This controlled, randomized Phase I trial in HIV-negative adults will evaluate the safety and immunogenicity of the HIV-1 SF-2 recombinant p24 subunit vaccine when administered as part of """"""""prime-boost"""""""" HIV-1 vaccination regimens employing ALVAC-HIV vCP205 w/or without HIV-1 SF-2 rgp 120. TRAIL ENDPOINTS PRIMARY: The safety and tolerability of HIV-1 SF-2 p24 when administered simultaneouly w/ ALVAC-HIV vCP205 (Groups 1 and 2), or when combined w/HIV-1 SF-2 rgp120 administered simultaneously w/ ALVAC HIV-1 vCP205 (Group 3). SECONDARY: Immunogenicity endpoints as follows, 1) T cell responses (CD8+ or CD4+) to gag or other HIV-1 proteins induced by the prime-boost regimens utilizing HIV-1 SF-2 p24 vaccine (arms 1,2 and 3) relative to """"""""standard"""""""" prime-boost regimens (arm 4 ro historical experience) or to canary-pox alone (historical experience). 2) Antibodies to gag antigens as detected on clinical ELISA or WB assays relative to historical experience. NOTE: Because of the relatively small arm sizes, analyses of gag-specific antibody or T cell responses will be performed for all p24 containing arms combined (n=48) as well as for each individual arm (n=16). TERTIARY: HIV-1 neutralizing antibodies (NAB) to confirm that addition of HIV-1 SF-2 p24 to prime-boost regimen doesn't reduce NAB.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000095-40
Application #
6409632
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
1977-12-01
Project End
2002-11-30
Budget Start
Budget End
Support Year
40
Fiscal Year
2000
Total Cost
Indirect Cost
Name
Vanderbilt University Medical Center
Department
Type
DUNS #
004413456
City
Nashville
State
TN
Country
United States
Zip Code
37203
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