NCT03132311

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Oswaldo Cruz Foundation · Academic / Other
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
BIOLOGICAL	Yellow Fever vaccination (17 DD Biomanguinhos)	One intramuscular injection

Timeline

• Start date: 2017-05-29
• Primary completion: 2018-12-01
• Completion: 2028-12-01
• First posted: 2017-04-27
• Last updated: 2018-07-30

Locations

1 site across 1 country: Brazil