Clinical trial NCT05746611: Phase IV Clinical Study of Recombinant Mycobacterium Tuberculosis Fusion Protein
Official title: To Conduct a Phase IV Clinical Trial of Recombinant Mycobacterium Tuberculosis Fusion Protein in Community Population Aged 6 Months and Above.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Latent Tuberculosis Infection
Lead sponsor: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-02-28
Enrollment: 7500
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: In Cohort 1, the diameter of redness or induration at the reaction site
timeFrame: The skin test was performed at 0 minute after injection.
measure: In Cohort 1, the diameter of redness or induration at the reaction site
timeFrame: The skin test was performed at 24 hours after injection.
measure: In Cohort 1, the diameter of redness or induration at the reaction site
timeFrame: The skin test was performed at 48 hours after injection.
measure: In Cohort 1, the diameter of redness or induration at the reaction site
timeFrame: The skin test was performed at 72 hours after injection.
measure: In Cohort 2, the diameter of redness or induration at the reaction site
timeFrame: 0 minute after the skin test
measure: In Cohort 2, the diameter of redness or induration at the reaction site
timeFrame: Within 48 to 72 hours after skin testing
measure: Number of cases in which all adverse events occurred.
timeFrame: The skin test was performed 72 hours after injection.
measure: Incidence of SAE
timeFrame: Incidence of SAE within 72 hours after full vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Liuzhou
country: China
facility: Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention
state: Guangxi
Study officials:
affiliation: Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention
name: Yi Mo, Master
role: PRINCIPAL_INVESTIGATOR
References: