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ACAM 3000 MVA (Acambis Modified Vaccinia Ankara) Immunization Followed by Dryvax® Vaccination of Healthy Vaccinia-Naïve Adults: A Phase I/II, Placebo-Controlled Study of the Effects of Dose and Route of Administration of MVA on Safety, Reactogenicity and Immunogenicity, Followed by Dryvax® Immunization to Assess Effects of MVA Vaccination on Dryvax® Takes
The purpose of this study is to assess the safety of an experimental smallpox vaccine (MVA: Modified Vaccinia Ankara) and to compare the body's immune (system that fights disease) response to this vaccine. Participants will be assigned to 1 of 6 study groups. Each group will include 12 subjects, 10 will receive the modified smallpox vaccine and two will receive placebo, an inactive substance. The vaccine will be administered in 1 of 3 ways: under the skin; in the muscle; or between the muscle and the skin. Groups A and B will receive Dryvax® 6-15 months after the initial MVA vaccine; groups C, D, E, and F will receive Dryvax® 6 months after the initial MVA vaccine. Study procedures will include documenting side effects for 14 days after each vaccination, electrocardiogram (picture of the hearts activity) and blood samples. Participants will be involved in study related procedures for up to 18 months.
Details
| Lead sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | COMPLETED |
| Enrolment | 72 |
| Start date | 2005-10 |
| Completion | 2008-04 |
Conditions
- Smallpox
Interventions
- MVA Smallpox Vaccine
- MVA Smallpox Vaccine
- Placebo
- Placebo
- MVA Smallpox Vaccine
- Live vaccinia virus vaccine
- Placebo
Primary outcomes
- Number of Participants Reporting Moderate or Greater Solicited Local Reactions — 15 days after vaccination
Number of participants reporting moderate or greater local reactions solicited on the memory aid as well as by study personnel at follow up visits after either vaccination. Participants are counted only once but may have experienced symptoms on multiple occasions. - Number of Participants Reporting Moderate or Greater Solicited Systemic Reactions — 15 days after vaccination
Number of participants reporting moderate or greater systemic reactions solicited on the memory aid as well as by study personnel at follow up visits after either vaccination. Participants are counted only once but may have experienced symptoms on multiple occasions. - Number of Participants With Hematologic Laboratory Abnormalities After Vaccination — 28 days after vaccination
Number of participants with hematologic laboratory abnormalities after vaccination, including hemoglobin, white blood cell count, neutrophil count and platelet count. Participants are counted only once for each parameter but may have experienced an abnormality of that parameter on multiple occasions. - Number of Participants With Clinical Chemistry Laboratory Abnormalities After Vaccination — 28 days after vaccination
Number of participants with clinical chemistry laboratory abnormalities after vaccination, including total bilirubin and serum creatinine. Participants are counted only once for each parameter but may have experienced an abnormality of that parameter on multiple occasions. - Number of Participants With Enzymatic Clinical Laboratory Abnormalities After Vaccination — 28 days after vaccination
Number of participants with enzymatic clinical laboratory abnormalities after vaccination, including AST, ALT and alkaline phosphatase. Participants are counted only once for each parameter but may have experienced an abnormality of that parameter on multiple occasions - Number of Participants With Urinalysis Laboratory Abnormalies After Vaccination — 28 days after vaccination
Number of participants with urinalysis laboratory abnormalies after vaccination, including proteinuria and hematuria by dipstick. Participants are counted only once for each parameter but may have experienced an abnormality of that parameter on multiple occasions.
Countries
United States