NIAID Vaccine Immune T cell and Antibody Laboratory Core

Koup, Richard A.

Abstract

NVITAL is a service laboratory that operates under GLP conditions to perform validated immune assays in support of VRC human and non-human primate vaccine trials. It also performs high throughput screening for monoclonal antibody discovery and immunogen design. NVITAL maintains all sample inventory and assay results in a fully auditable LIMS system that will support all aspects of regulatory scrutiny. This allows NVITAL to provide the VRC with documents necessary to support product regulatory filings.

Funding Agency

• Agency: National Institute of Health (NIH)
• Institute: National Institute of Allergy and Infectious Diseases (NIAID)
• Type: Scientific Cores Intramural Research (ZIC)
• Project #: 1ZICAI005123-01
• Application #: 8745778
• Support Year: 1
• Fiscal Year: 2013
• Total Cost: $4,100,903

Institution

• Name: National Institute of Allergy and Infectious Diseases

Publications

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

Kanekiyo, Masaru; Bu, Wei; Joyce, M Gordon et al. (2015) Rational Design of an Epstein-Barr Virus Vaccine Targeting the Receptor-Binding Site. Cell 162:1090-100

Wheatley, Adam K; Whittle, James R R; Lingwood, Daniel et al. (2015) H5N1 Vaccine-Elicited Memory B Cells Are Genetically Constrained by the IGHV Locus in the Recognition of a Neutralizing Epitope in the Hemagglutinin Stem. J Immunol 195:602-10

Ledgerwood, Julie E; Bellamy, Abbie R; Belshe, Robert et al. (2015) DNA priming for seasonal influenza vaccine: a phase 1b double-blind randomized clinical trial. PLoS One 10:e0125914

Sarwar, Uzma N; Costner, Pamela; Enama, Mary E et al. (2015) Safety and immunogenicity of DNA vaccines encoding Ebolavirus and Marburgvirus wild-type glycoproteins in a phase I clinical trial. J Infect Dis 211:549-57

Ledgerwood, Julie E; Coates, Emily E; Yamshchikov, Galina et al. (2015) Safety, Pharmacokinetics, and Neutralization of the Broadly Neutralizing HIV-1 Human Monoclonal Antibody VRC01 in Healthy Adults. Clin Exp Immunol :

Ledgerwood, Julie E; Hu, Zonghui; Costner, Pamela et al. (2015) Phase I clinical evaluation of seasonal influenza hemagglutinin (HA) DNA vaccine prime followed by trivalent influenza inactivated vaccine (IIV3) boost. Contemp Clin Trials 44:112-118

Kibuuka, Hannah; Berkowitz, Nina M; Millard, Monica et al. (2015) Safety and immunogenicity of Ebola virus and Marburg virus glycoprotein DNA vaccines assessed separately and concomitantly in healthy Ugandan adults: a phase 1b, randomised, double-blind, placebo-controlled clinical trial. Lancet 385:1545-54

Sarwar, Uzma N; Novik, Laura; Enama, Mary E et al. (2014) Homologous boosting with adenoviral serotype 5 HIV vaccine (rAd5) vector can boost antibody responses despite preexisting vector-specific immunity in a randomized phase I clinical trial. PLoS One 9:e106240