help reduce genital warts (one of the kinds of warts most harmful to people), but many struggle with low coverage rates. An important barrier to vaccination is the cost of the vaccines and less developed countries also face considerable logistical challenges. Both vaccines were administered as three dose schedules, but in early 2014 the WHO’s Strategic Advisory Group of Experts and the European Medicines Agency reviewed the evidence of reduced dose schedules of HPV vaccination, and subsequently recommended a two dose schedule for young girls. A reduction of the number of doses has obvious advantages; it would lower the costs, ease implementation of vaccination schedules and potentially increase coverage rates. Based on these recommendations, countries around the world have reduced the dosing schedule in their HPV vaccination programs for young girls to two doses. However, the current evidence is based primarily on immunological studies, and because the immune correlate of protection is not known, studies with disease endpoints are very important. Using the biologically relevant endpoint of genital warts, this study aimed to assess the clinical effectiveness of a two dose schedule of quadrivalent HPV vaccine compared with the standard three-dose regimen administered at month 0, 2 and 6. We found that with the standard vaccination schedule, completion of the three dose regimen is important to gain maximal protection. However, the effectiveness of two doses increased significantly with increasing time between the doses, and with an interval of approximately 6 months between dose one and two, no differences could be found between two and three doses. (more…)
Author Interviews, CDC, Pediatrics, Vaccine Studies / 07.05.2015

MedicalResearch.com Interview with: Tejpratap S.P. Tiwari, MD Meningitis and Bacterial Vaccine Preventable Diseases Branch Division of Bacterial Diseases National Center for Immunization and Respiratory Diseases Division of Global HIV/AIDS, Center for Global Health Centers for Disease Control and Prevention, Atlanta, Georgia Medical Research: What is the background for this study? What are the main findings? Dr. Tiwari: Infants younger than one year old in the United States are at highest risk for severe outcomes from pertussis and death. The first childhood pertussis vaccine dose is recommended at 2 months old, with additional doses in the first year of life at 4 and 6 months. Studies have established that pertussis vaccines can protect against pertussis disease, complications, and hospitalization in infants when 1 to 3 doses are administered by six months old. This study’s findings suggest that the first pertussis vaccine dose and appropriate antibiotic treatment protect infants against death, hospitalization, and pneumonia. Improved on-time infant vaccination (at 2, 4, and 6 months) could potentially prevent up to 1 out of every 4 infant pertussis deaths. (more…)
AACR, Author Interviews, HPV, University Texas, Vaccine Studies / 27.04.2015

Jacqueline Hirth, PhD, MPH Assistant Professor andMedicalResearch.com Interview with: Jacqueline Hirth, PhD, MPH Assistant Professor and Dr. Abbey B. Berenson MD, MMS, PhD Center for Interdisciplinary Research in Women's Health Obstetrics and Gynecology The University of Texas Medical Branch at Galveston TexasDr. Abbey B. Berenson MD, MMS, PhD Center for Interdisciplinary Research in Women's Health Obstetrics and Gynecology The University of Texas Medical Branch at Galveston Texas

Medical Research: What is the background for this study? What are the main findings? Response: In this sample of young women, vaccination was effective at reducing prevalence of vaccine-type HPV (6,11,16,18) compared to women who were unvaccinated. We also found a dose response, with young women who received at least 2 doses of the 3 dose vaccine series having a lower rate of vaccine-type HPV compared to those who only received one dose (8.6% compared to 16.9%, respectively). (more…)
Author Interviews, CDC, Infections, Lancet, Vaccine Studies / 25.04.2015

Mary J Hamel, M.D. Chief, Strategic and Applied Sciences Unit, And Deputy Branch Chief for Science, CDC Malaria Branch US Centers for Disease Control and Prevention 1600 Clifton Rd, NE, MS A06 Atlanta GA 30333MedicalResearch.com Interview with: Mary J Hamel, M.D. Chief, Strategic and Applied Sciences Unit, And Deputy Branch Chief for Science, CDC Malaria Branch US Centers for Disease Control and Prevention 1600 Clifton Rd, NE, MS A06 Atlanta GA 30333 Dr. Hamel was principal investigator at the Siaya site in western Kenya. Medical Research: What is the background for this study? What are the main findings? Dr. Hamel: Major progress has been made in malaria control during the past decade with the scale up of proven interventions including insecticide treated nets (ITNs), indoor residual spraying, effective diagnosis and treatment for malaria, and intermittent preventive treatment of malaria in pregnancy. Nonetheless, malaria remains a major cause of morbidity and mortality, and a leading cause of pediatric death worldwide. An estimated 198 million cases of malaria and 580,000 deaths occurred in 2013 – most of these in African children. Now we face additional challenges in malaria control – the emergence of insecticide and drug resistance threatens some of our most effective interventions. New tools are needed to reach the goal of malaria elimination and eventual eradication. Vaccines are some of our most cost-effective interventions, and an effective malaria vaccine would be an important addition to our current malaria control tools. This week, the RTS,S Clinical Trials Partnership published the final vaccine efficacy and safety results from the RTS,S/AS01 malaria vaccine phase 3 trial in the Lancet (Efficacy and safety of RTS,S/AS01 malaria vaccine with or without a booster dose in infants and children in Africa: final results of a phase 3, individually randomised, controlled trial, http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)60721-8/abstract). This large randomized controlled double-blind phase 3 clinical trial was conducted in 11 sites in 7 African countries across a range of malaria transmission levels. In all, 15,460 children and young infants were enrolled in two age-categories, those first vaccinated at 5-17 months of age (referred to as children), and those first vaccinated at 6-12 weeks of age (referred to as young infants) who received the RTS,S/AS01 vaccine along with their routine childhood immunizations. Participants were randomized into 3 groups – the first group received three doses of the RTS,S/AS01 vaccine followed 18 months later by a booster dose; the second group received three doses of the RTS,S/AS01 vaccine without a booster; and the third group received a comparator vaccine. All participants received an ITN. Children were followed for an average of 48 months and infants for an average of 38 months. We found that vaccine efficacy was modest. Vaccine efficacy against clinical malaria in children was 36% with a booster and 28% without, and vaccine efficacy against severe malaria was 32% with a booster and non-significant without.   Efficacy results in young infants were lower than those in children– vaccine efficacy against clinical malaria was 36% with a booster and 28% without, and vaccine efficacy against severe malaria was non-significant. However, impact, defined as the number of cases averted per 1000 participants vaccinated, was substantial in both age-categories, and highest where malaria burden was greatest. In children who received the booster, during 4 years follow-up, 1700 cases of clinical malaria were averted per 1000 children vaccinated. In young infants, during 3 years follow-up, nearly 1000 cases were averted per 1000 young infants vaccinated. The safety findings were comparable overall in the different study arms, but two safety findings are notable. Meningitis occurred more frequently among children (but not young infants) who received RTS,S/AS01 than among those who received the comparator vaccines. There was no relationship between when the vaccine was administered and when meningitis occurred, most cases occurred in only two study sites, and the finding may be due to chance. If RTS,S/AS01 is licensed, post-licensing studies will be done to establish the significance of this finding. Both children and young infants experienced more episodes of fever and associated febrile convulsions during the 7 days following vaccination; convulsions occurred in 2.2 - 2.5/1000 vaccine doses. (more…)