NVITAL Facilitates Scientific Trials

Reliable, accurate testing is an indispensable component of high-quality scientific trials.

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has a state-of-the-art facility that provides testing for NIH-sponsored vaccine trials: the NIAID Vaccine Immunogenicity T-Cell and Antibody Laboratory, or NVITAL.

NVITAL works in conjunction with NIH’s Vaccine Research Center to provide high-throughput, comprehensive testing and sample analysis for both military and civilian trials. The laboratory processes and analyzes blood samples for both preclinical and clinical studies. The facility is improving NIH’s vaccine testing capabilities by performing endpoint immunogenicity tests on candidate vaccines for both cellular and humoral vaccine-induced immune responses.

The lab provides reliable and accurate analytical services for government and private-sector business partners through its technologically advanced facility. The facility has significantly expanded NIH’s testing resources and serves as a central location for data analysis from a variety of clinical trials, providing greater consistency for the results. In addition to the storage and archiving of preclinical/clinical samples, NVITAL is a Core Reagent Laboratory for the acquisition, storage and distribution of various reagents. These capabilities have been used for HIV vaccine studies but could be applied to a wide range of applications to help facilitate the clinical trial process.

The Food and Drug Administration requires vaccine manufacturers to perform key immune assays in accordance with federal guidelines before the agency licenses candidate vaccines. NVITAL fills an urgent need for NIAID-sponsored products progressing through clinical trials to provide these data to regulatory authorities both to support vaccine efficacy and to potentially establish surrogate endpoints. The facility operates under Good Clinical Laboratory Practices standards.

HJF established NVITAL’s facilities in Gaithersburg, Md., when the laboratory was set up in 2004. The Foundation leased and renovated the office and research space, established an information systems infrastructure, and hired staff. HJF continues to manage and operate the laboratory.