Ignite Creation Date:
2024-05-06 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 12:23 PM
Study NCT ID:
NCT03132311
Status:
RECRUITING
Last Update Posted:
2018-07-30
First Post:
2017-04-24
Brief Title:
Immunogenicity and Safety of the Yellow Fever Vaccine in HIV Infected Individuals
Sponsor:
Oswaldo Cruz Foundation
Organization:
Oswaldo Cruz Foundation
Study Overview
Official Title:
Immunogenicity and Safety of the Yellow Fever Vaccine in HIV Infected Individuals
Status:
RECRUITING
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
YF-HIV
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 vaccineTo compare the incidence of adverse events in HIV-infected and 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 vaccineTo compare the incidence of adverse events in HIV-infected and non-HIV-infected individuals
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None