Latent Tuberculosis InfectionPhase 4NCT05746611
Phase IV Clinical Study of Recombinant Mycobacterium Tuberculosis Fusion Protein
A Phase 4 study testing Recombinant Mycobacterium tuberculosis fusion protein for injection and TB-PPD was injected in people with Latent Tuberculosis Infection, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. at 1 site in China.
Trial summary
Cohort 1 was a randomized, double-blind, controlled clinical trial with a planned enrollment of 500 patients. Cohort 2 is a non-randomized, open-label clinical trial with a planned enrollment of approximately 60000 patients. Cohort I was injected with EC and TB-PPD in both arms, and cohort II was injected with EC only Read more about this study
- Who is it for?
- Ages 6 months and olderHealthy volunteers can take part
- Conditions the study is for
- Latent Tuberculosis Infection
- What is being tested?
- Recombinant Mycobacterium tuberculosis fusion protein for injection and TB-PPD was injected
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,500 participants
- Where
- 1 siteChina
- Study dates
- 17 Apr 2023to 13 May 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- People aged 6 months and above (≥6 months).
- Normal armpit body temperature (body temperature below 37.5℃ from 6 months to 14 years old, body temperature below 37.3℃ from 15 years old and above).
- I or my guardian agree to participate in this study and sign the informed consent, willing and able to comply with the requirements of this clinical study protocol.
Who cannot join
- Patients with acute infectious diseases (such as measles, pertussis, influenza, pneumonia, etc.), acute eye conjunctivitis, acute otitis media, extensive skin diseases and allergic diseases
- A pure protein derivative or similar product was used within 3 months prior to the initiation of this trial.
- Participated in other new drug clinical trials within 3 months prior to clinical trials.
- Any circumstances were considered by the investigators to have the potential to influence the assessment of the trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention
Liuzhou, Guangxi, 545000
About this study
Official title: To Conduct a Phase IV Clinical Trial of Recombinant Mycobacterium Tuberculosis Fusion Protein in Community Population Aged 6 Months and Above.
Cohort 1 was a randomized, double-blind, controlled clinical trial with a planned enrollment of 500 patients. Cohort 2 is a non-randomized, open-label clinical trial with a planned enrollment of approximately 60000 patients. Cohort I was injected with EC and TB-PPD in both arms, and cohort II was injected with EC only
Read the detailed description
Assessment of effectiveness:
In cohort 1, the injection site reaction was examined at 0min, 24h, 48h and 72h after skin test, and the transverse and longitudinal diameters of the erythema and induration were measured and recorded in millimeters (mm), the larger the erythema or induration. Any blisters, necrosis, lymphangitis should be faithfully recorded.
In cohort 2, the injection site reaction was examined at 0min and 48-72 h after skin test, and the transverse and longitudinal diameters of the erythema and induration were measured and recorded in millimeters (mm), the larger the erythema or induration. Any blisters, necrosis, lymphangitis should be faithfully recorded.
Safety assessments:
The safety assessment included all expected and unexpected medical events that occurred during the observation period of the clinical trial (within 72 hours after the skin test) and were related or unrelated to the injection of the investigational drug. These included specific reactions such as redness, induration, blister, necrosis, and lymphangitis at the injection site (palmar forearm). Common and occasional adverse reactions include:
Local adverse reactions: injection site pruritus, injection site pain, injection site rash;
Systemic adverse reactions included fever, headache, nausea, fatigue, myalgia, diarrhea, vomiting, paresthesia.
- Conditions
- Latent Tuberculosis Infection
- Being tested
- Recombinant Mycobacterium tuberculosis fusion protein for injection, TB-PPD was injected
- Medical subject headings
- Latent Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Mycobacterium tuberculosis fusion protein for injectionBiological
For the suction test, EC0.1ml was injected into the palmar skin of the forearm by the Mondu's method
TB-PPD was injectedBiological
For the aspiration test, 0.1ml TB-PPD was injected into the palmar skin of the forearm by the Mondu's method
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Recombinant Mycobacterium Tuberculosis Fusion Protein (EC):
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.
