The objective of this project is to conduct Phase I and Phase II clinical trials of candidate AIDS vaccines among HIV-seronegative volunteers at low risk of infection. The Offeror shall furnish all the necessary services, qualified personnel, materials, equipment, and facilities as needed to conduct collaborative trials sponsored by the National Institutes of Health and done at multiple institutions. The goal of these Phase I and Phase II studies is to define the safety, toxicity, and immunogenicity of such vaccines. The Offeror will cooperate as appropriate with other component parts of the AIDS Vaccine Evaluation Group (AIDS Vaccine Evaluation Units, Central Immunology laboratory, Data Coordinating and Analysis Center, and Central Repository). The Offeror will follow common protocols to test approved candidate vaccines and to determine the optimal dosage regimen. The Offeror will recruit, screen, and inoculate an average of 200 volunteers per year. The Offeror will conduct appropriate laboratory evaluations for toxicity (hematologic, hepatic/neural, gastrointestinal, neurologic, dermatologic), for viral antigens and antibodies (ELISA, Western Blot, Neutralization assays), and for changes in immunologic function (changes in T4/T8 cell counts, assays of cell mediated immunity, skin tests). The Offeror will be responsible for maintaining individual confidential patient records. The Offeror will record pertinent data obtained from the clinical trials, enter the data onto a microcomputer, and transmit this data via modem to the Data Coordinating and Analysis Center.

Project Start
1990-02-01
Project End
1995-01-31
Budget Start
1991-09-13
Budget End
1991-10-31
Support Year
Fiscal Year
1991
Total Cost
Indirect Cost
Name
Vanderbilt University Medical Center
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
004413456
City
Nashville
State
TN
Country
United States
Zip Code
37212
Gilbert, P B; Chiu, Y-L; Allen, M et al. (2003) Long-term safety analysis of preventive HIV-1 vaccines evaluated in AIDS vaccine evaluation group NIAID-sponsored Phase I and II clinical trials. Vaccine 21:2933-47
Keefer, M C; Graham, B S; McElrath, M J et al. (1996) Safety and immunogenicity of Env 2-3, a human immunodeficiency virus type 1 candidate vaccine, in combination with a novel adjuvant, MTP-PE/MF59. NIAID AIDS Vaccine Evaluation Group. AIDS Res Hum Retroviruses 12:683-93
Graham, B S; Keefer, M C; McElrath, M J et al. (1996) Safety and immunogenicity of a candidate HIV-1 vaccine in healthy adults: recombinant glycoprotein (rgp) 120. A randomized, double-blind trial. NIAID AIDS Vaccine Evaluation Group. Ann Intern Med 125:270-9
Graham, B S; Wright, P F (1995) Candidate AIDS vaccines. N Engl J Med 333:1331-9
Schwartz, D H; Mazumdar, A; Winston, S et al. (1995) Utility of various commercially available human immunodeficiency virus (HIV) antibody diagnostic kits for use in conjunction with efficacy trials of HIV-1 vaccines. Clin Diagn Lab Immunol 2:268-71
Graham, B S (1994) Serological responses to candidate AIDS vaccines. AIDS Res Hum Retroviruses 10 Suppl 2:S145-8
Keefer, M C; Graham, B S; Belshe, R B et al. (1994) Studies of high doses of a human immunodeficiency virus type 1 recombinant glycoprotein 160 candidate vaccine in HIV type 1-seronegative humans. The AIDS Vaccine Clinical Trials Network. AIDS Res Hum Retroviruses 10:1713-23
Pincus, S H; Messer, K G; Schwartz, D H et al. (1993) Differences in the antibody response to human immunodeficiency virus-1 envelope glycoprotein (gp160) in infected laboratory workers and vaccinees. J Clin Invest 91:1987-96
Montefiori, D C; Graham, B S; Kliks, S et al. (1992) Serum antibodies to HIV-1 in recombinant vaccinia virus recipients boosted with purified recombinant gp160. NIAID AIDS Vaccine Clinical Trials Network. J Clin Immunol 12:429-39
Montefiori, D C; Zhou, J; Shaff, D I (1992) CD4-independent binding of HIV-1 to the B lymphocyte receptor CR2 (CD21) in the presence of complement and antibody. Clin Exp Immunol 90:383-9

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