Immunogenicity and Safety of the Yellow Fever Vaccine in HIV Infected Individuals
ConditionHIV Infections
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-59
SponsorOswaldo Cruz Foundation
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Yellow Fever vaccination (17 DD Biomanguinhos)
Biological/VaccineOne intramuscular injection
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: HIV positive subjectsExperimental treatment 1 intervention
Group B: HIV negative subjectsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Immunogenicity
Seroconversion
Time frame
30 days after the vaccine2
Immunogenicity
Neutralizing antibodies titers
Time frame
30 days after the vaccine3
Immunogenicity
Seroconversion
Time frame
365 days after the vaccine4
Immunogenicity
Neutralizing antibodies titers
Time frame
365 days after the vaccineSecondary outcomes
1
Viremia
Yellow Fever vaccine viremia
Time frame
7 days after the vaccine2
Adverse events
Yellow Fever vaccine related adverse events
Time frame
up to 30 days after the vaccine3
Immunogenicity
Neutralizing antibodies titles
Time frame
5 years after the vaccine4
Immunogenicity
Neutralizing antibodies titles
Time frame
10 years after the vaccineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov