Immunogenicity and Safety of the Yellow Fever Vaccine in HIV Infected Individuals
Key facts
- Where
- Rio de Janeiro, BrazilSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 59 years old?
Source: NCT03132311, who can take part
Where in Brazil
- Instituto Nacional de Infectologia Evandro ChagasRio de Janeiro, BrazilTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Oswaldo Cruz Foundation
- Trial code
- NCT03132311
- Record updated
- 30 July 2018
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: 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; 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; Pregnant women; Use of anti-CCR5.