Clinical Trial – Immunogenicity and Safety of the Yellow Fever Vaccine – 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 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
Contacts
Contact: Lara E Coelho, MD +552122707064 lara.coelho@ini.fiocruz.br
Contact: Beatriz Grinsztejn, MD +552122707064 gbeatriz@ini.fiocruz.br
Locations
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
ClinicalTrials.gov Identifier: NCT03132311

 

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