Phase II Clinical Clical of the Pure Protein Derivatives of BCG

NCT06975774 | Completed Phase 1

• 1 other identifier: LKM-2021-PPD01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II clinical trial used randomized, double-blind, double-arm intradermal injection, and the same marketed products, selected 30 pulmonary tuberculosis patients aged 18-65 years who met the inclusion criteria and did not meet the exclusion criteria, and conducted the double-arm skin test using BCG-PPD and marketed BCG-PPD controls. During the screening period, the subjects underwent evidence collection of confirmed tuberculosis, physical examination, vital signs, blood routine, urine routine, blood biochemistry, electrocardiogram, chest CT, HIV antibody test, and blood pregnancy examination of women of childbearing age; Vital signs examination before the skin test, The injection site was photographed 0min after the skin test, Vital signs were performed 30min after the skin test; Vital signs were examined, pictures of the injection site was taken, and the injection site reaction was measured; Observe the skin test response, Record the redness, hardening longitudinal diameter and transverse diameter and other related reactions; All adverse events within 72h after the skin test were recorded and safety evaluated.

Conditions

Tuberculosis

Keywords

diagnosis of tuberculosis; epidemiological investigation of tuberculosis

Outcome Measures

Primary Outcomes (2)

• Injection-site reaction endpoint

  Evaluate the occurrence of positive reactions，like the transverse and longitudinal diameter of skin redness, induration, and strong positive reactions in 24 hours necrosis, and lymphangitis between 24 hours and 72 hours after the skin test

  Within 24 hours and 48 hours to 72 hours after the skin test

• Safety endpoint

  The incidence of all adverse events (AES) within 72 hours after drug injection in the subjects;

  Within 72 hours after the skin test

Study Arms (2)

BCG-PPD under test Is applied to the left arm, while the marketed BCG-PPD Is applied to the right

EXPERIMENTAL

Thirty subjects were randomized, double-blinded to perform a homogeneous double-arm BCG-PPD skin test

Drug: Purified Protein Derivative of BCG（BCG-PPD）

BCG-PPD under test Is applied to the right arm, while the marketed BCG-PPD Is applied to the left

EXPERIMENTAL

Thirty subjects were randomized, double-blinded to perform a homogeneous double-arm BCG-PPD skin test

Drug: Purified Protein Derivative of BCG（BCG-PPD）

Interventions

Purified Protein Derivative of BCG（BCG-PPD） DRUG

Thirty subjects were randomized, double-blinded to perform a homogeneous double-arm BCG-PPD skin test.

BCG-PPD under test Is applied to the left arm, while the marketed BCG-PPD Is applied to the right; BCG-PPD under test Is applied to the right arm, while the marketed BCG-PPD Is applied to the left

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject shall be judged as a confirmed tuberculosis patient by a clinician according to Section 5.3.1-5.3.6 of the Health Industry Standards of the People's Republic of China (WS288-2017) (Annex I).(The sampling time can be accepted for the laboratory examination is the examination results of the hospital within 30 days before the skin test);
• Age 18\~65, male or female;
• I agree to participate in this trial and sign the informed consent form;
• I am able to follow the follow-up requirements of the clinical trial protocol for follow-up

You may not qualify if:

• People suffering from acute infectious diseases (such as measles, whooping cough, influenza, pneumonia, etc.), acute ocular conjunctivitis, acute otitis media, extensive skin diseases and allergic constitution;
• Having serious diseases not considered suitable for enrollment by the investigator, such as: advanced tumor, acute onset of chronic obstructive pulmonary disease, acute or progressive liver disease or kidney disease, congestive heart failure, etc.;
• Those treated with immunosuppressants or immune enhancer, or those receiving glucocorticoids, immunoglobulin preparations other than the gastrointestinal tract, or blood products or plasma extracts within 1 month;
• Those who are participating in other new drug clinical trials or have participated in any other new drug clinical trials within 3 months before the clinical trial;
• Women during pregnancy or lactation;
• Patients with mental illness onset period;
• PPD or similar products within 3 months;
• The investigator considered poor compliance, past history, physical examination or laboratory findings.

Sponsors & Collaborators

• Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.: lead
• Shenzhen Third People's Hospital: collaborator

Study Sites (1)

The Third People's Hospital Of Shenzhen

Shenzhen, Guangdong, China

Location

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Lu Shuihua, Bachelor

  Shenzhen Third People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: May 16, 2025
• Study Start: July 26, 2023
• Primary Completion: December 31, 2023
• Study Completion: January 15, 2024
• Last Updated: May 16, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)