Phase 2 Study of Safety, Tolerability, and Immunogenicity of Three Dose Levels of ACAM3000 Smallpox Vaccine

• Status: Completed
• Trial end date: 2006-06-01
• Target enrollment: 0
• Participant gender: All

Summary

A phase 2 study to assess the MVA smallpox vaccine in previously vaccinated and vaccine- naive subjects at three dose levels.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sanofi Pasteur, a Sanofi Company
• Treatments: Vaccines

Criteria

Inclusion Criteria:

• subjects must be in good general health, checked on toxicity grading table.

• for previously vaccinated subjects- must be between the ages of 33 and 55 with a previous vaccine more than 10 years ago.

• for vaccine naive subjects- must be between the ages of 18 and 32, and have never been vaccinated for smallpox.

• Female subjects must not be pregnant or lactating.

Exclusion Criteria:

• Subjects who participated in a "first responder" program.

• any history of immunodeficiency.

• any autoimmune disease

• any history of cardiac disease

• any diagnosed risk factors for ischemic coronary disease

• any history of heart palpitations or abnormalities in cardiac rhythm.

• any current or history of eczema of any description.

• Known allergy to MVA or any of its components, including eggs or egg products.

• morbid obesity