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

Primary Purpose

HIV Infections

Status

Recruiting

Phase

Phase 4

Locations

Brazil

Study Type

Interventional

Intervention

Yellow Fever vaccination (17 DD Biomanguinhos)

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring yellow fever vaccine, hiv

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesAccepts 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.

Sites / Locations

Instituto Nacional de Infectologia Evandro ChagasRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HIV positive subjects

HIV negative subjects

Arm 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)

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

Outcomes

Primary Outcome Measures

Immunogenicity

Seroconversion

Immunogenicity

Neutralizing antibodies titers

Immunogenicity

Seroconversion

Immunogenicity

Neutralizing antibodies titers

Secondary Outcome Measures

Viremia

Yellow Fever vaccine viremia

Adverse events

Yellow Fever vaccine related adverse events

Immunogenicity

Neutralizing antibodies titles

Immunogenicity

Neutralizing antibodies titles

Full Information

NCT ID

NCT03132311

First Posted

April 24, 2017

Last Updated

July 27, 2018

Sponsor

Oswaldo Cruz Foundation

1. Study Identification

Unique Protocol Identification Number

NCT03132311

Brief Title

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

Acronym

YF-HIV

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Recruiting

Study Start Date

May 29, 2017 (Actual)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

December 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Oswaldo Cruz Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

yellow fever vaccine, hiv

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

HIV positive subjects

Arm Type

Experimental

Arm Description

Arm Title

HIV negative subjects

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Yellow Fever vaccination (17 DD Biomanguinhos)

Intervention Description

One intramuscular injection

Primary Outcome Measure Information:

Title

Immunogenicity

Description

Seroconversion

Time Frame

30 days after the vaccine

Title

Immunogenicity

Description

Neutralizing antibodies titers

Time Frame

30 days after the vaccine

Title

Immunogenicity

Description

Seroconversion

Time Frame

365 days after the vaccine

Title

Immunogenicity

Description

Neutralizing antibodies titers

Time Frame

365 days after the vaccine

Secondary Outcome Measure Information:

Title

Viremia

Description

Yellow Fever vaccine viremia

Time Frame

7 days after the vaccine

Title

Adverse events

Description

Yellow Fever vaccine related adverse events

Time Frame

up to 30 days after the vaccine

Title

Immunogenicity

Description

Neutralizing antibodies titles

Time Frame

5 years after the vaccine

Title

Immunogenicity

Description

Neutralizing antibodies titles

Time Frame

10 years after the vaccine

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

59 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lara E Coelho, MD

Phone

+552122707064

lara.coelho@ini.fiocruz.br

First Name & Middle Initial & Last Name or Official Title & Degree

Beatriz Grinsztejn, MD

Phone

+552122707064

gbeatriz@ini.fiocruz.br

Facility Information:

Facility Name

Instituto Nacional de Infectologia Evandro Chagas

City

Rio de Janeiro

ZIP/Postal Code

21040360

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lara Coelho, MD

Phone

+55 21 22707064

lara.coelho@ini.fiocruz.br

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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