Ignite Creation Date:
2024-05-06 @ 10:51 AM
Last Modification Date:
2024-10-26 @ 12:36 PM
Study NCT ID:
NCT03368053
Status:
COMPLETED
Last Update Posted:
2020-10-20
First Post:
2017-12-05
Brief Title:
Long-term Immunogenicity of the HIV gp120-NefTatAS01B Vaccine GSK SB732461
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Long-term Immunogenicity of the HIV gp120-NefTatAS01B Vaccine GSK SB732461
Status:
COMPLETED
Status Verified Date:
2020-09
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 purpose of this study is to evaluate the long-term persistence of binding antibody responses against V1V2 and gp120 in subjects who were vaccinated with the envelope glycoprotein 120 gp120-negative factor NefTat Adjuvant System 01B AS01B GSKSB732461 vaccine candidate Other immune parameters like the HIV-specific cluster of differentiation CD4 T cell and CD8 T cell responses will also be evaluated
Detailed Description:
GlaxoSmithKline GSK contributes to the public-private pox-protein partnership P5 which is currently assessing the safety immunogenicity and clinical efficacy of a prime-boost regimen aimed at preventing HIV transmission httpwwwhvtnorgenhtml The booster component of the candidate vaccine used in this program consists of two gp120 clade C proteins administered with an adjuvant In order to inform the selection of the adjuvant in future studies data on long-term persistence of immunity after vaccination with gp120AS01 would prove useful The present study was designed to address this question using a cohort of volunteers vaccinated several years ago with a candidate vaccine containing gp120 and AS01
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