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 #
1ZICAI005123-04
Application #
9339289
Study Section
Project Start
Project End
Budget Start
Budget End
Support Year
4
Fiscal Year
2016
Total Cost
Indirect Cost

  Institution

Name
Niaid Extramural Activities
Department
Type
DUNS #
City
State
Country
Zip Code

  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

Showing the most recent 10 out of 23 publications