Biodefense/Emerging Infection Vaccine Studies

Ledgerwood, Julie

Abstract

Evaluation of the investigational vaccines in this project are part of the VRC mission related to biodefense and emerging pathogens. In FY15 this project included clinical assessments and data analysis for clinical trials of investigational vaccines against several infectious diseases including filoviruses (Ebola) and influenza (seasonal and pandemic strains). Further evaluation of vaccine approaches will continue as the VRC develops additional candidate vaccine regimens. Published results from clinical trials have included: VRC 204: Ebola DNA vaccine study: Clin Vaccine Immunol. 2006. 13(11):1267-77 VRC 302: West Nile virus DNA vaccine study: J Infect Dis. 2007. 196(12):1732-40 VRC 301: SARS DNA vaccine study () Vaccine. 2008 Nov 25;26(50):6338-43 VRC 303: Second generation West Nile virus DNA vaccine study: J Infect Dis. 2011, May 15;203(10) VRC 205: Second generation Ebola rAd5 vaccine study: Vaccine. 2010 Oct 27 VRC 306: H5N1 gene based prime, inactivated boost study Lancet Infect Dis. 2011 Dec;11(12):916-24 VRC 304 and VRC 305: H5 DNA vaccine study and H5 route study: Clin Vaccine Immunol. 2012 Nov; 19(11):1792-7 VRC 310: Follow on H5N1 prime, inactivated boost interval examination study: J Infect Dis. 2013 Aug 1; 208(3):413-7, J Infect Dis. 2013 Aug 1; 208(3):418-22 VRC 312: Dose-escalation with experimental challenge to evaluate intravenous administration of PfSPZ vaccine trial: Science. 2013 Sep 20;341(6152):1359-65 VRC 311: a VLP vaccine for Chikungunya: Lancet. 2014 Aug 14 VRC 206: Ebola and Marburg vaccine study: J Infect Dis. 2015 Feb 15;211(4):549-57 VRC 207: cAd3-EBO Ebola vaccine study: N Engl J Med. 2014 Nov 26 RV 247: Ebola and Marburg vaccine study in Uganda: Lancet. 2015 Apr 18;385(9977):1545-54 VRC 308: Pandemic H1 DNA vaccine study: PLoS One. 2015 Apr 17;10(4):e0123969 VRC 701: DNA Priming for Seasonal Influenza vaccine study: PLoS One. 2015 May 7;10(5):e0125914 VRC 307 and VRC 309: Seasonal Influenza HA DNA Followed by TIV Boost vaccine study: Contemp Clin Trials. 2015 Aug 11 VRC 314: Experimental controlled human malaria infections to evaluate safety and durability following intravenous and intramuscular administration of PfSPZ vaccine in malaria-naive adults: Nat Med. 2016 Jun;22(6):614-23.

Funding Agency

• Agency: National Institute of Health (NIH)
• Institute: National Institute of Allergy and Infectious Diseases (NIAID)
• Type: Investigator-Initiated Intramural Research Projects (ZIA)
• Project #: 1ZIAAI005047-14
• Application #: 9353051
• Support Year: 14
• Fiscal Year: 2016

Institution

• Name: Niaid Extramural Activities

Publications

Goo, Leslie; DeMaso, Christina R; Pelc, Rebecca S et al. (2018) The Zika virus envelope protein glycan loop regulates virion antigenicity. Virology 515:191-202

Yassine, Hadi M; McTamney, Patrick M; Boyington, Jeffery C et al. (2018) Use of Hemagglutinin Stem Probes Demonstrate Prevalence of Broadly Reactive Group 1 Influenza Antibodies in Human Sera. Sci Rep 8:8628

Gaudinski, Martin R; Houser, Katherine V; Morabito, Kaitlyn M et al. (2018) Safety, tolerability, and immunogenicity of two Zika virus DNA vaccine candidates in healthy adults: randomised, open-label, phase 1 clinical trials. Lancet 391:552-562

Grifoni, Alba; Pham, John; Sidney, John et al. (2017) Prior Dengue virus exposure shapes T cell immunity to Zika virus in humans. J Virol :

Ishizuka, Andrew S; Lyke, Kirsten E; DeZure, Adam et al. (2016) Protection against malaria at 1 year and immune correlates following PfSPZ vaccination. Nat Med 22:614-23

Dowd, Kimberly A; DeMaso, Christina R; Pelc, Rebecca S et al. (2016) Broadly Neutralizing Activity of Zika Virus-Immune Sera Identifies a Single Viral Serotype. Cell Rep 16:1485-1491

Misasi, John; Gilman, Morgan S A; Kanekiyo, Masaru et al. (2016) Structural and molecular basis for Ebola virus neutralization by protective human antibodies. Science 351:1343-6

Corti, Davide; Misasi, John; Mulangu, Sabue et al. (2016) Protective monotherapy against lethal Ebola virus infection by a potently neutralizing antibody. Science 351:1339-42

Ewer, Katie; Rampling, Tommy; Venkatraman, Navin et al. (2016) A Monovalent Chimpanzee Adenovirus Ebola Vaccine Boosted with MVA. N Engl J Med 374:1635-46

Crank, Michelle C; Gordon, Ingelise J; Yamshchikov, Galina V et al. (2015) Phase 1 study of pandemic H1 DNA vaccine in healthy adults. PLoS One 10:e0123969