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© 1992 Oxford University Press

research-article

An Efficacy Trial of a Mammalian Cell-Derived Recombinant DNA Hepatitis B Vaccine in Infants Born to Mothers Positive for HBsAg, in Shanghai, China

MABEL L HALLIDAY*, LAI-YI KANG**, JAMES G RANKIN*, RANDALL A COATES*, PAUL N COREY*, ZONG-HAN HU{dagger}, TING-KAI ZHOU**, GUO-JUAN YUAN** and FEI-LI YAO**

* Department of Preventive Medicine and Biostatisiics, Faculty of Medicine, University of Toronto 4th Floor, McMurrich Buliding, 12 Queen's Park Crescent West, Toronto, Ontario, Canada M5S IA8
** Shanghai Hygiene and Anti-Epidemic Centre Shanghai, People's Republic of China
{dagger} National Institute for the Control of Pharmaceutical and Biological Products, Ministry of Health Beijing, People's Republic of China

We conducted a randomized, double-blind clinical trial of an experimental mammalian cell-derived DNA hepatitis B vaccine (Betagen, Connaught Laboratories Ltd. Toronto. Canada) to determine its efficacy in infants born to mothers who were carriers of hepatitis B surface antigen 1HB5Ag).

Four groups of 55 infants received injections as follows: (1) a licensed plasma-derived vaccine (Lanzhou, Lanzhou Institute for Biological Products, Lanzhou, People's Republic of China), 20 µg; (2) Betagen, 20 µg; (3) Betagen, 20 µg + hepatitis B immune globulin (HBIG); and (4) Betagen, 1Oµg + HBIG. Vaccine injections were given at birth and at 1 and 6 months and HBIG was given at birth. The vaccines were compared to a historical placebo control group.

The efficacy of Betagen alone was 82.6% compared to 51.0% for the Lanzhou. Efficacy of Betagen increased with the concomitant use of HBIG. No infants who were HBsAg negative at birth and/or were born to hepatitis B e antigen (HBeAg) negative mothers became carriers. The rate of HBsAg in infants receiving Betagen alone, and born to mothers who were HBeAg positive, decreased from 60% at birth to 20% by the ninth month, compared to 62.5% end 50% (respectively) for Lanzhou. The percentage of infants with protective levels of antiHBs was significantly higher for Betagen alone than for Lanzhou, but the geometric mean titre of antiHBs for responders was not significantly different.

We have shown that Betagen alone is highly efficacious in preventing the development of hepatitis B in infants born to mothers who are carriers of HBsA and is also highly effective in reducing the carnage of HBsAg in infants who are HBsA positive at birth and/or born to HBeAg positive mothers.

Received 1 January 1992


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C. Lee, Y. Gong, J. Brok, E. H Boxall, and C. Gluud
Effect of hepatitis B immunisation in newborn infants of mothers positive for hepatitis B surface antigen: systematic review and meta-analysis
BMJ, February 11, 2006; 332(7537): 328 - 336.
[Abstract] [Full Text] [PDF]


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