EXPERIMENTAL LEPROSY & VACCINE STUDIES IN MONKEYS

我们继续临床监测3组接种疫苗的[BCG或 BCG + 2剂热灭活M.麻风（HKML）]和一组 未接种疫苗（对照）恒河猴（RM）和未接种疫苗的白眉猴 (SMM)确定疫苗接种/活疫苗的长期临床后果 M.麻风病挑战 每组有10个RM和7个SMM。 的 临床结果如下：1）单独接种BCG 2）BCG +低剂量（LD）或高剂量（HD）HKML 接种卡介苗可显著降低RM的发病率， 和麻风进展程度的SMM，但未能显着 减少出现临床症状的动物总数 长期（单独使用BCG的长期保护可能 如果存在较大数量的SMM/组，则具有显著性）;以及4） BCG + LD或HD HKML疫苗接种增加麻风易感性， SMM。 因为我们已经观察到RM倾向于（大约）。 80%）发展 少杆菌型（PB）麻风和SMM发展（约 80%）多杆菌（MB）形式，数据表明BCG + HKML 保护易受感染的动物 PB形式的麻风病，但会加剧动物的易感性， 对MB型麻风病的先天易感性。 BCG似乎 在PB端非常有效地保护，而在MB端则不那么有效， 江西篇章 来自越南的一份报告与我们的观察一致， BCG + HKML仅在以下地理区域提供保护： 更高比例的易患PB的人。 因为它不能轻易地 预测哪些个体易受PB与MB形式的 麻风，建议不要使用BCG + HKML用于 人类的疫苗。 另一方面，BCG本身似乎 对所有类型的麻风病都是安全有效的，特别是 所以在谱的PB端。 这些观察有助于解释 BCG保护率的极端变异性（20-80%） 在不同人群中接种麻风疫苗（ PB：MB型麻风的比例各不相同）。 我们的BCG结果 与这些人类田间试验的报告一致 人口。

We continued to clinically monitor 3 groups of vaccinated [BCG or BCG + 2 doses of heat-killed M. leprae (HKML)] and one group of unvaccinated (control) rhesus monkeys (RM) and sooty mangabey monkeys (SMM) to determine long term clinical consequences of vaccination/live M. leprae challenge. There were 10 RM and 7 SMM per group. The clinical results were as follows 1) vaccination with BCG alone protected RM by 70%; 2) BCG + low dose (LD) or high dose (HD) HKML protected RM by 85%; 3) BCG vaccination significantly slowed the rate and the degree of leprosy progress in SMM, but failed to significantly diminish the total number of animals developing clinical symptoms long term (long-term protection by BCG alone would have probably been significant if there had been a larger number of SMM/group); and 4) BCG + LD or HD HKML vaccination exacerbated leprosy susceptibility in SMM. Since we have observed that RM tend (approx. 80%) to develop paucibacillary (PB) forms of leprosy and SMM develop (approx. 80%)multibacillary (MB) forms, the data suggest that BCG + HKML protect animals that have a predisposition towards susceptibility to PB forms of leprosy, but exacerbate susceptibility of animals with an innate predisposition towards MB forms of leprosy. BCG appears to protect very effectively at the PB end and less so at the MB end of the spectrum. A report from Vietnam agrees with our observations in that BCG + HKML only offered protection in geographic areas which had high percentages of PB-prone humans. Since it cannot be readily predicted which individuals are susceptible to PB vs. MB forms of leprosy, it is recommended that BCG + HKML not be utilized for vaccination of humans. BCG alone, on the other hand appears to be safe and effective over the entire range of leprosy types, especially so at the PB end of the spectrum. These observations help to explain the extreme variability (from 20-80%) in the protective rates of BCG vaccination against leprosy among various human populations (which vary in the proportions of PB:MB forms of leprosy). Our BCG results are in agreement with these reports of field trials among human populations.