title: [Protective efficacy of Heberbiovac HB at different dosage in physically and mentally-handicapped children].
abstract: BACKGROUND
  the protective efficacy follow-up studies in high risk groups for hepatitis B virus infection, which were inoculated with recombinant hepatitis B vaccines, are limited and the duration of protection is yet to be determined in those vaccinated people.
  
  
  OBJECTIVE
  to determine the protective efficacy of Heberbiovac HB vaccine at different dosage in physically and mentally-handicapped children after 14 years of the primary vaccination schedule.
  
  
  METHODS
  in 1991, an effectiveness study of vaccine Heberbiovac HB was conducted in 2 groups of physically and mentally-handicapped (A = 10 microg y B = 5 microg). The study was approved by the Committees of Medical Ethics and Revision of "Pedro Kouri" Tropical Medicine Institute and of the Center of Genetic Engineering and Biotechnology of the City of Havana; good clinical practice were followed and the ethical principles of Helsinki Declaration were respected for. The vaccination schedule at 0, 1 and 6 months was used in which children negative to hepatitis B virus surface antigen and to hepatitis B virus surface antigen antibody were included. The subjects were studied from the clinical and serological viewpoints up to 14 years after the implementation of the aforementioned vaccine schedule.
  
  
  RESULTS
  one year after the beginning of the vaccination, there was full seroprotection in both groups. After 14 years of follow-up, none of the subjects was positive to hepatitis B virus surface antigen, neither were they affected by acute hepatitis B, which meant 100 % individual protection.
  
  
  CONCLUSIONS
  the immunogenic power of Heberbiovac HB vaccine was high and its protective efficacy was 100% in physically and mentally-handicapped children according to the results of the clinical and serological follow-up extending up to 14 years after the implementation of the primary vaccination schedule. These results are achieved for the first time for this kind of vaccine.
authors: Instituto de Medicina Tropical Pedro Kouri, Ciudad de La Habana, Cuba. placido@ipk.sld.cu
authors: Plácido
authors: P
authors: Pedroso Flaquet
authors: Manuel
authors: M
authors: Díaz González
authors: Licel
authors: L
authors: Rodríguez Lay
mesh_terms: D000293:Adolescent; D002648:Child; D019988:Children with Disabilities; D006509:Hepatitis B / Q000517:prevention & control*; D006801:Humans; D019989:Persons with Intellectual Disabilities; D013997:Time Factors; D019444:Vaccines, DNA / Q000008:administration & dosage*
chemical_list: D019444:Vaccines, DNA; C115360:heberbiovac-HB