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GSK Biologicals' Candidate Tuberculosis Vaccine

Phase 2

Tuberculosis (TB) | Vaccine | Infectious Disease |GSK plc|Trials Updated: Oct 12, 2020

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment45

FDA Designations

No designations recorded

GSK Biologicals' Candidate Tuberculosis Vaccine clinical trials

GSK Biologicals' Candidate Tuberculosis Vaccine · 1 trial · 2 indications

Phase 2 1
NCT00600782Immunogenicity and Safety of a Candidate Tuberculosis (TB) Vaccine Given to Healthy Adults in a TB-endemic RegionTuberculosis (TB)
COMPLETED45 Analytics
PHASE2COMPLETED
Immunogenicity and Safety of a Candidate Tuberculosis (TB) Vaccine Given to Healthy Adults in a TB-endemic Region
Tuberculosis (TB)Unlock trial analytics

Study Endpoints

Primary Endpoints

Occurrence, intensity and relationship to vaccination of solicited local and general symptoms
During the 7-day follow-up period following vaccination after each vaccine dose
Occurrence, intensity and relationship to vaccination of unsolicited symptoms
During the 30-day follow-up period following vaccination after each vaccine dose
Occurrence and relationship to vaccination of serious adverse events
During the entire study period
Haematological and biochemical levels
At protocol defined time points

Secondary Endpoints

Analysis of cytokine expression by M72-specific CD4+/CD8+ T cells by means of invitro flow cytometry
At protocol defined time points
Antibody titres to M72 measured by ELISA
At protocol defined time points
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group AEXPERIMENTALThese subjects were further stratified into 3 groups according to the size of their PPD skin test reactions

Interventions

NameTypeDescription
GSK Biologicals' Candidate Tuberculosis (TB) Vaccine (692342)BIOLOGICALIntramuscular injection, 2 doses at 0, 1 month
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Eligibility Criteria

Age Range21 Years to 40 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Subjects who the Investigator believes that they can and will comply with the requirements of the protocol. * A male or female between, and including, 21 and 40 years of age at the time of the first vaccination. * Written informed consent obtained from the subject prior to any...

Countries:South Africa
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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 GSK Biologicals' Candidate Tuberculosis Vaccine

What is GSK Biologicals' Candidate Tuberculosis Vaccine?

GSK Biologicals' Candidate Tuberculosis Vaccine is an investigational vaccine developed by GSK plc for the prevention of tuberculosis (TB). It is a Phase 2 candidate in the infectious disease therapeutic area. It has been studied in healthy adult volunteers in a TB-endemic region and is not an approved product.

What is GSK Biologicals' Candidate Tuberculosis Vaccine used for in tuberculosis?

It is being developed for tuberculosis (TB), the infectious disease caused by Mycobacterium tuberculosis. The vaccine is intended for use in healthy adults, including those living in TB-endemic regions. Its development remains at the Phase 2 stage, so it is not available as a licensed vaccine for TB prevention.

Who makes GSK Biologicals' Candidate Tuberculosis Vaccine?

GSK Biologicals' Candidate Tuberculosis Vaccine is developed by GSK plc, which trades under the ticker GSK. GSK Biologicals is the vaccines unit of the company. The candidate carries the internal identifier 692342 and is referred to as Formulation 1 in its trial documentation.

What phase is GSK Biologicals' Candidate Tuberculosis Vaccine in?

GSK Biologicals' Candidate Tuberculosis Vaccine is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by the FDA or any other regulator. One Phase 2 trial has been completed, and no trials of this candidate are currently listed as active.

What clinical trials is GSK Biologicals' Candidate Tuberculosis Vaccine in?

The candidate has been evaluated in one completed Phase 2 trial, NCT00600782, titled Immunogenicity and Safety of a Candidate Tuberculosis (TB) Vaccine Given to Healthy Adults in a TB-endemic Region. The study enrolled 45 healthy adults aged 21 years and older in South Africa and was an uncontrolled, non-randomized trial.