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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 smallpox vaccine is used for the prevention of smallpox, an infectious disease caused by the variola virus. It is a live vaccinia virus vaccine that is being studied for use in adults who have not previously received a smallpox vaccination.
ACAM2000 smallpox vaccine is being developed by Emergent BioSolutions Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol EBS. The company is conducting clinical research to evaluate the vaccine's safety and tolerability.
ACAM2000 smallpox vaccine is in Phase 2 clinical development for smallpox. It is an investigational vaccine and has not yet been approved by regulatory authorities. The Phase 2 trial has been completed, and the vaccine remains under clinical investigation.
ACAM2000 smallpox vaccine has one completed Phase 2 clinical trial, identified as NCT00053495. This trial evaluated the effect of dose, safety, and tolerability of the vaccine in 353 healthy adults aged 18 years and older in the United States who had no prior smallpox vaccination.
No, ACAM2000 smallpox vaccine is not a monoclonal antibody. It is a live vaccinia virus vaccine, which is a different modality. The vaccine is designed to elicit an immune response against the variola virus, the causative agent of smallpox.
Yes, the Phase 2 clinical trial for ACAM2000 smallpox vaccine, NCT00053495, was a randomized, double-blind, active-controlled study. It enrolled 353 healthy adult volunteers in the United States to assess the vaccine's safety and tolerability at different doses.