The purpose of this study is to assess safety and tolerability of late boost regimens of AIDSVAX B/E alone, ALVAC-HIV alone, or ALVAC-HIV/AIDSVAX B/E combination in HIV-uninfected participants from RV 144.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
162
1 mL per injection containing 10\^6 CCID50/dose administered
1 mL per injection (300 ug dose/antigen for a total of 600ug/dose administered)
1 ml per injection
Bang Lamung District Hospital
Chon Buri, Thailand
Phan Thong District Hospital
Chon Buri, Thailand
Primary Immunogenicity Endpoint
Characterization of vaccine-induced immune responses by IFN-gamma ELISPOT, intracellular cytokine staining (ICS), and 3H-thymidine incorporation assay.
Time frame: Week 0
Safety Endpoints
Post-vaccination reactions including erythema, induration, pain/tenderness, swelling, limitation of arm movement, fever, tiredness, chills, myalgia, arthralgia, headache, nausea, dizziness, and rash will be assessed and recorded on diary cards.
Time frame: During the 3 days post-vaccination
Primary Immunogenicity Endpoint
Characterization of vaccine-induced immune responses by IFN-gamma ELISPOT, intracellular cytokine staining (ICS), and 3H-thymidine incorporation assay.
Time frame: Week 2
Primary Immunogenicity Endpoint
Characterization of vaccine-induced immune responses by IFN-gamma ELISPOT, intracellular cytokine staining (ICS), and 3H-thymidine incorporation assay.
Time frame: Week 24
Primary Immunogenicity Endpoint
Characterization of vaccine-induced immune responses by IFN-gamma ELISPOT, intracellular cytokine staining (ICS), and 3H-thymidine incorporation assay.
Time frame: Week 26
Primary Immunogenicity Endpoint
Characterization of vaccine-induced immune responses by IFN-gamma ELISPOT, intracellular cytokine staining (ICS), and 3H-thymidine incorporation assay.
Time frame: Week 48
Primary Immunogenicity Endpoint
Characterization of vaccine-induced immune responses by IFN-gamma ELISPOT, intracellular cytokine staining (ICS), and 3H-thymidine incorporation assay.
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1 ml per injection
Time frame: Week 72
Secondary Immunogenicity Endpoints
Characterization of vaccine-induced immune responses by lymphoproliferation assays (LPA), human leukocyte antigen (HLA) subtyping, characterization of natural killer (NK) cells using multiparameter flow, assessment of APOBEC 3G (A3G) antiretroviral factor expression, B-cell ELISPOT, HIV-specific binding antibody assays, neutralizing antibody assays, mucosal IgG and IgA binding antibody assays, antibody-dependent cell mediated cytotoxicity (ADCC) and antibody-dependent cell mediated viral inhibition (ADCVI) assays
Time frame: Baseline, Weeks 2, 24, 26, 48 and 72