Clinical Trial: Immunogenicity and Safety of the Yellow Fever Vaccine in HIV Infected Individuals

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Immunogenicity and Safety of the Yellow Fever Vaccine in HIV Infected Individuals

Brief Summary:

Phase 4 study to evaluate the immunogenicity and Safety of the 17DD Yellow Fever vaccine in HIV infected individuals, compared to non-HIV-infected individuals.

Main objective:

To compare the proportion of seroconversion and the geometric mean of neutralizing antibodies 30 days and 365 days after vaccine.

Secondary objectives:

To evaluate whether the titles of neutralizing antibodies are associated with CD4 lymphocyte counts, CD8 lymphocyte counts, CD4 nadir, HIV viral load and use of antiretroviral therapy. To assess the yellow fever vaccine viremia at day 10 after vaccine.To compare the incidence of adverse events in HIV-infected and non-HIV-infected individuals.


Detailed Summary:
Sponsor: Oswaldo Cruz Foundation

Current Primary Outcome:

  • Immunogenicity [ Time Frame: 30 days after the vaccine ]
    Seroconversion
  • Immunogenicity [ Time Frame: 30 days after the vaccine ]
    Neutralizing antibodies titles
  • Immunogenicity [ Time Frame: 365 days after the vaccine ]
    Seroconversion
  • Immunogenicity [ Time Frame: 365 days after the vaccine ]
    Neutralizing antibodies titles


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Viremia [ Time Frame: 7 days after the vaccine ]
    Yellow Fever vaccine viremia
  • Adverse events [ Time Frame: up to 30 days after the vaccine ]
    Yellow Fever vaccine related adverse events
  • Immunogenicity [ Time Frame: 5 years after the vaccine ]
    Neutralizing antibodies titles
  • Immunogenicity [ Time Frame: 10 years after the vaccine ]
    Neutralizing antibodies titles


Original Secondary Outcome: Same as current

Information By: Oswaldo Cruz Foundation

Dates:
Date Received: April 24, 2017
Date Started: May 2017
Date Completion: December 2028
Last Updated: April 24, 2017
Last Verified: April 2017