Operation of a Facility for the Study of Infectious Agents, Vaccines and Antivirals in Adult and Pediatric Human Subjects   2

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, Vietnam, Taiwan, and the US. A phase 3 study of the lead tetravalent dengue vaccine formulation is currently under way in Brazil, and Phase 2 studies are being performed in Bangladesh and Thailand.