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MVA85A

Phase 1

Tuberculosis | Monoclonal antibody | Infectious Disease |Emergent BioSolutions Inc.|Last Updated: Sep 17, 2014

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

MVA85A · 1 trial · 1 indication

Phase 1 1
NCT01683773Safety Study of Tuberculosis Vaccines AERAS-402 and MVA85ATuberculosis
COMPLETED40 Analytics
PHASE1COMPLETED
Safety Study of Tuberculosis Vaccines AERAS-402 and MVA85A
TuberculosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety of AERAS-402 followed by MVA85A
3 months after final vaccination

To evaluate the safety profile of multiple doses of AERAS-402 alone, compared to one and two doses of AERAS-402 followed by MVA85A in healthy, BCG vaccinated adults, measured by number and severity of local and systemic adverse events

Secondary Endpoints

Immunogenicity of AERAS-402 followed by MVA85A
12-18 months after first vaccination
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group AEXPERIMENTALTwo doses of AERAS-402 (1x10\^11 vp intramuscular injection) followed by one dose of MVA85A (1x10\^8 pfu intradermal injection)
Group BEXPERIMENTALOne dose of AERAS-402 (1x10\^11 vp intramuscular injection) followed by one dose of MVA85A (1x10\^8 pfu intradermal injection)
Group CEXPERIMENTALThree doses of AERAS-402 (1x10\^11 vp intramuscular injection)

Interventions

NameTypeDescription
AERAS-402BIOLOGICALIntramuscular needle injection 1x10\^11 vp
MVA85ABIOLOGICALIntradermal needle injection 1x10\^8 pfu
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: Subjects must meet all of the following criteria to enter the trial: * Healthy adult aged 18-55 years * Resident in or near Oxford (for CCVTM) or Birmingham (for WTCRF; and able to travel to Oxford for vaccinations) for the duration of the trial period * No relevant findings in...

Countries:United Kingdom
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Competitive Landscape -Tuberculosis 7 trials

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