Ignite Creation Date:
2024-05-06 @ 8:29 AM
Last Modification Date:
2024-10-26 @ 12:00 PM
Study NCT ID:
NCT02741128
Status:
COMPLETED
Last Update Posted:
2023-02-08
First Post:
2016-04-08
Brief Title:
Safety and Immunogenicity of a Tetravalent Dengue Vaccine in HIV-Positive Adults
Sponsor:
Sanofi Pasteur a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
Safety and Immunogenicity of a Tetravalent Dengue Vaccine in HIV-Positive Adults Aged 18 to 50 Years in Brazil
Status:
COMPLETED
Status Verified Date:
2024-01
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:
None
Brief Summary:
The aim of the study was to evaluate the safety and immunogenicity of the Dengue vaccine in a population of special interest such as HIV-positive adults previously exposed to dengue
Primary Objective
To describe the safety of each injection of CYD dengue vaccine in HIV-positive adults previously exposed to dengue
Secondary Objectives
To describe the humoral immune response to each dengue serotype at baseline and after each injection of CYD dengue vaccine in HIV-positive adults previously exposed to dengue
To detect the CYD dengue vaccinal viremia post-Inj 1 in HIV-positive adults previously exposed to dengue
To describe changes in CD4 count and HIV RNA viral load after each injection of CYD dengue vaccine in HIV-positive adults previously exposed to dengue
Observational Objective
To describe the FV YF Dengue Zika serological status in the study population at baseline
Primary Objective
To describe the safety of each injection of CYD dengue vaccine in HIV-positive adults previously exposed to dengue
Secondary Objectives
To describe the humoral immune response to each dengue serotype at baseline and after each injection of CYD dengue vaccine in HIV-positive adults previously exposed to dengue
To detect the CYD dengue vaccinal viremia post-Inj 1 in HIV-positive adults previously exposed to dengue
To describe changes in CD4 count and HIV RNA viral load after each injection of CYD dengue vaccine in HIV-positive adults previously exposed to dengue
Observational Objective
To describe the FV YF Dengue Zika serological status in the study population at baseline
Detailed Description:
Eligible subjects were randomized in a 21 ratio into 1 of 2 groups to receive 3 injections of either CYD dengue vaccine or placebo at 0 6 and 12 months The enrollment of subjects was carried out in two steps including an early safety data review before the second step The duration of each subjects participation in the study was approximately 18 months
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1174-4398 | OTHER | WHO | None |