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MVA Smallpox vaccine

Phase 2

Smallpox | Small molecule | Infectious Disease |Sanofi|Last Updated: Jan 22, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment590

FDA Designations

No designations recorded

Clinical trial landscape

MVA Smallpox vaccine · 1 trial · 1 indication

Phase 2 1
NCT00466245Phase 2 Study of Safety, Tolerability, and Immunogenicity of Three Dose Levels of ACAM3000 Smallpox VaccineSmallpox
COMPLETED590 Analytics
PHASE2COMPLETED
Phase 2 Study of Safety, Tolerability, and Immunogenicity of Three Dose Levels of ACAM3000 Smallpox Vaccine
SmallpoxUnlock trial analytics

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
AEXPERIMENTALPreviously vaccinated for smallpox, 1x10-8 dose
BEXPERIMENTALSmallpox vaccine naive, 1x10-8 dose
CEXPERIMENTALPrevious smallpox vaccination, 1x10-7 dose
DEXPERIMENTALSmallpox vaccine naive, 1x10-7 dose
EEXPERIMENTALPrevious smallpox vaccination, 1x10-6 dose
FEXPERIMENTALSmallpox vaccine naive, 1x10-6 dose
GEXPERIMENTALPrevious smallpox vaccination, placebo dose
HEXPERIMENTALSmallpox vaccine naive, placebo dose

Interventions

NameTypeDescription
MVA Smallpox vaccineDRUGTwo 0.5mL subcutaneous injections, separated by 28 days
PlaceboDRUGTwo 0.5mL subcutaneous injections, separated by 28 days
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * subjects must be in good general health, checked on toxicity grading table. * for previously vaccinated subjects- must be between the ages of 33 and 55 with a previous vaccine more than 10 years ago. * for vaccine naive subjects- must be between the ages of 18 and 32, and have...

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Frequently asked questions about MVA Smallpox vaccine

What is MVA Smallpox vaccine used for?

MVA Smallpox vaccine is an investigational vaccine being studied for the prevention of smallpox. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities. The vaccine is being evaluated for its safety, tolerability, and immunogenicity in healthy adult volunteers.

Who makes MVA Smallpox vaccine?

MVA Smallpox vaccine is being developed by Sanofi, a multinational pharmaceutical company traded on the stock exchange under the ticker symbol SNY. The company is conducting clinical trials to evaluate the vaccine's potential for preventing smallpox.

What phase is MVA Smallpox vaccine in?

MVA Smallpox vaccine is currently in Phase 2 clinical development. It is an investigational vaccine and has not yet received regulatory approval. The Phase 2 trial has been completed, and the vaccine remains under investigation for its safety and immunogenicity profile.

What clinical trials is MVA Smallpox vaccine in?

MVA Smallpox vaccine has been studied in one completed Phase 2 clinical trial registered as NCT00466245. This trial, titled 'Phase 2 Study of Safety, Tolerability, and Immunogenicity of Three Dose Levels of ACAM3000 Smallpox Vaccine,' enrolled 590 healthy adult volunteers aged 18 years and older.

Is MVA Smallpox vaccine the same as ACAM3000?

Yes, MVA Smallpox vaccine is also known as ACAM3000. The Phase 2 clinical trial NCT00466245 refers to the vaccine as ACAM3000 Smallpox Vaccine, confirming that these names refer to the same investigational vaccine being developed by Sanofi.