RecruitingPhase 4NCT03132311

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

Sponsor

Oswaldo Cruz Foundation

Enrollment

400 participants

Start Date

May 29, 2017

Study Type

INTERVENTIONAL

Conditions

HIV Infections

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.

Eligibility

Min Age: 18 YearsMax Age: 59 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how well the yellow fever vaccine works and how safe it is in people living with HIV, compared to people without HIV. **You may be eligible if...** - You are between 18 and 60 years old - You are either HIV-positive with a CD4 count above 200 (a measure of immune health), or you are HIV-negative and healthy - You have never received the yellow fever vaccine - You are willing to participate and sign a consent form **You may NOT be eligible if...** - You have a chronic illness that is not well-controlled - You have a severely weakened immune system - You have a known allergy to the vaccine components - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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