Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00282581
Status:
TERMINATED
Last Update Posted:
2014-01-22
First Post:
2006-01-26
Brief Title:
Safety Study of MVA Smallpox Vaccine in HIV-positive Subjects Who Are Vaccinia Naive
Sponsor:
Sanofi Pasteur a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
A Phase 1 Double-Blind Placebo-Controlled Study to Assess the Safety and Immunogenicity of MVA3000 Modified Vaccinia Ankara MVA Smallpox Vaccine in Vaccinia-Naive Human Immunodeficiency Virus HIV-Seropositive Subjects
Status:
TERMINATED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Senior managemnt decision
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 assess the safety and immunogenicity of two MVA smallpox vaccine injections in healthy adults that are 18-35 years of age with HIV infection
Detailed Description:
This is a multi-center study 90 HIV-seropositive subjects There will be an injection of MVA smallpox vaccine or placebo on day 0 and day 28
Subjects will be enrolled and vaccinated in two cohorts according to CD4 cell count levels and number of subjects vaccinated Excluding the screening period the study duration will be approximately 56 days with a follow up safety visit at study day 148 and a telephone health status interview at study day 208
Subjects will be enrolled and vaccinated in two cohorts according to CD4 cell count levels and number of subjects vaccinated Excluding the screening period the study duration will be approximately 56 days with a follow up safety visit at study day 148 and a telephone health status interview at study day 208
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