Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00434512
Status:
COMPLETED
Last Update Posted:
2019-10-01
First Post:
2007-02-12
Brief Title:
Dose-ranging Study to Evaluate the Safety Immunogenicity of a HIV Vaccine 732461 in Healthy HIV Seronegative Volunteers
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Dose-ranging Study to Compare the Safety and Immunogenicity of a Candidate Human Deficiency Virus HIV Vaccine 732461 Adjuvanted or Not Administered According to a 0 1 Month Schedule to Healthy Adult HIV Seronegative Volunteers
Status:
COMPLETED
Status Verified Date:
2019-09
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:
GSK has constructed a new HIV immunogen comprised of conserved parts of the HIV virus gag pol and nef The principal objectives of this study are to evaluate the reactogenicity and safety of this candidate vaccine with or without a GSK proprietary adjuvant system at three different doses and to evaluate the CD4 T-cell response in terms of proportion of responders to the antigens two weeks after the second vaccination
Detailed Description:
This is a single center observer-blind randomized dose-escalating staggered study with 6 groups 3 groups of 50 subjects receiving the adjuvanted candidate vaccine at 3 different doses and 3 groups of 10 subjects receiving the non-adjuvanted candidate vaccine in water for injection at 3 different doses The vaccination schedule will be 0-1 month Blood samples will be collected at 8 visits The duration of the study will be approximately 14 months for each subject Rationale for Protocol Posting Amendment The third vaccination will be cancelled and the visit at Month 7 will be postponed to Month 9 The Protocol Posting has also been updated in order to comply with the FDA Amendment Act Sep 2007
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| 2006-003796-12 | EUDRACT_NUMBER | None | None |