Immunogenicity and Safety of the Yellow Fever Vaccine in HIV Infected Individuals (YF-HIV)

Oswaldo Cruz Foundation

Status and phase: Enrolling; Phase 4

Conditions: HIV Infections

Treatments: Biological: Yellow Fever vaccination (17 DD Biomanguinhos)

Study type: Interventional

Funder types: Other

Identifiers

NCT03132311

001

Details and patient eligibility

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 59 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

400 participants in 2 patient groups

HIV positive subjects

Experimental group

Description:

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)

Treatment:

Biological: Yellow Fever vaccination (17 DD Biomanguinhos)

HIV negative subjects

Active Comparator group

Description:

100 HIV negative adults. Assigned intervention: Yellow fever vaccination (17 DD Biomanguinhos)

Treatment:

Biological: Yellow Fever vaccination (17 DD Biomanguinhos)