Purified protein derivative (TB-PPD) :
Dosage form: Injection. Main components and contents: Purified protein derivative of tuberculin 50IU/ml. 0.1ml (5U) of the product was inhaled and injected into the palmar skin of the forearm by the Mondu's method. Receives: Biological: Recombinant Mycobacterium tuberculosis fusion protein for injection; Biological: TB-PPD was injected |
| Cohort 2 | Experimental | Recombinant Mycobacterium Tuberculosis Fusion Protein (EC):
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. Receives: Biological: Recombinant Mycobacterium tuberculosis fusion protein for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
In Cohort 1, the diameter of redness or induration at the reaction site
In cohort 1, the diameter of redness or induration at the reaction site was measured with a scale at 0 minute after skin testing.
Measured: The skin test was performed at 0 minute after injection.
In Cohort 1, the diameter of redness or induration at the reaction site
In cohort 1, the diameter of redness or induration at the reaction site was measured with a scale at 24 hours after skin testing.
Measured: The skin test was performed at 24 hours after injection.
In Cohort 1, the diameter of redness or induration at the reaction site
In cohort 1, the diameter of redness or induration at the reaction site was measured with a scale at 48 hours after skin testing.
Measured: The skin test was performed at 48 hours after injection.
In Cohort 1, the diameter of redness or induration at the reaction site
In cohort 1, the diameter of redness or induration at the reaction site was measured using a scale at 72 hours after skin testing.
Measured: The skin test was performed at 72 hours after injection.
In Cohort 2, the diameter of redness or induration at the reaction site
In cohort 2, the diameter of skin redness or induration at the injection site was measured with a scale at 0 minute after the skin test.
Measured: 0 minute after the skin test
In Cohort 2, the diameter of redness or induration at the reaction site
In cohort 2, the diameter of skin redness or induration at the primary injection site was measured with a scale between 48 and 72 hours after skin testing.
Measured: Within 48 to 72 hours after skin testing
Number of cases in which all adverse events occurred.
Number of cases in which all adverse events occurred within 72 hours after skin testing.
Measured: The skin test was performed 72 hours after injection.
Incidence of SAE
Incidence of SAE within 72 hours after injection
Measured: Incidence of SAE within 72 hours after full vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start17 Apr 2023
- Primary completion13 May 2024
- Study completion13 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Latent Tuberculosis InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 7,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yi Mo, Master, Principal investigator, Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05746611
- Sponsor's protocol ID
- LKM-2022-EC02
- Status last verified
- Sep 2024
- First submitted
- 9 Feb 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen J, Zhao L, Zhou X, Mo Y, Kong L, Ma F, Wu L, Huang D, Yang H, Gong L. Safety and Diagnostic Performance of Recombinant Fusion Protein ESAT6-CPF10 Skin Test in A Large Population: A Phase 4 Clinical Trial. J Infect Dis. 2025 Oct 15;232(4):882-891. doi: 10.1093/infdis/jiaf332.
PubMed 40560769
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Conduct a Phase IV Clinical Trial of Recombinant Mycobacterium Tuberculosis Fusion Protein in Community Population Aged 6 Months and Above.
- ClinicalTrials.gov ID
- NCT05746611
- Acronym / sponsor ID
- LKM-2022-EC02
- Conditions
- Latent Tuberculosis Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,500 participants (actual)
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 13 May 2024 (actual)
- Study completion
- 13 May 2024 (actual)
- First posted
- 28 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cohort 1 was a randomized, double-blind, controlled clinical trial with a planned enrollment of 500 patients. Cohort 2 is a non-randomized, open-label clinical trial with a planned enrollment of approximately 60000 patients. Cohort I was injected with EC and TB-PPD in both arms, and cohort II was injected with EC only
Detailed description
Assessment of effectiveness:
In cohort 1, the injection site reaction was examined at 0min, 24h, 48h and 72h after skin test, and the transverse and longitudinal diameters of the erythema and induration were measured and recorded in millimeters (mm), the larger the erythema or induration. Any blisters, necrosis, lymphangitis should be faithfully recorded.
In cohort 2, the injection site reaction was examined at 0min and 48-72 h after skin test, and the transverse and longitudinal diameters of the erythema and induration were measured and recorded in millimeters (mm), the larger the erythema or induration. Any blisters, necrosis, lymphangitis should be faithfully recorded.
