Recent Updates
Recently added Catalysts

MVA Smallpox vaccine

Phase 2

Smallpox | Vaccine | Infectious Disease |Sanofi|Trials Updated: Jan 22, 2014

MVA Smallpox vaccine development status

Highest phase Phase 2
Registered trials 9 across 2 sponsors since May 2004

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment590

FDA Designations

No designations recorded

MVA Smallpox vaccine clinical trials

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
Unlock Study Endpoints

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
Unlock Study Design Details

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...

Unlock Eligibility Criteria

Frequently asked questions about MVA Smallpox vaccine

What is MVA Smallpox vaccine?

MVA Smallpox vaccine is an investigational vaccine being developed for protection against smallpox, an infectious disease caused by the variola virus. It is a modified vaccinia Ankara (MVA) based vaccine candidate. Sanofi is developing this vaccine, which has been studied in a Phase 2 clinical trial.

What is MVA Smallpox vaccine used for?

MVA Smallpox vaccine is intended for the prevention of smallpox. It is designed to induce an immune response against the variola virus. The vaccine is being developed by Sanofi and has completed a Phase 2 trial in healthy volunteers.

Who makes MVA Smallpox vaccine?

MVA Smallpox vaccine is being developed by Sanofi, a global pharmaceutical company. Sanofi trades on the New York Stock Exchange under the ticker symbol SNY. The vaccine candidate is part of Sanofi's infectious disease portfolio.

What phase is MVA Smallpox vaccine in?

MVA Smallpox vaccine is in Phase 2 of clinical development. A Phase 2 trial has been completed, but the vaccine is not yet approved. It remains an investigational product and further studies would be needed to support potential regulatory approval.

What clinical trials is MVA Smallpox vaccine in?

MVA Smallpox vaccine has been evaluated in a completed Phase 2 clinical trial, NCT00466245. This study assessed the safety, tolerability, and immunogenicity of three dose levels of the ACAM3000 Smallpox Vaccine. It enrolled 590 healthy volunteers aged 18 years and older and was randomized, double-blind, and controlled.