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ACAM3000 MVA Vaccine

Phase 1

Smallpox | Monoclonal antibody | Other |Sanofi|Last Updated: Jan 13, 2014

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment110
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00079820Safety, Tolerability, and Immune Response of ACAM3000 Modified Vaccinia Ankara (MVA) Smallpox Vaccine in AdultsPHASE1 COMPLETED 110Apr 1, 2004Oct 1, 2006Jan 13, 20142 United States
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Study Endpoints
Primary Endpoints
Safety
Study Completion
Secondary Endpoints
Immunogenicity
Study Completion
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
AEXPERIMENTALMVA3000 Smallpox vaccine (1x10-8) with Dryvax Challenge at Day 112
BEXPERIMENTALMVA3000 Smallpox vaccine (1x10-8) with no Challenge
CPLACEBO_COMPARATORPlacebo
DEXPERIMENTALMVA3000 Smallpox vaccine (1x10-7) with Dryvax challenge at Day 112
EEXPERIMENTALMVA3000 Smallpox vaccine (1x10-6) with Dryvax challenge at Day 112
Interventions
NameTypeDescription
ACAM3000 MVA VaccineBIOLOGICALTwo subcutaneous injections of MVA3000 smallpox vaccine, separated by 28 days
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Eligibility Criteria
Age Range18 Years — 31 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: Subjects must meet the following to be eligible for the study: * adult males or females who provided informed consent for the study. * adults 18 and 31 years (inclusive). * good general health, * female subjects must not be pregnant or lactating and be on appropriate contracept...

Countries:United States
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