An interventional study of Recombinant Mycobacterium Tuberculosis Fusion Protein Tuberculin Skin Test (C-TST) in Latent Tuberculosis Infection (LTBI), sponsored by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.. Completed at 1 site in Indonesia. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-03.
Sponsored by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. (part of Chongqing Zhifei Biological Products Co., Ltd.) · Not applicable, Interventional, and Diagnostic
This is an operational research in household/close contacts of confirmed TB patients to evaluate the effectiveness of C-TST compared to IGRA test in identifying latent TB cases using parameters of effectiveness and safety.
The study is designed as an operational research. After informed consent and screening by evaluation of medical history followed by thorough physical examination and vital signs test (body temperature, blood pressure, pulse rate, and respiration rate) and urine pregnancy test for women of childbearing potential, blood collection will be done in 300 eligible subjects for IGRA test, followed by C-TST skin test. Measure the body temperature of all subjects 30 min after the skin test. Test results will be observed with skin reaction at the injection site 48\~72 h after the skin test. Test results along with presence of adverse events until 7 days follow-up will be recorded. If there are discrepancies in the test result, a T-SPOT test will be conducted after the skin test.
199 studies on the registry are indexed under Latent Tuberculosis; 48 are open to participants now.
This study's enrollment of 300 is close to 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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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.
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.
The study was a prospective, open-label, non-randomized study. All subjects underwent IGRA testing (QFT), followed by C-TST administration. T-SPOT.TB tests were performed only in cases of any discrepancies in the results between C-TST and QFT and were used as part of a composite reference standard. Subjects then underwent blood collection (6 mL venous blood) using lithium-heparin tube for IGRA Quantiferon® testing, followed by administration of 0.1 mL 5 U C-TST intradermally on the palm side of the forearm using Mantoux method on Day 1. Blood collection and administration of C-TST were performed by an authorized site nurse from each site.
Drug: Recombinant Mycobacterium Tuberculosis Fusion Protein Tuberculin Skin Test (C-TST)
The study was a prospective, open-label, non-randomized study. All subjects underwent IGRA testing (QFT), followed by C-TST administration. T-SPOT.TB tests were performed only in cases of any discrepancies in the results between C-TST and QFT and were used as part of a composite reference standard. Subjects then underwent blood collection (6 mL venous blood) using lithium-heparin tube for IGRA Quantiferon® testing, followed by administration of 0.1 mL 5 U C-TST intradermally on the palm side of the forearm using Mantoux method on Day 1. Blood collection and administration of C-TST were performed by an authorized site nurse from each site.
Acceptance rate between C-TST and IGRA test in identifying latent TB infection in household and close contact populations.
The primary outcome is the concordance between C-TST and QuantiFERON-TB (QFT) results. All subjects underwent QFT testing followed by 0.1 mL 5 U C-TST administered intradermally on the forearm using the Mantoux method. In cases of discrepant results between C-TST and QFT, T-SPOT.TB testing was performed as part of a composite reference standard. Concordance will be calculated based on agreement rates between the tests.
Time frame: 7 days after the skin test
Safety endpoints: Incidence of all AEs within 7 days after skin test injection.
1. Overall incidence of AEs; 2. Immediate AEs within 30 minutes after skin test injection; 3. Incidence of AEs related to the investigational product; 4. Incidence of AEs ≥ grade 3; 5. Incidence of AEs ≥ grade 3 related to the investigational product; 6. Incidence of AEs leading to withdrawal; 7. Incidence of AEs related to the investigational product leading to withdrawal; Incidence of all serious adverse events (SAEs) and incidence of SAEs related to the investigational product within 7 days after the skin test.
Time frame: within 7 days after the skin test
Incremental Cost Effectiveness Ratio
On the third visit, subjects will be asked to fill out an acceptability questionnaire. In additional to assess cost-effectiveness, investigator will use primary data obtained from health workers (doctors, nurses, and laboratory workers) as well as cost summary used in laboratories. Other data will be obtained from secondary data and model assumptions.
Time frame: Day 7 after skin test
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2025 to primary completion in Aug 2025, 2 months.
Of 30 interventional studies with no phase under Latent Tuberculosis, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 47. This study's 2 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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