Evaluating the Yellow Fever Vaccine in People with HIV
Immunogenicity and Safety of the Yellow Fever Vaccine in HIV Infected Individuals
This study is testing how well the Yellow Fever vaccine works and how safe it is for people with HIV compared to those without HIV.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 59 Years |
| Sex | All |
| Sponsor | Oswaldo Cruz Foundation Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (Rio de Janeiro) |
| Trial ID | NCT03132311 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include HIV-infected adults aged 18 to 60 with a CD4 count above 200 cells/mm³.
Not a fit: Patients with chronic diseases, pregnant women, or those with a history of severe allergies related to the vaccine may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance vaccination strategies for HIV-infected individuals, improving their protection against yellow fever.
How similar studies have performed: Previous studies have shown varying results regarding vaccine responses in immunocompromised populations, making this approach both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion 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-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 this trial is running
Rio de Janeiro
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.