Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase I Double Blind Placebo-controlled Clinical Trial to Evaluate the Safety and Immunogenicity of the Combination of DNA-HIV-PT123 and AIDSVAX®B/Ein HIV-1-uninfected Adult Participants With o
Brief Summary:
The primary objective of the proposed phase I trial is to evaluate the safety and tolerability of DNA-HIV-PT123 and AIDSVAX®B/E combination regimen. Though both DNA-HIV-PT123 and AIDSVAX®B/E and the combination of the two vaccines have been evaluated in humans and have shown to be safe and well tolerated, this is the first time the combination regimen is being evaluated in HIV-1 uninfected African populations with and without S. mansoni. The secondary objective of the trial is to evaluate the effect of S. mansoni infection on the immunogenicity of the combination of DNA-HIV-PT123 and AIDSVAX® B/E vaccine regimen. Successful vaccination against most viruses requires efficient Th1 response. There is evidence that helminth infections skew the host immune system of human and animals to T-helper type 2 (Th2) and induce immunosuppression. Therefore, there is a potential that helminth infected populations may not generate the desired immune responses to vaccines designed to drive Th1-type and cytotoxic T-cell responses.
Furthermore, the influence of helminth infections on the development of protective antibody responses remains unclear. Limited data in animal models suggests that worm infections reduced efficacy of vaccines.
The proposed vaccine trial will generate safety, tolerability and immunogenicity data of a vaccination regimen with simultaneous administration of a candidate HIV DNA vaccine (DNA-HIV-PT123) and a gp120 protein vaccine (AIDSVAX®B/E). This will be the first HIV vaccine trial to prospectively evaluate the impact of the S. mansoni infection on safety and immune responses to HIV vaccines.