In FY 06, this project included one screening protocol and clinical trials of investigational vaccines against three infectious diseases, Ebola, SARS, and West Nile virus. In FY 07 evaluation of influenza and Marburg virus vaccines are expected to begin. VRC 300 is designed to recruit and screen healthy, HIV-negative subjects for investigational studies of vaccines to prevent infectious diseases (other than HIV). In FY 06 the VRC completed recruitment of 30 subjects for the VRC 303 clinical trial of an investigational West Nile vaccine trial. A SARS vaccine study (VRC 301) and West Nile virus vaccine study (VRC 302) started in FY05 were completed in FY 06. Evaluation of these investigational vaccines are part of the VRC mission related to biodefense and emerging pathogens. A phase I, randomized, placebo-controlled, dose-escalation study of an investigational DNA plasmid vaccine for prevention of Ebola virus infection (VRC 204) was completed in FY 05 and the analysis of study results was completed in FY 06. A new Phase I, dose-escalation study of a recombinant adenoviral vector Ebola vaccine study, VRC 205, was written and completed regulatory approvals to begin in FY06. This study is designed to enroll 48 subjects and is expected to complete enrollment in FY 07. In FY 06 plans were initiated for development of Phase I protocols for evaluation of investigational influenza and Marburg virus vaccines.
| Sullivan, Nancy J; Martin, Julie E; Graham, Barney S et al. (2009) Correlates of protective immunity for Ebola vaccines: implications for regulatory approval by the animal rule. Nat Rev Microbiol 7:393-400 |
| Martin, Julie E; Pierson, Theodore C; Hubka, Sarah et al. (2007) A West Nile virus DNA vaccine induces neutralizing antibody in healthy adults during a phase 1 clinical trial. J Infect Dis 196:1732-40 |
| Martin, Julie E; Sullivan, Nancy J; Enama, Mary E et al. (2006) A DNA vaccine for Ebola virus is safe and immunogenic in a phase I clinical trial. Clin Vaccine Immunol 13:1267-77 |
