NCT00389103

Safety Study of MVA Smallpox Vaccine in Subjects With a History of Atopic Dermatitis (AD)

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• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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.

Conditions

• Smallpox
• Atopic Dermatitis

Interventions

Type	Name	Description
BIOLOGICAL	MVA (smallpox vaccine)	0.5ml of MVA3000 Smallpox vaccine, administered twice separated by 28 days, subcutaneous injections

Timeline

• Start date: 2006-10-01
• Primary completion: 2007-01-01
• Completion: 2007-01-01
• First posted: 2006-10-18
• Last updated: 2014-01-22

Locations

3 sites across 1 country: United States