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Vaccinia virus: ACAM2000 smallpox vaccine · 1 trial · 1 indication
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...
ACAM2000 is a smallpox vaccine developed by Emergent BioSolutions Inc. (ticker: EBS). It is intended for active immunization against smallpox, an infectious disease caused by the variola virus. The vaccine was studied in adults without previous smallpox vaccination.
ACAM2000 is developed by Emergent BioSolutions Inc., which trades under the ticker EBS. The company is the sponsor of the clinical development program for this smallpox vaccine candidate.
ACAM2000 has completed a Phase 2 clinical trial. It is an investigational vaccine still in clinical development, and the available information does not indicate FDA approval. The completed study enrolled 353 participants.
ACAM2000 was evaluated in one completed Phase 2 trial, NCT00053495, titled "Effect of Dose, Safety, Tolerability of a New Smallpox Vaccine in Adults Without Previous Smallpox Vaccination." The randomized, double-blind, active-controlled study enrolled 353 healthy adult volunteers aged 18 years and older in the United States.
The Phase 2 trial NCT00053495 was a randomized, double-blind, active-controlled study of ACAM2000 in adults without previous smallpox vaccination. It enrolled 353 healthy volunteers aged 18 years and older across sites in the United States and has been completed.