Passive-active immunization in infants of hepatitis Be antigen-positive mothers. Comparison of the efficacy of early and delayed active immunization
P. M. Grosheide, R. del Canho, R. A. Heijtink, A. S. Nuijten, J. Zwijnenberg, J. R. Banffer, Y. W. Wladimiroff, M. J. Botman, J. A. Mazel, G. C. de Gast and al. et
Department of Internal Medicine, Academic Hospital, Dijkzigt, The Netherlands.
OBJECTIVE--To assess the efficacy of late active immunization against
hepatitis B concomitant with diphtheria, pertussis, tetanus, and polio
vaccine in high-risk infants receiving hepatitis B immune globulin at
birth. DESIGN--Randomized study of infants born to mothers positive for
hepatitis B surface antigen (HBsAg) and hepatitis Be antigen (HBeAg).
SETTING--Three large city hospitals and one rural area providing prenatal
care and obstetric services. SUBJECTS--Eighty neonates of HBsAg- and
HBeAg-positive carrier mothers received 0.5 mL/kg of body weight hepatitis
B immune globulin within 2 hours of birth and hepatitis B vaccine (10
micrograms) at 0, 1, 2, and 11 months of age (group A) or at 3, 4, 5, and
11 months of age concomitant with diphtheria, pertussis, tetanus, and polio
immunization (group B). A second dose of hepatitis B immune globulin was
given to infants on schedule B at 3 months. MAIN OUTCOME MEASURES--Blood
samples were collected at 0, 3, 6, 11, and 12 months of age and tested for
antibodies against hepatitis B core antigen and HBsAg. Follow-up visits
were scheduled annually up to 5 years of age. RESULTS--Eight infants were
excluded from analysis. During the study period, six children became HBsAg
carriers, three in each group, which corresponds to a 5-year incidence of
infection of 9% and 8% for groups A (three of 35) and B (three of 37),
respectively. Subclinical infections (persistent anti-HBc positivity beyond
month 12 or appearance of anti-HBc) were encountered in another eight
infants (four in each group). CONCLUSION--Late active immunization starting
at 3 months of age appears to provide similar protective efficacy as active
immunization starting at birth when combined with hepatitis B immune
globulin at 0 and 3 months of age.
