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ACAM2000 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Vaccination | OTHER | This study was a single arm study. All eligible subjects received ACAM2000. |
| Name | Type | Description |
|---|---|---|
| ACAM2000 | BIOLOGICAL | Percutaneous administration of a droplet (2.5µg) of ACAM2000 using a bifurcated needle. |
Inclusion Criteria: * Signed written informed consent. * Age 18 - 65 years. * Normal and healthy as determined by medical history, physical exam, vital signs and clinical laboratory tests at screening visit. * Subject must meet all required subject suitability criteria that pertain to normal Source...
ACAM2000 is a monoclonal antibody being studied for the treatment of Smallpox Vaccine Adverse Reaction, a condition that can occur as a complication of smallpox vaccination. It is currently in Phase 3 clinical development as an investigational therapy for this indication.
ACAM2000 is a monoclonal antibody, but its specific molecular target has not been disclosed. It is being investigated for its potential to treat adverse reactions to the smallpox vaccine, though the exact mechanism of action has not been publicly detailed.
ACAM2000 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 on this investigational therapy for Smallpox Vaccine Adverse Reaction.
ACAM2000 is currently in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 trial for this therapy has been completed, and it remains under evaluation for the treatment of Smallpox Vaccine Adverse Reaction.
ACAM2000 has one completed Phase 3 clinical trial registered as NCT01158157, titled 'VA-006 Vaccinia Vaccine (ACAM2000) for the Production of VIGIV'. This trial enrolled 25 participants in the United States, including healthy volunteers aged 18 years and older, and was not randomized or blinded.
ACAM2000 is not the same as VIGIV. The clinical trial NCT01158157 uses ACAM2000, a vaccinia vaccine, to stimulate production of VIGIV, which is Vaccinia Immune Globulin Intravenous. ACAM2000 is the vaccine administered to healthy volunteers to generate antibodies for VIGIV production.