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MVA85A

Phase 1

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

MVA85A development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Sep 2001

MVA85A target and mechanism

ModalityMonoclonal antibody

Also known as AERAS-485

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

MVA85A clinical trials

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 17 trials

Top 2 of 3 competitors

CompanyTickerTrialsLead PhaseDrugs
BioNTech SE Sponsored ADRBNTX1PHASE1BNT164a1, BNT164b1
GSK plc Sponsored ADRGSK1PHASE1Ganfeborole
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Frequently asked questions about MVA85A

What is MVA85A?

MVA85A is an investigational product being developed for tuberculosis, an infectious disease. It has been studied in a Phase 1 clinical trial conducted in the United Kingdom that enrolled 40 healthy adult volunteers aged 18 years and older. It is not an approved product and remains in clinical development.

What is MVA85A used for in tuberculosis?

MVA85A is being studied for tuberculosis, in a Phase 1 trial that evaluated it alongside the tuberculosis vaccine AERAS-402. The completed study enrolled 40 healthy volunteers in the United Kingdom and assessed safety in adults 18 years and older. MVA85A is investigational and has no approved use.

Who is developing MVA85A?

MVA85A is being developed by Emergent BioSolutions Inc., which trades under the ticker EBS. The company is the developer associated with the Phase 1 program for this tuberculosis candidate.

What phase is MVA85A in?

MVA85A is in Phase 1 clinical development for tuberculosis. One Phase 1 trial has been completed, and no trials are currently active. The program enrolled 40 participants in total. MVA85A is investigational and is not an approved product.

What clinical trials is MVA85A in?

MVA85A has been studied in the Phase 1 trial NCT01683773, titled Safety Study of Tuberculosis Vaccines AERAS-402 and MVA85A. That trial was completed, enrolled 40 healthy volunteers, and was conducted in the United Kingdom. It was a controlled study without randomization or double blinding.

How many people were enrolled in MVA85A trials?

Across its clinical program, MVA85A has enrolled 40 participants in total, all in the completed Phase 1 trial NCT01683773. That study was conducted in the United Kingdom and included healthy volunteers aged 18 years and older.