无细胞耻垢分枝杆菌疫苗的Ⅰ期临床研究

A phase Ⅰ clinical study of M.smegmatis vaccine

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 evaluate the safety, tolerance and PPD skin reactions of M. smegmatis vaccine. Methods：In a phase Ⅰ clinical study, 55 healthy volunteers were subcutaneously injected with a single cycle of M. smegmatis vaccine （8.7, 17.5 or 35.0μg）, once every other week, 6 injections per cycle. The efficacy was evaluated based on physical examinations including rhythm of the heart and blood pressure, blood and urine lab tests including live functions, chest X-ray examination, and type B ultrasonic abdominal examination. The safety was assessed based on incidence of adverse events and PPD skin reactions before and after the injections of M. smegmatis vaccine. Results ： Of 55 volunteers with total 330 injections, 14 volunteers （17 incidences） experienced mild adverse events including local pain, lymph swelling, fever, local hardening, nervousness, rash and faint. All volunteers were well tolerated to M. smegmatis vaccine. The volunteers with strongly positive for PPD skin reactions were seen with a reduced positive for PPD skin reactions after the injections （P 〈 0.05 ）. Conclusion ： M. smegmatis vaccine with a safe profile may reduce the positive degree for PPD skin reactions for people vulnerable to tuberculosis.