EV07 is an open label phase I clinical trial to evaluate the effect of late boost on HIV-uninfected vaccinees from EV06 trial. The outcome of the EV06 trial has shown that the vaccine regimen is safe and well tolerated. Preliminary antibody immunogenicity analysis has demonstrated that the DNA/gp120 protein vaccine regimen induced strong gp120, gp140 and V1V2 region-focused binding IgG and neutralizing antibody responses. There is also preliminary evidence that S. mansoni infection may modulate antibody responses induced by vaccination1. Based on these preliminary immunogenicity results of the EV06 study, a study with an additional boost with DNA-HIV-PT123 and AIDSVAX®B/E (Late Boost) is warranted in order to better investigate and understand the effects of the late boost on the response rate, magnitude and durability of vaccine induced immune responses. The primary objective of EV07 is to evaluate the ability of the late boost combination of DNA-HIV-PT123 and AIDSVAX® B/E to enhance the pre-existing vaccine induced antibody responses.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
49
DNA-HIV-PT123 encodes clade C ZM96 Gag and gp140, CN54 Pol-Nef; AIDSVAX®B/E is a subtype B (MN) and subtype E (A244) HIV gp120 glycoprotein adsorbed onto aluminium hydroxide gel adjuvant
Uganda Virus Research Institute - International AIDS Vaccine Initiative HIV Vaccine Program (UVRI-IAVI)
Entebbe, Uganda
Vaccine induced binding antibody responses
HIV-specific Env binding Antibody response
Time frame: week 24
Vaccine induced neutralizing antibody responses
Neutralizing antibody responses against tier 1 and tier 2 HIV-1 isolates
Time frame: week 24
Safety and tolerability of the late boost vaccination
Proportion of volunteers with local and systemic reactogenicity events
Time frame: 7 days follow-up period after the late boost
Safety and tolerability of the late boost vaccination
Proportion of volunteers with adverse events
Time frame: 4-week follow-up period after the late boost
Safety and tolerability of the late boost
Proportion of volunteers with serious adverse events
Time frame: Up to 24 weeks
Ability of the late boost combination of DNA-HIV-PT123 and AIDSVAX® B/E to enhance the pre-existing vaccine induced T-cell responses
HIV-specific CD4 and CD8 T cell responses
Time frame: Week 2, 12 and 24
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