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Title: An efficacy trial of a mammalian cell-derived recombinant DNA hepatitis B vaccine in infants born to mothers positive for HBsAg, in Shanghai, China.
Author: Halliday ML, Kang LY, Rankin JG, Coates RA, Corey PN, Hu ZH, Zhou TK, Yuan GJ, Yao FL.
Journal: Int J Epidemiol; 1992 Jun; 21(3):564-73. PubMed ID: 1386063.
Abstract:
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 (HBsAg). 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 micrograms; (2) Betagen, 20 micrograms; (3) Betagen, 20 micrograms+hepatitis B immune globulin (HBIG); and (4) Betagen, 10 micrograms+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% and 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 HBsAg and is also highly effective in reducing the carriage of HBsAg in infants who are HBsAg positive at birth and/or born to HBeAg positive mothers. Researchers assigned 220 infants born at 5 participating hospitals in Shanghai, China to receive either a 20mcg of an experimental recombinant DNA hepatitis B vaccine (Betagen), a licensed plasma derived hepatitis B vaccine (Lanzhou), 20 mcg of Betagen and hepatitis B immune globulin (HBIG), or 10mcg of Betagen and HBIG to determine the efficacy of Betagen in infants born to mothers with hepatitis B surface antigen (HBsAg) positive. Since China is a hyperendemic hepatitis B carrier area (in Shanghai, for example, prevalence rate is 57%), China hopes to reduce the carrier state via a low cost, safe, immunogenic, and efficacious recombinant vaccine. 20mcg of Betagen resulted in 82.6% efficacy which was significantly higher than that of Lanzhou (51%). The efficacy increased when HBIG was administered with the 20mcg of Betagen (92%). None of the infants born HBsAg negative and/or born to hepatitis B e antigen (HBeAg) mothers later became carriers. Further the HBsAg positive fell from 60-2-% in 9 months whereas these corresponding figures for those who received only Lanzhou were 62.5% and 50%. Even though the percentage of infants with protective levels of antiHBs stood much higher in those who received only Betagen than for those who received Lanzhou in all the months of follow up, except the 1st, their geometric mean titre of antiHBs was not statistically significant. Since Betagen prompted a quick antibody response which probably helped decrease HBsAg in the serum of those infants already positive for HBsAg at birth, it had an advantage over Lanzhou. In conclusion, Betagen given alone proved to be very efficacious in preventing hepatitis B in infants born to carriers of HBsAg. Further it was effective in reducing carriage of HBsAg in infants born HBsAg positive and/or born to HBeAg positive mothers.

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