Ignite Creation Date:
2025-12-24 @ 7:14 PM
Ignite Modification Date:
2025-12-28 @ 4:16 PM
Study NCT ID:
NCT00389103
Status:
WITHDRAWN
Last Update Posted:
2014-01-22
First Post:
2006-10-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of MVA Smallpox Vaccine in Subjects With a History of Atopic Dermatitis (AD)
Sponsor:
Sanofi Pasteur, a Sanofi Company
Organization:
Study Overview
Official Title:
A Phase 1, Placebo-Controlled, Double-Blind Study of the Safety and Immunogenicity of Two Injections of MVA3000 Modified Vaccinia Ankara (MVA) Smallpox Vaccine in Vaccinia Naive Adult Subjects With a History of Atopic Dermatitis (AD)
Status:
WITHDRAWN
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Senior management decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 a history of mild to moderate Atopic Dermatitis.
Detailed Description:
This is a randomized, double-blind, placebo-controlled study. subjects will be randomized to receive investigational vaccine or placebo at a ratio of 3.5:1, MVA3000 to placebo. All subjects will undergo a screening period, a treatment/observation period during which all subjects will receive injections on study day 0 and study day 28 of investigational vaccine or placebo. The clinical observation period will be completed at day 56. A visit will occur at approximately 3 months after the second study injection (study day 118) for additional blood collection and a review of the subject's health status. Follow-up will be obtained via telephone contacts approximately 6 months after the end of the second injection during the treatment/observation period.
Study Oversight
Has Oversight DMC:
True
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?: