Evaluation of the investigational vaccines in this project are part of the VRC mission related to biodefense and emerging pathogens. In FY 13 this project included clinical assessments and data analysis for clinical trials of investigational vaccines against four types of infectious diseases: filoviruses (Marburg and Ebola), influenza (avian and seasonal strains), alphaviruses (Chikungunya) and malaria. Further evaluation of vaccine approaches will continue as the VRC develops additional candidate vaccine regimens. Published results from 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 study (VRC 302) J Infect Dis, 2007. 196(12):1732-40, a SARS DNA vaccine study (VRC 301) Vaccine 2008 Nov 25;26(50):6338-43. a second generation West Nile virus DNA vaccine study (VRC 303) J Infect Dis, 2011, May 15;203(10). a second generation Ebola rAd5 vaccine study (VRC 205) Vaccine 2010 Oct 27. an H5N1 gene based prime, inactivated boost study (VRC 306) Lancet Infect Dis. 2011 Dec;11(12):916-24 an H5 DNA vaccine study and H5 route study (VRC 304 and VRC 305) Clin Vaccine Immunol. 2012 Nov;19(11):1792-7 a follow on H5N1 prime, inactivated boost interval examination study (VRC 310) J Infect Dis. 2013 Aug 1;208(3):413-7, J Infect Dis. 2013 Aug 1;208(3):418-22 a dose-escalation with experimental challenge to evaluate intravenous administration of PfSPZ vaccine trial (VRC 312) Science. 2013 Aug 8

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Chang, Lee-Jah; Dowd, Kimberly A; Mendoza, Floreliz H et al. (2014) Safety and tolerability of chikungunya virus-like particle vaccine in healthy adults: a phase 1 dose-escalation trial. Lancet :
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Khurana, Surender; Wu, Jian; Dimitrova, Milena et al. (2013) DNA priming prior to inactivated influenza A(H5N1) vaccination expands the antibody epitope repertoire and increases affinity maturation in a boost-interval-dependent manner in adults. J Infect Dis 208:413-7
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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

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