Van Damme P, Matheï C, Thoelen S, Meheus A, Safary A, André F E
Department of Epidemiology, University of Antwerp, Belgium.
J Med Virol. 1994 Dec;44(4):435-41. doi: 10.1002/jmv.1890440422.
In comparison with the classical immunisation schedules (0-1-6 or 0-1-12 months) for hepatitis A, a 0- and 12- or a 0- and 6-month schedule would have important advantages by reducing the number of injections and discomfort and increasing scheduling convenience and patient compliance. It would be convenient if a single dose with enough antigen could protect both rapidly and for at least 12 months, when the booster dose would be given. Several clinical trials have been carried out with an inactivated hepatitis A vaccine containing 1,440 EL.U. (1 ml), according to a 0-12 and a 0-6 vaccination schedule. This hepatitis A vaccine is safe and well tolerated. It offers a rapid seroresponse: 14 days after a single dose the seroconversion is 88% (95% C.I.: 84.6-90.9). The 0-12 schedule study showed good persistence of hepatitis A virus (HAV) antibodies with a seroconversion rate of almost 95% at month 12. Booster doses given at 6 or 12 months result in a substantial rise in antibody levels; according to these antibody titres, the 1,440 EL.U. vaccine can be expected to confer comparable duration of protection as the 720 EL.U. vaccine, i.e., 10-20 years. Preliminary data show that timing of the booster may not be critical for the antibody response. In conclusion, the 1,440 EL.U. hepatitis A vaccine is safe, offers rapid seroconversion, and is highly immunogenic. The persistence of HAV antibodies until month 12 allows a certain flexibility in the administration of the booster: month 6 or 12, and a 0-12 or 0-6 schedule can increase the vaccination compliance.
与甲型肝炎的经典免疫程序（0、1、6个月或0、1、12个月）相比，0月和12月或0月和6月的免疫程序具有重要优势，可减少注射次数和不适，增加接种安排的便利性和患者依从性。如果一剂含有足够抗原的疫苗既能快速提供保护，又能至少保护12个月直至接种加强针，那就很方便了。已经根据0-12和0-6接种程序，对一种含1440 EL.U.（1毫升）的甲型肝炎灭活疫苗进行了多项临床试验。这种甲型肝炎疫苗安全且耐受性良好。它能快速产生血清反应：单剂接种14天后血清转化率为88%（95%置信区间：84.6-90.9）。0-12程序研究显示甲型肝炎病毒（HAV）抗体具有良好的持久性，在第12个月时血清转化率接近95%。在6个月或12个月时接种加强针会使抗体水平大幅上升；根据这些抗体滴度，预计1440 EL.U.疫苗可提供与720 EL.U.疫苗相当的保护期，即10至20年。初步数据表明，加强针的接种时间对抗体反应可能并不关键。总之，1440 EL.U.甲型肝炎疫苗安全，能快速产生血清转化，且免疫原性高。HAV抗体在第12个月前的持久性使得加强针接种在时间安排上有一定灵活性：可在第6个月或第12个月接种，0-12或0-6程序可提高接种依从性。
