Phase IV Clinical Study of Recombinant Mycobacterium Tuberculosis Fusion Protein

NCT05746611 | Completed Phase 4

• 1 other identifier: LKM-2022-EC02
• Study Type: interventional
• Target: 7,500
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Latent Tuberculosis Infection

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  The skin test was performed 72 hours after injection.

• Incidence of SAE

  Incidence of SAE within 72 hours after injection

  Incidence of SAE within 72 hours after full vaccination

Study Arms (2)

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.

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.

Biological: Recombinant Mycobacterium tuberculosis fusion protein for injection

Interventions

Recombinant Mycobacterium tuberculosis fusion protein for injection BIOLOGICAL

For the suction test, EC0.1ml was injected into the palmar skin of the forearm by the Mondu's method

Cohort 1; Cohort 2

TB-PPD was injected BIOLOGICAL

For the aspiration test, 0.1ml TB-PPD was injected into the palmar skin of the forearm by the Mondu's method

Cohort 1

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.: lead

Study Sites (1)

Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention

Liuchow, Guangxi, 545000, China

Location

Related Publications (1)

• 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.

  PMID: 40560769 DERIVED

MeSH Terms

Conditions

Latent Tuberculosis

Interventions

Injections

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Yi Mo, Master

  Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: February 28, 2023
• Study Start: April 17, 2023
• Primary Completion: May 13, 2024
• Study Completion: May 13, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CN (1)