Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00252148
Status:
COMPLETED
Last Update Posted:
2013-02-11
First Post:
2005-11-09
Brief Title:
Safety and Immunogenicity of a Modified Vaccinia Ankara MVA HIV Vaccine in HIV Uninfected Adults
Sponsor:
International AIDS Vaccine Initiative
Organization:
International AIDS Vaccine Initiative
Study Overview
Official Title:
Randomized Placebo-Controlled Dose-Escalating Double-Blinded Phase 1 Safety and Immunogenicity Study of a Modified Vaccinia Ankara MVA Vectored HIV-1 ADMVA Vaccine Administered Intramuscularly to HIV-Uninfected Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2010-06
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 determine the safety of an immune response to an investigational HIV vaccine ADMVA at three different dosage levels in adults who are not infected with HIV
Detailed Description:
This is a dose escalation trial Study site staff and volunteers will be blinded Blinding will not apply to the assignment of dose levels low middle or high
Volunteers will be screened up to 42 days before enrolment and will be followed for 18 months after the first vaccination
16 volunteers will be randomized in a 31 ratio of active vaccine to placebo Safety and tolerability of the ADMVA vaccineplacebo will be evaluated at least 14 days after the 12th volunteer in the low dose group receives the second injection before proceeding to the middle dose group
Volunteers will be screened up to 42 days before enrolment and will be followed for 18 months after the first vaccination
16 volunteers will be randomized in a 31 ratio of active vaccine to placebo Safety and tolerability of the ADMVA vaccineplacebo will be evaluated at least 14 days after the 12th volunteer in the low dose group receives the second injection before proceeding to the middle dose group
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