Clinical Study of Recombinant Mycobacterium Tuberculosis ESAT6-CFP10 Allergen for Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

In this clinical research,48 cases TB (Tuberculosis patients) participants and 48 cases non-TB participants with lung disease who all meet the standard are divided into different groups through a randomized and blind method. Every subject inject intradermally ESAT6-CFP10 and TB-PPD (tuberculin purified protein derivative) in different arms of the same person by blind method. Specific gama-interferon (γ-IFN) detection is needed before the injection.Measure the induration and (or) redness of longitudinal diameter size and transverse diameter vernier caliper by vernier caliper after injection 24h, 48h and 72h. At the same time, we observe all kind of adverse events in order to assess the safety of drug.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical Study of Recombinant Mycobacterium Tuberculosis ESAT6-CFP10 Allergen

NCT02623556

Tuberculosis

COMPLETED PHASE3

Phase IIb Clinical Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10

NCT02336542

Tuberculosis

COMPLETED PHASE2

Phase IIa Clinical Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10

NCT02329730

Tuberculosis

COMPLETED PHASE2

Phase IIb Clinical Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 on Healthy People Aged 18-65

NCT02389322

Tuberculosis

COMPLETED PHASE2

Clinical Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 on Healthy People Aged 18-65(III-healthy)

NCT02795260

Tuberculosis

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In this clinical research,we make sure of the safety in the crowd 5-18 years old firstly,then carry out the crowd of under 5 years old(including 5).

Firstly, 24 cases TB (Tuberculosis) participants and 24 cases non-TB participants with lung disease who are all 5-18 years old and meet the standard respectively are divided into different groups through a randomized and blind method.

1. ESAT6-CFP10(10ug/ml) in left arm and TB-PPD in right arm
2. ESAT6-CFP10(10ug/ml) in right arm and TB-PPD in left arm Inject intradermally ESAT6-CFP10 and TB-PPD in different arms of the same participant. For each of participant, the person in this clinical research, the study uniform is that every subject injects firstly left arm, observe no obvious adverse reaction, then another drug inject in right arm. Measure the induration and (or) redness of longitudinal diameter size and transverse diameter vernier caliper by vernier caliper after injection 24h, 48h and 72h. At the same time, we observe the vital signs (breathing, heart rate, blood pressure and temperature), local reactions (rash, pain, itching and skin mucous membrane) and a variety of adverse events.

Secondly, 24 cases TB (Tuberculosis) participants and 24 cases non-TB participants with lung disease who are all less than 5 years old are divided into two different groups and the procedure are as the same as 5-18 years old.

Finally, we calculate the sensitivity (positive coincidence rate) by TB (Tuberculosis patients), the specificity (negative coincidence rate) by non-TB participants with lung disease, and verify the safety and effectiveness of ESAT6-CFP10(10ug/ml) for the clinical auxiliary diagnosis of tuberculosis.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tuberculosis Diagnosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TB subjects in 5-18 years old

24 cases TB subjects in 5-18 years old are injected ESAT6-CFP10 in left arm and TB-PPD in right arm or ESAT6-CFP10 in right arm and TB-PPD in left arm. For each of participant,the person in this clinical research, the study uniform is that every subject injects firstly left arm, observe no obvious adverse reaction, then another drug inject in right arm. Measure the induration and (or) redness of longitudinal diameter size and transverse diameter vernier caliper by vernier caliper after injection 24h, 48h and 72h.

Group Type EXPERIMENTAL

ESAT6-CFP10 in left arm and TB-PPD in right arm

Intervention Type BIOLOGICAL

All subjects including TB subjects in 5-18 years old、non-TB subjects in 5-18 years old、TB subjects under 5 years old and non-TB subjects under 5 years old inject ESAT6-CFP10 in left arm and TB-PPD in right arm respectively. Two drug must use at the same participant and in different arms.

ESAT6-CFP10 in right arm and TB-PPD in left arm

Intervention Type BIOLOGICAL

All subjects including TB subjects in 5-18 years old、non-TB subjects in 5-18 years old、TB subjects under 5 years old and non-TB subjects under 5 years old inject ESAT6-CFP10 in right arm and TB-PPD in left arm respectively. Two drug must use at the same participant and in different arms.

non-TB subjects in 5-18 years old

24 cases non-TB subjects in 5-18 years old are injected ESAT6-CFP10 in left arm and TB-PPD in right arm or ESAT6-CFP10 in right arm and TB-PPD in left arm. For each of participant,the person in this clinical research, the study uniform is that every subject injects firstly left arm, observe no obvious adverse reaction, then another drug inject in right arm. Measure the induration and (or) redness of longitudinal diameter size and transverse diameter vernier caliper by vernier caliper after injection 24h, 48h and 72h.

Group Type EXPERIMENTAL

ESAT6-CFP10 in left arm and TB-PPD in right arm

Intervention Type BIOLOGICAL

All subjects including TB subjects in 5-18 years old、non-TB subjects in 5-18 years old、TB subjects under 5 years old and non-TB subjects under 5 years old inject ESAT6-CFP10 in left arm and TB-PPD in right arm respectively. Two drug must use at the same participant and in different arms.

ESAT6-CFP10 in right arm and TB-PPD in left arm

Intervention Type BIOLOGICAL

All subjects including TB subjects in 5-18 years old、non-TB subjects in 5-18 years old、TB subjects under 5 years old and non-TB subjects under 5 years old inject ESAT6-CFP10 in right arm and TB-PPD in left arm respectively. Two drug must use at the same participant and in different arms.

