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AERAS-402

Phase 1

Tuberculosis | Monoclonal antibody | Infectious Disease |Emergent BioSolutions Inc.|Last Updated: Sep 17, 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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01683773Safety Study of Tuberculosis Vaccines AERAS-402 and MVA85APHASE1 COMPLETED 40Sep 1, 2012Aug 1, 2014Sep 17, 20142 United Kingdom
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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 — 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