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Phase II Clinical Clical of the Pure Protein Derivatives of BCG

NCT06975774 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-05-16

No results posted yet for this study

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

Interventions

DRUG

Purified Protein Derivative of BCG（BCG-PPD）

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

Sponsors & Collaborators

  • Shenzhen Third People's Hospital

    collaborator OTHER

  • Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Lu Shuihua, Bachelor · Shenzhen Third People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-26
Primary Completion
2023-12-31
Completion
2024-01-15

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06975774 on ClinicalTrials.gov