CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 25 enrolled
Drug / intervention
Placebo +4 morebiological
Likely dose
Placebo 20mgfrom record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03026972
NCT03026972Phase 1Completed
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A Phase ⅠStudy of the Human Body Tolerance Research of the Recombinant Mycobacterium Tuberculosis Vaccine Freeze-dried

Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.·interventional·Posted Jan 20, 2017·Updated Mar 24, 2022

In Brief

A Phase 1 clinical trial evaluating Placebo, Low dose adjuvant, and 3 other interventions for Tuberculosis. Completed, enrolled 25 participants across 1 site.

Detailed Summary

There are four populations in Recombinant Mycobacterium tuberculosis Vaccine Freeze-dried (AEC/BC02) phase I clinical research. The clinical study adopt open research design. Population I have 25 subjects who received Tuberculin purified protein derivative(TB-PPD) skin test and specific gamma-interferon (γ-IFN)detection whose results are both negative ;Population II have 30 subjects who received Tuberculin purified protein derivative(TB-PPD) and ESAT6-CFP10 skin test in different arms , specific gamma-interferon (γ-IFN) detection whose results are all negative.We call polulation III as uninfected TB PPD positve population.This group screened 30 subjects whose ESAT6-CFP10 skin test and specific gamma-interferon (γ-IFN)detection results are both negative,but Tuberculin purified protein derivative(TB-PPD) skin test positive.50 subjects whose three kinds of detection results are all positive γ-IFN,TB-PPD and ESAT6-CFP10 ) are named as population IV. After filtrating, injecting of population I start firstly.After ensure the safety of the population I,the population II～polulation IV carry out in turn the implementation at the same time.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTuberculosis
CountriesChina
CollaboratorsShanghai Public Health Clinical Center, Beijing Simoonrecord Pharmaceutical Information Consulting Co.,Ltd

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 20, 2017
Enrollment StartApr 16, 2018
Primary CompletionSep 4, 2018
Study CompletionOct 30, 2019
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 9.5 years ago

Interventions

Placebobiological

The placebo drug contains 20mg mannitol and 10 millimole(mM) phosphate buffer(PB).population I～population IV are coxal muscle injection of placebo.

Low dose adjuvantbiological

Population I and polulation IV are coxal muscle injection of low dose adjuvant.

High dose adjuvantbiological

Population II ,Population III and Population IV are coxal muscle injection of high dose adjuvant.

Low dose vaccinebiological

Population I and population IV are coxal muscle injection of low dose vaccine.

High dose vaccinebiological

Population II,population III and population IV are coxal muscle injection of high dose vaccine .