NEWBORN UNIVERSAL IMMUNIZATION AGAINST HEPATITIS-B - IMMUNOGENICITY AND REACTOGENICITY OF SIMULTANEOUS ADMINISTRATION OF DIPHTHERIA TETANUS/PERTUSSIS (DTP) AND ORAL POLIO VACCINES WITH HEPATITIS-B VACCINE AT 0, 2 AND 6 MONTHS OF AGE/

The reactogenicity and immunogenicity of the administration of recombi nant vaccine against hepatitis B simultaneously (but at separate sites ) with diphtheria/tetanus/pertussis (DTP) and oral polio vaccines were examined Six hundred and twenty-six children (group I) were given hep atitis B vaccine at 0, 2 and 6 months of age, the other vaccines were administered at 2, 4 and 6 months of age. A control group of 731 child ren (group II) received only DTP and oral polio vaccines. The results showed that 93% of the infants in group I had anti-HBs titres above th e protective level (greater than or equal to 10 mlU ml(-1)) after vacc ination. There were no differences in the immune responses for DTP and polio between the two study groups. The vaccine efficacy against poli omyelitis was 96% for serotype I, 100% for serotype If and 97-98% for serotype III. Of the infants in both groups, 97% had antibodies agains t B. pertussis; all children were positive for tetanus and diphtheria. There were no differences in the incidences of general reactions betw een groups. Local swelling and redness were reported following 4.2 and 4.4%, respectively, of all injections of hepatitis B vaccine. These r eactions were reported following 31 and 33%, respectively, of all dose s of DTP vaccine. It can be concluded that the simultaneous administra tion of hepatitis B vaccine with the DTP and polio vaccines is well-to lerated hepatitis B vaccine remained highly immunogenic and did not in terfere with the immune response to the other antigens.