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A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of MVA-BN in a Dose Response Regimen Followed by Administration of Dryvax in Healthy Adult Volunteers
The overall goals of this study are to expand the available data on the safety and immunogenicity of MVA-BN in vaccinia-naive adults and to determine the optimum dose of MVA-BN to induce immune responses and attenuate Dryvax take reactions. Participants will include 90 healthy volunteers, ages 18-32 years. Participants will be randomly assigned to 1 of 6 study groups (groups A-F). Participants will be involved in study related procedures for up to 2 years. During this time, volunteers will return periodically for blood draws to check immune responses.
Details
| Lead sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 91 |
| Start date | 2004-05 |
| Completion | 2007-08 |
Conditions
- Smallpox
Interventions
- Live vaccinia virus vaccine
- MVA Smallpox Vaccine
- MVA Smallpox Vaccine
- Placebo
- Placebo
Primary outcomes
- Adverse Events and side effects to the vaccines. — Reactogenicity will be evaluated for a 2-week period post-vaccination at each time point and for the duration of study.
Countries
United States