Clinical Trial

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

Study acronym: YF-HIV
Recruiting Phase 4
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Record status
This record was last updated July 30, 2018 (before its estimated December 2018 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2017-04-24; most recent amendment 2018-07-27.
Status change: Not Yet Recruiting → Recruiting 2017-07-06
Trial Details
NCT Number NCT03132311
Lead Sponsor Oswaldo Cruz Foundation
Conditions HIV Infections
Enrollment 400 participants
Start Date 2017-05-29
Primary Completion 2018-12 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2018-07-30