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ACAM2000 Smallpox Vaccine

Phase 2

Smallpox | Vaccine | Infectious Disease |Emergent BioSolutions Inc.|Trials Updated: Mar 18, 2024

ACAM2000 Smallpox Vaccine development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Jan 2003

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment357

FDA Designations

No designations recorded

ACAM2000 Smallpox Vaccine clinical trials

ACAM2000 Smallpox Vaccine · 1 trial · 1 indication

Phase 2 1
NCT00053482Dose Study of ACAM2000 Smallpox Vaccine in Previously Vaccinated AdultsSmallpox
COMPLETED357 Analytics
PHASE2COMPLETED
Dose Study of ACAM2000 Smallpox Vaccine in Previously Vaccinated Adults
SmallpoxUnlock trial analytics

Study Endpoints

Primary Endpoints

The Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Day 30 post-vaccination

The neutralizing antibody response titers were determined by the Plaque-Reduction Neutralization Test (PRNT50)

Participants With ≥ 4-fold Increase in Plaque-Reduction Neutralization Test (PRNT50) Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine.
Day 30 post-vaccination
Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Days 0 to 30 post-vaccination
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group 1: ACAM2000EXPERIMENTALParticipants will receive dose 1 of the ACAM2000 smallpox vaccine
Group 2: ACAM2000EXPERIMENTALParticipants will receive dose 2 of the ACAM2000 smallpox vaccine
Group 3: ACAM2000EXPERIMENTALParticipants will receive dose 3 of the ACAM2000 smallpox vaccine
Group 4: ACAM2000EXPERIMENTALParticipants will receive dose 4 of the ACAM2000 smallpox vaccine
Group 5: Dryvax®ACTIVE_COMPARATORParticipants will receive dose 1 of Dryvax® smallpox vaccine.

Interventions

NameTypeDescription
ACAM2000 Smallpox VaccineBIOLOGICALGroup 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®BIOLOGICALGroup 5 dose: 1.0x10-8th PFU/ml
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Eligibility Criteria

Age Range28 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites3

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 ...

Countries:United States
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Frequently asked questions about ACAM2000 Smallpox Vaccine

What is ACAM2000 Smallpox Vaccine?

ACAM2000 Smallpox Vaccine is a vaccine developed for protection against smallpox, an infectious disease. It is being developed by Emergent BioSolutions Inc. under the ticker EBS. The vaccine has been studied in a Phase 2 clinical trial in previously vaccinated adults.

What is ACAM2000 Smallpox Vaccine used for?

ACAM2000 Smallpox Vaccine is intended for use against smallpox, a serious infectious disease. Its clinical development has focused on evaluating the vaccine in adults who were previously vaccinated against smallpox, with the goal of supporting protection against the disease.

Who makes ACAM2000 Smallpox Vaccine?

ACAM2000 Smallpox Vaccine is developed by Emergent BioSolutions Inc., which trades under the ticker EBS. The company is the sponsor of the clinical program evaluating the vaccine for smallpox.

What phase is ACAM2000 Smallpox Vaccine in?

ACAM2000 Smallpox Vaccine is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. The program has not been described as approved, so the vaccine remains in clinical development for smallpox.

What clinical trials is ACAM2000 Smallpox Vaccine in?

ACAM2000 Smallpox Vaccine has been studied in one completed Phase 2 trial, NCT00053482, titled Dose Study of ACAM2000 Smallpox Vaccine in Previously Vaccinated Adults. The trial enrolled 357 participants in the United States, was randomized, double blind, and used an active control.