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 vaccine 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/renal, 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 dat via modem to the Data Coordinating and Analysis Center.

Project Start
1990-02-01
Project End
1995-01-31
Budget Start
1993-09-23
Budget End
1994-03-31
Support Year
Fiscal Year
1993
Total Cost
Indirect Cost
Name
University of Rochester
Department
Internal Medicine/Medicine
Type
Schools of Dentistry
DUNS #
208469486
City
Rochester
State
NY
Country
United States
Zip Code
14627
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
Gorse, G J; Patel, G B; Mandava, M et al. (1999) MN and IIIB recombinant glycoprotein 120 vaccine-induced binding antibodies to native envelope glycoprotein of human immunodeficiency virus type 1 primary isolates. National Institute of Allergy and Infectious Disease Aids Vaccine Evaluation Group. AIDS Res Hum Retroviruses 15:921-30
Keefer, M C; Wolff, M; Gorse, G J et al. (1997) Safety profile of phase I and II preventive HIV type 1 envelope vaccination: experience of the NIAID AIDS Vaccine Evaluation Group. AIDS Res Hum Retroviruses 13:1163-77
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
Belshe, R B; Clements, M L; Keefer, M C et al. (1994) Interpreting HIV serodiagnostic test results in the 1990s: social risks of HIV vaccine studies in uninfected volunteers. NIAID AIDS Vaccine Clinical Trials Group. Ann Intern Med 121:584-9
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
Ukwu, H N; Graham, B S; Lambert, J S et al. (1992) Perinatal transmission of human immunodeficiency virus-1 infection and maternal immunization strategies for prevention. Obstet Gynecol 80:458-68