NCT03132311 Immunogenicity and Safety of the Yellow Fever Vaccine in HIV Infected Individuals
| NCT ID | NCT03132311 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Oswaldo Cruz Foundation |
| Condition | HIV Infections |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2017-05-29 |
| Primary Completion | 2018-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 400 participants in total. It began in 2017-05-29 with a primary completion date of 2018-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03132311 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 59 Years, studying HIV Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03132311 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT03132311 currently recruiting?
Yes, NCT03132311 is actively recruiting participants. Contact the research team at lara.coelho@ini.fiocruz.br for enrollment information.
Where is the NCT03132311 trial being conducted?
This trial is being conducted at Rio de Janeiro, Brazil.
Who is sponsoring the NCT03132311 clinical trial?
NCT03132311 is sponsored by Oswaldo Cruz Foundation. The trial plans to enroll 400 participants.
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