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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
400
One intramuscular injection
Instituto Nacional de Infectologia Evandro Chagas
Rio de Janeiro, Brazil
RECRUITINGImmunogenicity
Seroconversion
Time frame: 30 days after the vaccine
Immunogenicity
Neutralizing antibodies titers
Time frame: 30 days after the vaccine
Immunogenicity
Seroconversion
Time frame: 365 days after the vaccine
Immunogenicity
Neutralizing antibodies titers
Time frame: 365 days after the vaccine
Viremia
Yellow Fever vaccine viremia
Time frame: 7 days after the vaccine
Adverse events
Yellow Fever vaccine related adverse events
Time frame: up to 30 days after the vaccine
Immunogenicity
Neutralizing antibodies titles
Time frame: 5 years after the vaccine
Immunogenicity
Neutralizing antibodies titles
Time frame: 10 years after the vaccine
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