A Phase 3 interventional study of Recombinant Mycobacterium Tuberculosis Fusion Protein and Purified Protein Derivative of Tuberculin in Latent Tuberculosis Infection, sponsored by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.. Completed at 8 sites in China. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-30.
Sponsored by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. (part of Chongqing Zhifei Biological Products Co., Ltd.) · Phase 3, Interventional, and Diagnostic
A multicenter, randomized, blind, controlled trial design was used to select 240 tuberculosis (TB) patients, 120 non-tuberculous community population with other lung diseases, and 420 healthy community population without other lung diseases who met the inclusion criteria of this study. Blood supply specific gamma-interferon (T-SPOT) detection was performed first. Then, EC and Purified Protein derivation of tuberculin (TB-PPD) skin tests were performed on both arms, and the recorded results were observed. The first 24 cases of TB patients, the first 12 cases of non-tuberculous community population with other lung diseases, and the first 42 cases of healthy community population without other lung diseases were included in the trial subgroup. Physical examination, blood routine, urine routine, liver and kidney function, and electrocardiogram tests were required before and 7 days after skin test after study number assignment.
A multicenter, randomized, blind, controlled trial design was adopted in this study. Subjects were enrolled in this clinical study after being qualified by physical examination, vital signs detection (body temperature, blood pressure, pulse and respiration), chest imaging (DR/CT) examination, mycobacterium tuberculosis etiology examination, HIV antibody detection, fasting blood glucose detection, etc.
A total of 240 TB patients, 120 non-tuberculous community people with other lung diseases, and 420 healthy community people without other lung diseases were selected for inclusion in this study. Blood samples were collected for specific gamma-interferon (T-SPOT) detection, and then EC and TB-PPD in the same double arm skin test were used to observe and record the results.
The first 24 cases of TB patients, the first 12 cases of non-tuberculous community population with other lung diseases, and the first 42 cases of healthy community population without other lung diseases were included in the trial subgroup. Physical examination, blood routine, urine routine, liver and kidney function, and electrocardiogram tests were required before and 7 days after skin test after study number assignment.
Vital signs (body temperature, blood pressure, pulse and respiration) were measured 30min and 24h after skin test, and body temperature was measured 48h and 72h after skin test. The skin reaction at the injection site was observed at 0min, 24h, 48h and 72h after skin test.
199 studies on the registry are indexed under Latent Tuberculosis; 48 are open to participants now.
This study's enrollment of 780 is above the median of 300 across 110 interventional studies indexed under Latent Tuberculosis.
Browse Latent Tuberculosis studies →Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. is the lead sponsor of 49 studies on the registry; 4 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The Recombinant Mycobacterium tuberculosis fusion protein(EC) was injected intradermally into the volar side of the left forearm by the Mondu's method. After observing no abnormality for 5 minutes, TB-PPD was injected intradermally into the volar side of the right forearm.
Biological: Recombinant Mycobacterium Tuberculosis Fusion Protein · Biological: Purified Protein Derivative of Tuberculin
The Recombinant Mycobacterium tuberculosis fusion protein(EC) was injected intradermally into the volar side of the right forearm by the Mondu's method. After observing no abnormality for 5 minutes, TB-PPD was injected intradermally into the volar side of the left forearm.
Biological: Recombinant Mycobacterium Tuberculosis Fusion Protein · Biological: Purified Protein Derivative of Tuberculin
Dosage form:injection. Main ingredients and contents: Recombinant Mycobacterium tuberculosis fusion protein, 0.3ml, 0.5ml, 1.0ml per bottle. 1\. This product is used alone: 0.1ml (5U) of this product is inhaled and injected into the palmar skin of the forearm by the Mondu's method. 2. This product combined with TB-PPD: 0.1ml(5U) of this product and 0.1ml(5U) of TB-PPD were inhaled respectively, and the product was injected intradermally into the volar side of the left forearm by the Mondu's method. After observing no abnormality for 5 minutes, TB-PPD was injected intradermally into the volar side of the right forearm.
Also known as: EC
Dosage form:injection. Main ingredients and contents:Pure protein derivatives of tuberculin,0.1ml per bottle. Usage:0.1ml (5IU) of this product is inhaled and injected into the palmar skin of the forearm by the Mondu's method.
Also known as: TB-PPD
Measure the diameter of redness or induration at the reaction site
The diameter of redness or induration at the reaction site was measured with a scale at 0 minute after skin testing. Take the larger one of redness or induration as the measurement result. The average diameter of the reaction (sum of transverse and longitudinal diameters divided by 2) below 5 mm at any point in time is negative. The average diameter of the reaction (sum of transverse and longitudinal diameters divided by 2) of not less than 5 mm at any point in time is positive. Where there are blisters, necrosis, lymphangitis are strong positive reaction.
Time frame: The skin test was performed at 0 minute after injection.
Measure the diameter of redness or induration at the reaction site
The diameter of redness or induration at the reaction site was measured with a scale at 24 hours after skin testing. Take the larger one of redness or induration as the measurement result. The average diameter of the reaction (sum of transverse and longitudinal diameters divided by 2) below 5 mm at any point in time is negative.The average diameter of the reaction (sum of transverse and longitudinal diameters divided by 2) of not less than 5 mm at any point in time is positive. Where there are blisters, necrosis, lymphangitis are strong positive reaction.
Time frame: The skin test was performed at 24 hours after injection.
