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

Phase 4

Recruiting

• Conditions: HIV Infections
• Interventions: Biological: Yellow Fever vaccination (17 DD Biomanguinhos)

• Registration Number: NCT03132311
• Lead Sponsor: Oswaldo Cruz Foundation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-24
• Study First Submitted QC: 2017-04-24
• Study First Posted: 2017-04-27
• Study Start: 2017-05-29
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-27
• Last Update Posted: 2018-07-30
• Primary Completion: 2018-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HIV negative subjects	Yellow Fever vaccination (17 DD Biomanguinhos)	100 HIV negative adults. Assigned intervention: Yellow fever vaccination (17 DD Biomanguinhos)
HIV positive subjects	Yellow Fever vaccination (17 DD Biomanguinhos)	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)

Primary Outcome Measures

Name	Time	Method
Immunogenicity	365 days after the vaccine	Neutralizing antibodies titers

Secondary Outcome Measures

Name	Time	Method
Adverse events	up to 30 days after the vaccine	Yellow Fever vaccine related adverse events
Immunogenicity	10 years after the vaccine	Neutralizing antibodies titles
Viremia	7 days after the vaccine	Yellow Fever vaccine viremia

Trial Locations

Locations (1)

Instituto Nacional de Infectologia Evandro Chagas; 🇧🇷 Rio de Janeiro, Brazil