Major Areas of Research
- Perform high throughput immunology assays necessary for pivotal Phase 1- Phase III vaccine trials
- Perform high throughput immunology assays to support VRC research programs
- Perform sample processing in support of all VRC phase 1 intramural/extramural clinical trials
- Method qualification
The Vaccine Immunology Testing Laboratory (VITL) is part of the Vaccine Immunology Program (VIP). To meet the demand to perform high-throughput immunology assays necessary for pivotal Phase I to Phase III vaccine and broadly neutralizing antibody trials, VITL is a fully GCLP-compliant laboratory. VITL supports intra mural and extra mural studies assisting vaccine evolution for HIV, Influenza and other potentially preventable diseases through clinical trial support. Performance includes;
- End point immune analysis, inclusive of inter-study comparisons
- Production, monitoring, and distribution of key standard reagents to other collaborator laboratories
- Repository of immunological data for distribution to statistical centers, collaborators
- Implementation and development of new high-throughput immunological methodologies
- Assay technology transfer from both intra- and extramural labs and collaborators
- Clinical trial sample processing, testing and cryopreservation
- Support of manufacturing product release testing
- High throughput viral neutralization analysis is support of research programs.
The use of qualified methods following GCLP practices assures all data generated is useful to support product licensure. In addition, well characterized and reproducible assays permit the VRC to rapidly assess immunogenicity of products in Phase I testing, decide if the immunogenicity is sub-optimal, and make vector changes leading to critical product development improvements.
For more information on research conducted by Dr. Bailer, visit the Vaccine Immunology Program.
Dr. Bailer received a B.S. in microbiology from Colorado State University and worked for four years at Abbott Laboratories in the Pharmaceutical Products and Diagnostic Divisions. He went on to receive a Ph.D. from Ohio State University, followed by post-doctorate positions at the Ohio State University School of Dentistry and the Wistar Institute (Philadelphia, Pennsylvania). Dr. Bailer then returned to industry as a Senior Scientist at Merck & Co., West Point, Pennsylvania, where he provided technical support for analytical testing of licensed and new biological products.
Dr. Bailer started at the VRC as Manager of the Immunology Core Laboratory in February 2002. In May 2005, Dr. Bailer was promoted to the position of director of the NVITAL.
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