Evaluating the Yellow Fever Vaccine in People with HIV

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 4 study aims to assess the immunogenicity and safety of the 17DD Yellow Fever vaccine in individuals infected with HIV, comparing their responses to those of non-HIV-infected individuals. The primary objective is to measure the proportion of seroconversion and the geometric mean of neutralizing antibodies at 30 and 365 days post-vaccination. Secondary objectives include examining the relationship between antibody levels and various HIV-related health markers, as well as monitoring vaccine-related adverse events. The study will involve both HIV-infected adults and healthy controls aged 18 to 60.

Why it matters

Who can join: the full rules

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-uninfected individuals (aged \>= 18 and \< 60)
* No history of Yellow Fever vaccination
* Willing to participate and to sign the consent

Exclusion Criteria:

* Individuals with chronic diseases such as: decompensated diabetes, kidney failure (in dialysis), liver failure/cirrhosis, cancer (except for non-melanoma skin cancer and in situ HIV related carcinoma), use of immunosuppressive agents (including prednisone ≥ 20mg/day, during 7 or more days in the last 30 days before inclusion).
* Pregnant women
* Hypersensitivity reaction to eggs, chicken protein. Allergy to erythomycin or kanamycin. Hereditary fructose intolerance.
* Administration of immunoglobulins or blood derivates \< 3 months or life attenuated vaccine \<1 month.
* History of thymic dysfunction (including thymoma and thymectomy).
* Use of anti-CCR5
* symptoms of severe acute illnesses or fever (axillary temperature ≥ 38°C)
* HIV positive rapid test for HIV negative subjects.

Where it's running

• Instituto Nacional de Infectologia Evandro Chagas
  Rio de Janeiro, Brazil Recruiting

Study contacts

• Study coordinator: Lara E Coelho, MD
• Email: lara.coelho@ini.fiocruz.br
• Phone: +552122707064

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.