Halliday M L, Kang L Y, Rankin J G, Coates R A, Corey P N, Hu Z H, Zhou T K, Yuan G J, Yao F L
Department of Preventive Medicine and Biostatistics, Faculty of Medicine, University of Toronto, Ontario, Canada.
Int J Epidemiol. 1992 Jun;21(3):564-73. doi: 10.1093/ije/21.3.564.
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.
我们进行了一项关于一种实验性哺乳动物细胞源性DNA乙肝疫苗（贝他肝疫苗，加拿大康诺特实验室有限公司，多伦多）的随机双盲临床试验，以确定其对乙肝表面抗原（HBsAg）携带者母亲所生婴儿的有效性。四组各55名婴儿接受如下注射：（1）一种已获许可的血浆源性疫苗（兰州生物制品研究所，中国兰州），20微克；（2）贝他肝疫苗，20微克；（3）贝他肝疫苗，20微克+乙肝免疫球蛋白（HBIG）；（4）贝他肝疫苗，10微克+HBIG。疫苗在出生时、1个月和6个月时注射，HBIG在出生时注射。将这些疫苗与一个历史安慰剂对照组进行比较。单独使用贝他肝疫苗的有效性为82.6%，而兰州疫苗为51.0%。贝他肝疫苗与HBIG同时使用时有效性增加。出生时HBsAg阴性和/或母亲为乙肝e抗原（HBeAg）阴性的婴儿均未成为携带者。单独接受贝他肝疫苗且母亲为HBeAg阳性的婴儿，其HBsAg率从出生时的60%降至第九个月时的20%，而兰州疫苗组分别为62.5%和50%。单独使用贝他肝疫苗的婴儿中具有保护性抗HBs水平的百分比显著高于兰州疫苗组，但应答者的抗HBs几何平均滴度无显著差异。我们已表明，单独使用贝他肝疫苗在预防HBsAg携带者母亲所生婴儿感染乙肝方面高度有效，并且在降低出生时HBsAg阳性和/或母亲为HBeAg阳性的婴儿的HBsAg携带率方面也非常有效。
