Clinical Studies of Infectious Agents, Vaccines and Antivirals in Adult and Pediatric Human Subjects

The National Institutes of Health (NIH), the National Institute of Allergy and Infectious Diseases (NIAID), and the Laboratory of Infectious Diseases (LID) have been performing clinical studies in adult and/or pediatric volunteer populations since the 1950's, with the goal of developing safe and effective vaccines against influenza viruses, human parainfluenza viruses (HPIV), respiratory syncytial viruses (RSV), human metapneumovirus (HMPV), viral agents of gastroenteritis, and flaviviruses. These studies have identified promising candidate vaccines against RSV and other viruses, leading to Cooperative Research And Development Agreements (CRADAs) with commercial collaborators. Safe and immunogenic live-attenuated vaccines against all four dengue virus serotypes were identified and combined into a single-dose tetravalent vaccine, leading to licensing agreements in Brazil, India, Bangladesh, Vietnam, Taiwan, and the US. A Phase 3 study of the lead tetravalent dengue vaccine formulation was recently completed in Brazil, a Phase 3 study is currently underway in India, and other Phase 2 studies are being conducted in Bangladesh, India, and the US.

LID and the Laboratory of Viral Diseases (LVD) of NIAID require clinical trials to investigate the safety, immunogenicity, and protective efficacy of vaccines against pneumoviruses, paramyxoviruses (primarily HPIVs), influenza viruses, flaviviruses, alphaviruses, and bunyaviruses, including newly emerging viruses such as Zika virus, noroviruses, rotavirus, and virally-vectored vaccines. Vaccine studies will include adult and pediatric subjects. Clinical trials in adults may also be required for pathogenesis research and to develop viral human challenge models for the testing of antivirals and vaccines.