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
1993-12-13
Budget End
1995-05-31
Support Year
Fiscal Year
1994
Total Cost
Indirect Cost
Name
Saint Louis University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
City
Saint Louis
State
MO
Country
United States
Zip Code
63103
Gorse, G J; Corey, L; Patel, G B et al. (1999) HIV-1MN recombinant glycoprotein 160 vaccine-induced cellular and humoral immunity boosted by HIV-1MN recombinant glycoprotein 120 vaccine. National Institute of Allergy and Infectious Diseases AIDS Vaccine Evaluation Group. AIDS Res Hum Retroviruses 15:115-32
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
Gorse, G J; McElrath, M J; Matthews, T J et al. (1998) Modulation of immunologic responses to HIV-1MN recombinant gp160 vaccine by dose and schedule of administration. National Institute of Allergy and Infectious Diseases AIDS Vaccine Evaluation Group. Vaccine 16:493-506
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Gorse, G J; Yang, E Y; Belshe, R B et al. (1996) Salivary binding antibodies induced by human immunodeficiency virus type 1 recombinant gp120 vaccine. The NIAID AIDS Vaccine Evaluation Group. Clin Diagn Lab Immunol 3:769-73
Gorse, G J; Rogers, J H; Perry, J E et al. (1995) HIV-1 recombinant gp160 vaccine induced antibodies in serum and saliva. The NIAID AIDS Vaccine Clinical Trials Network. Vaccine 13:209-14
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
Gorse, G J; Patel, G B; Newman, F K et al. (1995) Recombinant gp160 vaccination schedule and MHC HLA type as factors influencing cellular responses to HIV-1 envelope glycoprotein. NIAID AIDS Vaccine Clinical Trials Network. Vaccine 13:1170-9
Gorse, G J; Frey, S E; Patel, G et al. (1994) Vaccine-induced antibodies to native and recombinant human immunodeficiency virus type 1 envelope glycoproteins. NIAID AIDS Vaccine Clinical Trials Network. Vaccine 12:912-8
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

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