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

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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

April 24, 2017
April 27, 2017
July 30, 2018
May 29, 2017
December 2018   (Final data collection date for primary outcome measure)
  • Immunogenicity [ Time Frame: 30 days after the vaccine ]
    Seroconversion
  • Immunogenicity [ Time Frame: 30 days after the vaccine ]
    Neutralizing antibodies titers
  • Immunogenicity [ Time Frame: 365 days after the vaccine ]
    Seroconversion
  • Immunogenicity [ Time Frame: 365 days after the vaccine ]
    Neutralizing antibodies titers
  • Immunogenicity [ Time Frame: 30 days after the vaccine ]
    Seroconversion
  • Immunogenicity [ Time Frame: 30 days after the vaccine ]
    Neutralizing antibodies titles
  • Immunogenicity [ Time Frame: 365 days after the vaccine ]
    Seroconversion
  • Immunogenicity [ Time Frame: 365 days after the vaccine ]
    Neutralizing antibodies titles
Complete list of historical versions of study NCT03132311 on ClinicalTrials.gov Archive Site
  • Viremia [ Time Frame: 7 days after the vaccine ]
    Yellow Fever vaccine viremia
  • Adverse events [ Time Frame: up to 30 days after the vaccine ]
    Yellow Fever vaccine related adverse events
  • Immunogenicity [ Time Frame: 5 years after the vaccine ]
    Neutralizing antibodies titles
  • Immunogenicity [ Time Frame: 10 years after the vaccine ]
    Neutralizing antibodies titles
Same as current
Not Provided
Not Provided
 
Immunogenicity and Safety of the Yellow Fever Vaccine in HIV Infected Individuals
Immunogenicity and Safety of the Yellow Fever Vaccine in HIV Infected Individuals

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
HIV Infections
Biological: Yellow Fever vaccination (17 DD Biomanguinhos)
One intramuscular injection
  • 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)

    Intervention: Biological: Yellow Fever vaccination (17 DD Biomanguinhos)
  • Active Comparator: HIV negative subjects

    100 HIV negative adults.

    Assigned intervention: Yellow fever vaccination (17 DD Biomanguinhos)

    Intervention: Biological: Yellow Fever vaccination (17 DD Biomanguinhos)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
Same as current
December 2028
December 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 59 Years   (Adult)
Yes
Contact: Lara E Coelho, MD +552122707064 lara.coelho@ini.fiocruz.br
Contact: Beatriz Grinsztejn, MD +552122707064 gbeatriz@ini.fiocruz.br
Brazil
 
 
NCT03132311
001
No
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
Plan to Share IPD: No
Oswaldo Cruz Foundation
Oswaldo Cruz Foundation
Not Provided
Not Provided
Oswaldo Cruz Foundation
July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP