Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00051454
Status:
COMPLETED
Last Update Posted:
2007-08-27
First Post:
2003-01-10
Brief Title:
Evaluation of the Safety of and Immune Response to an HIV Vaccine in Healthy Adults
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomised Placebo-Controlled Double-Blind Phase IIIa Clinical Trial to Evaluate the Safety and Immunogenicity of a Candidate Prophylactic DNA Prime-rFPV Boost HIV Vaccination Strategy
Status:
COMPLETED
Status Verified Date:
2007-08
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:
This study will examine the safety and immune response to a two-part HIV vaccine Healthy volunteers who are at low risk of HIV infection will receive either active vaccine or a placebo
Detailed Description:
The purpose of this study is to examine the safety and immunogenicity of a candidate vaccine strategy for HIV prophylaxis using a DNA-prime plus recombinant fowlpox boost The DNA plasmid and fowlpox vector contain HIV genes However these vaccines contain only some HIV genes and cannot themselves cause HIV or AIDS
Eligible volunteers at low risk of HIV infection will be randomized to receive either active vaccine or placebo injections at Day 0 Week 4 and Week 8 Intensive immunologic and safety monitoring will be done during the first 16 weeks of the study Follow-up will continue to Week 52
Eligible volunteers at low risk of HIV infection will be randomized to receive either active vaccine or placebo injections at Day 0 Week 4 and Week 8 Intensive immunologic and safety monitoring will be done during the first 16 weeks of the study Follow-up will continue to Week 52
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