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

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.

Study Overview

• Status: Recruiting
• Conditions: HIV Infections
• Intervention / Treatment: Biological: Yellow Fever vaccination (17 DD Biomanguinhos)

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Lara E Coelho, MD; Phone Number: +552122707064; Email: lara.coelho@ini.fiocruz.br
• Study Contact Backup: Name: Beatriz Grinsztejn, MD; Phone Number: +552122707064; Email: gbeatriz@ini.fiocruz.br

Study Locations

• Brazil
  • Rio de Janeiro, Brazil, 21040360
    • Recruiting
    • Instituto Nacional de Infectologia Evandro Chagas
    • Contact: Lara Coelho, MD; Phone Number: +55 21 22707064; Email: lara.coelho@ini.fiocruz.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Biological: Yellow Fever vaccination (17 DD Biomanguinhos); One intramuscular injection
Active Comparator: HIV negative subjects; 100 HIV negative adults. Assigned intervention: Yellow fever vaccination (17 DD Biomanguinhos)	Biological: Yellow Fever vaccination (17 DD Biomanguinhos); One intramuscular injection

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Oswaldo Cruz Foundation

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2017
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2028

Study Registration Dates

• First Submitted: April 24, 2017
• First Submitted That Met QC Criteria: April 24, 2017
• First Posted (Actual): April 27, 2017

Study Record Updates

• Last Update Posted (Actual): July 30, 2018
• Last Update Submitted That Met QC Criteria: July 27, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: hiv; yellow fever vaccine
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Arbovirus Infections; Vector Borne Diseases; Flavivirus Infections; Flaviviridae Infections; Hemorrhagic Fevers, Viral; Yellow Fever
• Other Study ID Numbers: 001 (Buy Pharma Ecza Deposu San. Tic. Ltd.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No