Actively Recruiting
Immunogenicity and Safety of the Yellow Fever Vaccine in HIV Infected Individuals
Led by Oswaldo Cruz Foundation · Updated on 2018-07-30
400
Participants Needed
1
Research Sites
600 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Immunogenicity and Safety of the Yellow Fever Vaccine in HIV Infected Individuals
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to under 60 years
- HIV infected adults with CD4 > 200 cells/mm³ within the last 6 months, or those without recent CD4 results but with undetectable HIV viral load and last CD4 count > 350
- Healthy HIV-uninfected adults aged 18 to under 60 years
- No history of Yellow Fever vaccination
- Willingness to participate and sign informed consent
You will not qualify if you...
- Chronic diseases such as decompensated diabetes, kidney failure requiring dialysis, liver failure or cirrhosis, cancer except non-melanoma skin cancer and in situ HIV-related carcinoma
- Use of immunosuppressive agents including prednisone ≥ 20mg/day for 7 or more days within the last 30 days
- Pregnant women
- Allergies to eggs, chicken protein, erythromycin, kanamycin, or hereditary fructose intolerance
- Receipt of immunoglobulins or blood derivatives within 3 months or live attenuated vaccine within 1 month
- History of thymic dysfunction including thymoma or thymectomy
- Use of anti-CCR5 medication
- Symptoms of severe acute illness or fever with axillary temperature ≥ 38°C
- HIV positive rapid test in individuals who are HIV negative
AI-Screening
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Trial Site Locations
Total: 1 location
1
Instituto Nacional de Infectologia Evandro Chagas
Rio de Janeiro, Brazil, 21040360
Actively Recruiting
Research Team
L
Lara E Coelho, MD
CONTACT
B
Beatriz Grinsztejn, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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