Instituto Nacional de Infectologia Evandro Chagas
Rio de Janeiro, 21040360, Brazil
Location status: Recruiting
NCT Number: NCT03132311
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.
Interested in participating?
Request Info18 year–59 year
All sexes
Interventional
Phase 4
Rio de Janeiro, 21040360, Brazil
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
One intramuscular injection
Time frame: 30 days after the vaccine
Seroconversion
Time frame: 30 days after the vaccine
Neutralizing antibodies titers
Time frame: 365 days after the vaccine
Seroconversion
Time frame: 365 days after the vaccine
Neutralizing antibodies titers
Time frame: 7 days after the vaccine
Yellow Fever vaccine viremia
Time frame: up to 30 days after the vaccine
Yellow Fever vaccine related adverse events
Time frame: 5 years after the vaccine
Neutralizing antibodies titles
Time frame: 10 years after the vaccine
Neutralizing antibodies titles
Contact information is provided by the study sponsor or research team.
Beatriz Grinsztejn, MD
CONTACT
Lara E Coelho, MD
CONTACT
Oswaldo Cruz Foundation
Other
Acronym: YF-HIV
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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