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Mtb72F/AS02

Phase 2

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

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

Clinical trial landscape

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 7 trials (matched to "Tuberculosis (TB)")

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Frequently asked questions about Mtb72F/AS02

What is Mtb72F/AS02 used for?

Mtb72F/AS02 is an investigational vaccine candidate being developed for the prevention of tuberculosis (TB). It is currently in clinical development and has not been approved by regulatory authorities. The vaccine is designed to be administered to healthy adults, as studies have enrolled healthy volunteers to assess its safety and immunogenicity.

Who makes Mtb72F/AS02?

Mtb72F/AS02 is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The company has conducted clinical trials to evaluate the safety and immunogenicity of this tuberculosis vaccine candidate in healthy adult populations.

What phase is Mtb72F/AS02 in?

Mtb72F/AS02 is in Phase 2 clinical development. It has completed two clinical trials, one Phase 2 study and one Phase 1 study, both of which have been completed. The vaccine remains investigational and is not yet approved for use outside of clinical research settings.

What clinical trials is Mtb72F/AS02 in?

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

How does Mtb72F/AS02 work?

Mtb72F/AS02 is a vaccine candidate that combines the Mtb72F antigen with the AS02 adjuvant system. The antigen is designed to stimulate an immune response against Mycobacterium tuberculosis, the bacterium that causes tuberculosis. The AS02 adjuvant is intended to enhance the body's immune response to the antigen.