Evaluation of the investigational vaccines in this project are part of the VRC mission related to biodefense and emerging pathogens. The ongoing screening protocol, 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 08, this project included clinical trials of investigational vaccines against three infectious diseases: Ebola, avian influenza, and Marburg virus. In FY 09 a Phase I evaluation of the Marburg virus DNA vaccine is expected to be completed and a Phase I evaluation of an Ebola virus DNA vaccine to begin. The evaluation of a recombinant adenoviral vector serotype 5 Ebola vaccine (Ebola-rAd5) is nearing completion. Two Phase I stuides of an avian influenza (H5) DNA vaccine were completed; one study was to evaluate dosage (VRC 304) and the other was to evaluate intradermal administration (VRC 305). The VRC 303 clinical trial of an investigational West Nile vaccine trial analysis was completed. ? ? Published results from Phase I dose clinical trials have included an Ebola DNA vaccine study (VRC 204) Clin Vaccine Immunol, 2006. 13(11):1267-77; a West Nile virus DNA vaccine (VRC 302) study J Infect Dis, 2007. 196(12):1732-40, and a SARS DNA vaccine (VRC 301) study.
| 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 |
