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Field trial of the Cuban recombinant vaccine against hepatitis B (Heberbiovac HB). Study in newborn infants born to AgsHB+ mothers

Abstract:

A study was conducted on 106 newborns, whose AgsHB positive mothers received active protection against hepatitis B (83 with the Cuban-produced Heberbiovac HB vaccine and 23 with the Engerix-B vaccine manufactured by S. Kline as control group, following the scheme 0, 1 and 2 months with the first dose administered in the first 12 hours after birth. Samples were taken to study virus B markers at birth (umbilical cord) after 30, 60, 90 and 180 days. Laboratory determinations were carried out by the ELISA technique with diagnostic kits from the firm Organon Tecknica. Ten or more IU/L of anti-HBs present in serum was considered as the lowest protective level. Children were classified according to the AgeHB present in mothers, AgsHB in the umbilical cord and the concentration of Ags HB in maternal serum. 100% of the children who received the control vaccine showed serological evidence of seroconversion to anti HBs with protective titres, and the values of the geometric mean of the titres of antibodies were statistically significant (p < 0.01) in all the extractions, favoring the Cuban vaccine. The efficacy of the two preparations used in this research work was 100%. This study makes it possible to report on a recombinant vaccine against hepatitis B (Heberbiovac HB) which represents the first vaccine of this type produced in Latin America, the efficacy of which was proved in the field trial.