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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-29

Study Completion Date

2028-12-31

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.

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Detailed Description

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Conditions

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HIV Infections

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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HIV positive subjects

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)

Group Type EXPERIMENTAL

Yellow Fever vaccination (17 DD Biomanguinhos)

Intervention Type BIOLOGICAL

One intramuscular injection

HIV negative subjects

100 HIV negative adults.

Assigned intervention: Yellow fever vaccination (17 DD Biomanguinhos)

Group Type ACTIVE_COMPARATOR

Yellow Fever vaccination (17 DD Biomanguinhos)

Intervention Type BIOLOGICAL

One intramuscular injection

Interventions

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Yellow Fever vaccination (17 DD Biomanguinhos)

One intramuscular injection

Intervention Type BIOLOGICAL

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes