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Vaccine Research Center (VRC)

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Robert Bailer, Ph.D.

Chief, NIAID Vaccine Immune T-Cell and Antibody Laboratory (NVITAL)

Focus Area

  • Perform high throughput immunology assays necessary for pivotal Phase II and Phase III vaccine trial
 

Program Description

Initially, the Immunology Core (IMC) at the VRC was responsible for the method development, assay qualification, and end-point immunogenicity testing of all samples from VRC clinical trials following Good Clinical Laboratory Practices (GCLP). The rational for use of qualified methods following GCLP practices was to assure all data generated would be useful to support product licensure. In addition, well characterized and reproducible assays permits 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.

To meet the demands of increased samples associated with expanded scope of work of the VRC and Phase II trials, there was a need to expand the capabilities of the IMC and expand the scope of the laboratory to cover other NIAID sponsored products. Since there was no existing domestic or international immunology laboratory that possessed the ability to perform the high-throughput immunology assays necessary for pivotal Phase II and Phase III vaccine trials, the NIAID Vaccine Immune T cell and Antibody Laboratory (NVITAL) was established in 2005. It is a 15,000 sq. ft. state-of-the-art, fully GCLP-compliant laboratory that supports NIAID vaccine efforts and can perform

  • 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 NIAID labs and collaborators
  • Clinical trial sample processing and cryopreservation

Biography

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.

Selected Publications

Huang J, Ofek G, Laub L, Louder MK, Doria-Rose NA, Longo NS, Imamichi H, Bailer RT, Chakrabarti B, Sharma SK, Alam SM, Wang T, Yang Y, Zhang B, Migueles SA, Wyatt R, Haynes BF, Kwong PD, Mascola JR, Connors M. Broad and potent neutralization of HIV-1 by a gp41-specific human antibody. Nature. 2012 Nov 15;491(7424):406-12.

Haynes BF, Gilbert PB, McElrath MJ, Zolla-Pazner S, Tomaras GD, Alam SM, Evans DT, Montefiori DC, Karnasuta C, Sutthent R, Liao HX, DeVico AL, Lewis GK, Williams C, Pinter A, Fong Y, Janes H, DeCamp A, Huang Y, Rao M, Billings E, Karasavvas N, Robb ML, Ngauy V, de Souza MS, Paris R, Ferrari G, Bailer RT, Soderberg KA, Andrews C, Berman PW, Frahm N, De Rosa SC, Alpert MD, Yates NL, Shen X, Koup RA, Pitisuttithum P, Kaewkungwal J, Nitayaphan S, Rerks-Ngarm S, Michael NL, Kim JH. Immune-correlates analysis of an HIV-1 vaccine efficacy trial. N Engl J Med. 2012 Apr 5;366(14):1275-86

Roederer M, Keele BF, Schmidt SD, Mason RD, Welles HC, Fischer W, Labranche C, Foulds KE, Louder MK, Yang ZY, Todd JP, Buzby AP, Mach LV, Shen L, Seaton KE, Ward BM, Bailer RT, Gottardo R, Gu W, Ferrari G, Alam SM, Denny TN, Montefiori DC, Tomaras GD, Korber BT, Nason MC, Seder RA, Koup RA, Letvin NL, Rao SS, Nabel GJ, Mascola JR Immunological and virological mechanisms of vaccine-mediated protection against SIV and HIV. Nature. 2014 Jan 23;505(7484):502-8.

Casazza JP, Bowman KA, Adzaku S, Smith EC, Enama ME, Bailer RT, Price DA, Gostick E, Gordon IJ, Ambrozak DR, Nason MC, Roederer M, Andrews CA, Maldarelli FM, Wiegand A, Kearney MF, Persaud D, Ziemniak C, Gottardo R, Ledgerwood JE, Graham BS, Koup RA; VRC 101 Study Team. 2013. Therapeutic vaccination expands and improves the function of the HIV-specific memory T-cell repertoire. J Infect Dis. 2013 Jun 15;207(12):1829-40.

Ledgerwood JE, Zephir K, Hu Z, Wei CJ, Chang L, Enama ME, Hendel CS, Sitar S, Bailer RT, Koup RA, Mascola JR, Nabel GJ, Graham BS; VRC 310 Study Team. Prime-boost interval matters: a randomized phase 1 study to identify the minimum interval necessary to observe the H5 DNA influenza vaccine priming effect. J Infect Dis. 2013 Aug 1;208(3):418-22.

For more information on research conducted by Robert Bailer, Ph.D. visit the Immunology Laboratory.

Last Updated March 14, 2014

Last Reviewed March 14, 2014