To Conduct a Phase IV Clinical Trial of Recombinant Mycobacterium Tuberculosis Fusion Protein in Community Population Aged 6 Months and Above.
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 60,500
- 试验地点
- 1
- 主要终点
- In Cohort 2, the diameter of redness or induration at the reaction site
研究概览
简要总结
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
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Cohort 1
Recombinant Mycobacterium Tuberculosis Fusion Protein (EC):
Dosage form: injection. Main ingredients and contents: Recombinant Mycobacterium tuberculosis fusion protein, 0.3ml, 0.5ml, 1.0ml per bottle.
- This product is used alone: 0.1ml (5U) of this product is inhaled and injected into the palmar skin of the forearm by the Mondu's method. 2. This product combined with TB-PPD: 0.1ml(5U) of this product and 0.1ml(5U) of TB-PPD were inhaled respectively, and the product was injected intradermally into the volar side of the left forearm by the Mondu's method. After observing no abnormality for 5 minutes, TB-PPD was injected intradermally into the volar side of the right forearm.
Purified protein derivative (TB-PPD) :
Dosage form: Injection. Main components and contents: Purified protein derivative of tuberculin 50IU/ml. 0.1ml (5U) of the product was inhaled and injected into the palmar skin of the forearm by the Mondu's method.
干预措施: Recombinant Mycobacterium tuberculosis fusion protein for injection (Biological)
Cohort 1
Recombinant Mycobacterium Tuberculosis Fusion Protein (EC):
Dosage form: injection. Main ingredients and contents: Recombinant Mycobacterium tuberculosis fusion protein, 0.3ml, 0.5ml, 1.0ml per bottle.
- This product is used alone: 0.1ml (5U) of this product is inhaled and injected into the palmar skin of the forearm by the Mondu's method. 2. This product combined with TB-PPD: 0.1ml(5U) of this product and 0.1ml(5U) of TB-PPD were inhaled respectively, and the product was injected intradermally into the volar side of the left forearm by the Mondu's method. After observing no abnormality for 5 minutes, TB-PPD was injected intradermally into the volar side of the right forearm.
Purified protein derivative (TB-PPD) :
Dosage form: Injection. Main components and contents: Purified protein derivative of tuberculin 50IU/ml. 0.1ml (5U) of the product was inhaled and injected into the palmar skin of the forearm by the Mondu's method.
干预措施: TB-PPD was injected (Biological)
Cohort 2
Recombinant Mycobacterium Tuberculosis Fusion Protein (EC):
Dosage form: injection. Main ingredients and contents: Recombinant Mycobacterium tuberculosis fusion protein, 0.3ml, 0.5ml, 1.0ml per bottle.
- This product is used alone: 0.1ml (5U) of this product is inhaled and injected into the palmar skin of the forearm by the Mondu's method. 2. This product combined with TB-PPD: 0.1ml(5U) of this product and 0.1ml(5U) of TB-PPD were inhaled respectively, and the product was injected intradermally into the volar side of the left forearm by the Mondu's method. After observing no abnormality for 5 minutes, TB-PPD was injected intradermally into the volar side of the right forearm.
干预措施: Recombinant Mycobacterium tuberculosis fusion protein for injection (Biological)
结局指标
主要结局
In Cohort 2, the diameter of redness or induration at the reaction site
时间窗: Within 48 to 72 hours after skin testing
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.
Number of cases in which all adverse events occurred.
时间窗: The skin test was performed 72 hours after injection.
Number of cases in which all adverse events occurred within 72 hours after skin testing.
In Cohort 1, the diameter of redness or induration at the reaction site
时间窗: The skin test was performed at 72 hours after injection.
In cohort 1, the diameter of redness or induration at the reaction site was measured using a scale at 72 hours after skin testing.
Incidence of SAE
时间窗: Incidence of SAE within 72 hours after full vaccination
Incidence of SAE within 72 hours after injection
次要结局
未报告次要终点