TB subjects under 5 years old

24 cases TB subjects under 5 years old are injected ESAT6-CFP10 in left arm and TB-PPD in right arm or ESAT6-CFP10 in right arm and TB-PPD in left arm. For each of participant,the person in this clinical research, the study uniform is that every subject injects firstly left arm, observe no obvious adverse reaction, then another drug inject in right arm. Measure the induration and (or) redness of longitudinal diameter size and transverse diameter vernier caliper by vernier caliper after injection 24h, 48h and 72h.

Group Type EXPERIMENTAL

ESAT6-CFP10 in left arm and TB-PPD in right arm

Intervention Type BIOLOGICAL

All subjects including TB subjects in 5-18 years old、non-TB subjects in 5-18 years old、TB subjects under 5 years old and non-TB subjects under 5 years old inject ESAT6-CFP10 in left arm and TB-PPD in right arm respectively. Two drug must use at the same participant and in different arms.

ESAT6-CFP10 in right arm and TB-PPD in left arm

Intervention Type BIOLOGICAL

All subjects including TB subjects in 5-18 years old、non-TB subjects in 5-18 years old、TB subjects under 5 years old and non-TB subjects under 5 years old inject ESAT6-CFP10 in right arm and TB-PPD in left arm respectively. Two drug must use at the same participant and in different arms.

non-TB subjects under 5 years old

24 cases non-TB subjects under 5 years old are injected ESAT6-CFP10 in left arm and TB-PPD in right arm or ESAT6-CFP10 in right arm and TB-PPD in left arm. For each of participant,the person in this clinical research, the study uniform is that every subject injects firstly left arm, observe no obvious adverse reaction, then another drug inject in right arm. Measure the induration and (or) redness of longitudinal diameter size and transverse diameter vernier caliper by vernier caliper after injection 24h, 48h and 72h.

Group Type EXPERIMENTAL

ESAT6-CFP10 in left arm and TB-PPD in right arm

Intervention Type BIOLOGICAL

All subjects including TB subjects in 5-18 years old、non-TB subjects in 5-18 years old、TB subjects under 5 years old and non-TB subjects under 5 years old inject ESAT6-CFP10 in left arm and TB-PPD in right arm respectively. Two drug must use at the same participant and in different arms.

ESAT6-CFP10 in right arm and TB-PPD in left arm

Intervention Type BIOLOGICAL

All subjects including TB subjects in 5-18 years old、non-TB subjects in 5-18 years old、TB subjects under 5 years old and non-TB subjects under 5 years old inject ESAT6-CFP10 in right arm and TB-PPD in left arm respectively. Two drug must use at the same participant and in different arms.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ESAT6-CFP10 in left arm and TB-PPD in right arm

All subjects including TB subjects in 5-18 years old、non-TB subjects in 5-18 years old、TB subjects under 5 years old and non-TB subjects under 5 years old inject ESAT6-CFP10 in left arm and TB-PPD in right arm respectively. Two drug must use at the same participant and in different arms.

Intervention Type BIOLOGICAL

ESAT6-CFP10 in right arm and TB-PPD in left arm

All subjects including TB subjects in 5-18 years old、non-TB subjects in 5-18 years old、TB subjects under 5 years old and non-TB subjects under 5 years old inject ESAT6-CFP10 in right arm and TB-PPD in left arm respectively. Two drug must use at the same participant and in different arms.

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* judge the pulmonary tuberculosis patient ,according to Chinese Medical Association branch of pediatrics breathing group: Tuberculosis Clinical Diagnostic Criteria and Treatment Programs for Child (trial) ;
* less than 18 years old ,no gender limited;
* Consent and signed informed consent forms (ICF) by the subject or the guardian;
* The subject or with the help of guardian(s) comply with follow-up.

* Diagnosed extra pulmonary tuberculosis by epidemiology, imaging, clinical symptoms, pathological examination and so on;
* Lesions outside the lungs;
* be in unfinished reinforced phase by chemotherapy;

* A clear respiratory disease but can exclude pulmonary tuberculosis by clinical symptoms, imaging, laboratory examination.
* less than 18 years old ,no gender limited;
* Consent and signed informed consent forms (ICF) by the subject or the guardian;
* The subject or with the help of guardian(s) comply with follow-up.

Exclusion Criteria

* Accompanied by the following severe illness: cancer, acute/progressive liver disease or kidney disease,autoimmune disease，diabetes, primary immunodeficiency diseases, other chronic diseases;
* Taking part in other clinical or within three months involved in any other clinical;
* Severe allergic constitution or familial history of allergy:allergic to two or more drugs;
* in pregnancy or lactation;
* in a mental illness;
* Any conditions affect the trial evaluation by investigator's judgement.

* Accompanied by the following severe illness: cancer, acute/progressive liver disease or kidney disease,autoimmune disease，diabetes, primary immunodeficiency diseases, other chronic diseases， ect;
* Taking part in other clinical or within three months involved in any other clinical;
* Severe allergic constitution or familial history of allergy: allergic to two or more drugs;
* in pregnancy or lactation;
* in a mental illness;
* active tuberculosis close contactor;
* Any conditions affect the trial evaluation by investigator's judgement.

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No