title: Challenges and opportunities in RSV vaccine development: Meeting report from FDA/NIH workshop.
abstract: Respiratory syncytial virus (RSV) is the most common cause of serious acute lower respiratory illness in infants and young children and a significant cause of disease burden in the elderly and immunocompromised. There are no licensed RSV vaccines to address this significant public health need. While advances in vaccine technologies have led to a recent resurgence in RSV vaccine development, the immune correlates of protection against RSV and the immunology of vaccine-associated enhanced respiratory disease (ERD) remain poorly understood. FDA's Center for Biologics Evaluation and Research (CBER) and NIH's National Institute of Allergy and Infectious Diseases (NIAID) organized and co-sponsored an RSV Vaccines Workshop in Bethesda, Maryland on June 1 and 2, 2015. The goal of the conference was to convene scientists, regulators, and industry stakeholders to discuss approaches to RSV vaccine development within the context of three target populations - infants and children, pregnant women, and individuals >60years of age. The agenda included topics related to RSV vaccine development in general, as well as considerations specific to each target population, such as clinical and serological endpoints. The meeting focused on vaccine development for high income countries (HIC), because issues relevant to vaccine development for low and middle income countries (LMIC) have been discussed in other forums. This manuscript summarizes the discussion of clinical, scientific, and regulatory perspectives, research gaps, and lessons learned.
authors: Office of Vaccines Research and Review (OVRR), Center for Biologics Evaluation and Research (CBER), FDA, Silver Spring, MD, USA. Electronic address: jeff.roberts@fda.hhs.gov.
authors: Jeffrey N
authors: JN
authors: Roberts
authors: Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
authors: Barney S
authors: BS
authors: Graham
authors: Center for Immunization Research, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205, USA.
authors: Ruth A
authors: RA
authors: Karron
authors: Department of Pediatrics and Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX, USA.
authors: Flor M
authors: FM
authors: Munoz
authors: Division of Infectious Diseases, Department of Medicine, Rochester General Hospital, University of Rochester, Rochester, NY, USA.
authors: Ann R
authors: AR
authors: Falsey
authors: Department of Pediatrics, School of Medicine, Emory University and Children's Healthcare of Atlanta, Atlanta, GA, USA.
authors: Larry J
authors: LJ
authors: Anderson
authors: Office of Vaccines Research and Review (OVRR), Center for Biologics Evaluation and Research (CBER), FDA, Silver Spring, MD, USA.
authors: V
authors: V
authors: Marshall
authors: Division of Microbiology and Infectious Disease, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
authors: Sonnie
authors: S
authors: Kim
authors: Office of Vaccines Research and Review (OVRR), Center for Biologics Evaluation and Research (CBER), FDA, Silver Spring, MD, USA.
authors: Judy A
authors: JA
authors: Beeler
mesh_terms: D000368:Aged; D000818:Animals; D035843:Biomedical Research; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D003226:Congresses as Topic; D005260:Female; D006801:Humans; D007223:Infant; D008396:Maryland; D009316:National Institutes of Health (U.S.); D011247:Pregnancy; D018357:Respiratory Syncytial Virus Infections / Q000517:prevention & control*; D022261:Respiratory Syncytial Virus Vaccines / Q000627:therapeutic use*; D018113:Respiratory Syncytial Virus, Human; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D022261:Respiratory Syncytial Virus Vaccines
keywords: Animal models; Bronchitis; Clinical trials; Elderly; Human challenge; Infants; Maternal immunization; Neutralization; RSV; Subunit vaccine; Vaccination; Vaccine vector; Vaccine-enhanced illness; Wheezing