Hari M, Gupte M D
BCG Vaccine Laboratory, Guindy, Chennai.
Indian J Lepr. 1998 Oct-Dec;70(4):389-95.
All the vaccines supplied for the large scale comparative leprosy vaccine trial of ICRC bacilli, M.w, BCG plus killed M. leprae (candidate vaccines), BCG and normal saline (control arms) at CJIL Field Unit, Chennai were tested for quality control by the suppliers following the procedures laid down in the WHO protocol for killed M. leprae. Quality control for BCG was carried out at BCG vaccine laboratory as per protocol. Toxicity and sterility tests were done on all the vaccine batches/lots received. As part of the quality control, bacterial count, and protein estimation were also done. Studies showed that the bacterial content and protein concentration were comparable with the original preparations. Vaccines were free from micro-organisms, toxic materials and safe for human use. Thus the quality of all vaccine preparations was satisfactory.
为红十字国际委员会杆菌、M.w、卡介苗加灭活麻风杆菌（候选疫苗）、卡介苗和生理盐水（对照组）在金奈CJIL现场单位进行的大规模麻风病疫苗对比试验提供的所有疫苗，供应商按照世界卫生组织灭活麻风杆菌方案规定的程序进行了质量控制检测。卡介苗的质量控制按照方案在卡介苗疫苗实验室进行。对收到的所有疫苗批次进行了毒性和无菌检测。作为质量控制的一部分，还进行了细菌计数和蛋白质测定。研究表明，细菌含量和蛋白质浓度与原始制剂相当。疫苗不含微生物、有毒物质，对人体使用安全。因此，所有疫苗制剂的质量令人满意。
