Vallishayee R S, Anantharaman D S, Gupte M D
CJIL Field Unit (ICMR), Avadi, Chennai.
Indian J Lepr. 1998 Jul-Sep;70(3):277-86.
BCG is one of the vaccines used, as control arm, in an ongoing large scale comparative leprosy vaccine trial in South India. The objective of the present study was to examine, in the local population, the sensitizing ability, as measured by skin test reactions to tuberculin, and reactogenecity, in terms of skin lesions at the site of vaccination, for the two batches of BCG vaccine used in the above trial. The study was undertaken in 816 tuberculin-negative, previously not vaccinated school children, aged five to 14 years. Each child received one of the two batches of BCG vaccine or normal saline (control), by random allocation. At 12 weeks from vaccination, character and size of local response, at the vaccination site, were recorded. At the same time, the children were retested with tuberculin and post-vaccination reactions to the test were measured after 72 hours. At three years after vaccination all available children were re-examined for the presence and size of BCG scar at the site of vaccination. It was found that healing of vaccination lesions was uneventful, with both batches of BCG. The mean size of the lesion was similar for the two batches, the overall mean being 6.3 mm. The mean size of post-vaccination tuberculin sensitivity increased with age, and it was 14.5 mm and 15.6 mm. The sensitizing effect attributable to the vaccine was 11 mm and 12 mm, for the two batches of BCG respectively. This study showed that the two batches of BCG, in a dose of 0.1 mg, used in the ongoing leprosy vaccine trial were acceptable in terms of vaccination lesion and were highly satisfactory in terms of development of hypersensitivity.
卡介苗是印度南部一项正在进行的大规模麻风病疫苗对比试验中作为对照臂使用的疫苗之一。本研究的目的是在当地人群中，针对上述试验中使用的两批卡介苗，通过结核菌素皮肤试验反应来检测其致敏能力，并根据接种部位的皮肤病变来检测其反应原性。该研究在816名5至14岁结核菌素阴性、此前未接种过疫苗的学童中进行。每个孩子通过随机分配接受两批卡介苗中的一批或生理盐水（对照）。接种后12周，记录接种部位局部反应的特征和大小。同时，用结核菌素对孩子们进行重新检测，并在72小时后测量接种后对该检测的反应。接种三年后，对所有可用的孩子重新检查接种部位卡介苗疤痕的存在情况和大小。结果发现，两批卡介苗接种部位的损伤愈合情况均正常。两批卡介苗损伤的平均大小相似，总体平均为6.3毫米。接种后结核菌素敏感性的平均大小随年龄增加，分别为14.5毫米和15.6毫米。两批卡介苗的疫苗致敏效果分别为11毫米和12毫米。本研究表明，正在进行的麻风病疫苗试验中使用的两批剂量为0.1毫克的卡介苗，在接种损伤方面是可接受的，在超敏反应发展方面非常令人满意。
