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Article
June 9, 1989

Protective Efficacy of a Recombinant DNA Hepatitis B Vaccine in Neonates of HBe Antigen—Positive Mothers

Author Affiliations

From the Departments of Pediatrics (Drs Poovorawan, Sanpavat, Pongpunlert, and Chumdermpadetsuk) and Obstetrics and Gynecology (Dr Sentrakul), Faculty of Medicine, Chulalongkorn University and Hospital, Bangkok, Thailand; and Medical and Scientific Services, Smith-Kline Biologicals, Rixensart, Belgium (Dr Safary).

From the Departments of Pediatrics (Drs Poovorawan, Sanpavat, Pongpunlert, and Chumdermpadetsuk) and Obstetrics and Gynecology (Dr Sentrakul), Faculty of Medicine, Chulalongkorn University and Hospital, Bangkok, Thailand; and Medical and Scientific Services, Smith-Kline Biologicals, Rixensart, Belgium (Dr Safary).

JAMA. 1989;261(22):3278-3281. doi:10.1001/jama.1989.03420220092033
Abstract

We have assessed the protective efficacy of a recombinant DNA hepatitis B vaccine alone in infants of women who were positive for the surface antigen and the e antigen. The infants received a 10-μg dose of the vaccine within 12 hours of birth and additional doses 1, 2, and 12 months later. No significant adverse reactions to vaccination were observed and the vaccine was highly immunogenic. Only 2 (3.6%) of the 55 infants followed up to 13 months became chronically infected with the hepatitis B virus, as evidenced by the persistent presence of hepatitis B surface antigen in serum samples. Without immunoprophylaxis, 65% to 90% of such infants would become chronic carriers. Immunization with a recombinant vaccine without concomitant administration of hepatitis B immunoglobulin, therefore, considerably decreased the incidence of the carrier state.

(JAMA. 1989;261:3278-3281)

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