Smith P G, Revill W D, Lukwago E, Rykushin Y P
Trans R Soc Trop Med Hyg. 1976;70(5-6):449-57. doi: 10.1016/0035-9203(76)90128-0.
In a BCG vaccination trial in an area of Uganda endemic for Mycobacterium ulcerans disease ("Buruli Ulcer"), 8,856 persons were examined for the disease in mid-1970 and tuberculin tested; BCG was given by intradermal injection to a random 50% of all those with negative, low or middle grade tuberculin reactions; Twelve months later the study group was re-examined for M. ulcerans lesions and, subsequently, new cases of the disease were detected, using a hospital registration system, to December 1974. One hundred and forty-nine patients with onset since July 1970 were thus ascertained and BCG was found to offer an overall protection of 47% against the disease, similar to that observed in a previous smaller trial by the Uganda Buruli Group (UBG, 1969). However, the protective effect was confined to those with tuberculin reactions of less than 4 mm before vaccination and was apparent only in the first year of the study. BCG offered no additional protection to those with previous M. ulcerans disease or an existing BCG scar at entry into the trial, although both these groups appeared to be protected against the disease, the protective effects being 88% and 82% respectively. An initial tuberculin reaction of 4 mm (or greater) offered some protection against the disease (37%). Lesions developing in the vaccinated group, or in those with initial tuberculin reactions of 4 mm or more, were smaller than those in unvaccinated persons. No relationship was found between the protective effect of BCG and either the prevalence of persons with evidence of previous M. ulcerans disease in different geographical areas, or the incidence of new cases in different areas during the first year of the study. A decline in the incidence was observed over the study period. The findings are consistent with BCG producing only short-lasting protection against M. ulcerans disease. However, long-lasting protection and a delay in onset of the disease in vaccinated persons, as suggested by the UBG in 1969, cannot be excluded on the basis of the data currently available from this trial.
在乌干达溃疡分枝杆菌病（“布鲁里溃疡”）流行地区进行的一项卡介苗接种试验中，1970年年中对8856人进行了该病检查并进行结核菌素检测；对所有结核菌素反应为阴性、弱阳性或中等强度阳性的人中随机抽取50%进行皮内注射卡介苗；12个月后，对研究组再次检查是否有溃疡分枝杆菌病变，随后，利用医院登记系统监测新发病例至1974年12月。由此确定了1970年7月以来发病的149例患者，发现卡介苗对该病的总体保护率为47%，与乌干达布鲁里研究组（UBG，1969年）之前规模较小的试验中观察到的结果相似。然而，保护作用仅限于接种前结核菌素反应小于4毫米的人群，且仅在研究的第一年明显。卡介苗对试验开始时已有溃疡分枝杆菌病或卡介苗疤痕的人没有额外保护作用，尽管这两组人似乎都对该病有一定保护作用，保护率分别为88%和82%。最初结核菌素反应为4毫米（或以上）对该病有一定保护作用（37%）。接种组或最初结核菌素反应为4毫米或以上的人群中出现的病变比未接种者的病变小。未发现卡介苗的保护作用与不同地理区域既往有溃疡分枝杆菌病证据的人群患病率或研究第一年不同区域新发病例发生率之间存在关联。在研究期间观察到发病率有所下降。这些结果与卡介苗仅对溃疡分枝杆菌病产生短期保护作用一致。然而，根据目前该试验的数据，不能排除1969年UBG所提出的接种者有长期保护作用且疾病发病延迟的情况。
