Dr. Mark Loeb[/caption]
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.
Dr. Nicole Basta[/caption]
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.
Dr. Marta Nunes[/caption]
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
Dr. Philip Bejon[/caption]
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.
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 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.
Dr. Julie Shakib[/caption]
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.
Dr. Melissa Stockwell[/caption]
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.
Dr. Robotham[/caption]
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.
Dr. Odile Launay[/caption]
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
Dr. Zeena Nawas[/caption]
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.
Dr. Sarah Tartoff[/caption]
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.
MedicalResearch.com Interview with: [caption id="attachment_21660" align="alignleft" width="200"] Dr. Michael Jarvis[/caption] 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...
Dr. Ikwo Oboho[/caption]
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.
Dr. Rick Fraunfelder[/caption]
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 Jr1, Steigleman WA, Saucedo-Sanchez E, Tuli 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.
Shannon Stokley MPH[/caption]
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.
MedicalResearch.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.
MedicalResearch.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).
MedicalResearch.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.
MedicalResearch.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.
MedicalResearch.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.
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.
MedicalResearch.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.