Immunogenicity, reactogenicity and comparison of two doses of recombinant DNA yeast-derived hepatitis B vaccine in Ethiopian children. 1991

E Tsega, and B Tafesse, and J Horton, and E Nordenfelt, and G Wolde-Hawariat, and B G Hansson, and J Lindberg
Department of Internal Medicine, Faculty of Medicine, Addis Ababa University, Ethiopia.

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.

UI MeSH Term Description Entries
D007115 Immunization Schedule Schedule giving optimum times usually for primary and/or secondary immunization. Immunization Schedules,Schedule, Immunization,Schedules, Immunization
D007273 Injections, Intramuscular Forceful administration into a muscle of liquid medication, nutrient, or other fluid through a hollow needle piercing the muscle and any tissue covering it. Intramuscular Injections,Injection, Intramuscular,Intramuscular Injection
D008297 Male Males
D002648 Child A person 6 to 12 years of age. An individual 2 to 5 years old is CHILD, PRESCHOOL. Children
D002675 Child, Preschool A child between the ages of 2 and 5. Children, Preschool,Preschool Child,Preschool Children
D005002 Ethiopia An independent state in eastern Africa. Ethiopia is located in the Horn of Africa and is bordered on the north and northeast by Eritrea, on the east by Djibouti and Somalia, on the south by Kenya, and on the west and southwest by Sudan. Its capital is Addis Ababa. Federal Democratic Republic of Ethiopia
D005260 Female Females
D006509 Hepatitis B INFLAMMATION of the LIVER in humans caused by a member of the ORTHOHEPADNAVIRUS genus, HEPATITIS B VIRUS. It is primarily transmitted by parenteral exposure, such as transfusion of contaminated blood or blood products, but can also be transmitted via sexual or intimate personal contact. Hepatitis B Virus Infection
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000293 Adolescent A person 13 to 18 years of age. Adolescence,Youth,Adolescents,Adolescents, Female,Adolescents, Male,Teenagers,Teens,Adolescent, Female,Adolescent, Male,Female Adolescent,Female Adolescents,Male Adolescent,Male Adolescents,Teen,Teenager,Youths

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