Immunogenicity and Safety of the Yellow Fever Vaccine in HIV Infected Individuals
Recruiting
Phase 4
Interventional Study
HIV Infections
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 59
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 400 (estimated)
- Sponsor
- Oswaldo Cruz Foundation · Other
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About This Trial
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 associ…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* HIV infected adults, age \>= 18 and \<60 years old.
* CD4 \> 200 cells/mm³ within the last 6 months prior to inclusion. Individuals with no CD4 results in the last 6 months which have undetectable HIV viral load and last CD4 count \> 350 can be included.
* Healthy HIV-uninfect…
Contacts