HIV/AIDS Clinical Trial
Official title:
An Open Label Phase I Clinical Trial to Evaluate the Effect of Late Boost on HIV-uninfected Vaccinees From EV06 Trial
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.
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