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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00053482 | Dose Study of ACAM2000 Smallpox Vaccine in Previously Vaccinated Adults | PHASE2 | COMPLETED | 357 | — | — | Jan 1, 2003 | Oct 1, 2003 | Mar 18, 2024 | 3 | United States |
The neutralizing antibody response titers were determined by the Plaque-Reduction Neutralization Test (PRNT50)
| Arm | Type | Description |
|---|---|---|
| Group 1: ACAM2000 | EXPERIMENTAL | Participants will receive dose 1 of the ACAM2000 smallpox vaccine |
| Group 2: ACAM2000 | EXPERIMENTAL | Participants will receive dose 2 of the ACAM2000 smallpox vaccine |
| Group 3: ACAM2000 | EXPERIMENTAL | Participants will receive dose 3 of the ACAM2000 smallpox vaccine |
| Group 4: ACAM2000 | EXPERIMENTAL | Participants will receive dose 4 of the ACAM2000 smallpox vaccine |
| Group 5: Dryvax® | ACTIVE_COMPARATOR | Participants will receive dose 1 of Dryvax® smallpox vaccine. |
| Name | Type | Description |
|---|---|---|
| ACAM2000 Smallpox Vaccine | BIOLOGICAL | Group 1 dose: 1.0x10-8th PFU/ml, Group 2 dose: 2.0x10-7th PFU/ml, Group 3 dose: 1.0x10-7th PFU/ml, Group 4 dose: 5.0x10-6th PFUL/ml |
| Vaccinia virus (calf lymph) smallpox vaccine: Dryvax® | BIOLOGICAL | Group 5 dose: 1.0x10-8th PFU/ml |
Inclusion criteria: * have a history of previous smallpox vaccination greater than 10 years previous to the date of screening and presence of a vaccination scar. * females must not be pregnant, lactating and must agree to use an effective form of birth control for the 30 days following vaccination ...