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RECRUITING
NCT03132311
PHASE4

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

Sponsor: Oswaldo Cruz Foundation

View on ClinicalTrials.gov

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

BIOLOGICAL

Yellow Fever vaccination (17 DD Biomanguinhos)

One intramuscular injection

Locations (1)

Instituto Nacional de Infectologia Evandro Chagas

Rio de Janeiro, Brazil