Phase IV Clinical Study of Recombinant Mycobacterium Tuberculosis Fusion Protein

Latent Tuberculosis Infection Clinical Trial

Official title:

To Conduct a Phase IV Clinical Trial of Recombinant Mycobacterium Tuberculosis Fusion Protein in Community Population Aged 6 Months and Above.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05746611
• Other study ID #: LKM-2022-EC02
• Status: Recruiting
• Phase: Phase 4
• Start date: April 17, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: June 2023
• Source: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
• Contact: Yi Mo, Master
• Phone: 13788686968
• Email: moyi0415[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60500
• Est. completion date: June 30, 2025
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Latent Tuberculosis
• Latent Tuberculosis Infection
• Tuberculosis

Intervention

Biological:
• Recombinant Mycobacterium tuberculosis fusion protein for injection
For the suction test, EC0.1ml was injected into the palmar skin of the forearm by the Mondu's method
• TB-PPD was injected
For the aspiration test, 0.1ml TB-PPD was injected into the palmar skin of the forearm by the Mondu's method

Locations

Country	Name	City	State
China	Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention	Liuzhou	Guangxi

Sponsors (1)

Lead Sponsor	Collaborator
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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
Primary	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
Primary	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.
Primary	Incidence of SAE	Incidence of SAE within 72 hours after injection	Incidence of SAE within 72 hours after full vaccination