Randomized, Double-blind, Double-mal Injection, Control Study of Phase II Clinical Dose Calibration of BCG Pure Protein Derivative (BCG-PPD)
概览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Injection-site reaction endpoint
概览
简要总结
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.
详细描述
Prior to the commencement of the study, the Investigator/his authorized officer will contact the subject and/or guardian to enroll the candidate subjects and invite them to participate in the study.Subjects who are eligible for screening receive the drug number in the order they arrive at the random number allocation room.During the screening period, tuberculosis diagnosis evidence collection, physical examination, vital signs, blood routine, urine routine test, blood biochemistry, electrocardiogram, chest CT, HIV antibody test and blood pregnancy examination of women of childbearing age were conducted; after screening, study number (drug number) was assigned, and double arm BCG-PPD skin test with 0.1ml injection. Vital signs should be taken before skin test, injection site photographed 0min and 30min after skin test; vital signs examined, injection site photographed and measured 48-72h after skin test; observe skin test reaction, record red, hard vertical diameter and transverse diameter and other related reactions of skin test; record all adverse events within 72h after skin test and perform safety evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
BCG-PPD under test Is applied to the left arm, while the marketed BCG-PPD Is applied to the right
Thirty subjects were randomized, double-blinded to perform a homogeneous double-arm BCG-PPD skin test
干预措施: Purified Protein Derivative of BCG（BCG-PPD） (Drug)
BCG-PPD under test Is applied to the right arm, while the marketed BCG-PPD Is applied to the left
Thirty subjects were randomized, double-blinded to perform a homogeneous double-arm BCG-PPD skin test
干预措施: Purified Protein Derivative of BCG（BCG-PPD） (Drug)
结局指标
主要结局
Injection-site reaction endpoint
时间窗: Within 24 hours and 48 hours to 72 hours after the skin test
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
Safety endpoint
时间窗: Within 72 hours after the skin test
The incidence of all adverse events (AES) within 72 hours after drug injection in the subjects;
次要结局
未报告次要终点