Approval Probability
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ACAM2000 Smallpox Vaccine · 1 trial · 1 indication
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 ...
ACAM2000 Smallpox Vaccine is used for the prevention of smallpox, an infectious disease. It is being developed by Emergent BioSolutions Inc. and is currently in Phase 2 clinical development. The vaccine is intended for use in adults, including those previously vaccinated against smallpox.
ACAM2000 Smallpox Vaccine is 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 trials to evaluate the vaccine's safety and efficacy in preventing smallpox.
ACAM2000 Smallpox Vaccine is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. One Phase 2 trial has been completed, involving 357 participants, to assess the vaccine's effects in previously vaccinated adults.
ACAM2000 Smallpox Vaccine has one completed Phase 2 clinical trial registered under NCT00053482, titled 'Dose Study of ACAM2000 Smallpox Vaccine in Previously Vaccinated Adults.' The trial enrolled 357 participants in the United States and was a randomized, double-blind, active-controlled study involving healthy volunteers aged 28 years and older.
ACAM2000 Smallpox Vaccine is classified as a monoclonal antibody modality, according to its development profile. However, it is being studied as a vaccine for smallpox prevention. The ongoing clinical development focuses on its use in adults, including those with prior smallpox vaccination.