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目的:通过Ⅰ期临床研究探讨无细胞耻垢分枝杆菌疫苗(M.S疫苗)的人群安全性和耐受性,并初步观察该疫苗对结核病高危人群皮试反应强度的影响。方法:给55例健康志愿者注射不同剂量的疫苗(8.7,17.5和35.0μg),每例注射6次,每2周注射1次。通过对受试者的随访、心率和血压测试、血液常规、尿液常规、肝功能、胸部X-片以及肝、胆、脾、胰的B超检查以及PPD皮肤试验,评估M.S疫苗的不良反应,并比较疫苗注射前后PPD反应强度的变化。结果:在55例、330例次M.S疫苗注射过程中,发生14例、17例次的轻度不良反应,包括局部疼痛、淋巴结肿大、发热、局部硬结、心慌、皮疹和乏力,轻度不良反应总发生率为25.5%(14/55),未发生中度及重度不良反应;PPD皮试强阳性者经不同剂量M.S疫苗的注射,PPD皮试反应强度均显著降低(P<0.05)。结论:M.S疫苗具有较高安全性,并可显著降低结核病高危人群PPD皮试反应的强度。
Objective: To investigate the safety and tolerability of the cell-free Mycobacterium smegmatis vaccine (M.S vaccine) in Phase Ⅰ clinical trials and to observe the effect of the vaccine on the test-reactivity of high-risk TB patients. Methods: 55 healthy volunteers were injected with different doses of vaccine (8.7, 17.5 and 35.0μg), 6 times for each injection and once every 2 weeks. Adverse reactions to MS vaccine were assessed by follow-up of subjects, heart rate and blood pressure tests, blood routine, urine routine, liver function, chest radiographs, and B-ultrasound of liver, gallbladder, spleen and pancreas and PPD skin test , And compare the changes of PPD reaction intensity before and after vaccine injection. RESULTS: In 55 and 330 MS vaccine shots, 14 and 17 minor adverse reactions occurred, including local pain, lymphadenopathy, fever, local induration, palpitation, rashes and weakness, mild malaise The total reaction rate was 25.5% (14/55), and no moderate or severe adverse reactions occurred. The PPD dermal test responses were significantly lower (P <0.05) by PPD dermal test with different dosages of MS vaccine. Conclusion: M.S vaccine has high safety and can significantly reduce the intensity of PPD skin test reaction in high-risk TB population.