NCT03132311RecruitingPhase 4
Immunogenicity and Safety of the Yellow Fever Vaccine in HIV Infected Individuals
Source: ClinicalTrials.gov · Last updated 30 Jul 2018 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 24 Apr 2017
- Start date
- 29 May 2017
- Primary completion date
- 31 Dec 2018
- Lead sponsor
- Oswaldo Cruz Foundation
- Diseases
- HIV
- NCT number
- NCT03132311
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 400
- From 29 May 2017 to the primary completion date, 31 Dec 2018
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
- Administration of immunoglobulins or blood derivates \< 3 months or life attenuated vaccine \<1 month.
Other illness
- Hypersensitivity reaction to eggs, chicken protein. Allergy to erythomycin or kanamycin. Hereditary fructose intolerance.
- History of thymic dysfunction (including thymoma and thymectomy).
- symptoms of severe acute illnesses or fever (axillary temperature ≥ 38°C)
- HIV positive rapid test for HIV negative subjects.
Other
- Pregnant women
- Use of anti-CCR5
Who the study is looking for
- 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
Age in the registry: 18 years to 59 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto Nacional de Infectologia Evandro Chagas Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.