Tsega E, Tafesse B, Horton J, Nordenfelt E, Wolde-Hawariat G, Hansson B G, Lindberg J
Department of Internal Medicine, Faculty of Medicine, Addis Ababa University, Ethiopia.
Trop Geogr Med. 1991 Jan-Apr;43(1-2):220-7.
Hepatitis B virus infection and its sequelae, chronic hepatitis, cirrhosis of the liver and primary hepatocellular carcinoma (PHC), are important medical problems in Ethiopia. There is a possibility to prevent these by mass immunization of neonates and children. To achieve this, the cost of the hepatitis B vaccine must be possible within the limited health budget of the country. This study, therefore, was conducted to find out comparative safety and immunogenicity of two doses, 10 mcg and 20 mcg, of recombinant DNA yeast-derived hepatitis B vaccine in children, 2-14 years old. Three hundred and fourteen non-immune children, from an initial sample of 380 children, were grouped into those below and those above 8 years of age. Each group was further subdivided into boys and girls and each group was given either 10 mcg or 20 mcg hepatitis B vaccine, alternately, using the 0-1-6 months schedule. Anti-HBs titres were determined at one, two and seven months. Side effects were recorded by parents for three days following each injection. Comparison of seroconversion rates (97-100%) and anti-HBs geometric mean titres (3421-6336) of boosted vaccinees in the different sex, age and dose groups showed no significant differences. There were minor side effects recorded in 76 children. Therefore, the 10 mcg and 20 mcg doses of recombinant DNA yeast-derived hepatitis B vaccine are equally safe and highly immunogenic in children 3-14 years of age.
乙型肝炎病毒感染及其后遗症，如慢性肝炎、肝硬化和原发性肝细胞癌（PHC），是埃塞俄比亚重要的医学问题。通过对新生儿和儿童进行大规模免疫接种，有可能预防这些疾病。为实现这一目标，乙肝疫苗的成本必须在该国有限的卫生预算范围内可行。因此，本研究旨在探讨两种剂量（10微克和20微克）的重组DNA酵母源性乙肝疫苗在2至14岁儿童中的相对安全性和免疫原性。从380名儿童的初始样本中选取314名非免疫儿童，分为8岁以下和8岁以上两组。每组再进一步分为男孩和女孩，每组交替接种10微克或20微克乙肝疫苗，接种程序为0-1-6月。在第1、2和7个月测定抗-HBs滴度。每次注射后，家长记录三天的副作用情况。不同性别、年龄和剂量组中加强免疫者的血清转化率（97-100%）和抗-HBs几何平均滴度（3421-6336）比较，差异无统计学意义。76名儿童记录到轻微副作用。因此，10微克和20微克剂量的重组DNA酵母源性乙肝疫苗在3至14岁儿童中同样安全且具有高度免疫原性。
