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December 1993

Passive-Active Immunization in Infants of Hepatitis Be Antigen-Positive Mothers: Comparison of the Efficacy of Early and Delayed Active Immunization

Author Affiliations

From the Department of Internal Medicine, Academic Hospital Dijkzigt (Drs Grosheide, del Canho, and Schalm); Department of Virology, Erasmus University (Dr Heijtink); Rijksopleidingscentrum voor verloskundigen (Dr Nuijten); Department of Pediatrics, Ruwaard van Putten Hospital (Dr Zwijnenberg); Regional Public Health Laboratory (Dr Bänffer); Department of Obstetrics, Academic Hospital Dijkzigt (Dr Wladimiroff), Rotterdam; Regional Laboratory of Pathology and Microbiology, Enschede (Dr Botman); General Practice, Borne (Dr Mazel); Blood Transfusion Laboratory (Dr de Gast); Department of Gynaecology and Obstetrics (Dr Christiaens); Academic Hospital Utrecht, Wilhelmina Childrens Hospital (Dr Gerards), Utrecht; and the Department of Pediatrics, St Sophia Hospital (Drs Fetter and Baerts), Zwolle, the Netherlands. Dr Grosheide is now with the National Institute of Public Health and Environmental Protection, Bilthoven, the Netherlands.

Am J Dis Child. 1993;147(12):1316-1320. doi:10.1001/archpedi.1993.02160360058019

• 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 μg) 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.(AJDC. 1993;147:1316-1320)