Clinical trial NCT03132311: Immunogenicity and Safety of the Yellow Fever Vaccine in HIV Infected Individuals
Official title: Immunogenicity and Safety of the Yellow Fever Vaccine in HIV Infected Individuals
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: HIV Infections
Keywords: yellow fever vaccine
hiv
Lead sponsor: Oswaldo Cruz Foundation
Sponsor class: OTHER
First posted: 2017-04-27
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Primary outcomes:
measure: Immunogenicity
timeFrame: 30 days after the vaccine
measure: Immunogenicity
timeFrame: 30 days after the vaccine
measure: Immunogenicity
timeFrame: 365 days after the vaccine
measure: Immunogenicity
timeFrame: 365 days after the vaccine
Secondary outcomes:
measure: Viremia
timeFrame: 7 days after the vaccine
measure: Adverse events
timeFrame: up to 30 days after the vaccine
measure: Immunogenicity
timeFrame: 5 years after the vaccine
measure: Immunogenicity
timeFrame: 10 years after the vaccine
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Infectologia Evandro Chagas
Study officials:
References: