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Mtb72F/AS02

Phase 2

Tuberculosis (TB) | Monoclonal antibody | Infectious Disease |GSK plc|Trials Updated: May 30, 2017

Mtb72F/AS02 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Feb 2006

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials2
Total Enrollment88

FDA Designations

No designations recorded

Mtb72F/AS02 clinical trials

Mtb72F/AS02 · 2 trials · 1 indication

Phase 2 1Phase 1 1
NCT00146744Safety and Immunogenicity of GSK Biological's Candidate Tuberculosis Vaccine Mtb72F/AS02A in Healthy PPD-positive AdultsTuberculosis (TB)
COMPLETED38 Analytics
PHASE2COMPLETED
Safety and Immunogenicity of GSK Biological's Candidate Tuberculosis Vaccine Mtb72F/AS02A in Healthy PPD-positive Adults
Tuberculosis (TB)Unlock trial analytics

Study Endpoints

Primary Endpoints

Occurrence of solicited symptoms during the 7-day follow-up period, unsolicited symptoms during the 30-day follow-up period, grade 3 vaccine related local and general symptoms during the 30-day follow-up and serious adverse events during the entire study

Secondary Endpoints

Immunogenicity as assessed by humoral and CMI response.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Interventions

NameTypeDescription
Mtb72F/AS02ABIOLOGICAL -
Mtb72F/AS02.BIOLOGICAL -
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

INCLUSION CRITERIA * Written informed consent * Healthy PPD-positive volunteers aged 18 to 50 years * No active pulmonary disease as confirmed by chest X-ray * No history of extrapulmonary TB * Seronegative for HIV 1 and 2, HBsAg, and HCV * Clinically normal laboratory values for creatinine, alanin...

Countries:SwitzerlandBelgium
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Competitive Landscape -Tuberculosis 17 trials (matched to "Tuberculosis (TB)")

Top 2 of 3 competitors

CompanyTickerTrialsLead PhaseDrugs
BioNTech SE Sponsored ADRBNTX1PHASE1BNT164a1, BNT164b1
GSK plc Sponsored ADRGSK1PHASE1Ganfeborole
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Frequently asked questions about Mtb72F/AS02

What is Mtb72F/AS02 used for?

Mtb72F/AS02 is an investigational vaccine candidate developed for the prevention of tuberculosis (TB). It was studied in healthy adult volunteers, including both PPD-negative and PPD-positive individuals, to evaluate its safety and immune response. It is not an approved product and remains in clinical development.

Who is developing Mtb72F/AS02?

Mtb72F/AS02 is being developed by GSK plc, which trades under the ticker GSK. GSK Biologicals, the company's vaccine division, sponsored the clinical trials of this candidate tuberculosis vaccine.

What phase is Mtb72F/AS02 in?

Mtb72F/AS02 has been studied in Phase 1 and Phase 2 clinical trials. Both trials have been completed, and there are currently no active trials of this candidate. It is an investigational vaccine and has not been approved for any indication.

What clinical trials is Mtb72F/AS02 in?

Mtb72F/AS02 has been evaluated in two completed clinical trials. NCT00291889 was a Phase 1 trial in 50 healthy PPD-negative adults in Belgium. NCT00146744 was a Phase 2 trial in 38 healthy PPD-positive adults in Switzerland. Both assessed safety and immunogenicity.