Evaluation of the investigational vaccines in this project are part of the VRC mission related to biodefense and emerging pathogens. In FY 07, this project included one screening protocol and clinical trials of investigational vaccines against three infectious diseases, Ebola, avian influenza, and West Nile virus. In FY 08 evaluation of Marburg virus vaccine is expected to move from preclinical testing to clinical testing. The 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 07 the VRC initiated evaluation of a recombinant adenoviral vector serotype 5 Ebola vaccine (Ebola-rAd5) in the VRC 205 protocol and evaluation of an avian influenza (H5) DNA vaccine in a Phase I study to evaluate dosage (VRC 304) and in a Phase I study to evaluate intradermal administration (VRC 305). The VRC 303 clinical trial of an investigational West Nile vaccine trial was completed and analysis begun. Analysis of data from a SARS vaccine study (VRC 301) and earlier West Nile virus vaccine study (VRC 302) was completed. Results of a Phase I dose escalation trial of an Ebola DNA vaccine was published and a manuscript reporting results of the VRC 302 study was accepted for publication.
| 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 |
