Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00053495 | Effect of Dose, Safety, Tolerability of a New Smallpox Vaccine in Adults Without Previous Smallpox Vaccination | PHASE2 | COMPLETED | 353 | — | — | Jan 1, 2003 | Nov 1, 2003 | Mar 18, 2024 | 4 | United States |
The severity of each reported adverse event was classified by the investigator according to the following definitions. None - no symptom; Mild - awareness of sign or symptoms, but easily tolerated; Moderate - discomfort enough to cause interference with usual activity; and Severe - incapacitating with inability to work or perform usual activity.
| Arm | Type | Description |
|---|---|---|
| Group 1: ACAM2000 Dose 1 | EXPERIMENTAL | Participants will receive a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units (PFU)/mL on Day 0. |
| Group 2: ACAM2000 Dose 2 | EXPERIMENTAL | Participants will receive a single dose of ACAM2000 smallpox vaccine, 2.0x10-8th plaque-forming units/mL on Day 0. |
| Group 3: ACAM2000 Dose 3 | EXPERIMENTAL | Participants will receive a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0 |
| Group 4: ACAM2000 Dose 4 | EXPERIMENTAL | Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0 |
| Group 5: Dryvax® Vaccine | ACTIVE_COMPARATOR | Participants will receive a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0 |
| Name | Type | Description |
|---|---|---|
| Vaccinia virus: ACAM2000 smallpox vaccine | BIOLOGICAL | Group 1 dose: 1.0x10-8th PFU/ml Group 2 dose: 2.0x10-8th PFU/ml Group 3 dose: 1.0x10-7th PFU/ml Group 4 dose: 5.0x10-6th PFU/ml |
| vaccinia virus (calf lymph): Dryvax | BIOLOGICAL | Group 5 dose: 1.0x10-8th PFU/ml |
Inclusion criteria: * females must not be pregnant, lactating and must agree to use an effective form of birth control for the 30 days following vaccination or unable to bear children. * agree to be available for the entire study and agree to comply with all requirements. Exclusion criteria: * mi...