Measure the diameter of redness or induration at the reaction site
The diameter of redness or induration at the reaction site was measured with a scale at 48 hours after skin testing.Take the larger one of redness or induration as the measurement result. The average diameter of the reaction (sum of transverse and longitudinal diameters divided by 2) below 5 mm at any point in time is negative. The average diameter of the reaction (sum of transverse and longitudinal diameters divided by 2) of not less than 5 mm at any point in time is positive. Where there are blisters, necrosis, lymphangitis are strong positive reaction.
Time frame: The skin test was performed at 48 hours after injection.
Measure the diameter of redness or induration at the reaction site
The diameter of redness or induration at the reaction site was measured with a scale at 72 hours after skin testing.Take the larger one of redness or induration as the measurement result. The average diameter of the reaction (sum of transverse and longitudinal diameters divided by 2) below 5 mm at any point in time is negative. The average diameter of the reaction (sum of transverse and longitudinal diameters divided by 2) of not less than 5 mm at any point in time is positive. Where there are blisters, necrosis, lymphangitis are strong positive reaction.
Time frame: The skin test was performed at 72 hours after injection.
Evaluate the incidence of all adverse events
Incidence of all adverse events within 7 days after skin testing.
Time frame: Incidence of all adverse events within 7 days after injection.
Evaluate the incidence of serious adverse event (SAE)
Incidence of SAE within 28 days after injection
Time frame: Incidence of SAE within 28 days after full vaccination
In subgroup, count the number of patients with changes in clinical significance of blood routine test before skin test compared with that 7 days after skin test
The subgroup included the first 24 cases of TB patients, the first 12 cases of non-tuberculous community population with other lung diseases, and the first 42 cases of healthy community population without other lung diseases. In subgroup, venous blood was collected before skin test for blood routine (3ml) . The number of patients with changes in clinical significance of blood routine before skin test compared with that 7 days after skin test was counted.
Time frame: before injection
In subgroup, count the number of patients with changes in clinical significance of urine routine test before skin test compared with that 7 days after skin test
The subgroup included the first 24 cases of TB patients, the first 12 cases of non-tuberculous community population with other lung diseases, and the first 42 cases of healthy community population without other lung diseases.In subgroup, urine sample was collected before skin test for urine routine (10ml) .The number of patients with changes in clinical significance of urine routine test before skin test compared with that 7 days after skin test was counted.
Time frame: before injection
In subgroup, count the number of patients with changes in clinical significance of liver and kidney function test before skin test compared with that 7 days after skin test
The subgroup included the first 24 cases of TB patients, the first 12 cases of non-tuberculous community population with other lung diseases, and the first 42 cases of healthy community population without other lung diseases.In subgroup, venous blood was collected before skin test for liver and kidney function test (3ml) .The number of patients with changes in clinical significance of liver and kidney function test before skin test compared with that 7 days after skin test test was counted.
Time frame: before injection
In subgroup, count the number of patients with changes in clinical significance of electrocardiogram test before skin test compared with that 7 days after skin test
Electrocardiogram test was performed in subgroup before skin test . The subgroup included the first 24 cases of TB patients, the first 12 cases of non-tuberculous community population with other lung diseases, and the first 42 cases of healthy community population without other lung diseases .The number of patients with changes in clinical significance of electrocardiogram test before skin test compared with that 7 days after skin test was counted.
Time frame: before injection
In subgroup, count the number of patients with changes in clinical significance of blood routine test 7 days after skin test compared with that before skin test
The subgroup included the first 24 cases of TB patients, the first 12 cases of non-tuberculous community population with other lung diseases, and the first 42 cases of healthy community population without other lung diseases. In subgroup, venous blood was collected 7 days after skin test for blood routine (3ml) . The number of patients with changes in clinical significance of blood routine test 7 days after skin test compared with that before skin test was counted.
Time frame: 7days after injection
In subgroup, count the number of patients with changes in clinical significance of urine routine test 7 days after skin test compared with that before skin test
The subgroup included the first 24 cases of TB patients, the first 12 cases of non-tuberculous community population with other lung diseases, and the first 42 cases of healthy community population without other lung diseases. In subgroup, urine sample was collected 7 days after skin test for urine routine (10ml) .The number of patients with changes in clinical significance of urine routine test 7 days after skin test compared with that before skin test was counted.
Time frame: 7days after injection
In subgroup, count the number of patients with changes in clinical significance of liver and kidney function test 7 days after skin test compared with that before skin test
The subgroup included the first 24 cases of TB patients, the first 12 cases of non-tuberculous community population with other lung diseases, and the first 42 cases of healthy community population without other lung diseases. In subgroup, venous blood was collected 7 days after skin test for liver and kidney function test (3ml) .The number of patients with changes in clinical significance of liver and kidney function test 7 days after skin test compared with that before skin test was counted.
Time frame: 7days after injection
In subgroup, count the number of patients with changes in clinical significance of electrocardiogram test 7 days after skin test compared with that before skin test
Electrocardiogram test was performed in subgroup. The subgroup included the first 24 cases of TB patients, the first 12 cases of non-tuberculous community population with other lung diseases, and the first 42 cases of healthy community population without other lung diseases 7 days after skin test.The number of patients with changes in clinical significance of electrocardiogram test 7 days after skin test compared with that before skin test was counted.
Time frame: 7days after injection
Ran from Aug 2023 to primary completion in Jul 2025, 23 months.
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