Clinical Trial: Safety and Immunogenicity Study of a DNA Vaccine Combined With Protein Vaccine Against HIV/AIDS

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.


Detailed Summary:
Sponsor: EuroVacc Foundation

Current Primary Outcome:

  • Proportion of volunteers with local and systemic reactogenicity events during a 7 day follow up period after each vaccination [ Time Frame: 7 days post each vaccination ]
  • Proportion of volunteers with adverse events during a 4 week follow up period after each vaccination [ Time Frame: 4 weeks post each vaccination ]
  • Proportion of volunteers with abnormal laboratory parameters during a 4 week follow up period after each vaccination [ Time Frame: 4 weeks post each vaccination ]
  • Proportion of volunteers with serious adverse events throughout the study period [ Time Frame: Each participant will be followed for 9 months ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Proportion of volunteers with HIV-specific CD4+ and CD8+ T cell responses as assessed by IFN-g ELISpot and multiparameter flow cytometry (IFN-g TNF-a and IL-2) 2 weeks after the 2nd and 3rd vaccination [ Time Frame: two weeks post 2nd and 3 vaccination ]
  • Magnitude of HIV-specific CD4+ and CD8+ T cell responses as assessed by IFN-g ELISpot and multiparameter flow cytometry (IFN-g TNF-a and IL-2) 2 weeks after the 2nd and 3rd vaccination [ Time Frame: two weeks post 2nd and 3 vaccination ]
  • HIV-specific Env binding Antibody response 2 weeks after the 2nd and 3rd vaccination [ Time Frame: two weeks post 2nd and 3 vaccination ]
  • Magnitude and breadth of neutralizing antibody responses against tier 1 and tier 2 HIV-1 isolates 2 weeks after the 2nd and 3rd vaccination [ Time Frame: two weeks post 2nd and 3 vaccination ]


Original Secondary Outcome: Same as current

Information By: EuroVacc Foundation

Dates:
Date Received: July 18, 2014
Date Started: September 2014
Date Completion:
Last Updated: January 21, 2016
Last Verified: January 2016