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Immunogenicity and Safety of the Yellow Fever Vaccine in HIV Infected Individuals
Sponsor: Oswaldo Cruz Foundation
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.
Key Details
Gender
All
Age Range
18 Years - 59 Years
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2017-05-29
Completion Date
2028-12
Last Updated
2018-07-30
Healthy Volunteers
Yes
Conditions
Interventions
Yellow Fever vaccination (17 DD Biomanguinhos)
One intramuscular injection
Locations (1)
Instituto Nacional de Infectologia Evandro Chagas
Rio de Janeiro, Brazil