Abstract

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.

  Funding Agency

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

  Institution

Name
Vanderbilt University Medical Center
Department
Type
DUNS #
004413456
City
Nashville
State
TN
Country
United States
Zip Code
37203

  Publications

Kaltenbach, Karol; O'Grady, Kevin E; Heil, Sarah H et al. (2018) Prenatal exposure to methadone or buprenorphine: Early childhood developmental outcomes. Drug Alcohol Depend 185:40-49
Gupta, Samir K; Yeh, Eunice; Kitch, Douglas W et al. (2017) Bone mineral density reductions after tenofovir disoproxil fumarate initiation and changes in phosphaturia: a secondary analysis of ACTG A5224s. J Antimicrob Chemother 72:2042-2048
Gilchuk, Pavlo; Knight, Frances C; Wilson, John T et al. (2017) Eliciting Epitope-Specific CD8+ T Cell Response by Immunization with Microbial Protein Antigens Formulated with ?-Galactosylceramide: Theory, Practice, and Protocols. Methods Mol Biol 1494:321-352
Sebag, Sara C; Koval, Olha M; Paschke, John D et al. (2017) Mitochondrial CaMKII inhibition in airway epithelium protects against allergic asthma. JCI Insight 2:e88297
Laird, Chris; Burdorf, Lars; Pierson 3rd, Richard N (2016) Lung xenotransplantation: a review. Curr Opin Organ Transplant 21:272-8
Chung, C P; Ormseth, M J; Connelly, M A et al. (2016) GlycA, a novel marker of inflammation, is elevated in systemic lupus erythematosus. Lupus 25:296-300
Towse, Theodore F; Childs, Benjamin T; Sabin, Shea A et al. (2016) Comparison of muscle BOLD responses to arterial occlusion at 3 and 7 Tesla. Magn Reson Med 75:1333-40
Joy, Nino G; Mikeladze, Maia; Younk, Lisa M et al. (2016) Effects of equivalent sympathetic activation during hypoglycemia on endothelial function and pro-atherothrombotic balance in healthy individuals and obese standard treated type 2 diabetes. Metabolism 65:1695-1705
Gilchuk, Pavlo; Hill, Timothy M; Guy, Clifford et al. (2016) A Distinct Lung-Interstitium-Resident Memory CD8(+) T Cell Subset Confers Enhanced Protection to Lower Respiratory Tract Infection. Cell Rep 16:1800-9
Jones, Hendrée E; Seashore, Carl; Johnson, Elisabeth et al. (2016) Measurement of neonatal abstinence syndrome: Evaluation of short forms. J Opioid Manag 12:19-23

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