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ACAM3000 MVA Vaccine

Phase 1

Smallpox | Vaccine | Infectious Disease |Sanofi|Trials Updated: Jan 13, 2014

ACAM3000 MVA Vaccine development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Mar 2004

ACAM3000 MVA Vaccine target and mechanism

ModalityVaccine

Also known as Dryvax smallpox vaccine

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment110

FDA Designations

No designations recorded

ACAM3000 MVA Vaccine clinical trials

ACAM3000 MVA Vaccine · 1 trial · 1 indication

Phase 1 1
NCT00079820Safety, Tolerability, and Immune Response of ACAM3000 Modified Vaccinia Ankara (MVA) Smallpox Vaccine in AdultsSmallpox
COMPLETED110 Analytics
PHASE1COMPLETED
Safety, Tolerability, and Immune Response of ACAM3000 Modified Vaccinia Ankara (MVA) Smallpox Vaccine in Adults
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
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 to 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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Frequently asked questions about ACAM3000 MVA Vaccine

What is ACAM3000 MVA Vaccine?

ACAM3000 MVA Vaccine is an investigational vaccine developed by Sanofi for protection against smallpox. It is based on Modified Vaccinia Ankara (MVA), a weakened strain of vaccinia virus. The vaccine is designed to stimulate an immune response without using replication-competent vaccinia virus. It has been studied in a Phase 1 clinical trial in healthy adults.

What is ACAM3000 MVA Vaccine used for?

ACAM3000 MVA Vaccine is being developed for the prevention of smallpox, a serious infectious disease caused by the variola virus. Smallpox has been eradicated globally, but the vaccine is intended for use in populations that may be at risk, including those who cannot safely receive traditional smallpox vaccines. It is not yet approved for any indication.

Who makes ACAM3000 MVA Vaccine?

ACAM3000 MVA Vaccine is developed by Sanofi, a global pharmaceutical company. Sanofi trades on the New York Stock Exchange under the ticker symbol SNY. The vaccine is part of Sanofi's infectious disease portfolio.

What phase is ACAM3000 MVA Vaccine in?

ACAM3000 MVA Vaccine is in Phase 1 clinical development. It has completed one Phase 1 trial in the United States. The vaccine is investigational and has not been approved by the FDA or any other regulatory agency for any indication.

What clinical trials is ACAM3000 MVA Vaccine in?

ACAM3000 MVA Vaccine has been evaluated in one completed Phase 1 clinical trial, NCT00079820, titled "Safety, Tolerability, and Immune Response of ACAM3000 Modified Vaccinia Ankara (MVA) Smallpox Vaccine in Adults." The trial enrolled 110 healthy adult volunteers in the United States and was randomized, double-blind, and placebo-controlled.