Safety assessments:
The safety assessment included all expected and unexpected medical events that occurred during the observation period of the clinical trial (within 72 hours after the skin test) and were related or unrelated to the injection of the investigational drug. These included specific reactions such as redness, induration, blister, necrosis, and lymphangitis at the injection site (palmar forearm). Common and occasional adverse reactions include:
Local adverse reactions: injection site pruritus, injection site pain, injection site rash;
Systemic adverse reactions included fever, headache, nausea, fatigue, myalgia, diarrhea, vomiting, paresthesia.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: Recombinant Mycobacterium tuberculosis fusion protein for injection, Biological: TB-PPD was injectedRecombinant Mycobacterium Tuberculosis Fusion Protein (EC): 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. Purified protein derivative (TB-PPD) : Dosage form: Injection. Main components and contents: Purified protein derivative of tuberculin 50IU/ml. 0.1ml (5U) of the product was inhaled and injected into the palmar skin of the forearm by the Mondu's method. |
| Cohort 2 | Experimental | Biological: Recombinant Mycobacterium tuberculosis fusion protein for injectionRecombinant Mycobacterium Tuberculosis Fusion Protein (EC): 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. |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- People aged 6 months and above (≥6 months).
- Normal armpit body temperature (body temperature below 37.5℃ from 6 months to 14 years old, body temperature below 37.3℃ from 15 years old and above).
- I or my guardian agree to participate in this study and sign the informed consent, willing and able to comply with the requirements of this clinical study protocol.
Key exclusion criteria (4 listed)
- Patients with acute infectious diseases (such as measles, pertussis, influenza, pneumonia, etc.), acute eye conjunctivitis, acute otitis media, extensive skin diseases and allergic diseases
- A pure protein derivative or similar product was used within 3 months prior to the initiation of this trial.
- Participated in other new drug clinical trials within 3 months prior to clinical trials.
- Any circumstances were considered by the investigators to have the potential to influence the assessment of the trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant Mycobacterium tuberculosis fusion protein for injectionFor the suction test, EC0.1ml was injected into the palmar skin of the forearm by the Mondu's method | Biological | Cohort 1, Cohort 2 |
| TB-PPD was injectedFor the aspiration test, 0.1ml TB-PPD was injected into the palmar skin of the forearm by the Mondu's method | Biological | Cohort 1 |
Primary outcome
In Cohort 1, the diameter of redness or induration at the reaction site
Time frame: The skin test was performed at 0 minute after injection.
In cohort 1, the diameter of redness or induration at the reaction site was measured with a scale at 0 minute after skin testing.
In Cohort 1, the diameter of redness or induration at the reaction site
Time frame: The skin test was performed at 24 hours after injection.
In cohort 1, the diameter of redness or induration at the reaction site was measured with a scale at 24 hours after skin testing.
In Cohort 1, the diameter of redness or induration at the reaction site
Time frame: The skin test was performed at 48 hours after injection.
In cohort 1, the diameter of redness or induration at the reaction site was measured with a scale at 48 hours after skin testing.
In Cohort 1, the diameter of redness or induration at the reaction site
Time frame: The skin test was performed at 72 hours after injection.
In cohort 1, the diameter of redness or induration at the reaction site was measured using a scale at 72 hours after skin testing.
In Cohort 2, the diameter of redness or induration at the reaction site
Time frame: 0 minute after the skin test
In cohort 2, the diameter of skin redness or induration at the injection site was measured with a scale at 0 minute after the skin test.
In Cohort 2, the diameter of redness or induration at the reaction site
Time frame: Within 48 to 72 hours after skin testing
In cohort 2, the diameter of skin redness or induration at the primary injection site was measured with a scale between 48 and 72 hours after skin testing.
Number of cases in which all adverse events occurred.
Time frame: The skin test was performed 72 hours after injection.
Number of cases in which all adverse events occurred within 72 hours after skin testing.
Incidence of SAE
Time frame: Incidence of SAE within 72 hours after full vaccination
Incidence of SAE within 72 hours after injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 40560769Chen J, Zhao L, Zhou X, Mo Y, Kong L, Ma F, Wu L, Huang D, Yang H, Gong L. Safety and Diagnostic Performance of Recombinant Fusion Protein ESAT6-CPF10 Skin Test in A Large Population: A Phase 4 Clinical Trial. J Infect Dis. 2025 Oct 15;232(4):882-891. doi: 10.1093/infdis/jiaf332.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi Mo, Master principal investigator
Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Recombinant Mycobacterium tuberculosis fusion protein for injection and TB-PPD was injected in people with Latent Tuberculosis Infection, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In Cohort 1, the diameter of redness or induration at the reaction site (time frame: The skin test was performed at 0 minute after injection.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05746611, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.