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GSK Biologicals' Candidate Tuberculosis Vaccine

Phase 2

Tuberculosis (TB) | Monoclonal antibody | Infectious Disease |GSK plc|Last 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

Clinical trial landscape

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)
NCT0060078245
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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 7 trials (matched to "Tuberculosis (TB)")

CompanyTickerTrialsLead PhaseDrugs
Viatris, Inc.VTRS1PHASE3Bedaquiline
Johnson & JohnsonJNJ1PHASE2Bedaquiline, Background Regimen
BioNTech SE Sponsored ADRBNTX1PHASE1BNT164a1, BNT164b1
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