Moulia-Pelat J P, Spiegel A, Martin P M, Cardines R, Boutin J P, Roux J F, Excler J L, Saliou P
Institut Territorial de Recherches Médicales Louis Malardé (ITRMLM), Tahiti, French Polynesia.
Vaccine. 1994 May;12(6):499-502. doi: 10.1016/0264-410x(94)90306-9.
A hepatitis immunization field trial, using a Chinese hamster ovary (CHO) cell recombinant vaccine, was implemented for newborns in the Austral archipelago of French Polynesia in 1988. Three different schedules were used: (1) four vaccine doses at months (M) M0, M1, M2 and M12; (2) three vaccine doses at M0, M1 and M6; and (3) three vaccine doses at M0, M1 and M12. The programme evaluation was performed yearly at fixed dates, i.e. October-November 1989, 1990 and 1991. After the third year, of the 582 children who received one or more doses of vaccine, four were HBsAg carriers. After one or two doses, 88 and 98%, respectively, had seroconverted for at least one of the two measured antibodies, anti-HBs or anti pre-S2. After three doses, seroconversion rates and geometric mean anti-HBs titres were, respectively, 94% and 187 mIU ml-1 using schedule M0, M1, M2; 95% and 507 mIU ml-1 using schedule M0, M1, M6 and 96% and 476 mIU ml-1 using schedule M0, M1, M12. After four doses (M0, M1, M2, M12) the corresponding results were 99% and 1518 mIU ml-1. One of the 16 vaccinated neonates born to HBsAg/HBeAg-positive mothers was an HBsAg carrier, implying a protective rate for the prevention of perinatal transmission of 93%. Overall, these results indicate that, in field conditions, indiscriminate vaccination of newborns with a CHO-recombinant vaccine without hepatitis B immunoglobulin (HiBG) resulted in high immunogenicity. Final evaluation in 1993-1994 will permit confirmation of the effectiveness of the two three-dose vaccine schedules.
1988年，在法属波利尼西亚的奥斯塔拉群岛对新生儿开展了一项使用中国仓鼠卵巢（CHO）细胞重组疫苗的肝炎免疫现场试验。采用了三种不同的接种程序：（1）在第0、1、2和12个月龄接种四剂疫苗；（2）在第0、1和6个月龄接种三剂疫苗；（3）在第0、1和12个月龄接种三剂疫苗。每年在固定日期（即1989年、1990年和1991年的10月至11月）进行项目评估。第三年结束时，在接种一剂或多剂疫苗的582名儿童中，有4名是HBsAg携带者。接种一剂或两剂后，分别有88%和98%的儿童针对两种检测抗体（抗-HBs或抗前S2）中的至少一种发生了血清转化。接种三剂后，采用第0、1、两个月龄程序，血清转化率和抗-HBs几何平均滴度分别为94%和187 mIU/ml；采用第0、1、6个月龄程序，分别为95%和507 mIU/ml；采用第0、1、12个月龄程序，分别为96%和476 mIU/ml。接种四剂（第0、1、2、12个月龄）后的相应结果为99%和1518 mIU/ml。16名HBsAg/HBeAg阳性母亲所生的接种疫苗新生儿中有1名是HBsAg携带者，这意味着预防围产期传播的保护率为93%。总体而言，这些结果表明，在现场条件下，对新生儿不加选择地接种不含乙肝免疫球蛋白（HiBG）的CHO重组疫苗具有高免疫原性。1993 - 1994年的最终评估将确认两种三剂疫苗接种程序的有效性。
