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Vaccae

Phase 3

Tuberculosis | Small molecule | Infectious Disease |JIN MEDICAL INTERNATIONAL LTD.|Last Updated: Jun 1, 2018

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment10,000
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01979900Phase III Clinical Study of Efficacy and Safety of Vaccae™ to Prevent TuberculosisPHASE3 COMPLETED 10,000Oct 1, 2013Nov 26, 2017Jun 1, 20184 China
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Study Endpoints
Primary Endpoints
The whole TB incidence after injection of Vaccae
Terminal Stage: two years after the last group of subjects enrolled

Medium-term: one year after the last group of subjects enrolled or after observation of 38 cases of the disease, Terminal Stage: two years after the last group of subjects enrolled or after observation of 76 cases of the disease

Secondary Endpoints
Lesion degree (Bacteriology indicators, cavity) of patients
two years after the last group of subjects enrolled or after observation of 76 cases of the disease
Systemic and local reactions and adverse events
within 30 days after last dosing
The relation between skin test results and paroxysm of TB-PPD
Terminal Stage: two years after the last group of subjects enrolled or after observation of 76 cases of the disease
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
VaccaeEXPERIMENTALExperiment group:One vial of Vaccae diluted with 1.0ml sterile water for injection, take deep coxal muscle injection after shaking well, once every 2 weeks, 6 times totally.
PlaceboPLACEBO_COMPARATORPlacebo group:One vial of placebo diluted with 1.0ml sterile water for injection, take deep coxal muscle injection after shaking well, once every 2 weeks, 6 times totally
Interventions
NameTypeDescription
VaccaeDRUGOne vial of Vaccae diluted with 1.0ml sterile water for injection, take deep coxal muscle injection after shaking well, once every 2 weeks, 6 times totally.
placeboDRUGOne vial of placebo diluted with 1.0ml sterile water for injection, take deep coxal muscle injection after shaking well,once every 2 weeks, 6 times totally.
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Eligibility Criteria
Age Range15 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites4

Inclusion Criteria: * Aged from 15 to 65 years old, all genders. * Skin test of Tuberculin Pure Protein Derivative (TB-PPD) is strongly positive ( the average diameter of PPD skin test induration is greater than or equal to 15mm,and(or)local blisters, necrosis). * Agreed to participate in the test ...

Countries:China
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Competitive Landscape -Tuberculosis 7 trials