Sierra G V, Campa H C, Varcacel N M, Garcia I L, Izquierdo P L, Sotolongo P F, Casanueva G V, Rico C O, Rodriguez C R, Terry M H
Finlay Institute, Center for Research and Production of Vaccines and Sera, Havana, Cuba.
NIPH Ann. 1991 Dec;14(2):195-207; discussion 208-10.
The Cuban vaccine, first in the world with proven efficacy against group B-caused disease, is based on outer membrane proteins from B meningococci capable of inducing long-lasting and high-titered bactericidal antibodies in humans. This bactericidal activity has a wide spectrum against all pathogenic group B Neisseria meningitidis tested. A randomized, double-blind controlled trial of the vaccine efficacy was performed during 1987-1989 with 106,000 10-14 years old students from 197 boarding schools in seven provinces. The efficacy obtained was 83% (chi 2, p less than 0.002; Fischer exact, p less than 0.001). In a second field trial including 133,600 persons from 5 months to 24 years of age in Ciego de Avila province (30 cases/10(5) inhabitants, the highest incidence rate in Cuba) by comparing vaccinated and non-vaccinated population after 2.5 years of observation and careful follow-up, the efficacy and safety was confirmed. Because of these results and because of the very low reactogenicity of the vaccine, the Ministry of Public Health took the advice of the Scientific Council to vaccinate all children between 3 months and 6 years of age in the most affected provinces. No severe or long lasting reactions to the vaccine were observed after the millions of doses administered. The efficacy of vaccination varied in the provinces between 83% and 94%, among age groups ranging from 3 months and 20 years. After 3 years of massive application no severe reactions occurred and one of the most severe epidemics has been practically eradicated.
古巴疫苗是世界上首个被证实对B群所致疾病有效的疫苗，它基于B群脑膜炎球菌的外膜蛋白，能够在人体中诱导产生持久且高滴度的杀菌抗体。这种杀菌活性对所有测试的致病性B群脑膜炎奈瑟菌具有广泛的谱效。1987年至1989年期间，对来自七个省份197所寄宿学校的106,000名10至14岁学生进行了疫苗效力的随机双盲对照试验。所获得的效力为83%（卡方检验，p<0.002；费舍尔精确检验，p<0.001）。在第二项现场试验中，对西恩富戈斯省5个月至24岁的133,600人（发病率为30例/10万居民，为古巴最高发病率）进行研究，通过对接种疫苗和未接种疫苗人群进行2.5年的观察和仔细随访后，证实了该疫苗的效力和安全性。由于这些结果以及该疫苗极低的反应原性，公共卫生部采纳了科学委员会的建议，对受影响最严重省份的所有3个月至6岁儿童进行接种。在接种了数百万剂疫苗后，未观察到对该疫苗的严重或持久反应。疫苗接种的效力在各省份之间为83%至94%，在3个月至20岁的年龄组中有所不同。经过3年的大规模应用，未发生严重反应，最严重的疫情之一已基本根除。
