Immunogenicity and Safety of the Yellow Fever Vaccine in HIV Infected Individuals

Study Overview
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Brief Summary
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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.

Official Title
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Immunogenicity and Safety of the Yellow Fever Vaccine in HIV Infected Individuals

Conditions
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HIV Infections

Intervention / Treatment
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* Biological: Yellow Fever vaccination (17 DD Biomanguinhos)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HIV positive subjects<br>300 HIV positive adults with CD4 > 200 cells/mm3, stratified in 3 groups (100 patients in each group) according to CD4 counts (200-350; 351-500, >500 cells/mm3). Assigned intervention: Yellow fever vaccination (17 DD Biomanguinhos) | Biological: Yellow Fever vaccination (17 DD Biomanguinhos)<br>* One intramuscular injection<br>|
| Active Comparator: HIV negative subjects<br>100 HIV negative adults. Assigned intervention: Yellow fever vaccination (17 DD Biomanguinhos) | Biological: Yellow Fever vaccination (17 DD Biomanguinhos)<br>* One intramuscular injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity | Seroconversion | 30 days after the vaccine | 
| Immunogenicity | Neutralizing antibodies titers | 30 days after the vaccine | 
| Immunogenicity | Seroconversion | 365 days after the vaccine | 
| Immunogenicity | Neutralizing antibodies titers | 365 days after the vaccine | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viremia | Yellow Fever vaccine viremia | 7 days after the vaccine | 
| Adverse events | Yellow Fever vaccine related adverse events | up to 30 days after the vaccine | 
| Immunogenicity | Neutralizing antibodies titles | 5 years after the vaccine | 
| Immunogenicity | Neutralizing antibodies titles | 10 years after the vaccine | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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yellow fever vaccine, hiv