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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03132311
Recruitment Status : Recruiting
First Posted : April 27, 2017
Last Update Posted : July 30, 2018
Sponsor:
Information provided by (Responsible Party):
Oswaldo Cruz Foundation

Study Description
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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.


Condition or disease Intervention/treatment Phase
HIV Infections Biological: Yellow Fever vaccination (17 DD Biomanguinhos) Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of the Yellow Fever Vaccine in HIV Infected Individuals
Actual Study Start Date : May 29, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2028

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Immunogenicity [ Time Frame: 30 days after the vaccine ]
    Seroconversion

  2. Immunogenicity [ Time Frame: 30 days after the vaccine ]
    Neutralizing antibodies titers

  3. Immunogenicity [ Time Frame: 365 days after the vaccine ]
    Seroconversion

  4. Immunogenicity [ Time Frame: 365 days after the vaccine ]
    Neutralizing antibodies titers


Secondary Outcome Measures :
  1. Viremia [ Time Frame: 7 days after the vaccine ]
    Yellow Fever vaccine viremia

  2. Adverse events [ Time Frame: up to 30 days after the vaccine ]
    Yellow Fever vaccine related adverse events

  3. Immunogenicity [ Time Frame: 5 years after the vaccine ]
    Neutralizing antibodies titles

  4. Immunogenicity [ Time Frame: 10 years after the vaccine ]
    Neutralizing antibodies titles


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03132311


Contacts
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Contact: Lara E Coelho, MD +552122707064 lara.coelho@ini.fiocruz.br
Contact: Beatriz Grinsztejn, MD +552122707064 gbeatriz@ini.fiocruz.br

Locations
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Brazil
Instituto Nacional de Infectologia Evandro Chagas Recruiting
Rio de Janeiro, Brazil, 21040360
Contact: Lara Coelho, MD    +55 21 22707064    lara.coelho@ini.fiocruz.br   
Sponsors and Collaborators
Oswaldo Cruz Foundation
More Information
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Responsible Party: Oswaldo Cruz Foundation
ClinicalTrials.gov Identifier: NCT03132311    
Other Study ID Numbers: 001
First Posted: April 27, 2017    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Oswaldo Cruz Foundation:
yellow fever vaccine
hiv
Additional relevant MeSH terms:
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Yellow Fever
Infections
RNA Virus Infections
Virus Diseases
Arbovirus Infections
 Vector Borne Diseases
Flavivirus Infections
Flaviviridae Infections
Hemorrhagic Fevers, Viral