Clemens R, Safary A, Hepburn A, Roche C, Stanbury W J, André F E
SmithKline Beecham Biologicals, Rixensart, Belgium.
J Infect Dis. 1995 Mar;171 Suppl 1:S44-9. doi: 10.1093/infdis/171.supplement_1.s44.
Clinical trials of an inactivated hepatitis A vaccine have encompassed 104 studies completed by December 1993 in 27 countries. Studies involved 50,677 subjects and administration of > 120,000 vaccine doses. Results show that the vaccine is safe, clinically well-tolerated, and highly immunogenic in all age groups. A seroconversion rate of 100% is achieved 1 month after primary vaccination. Vaccine-induced antibody titers persist after a primary vaccination course for > or = 1 year with a single dose of 1440 ELISA units (EL.U.) in adults and after two doses of 360 EL.U. in children. A booster dose 6-12 months after the first vaccine dose induces very high antibody titers, which according to a mathematical model, are expected to protect against hepatitis A for > 20 years. The vaccine is equally immunogenic when administered simultaneously with other traveler vaccines, therefore enabling flexible and convenient vaccination against hepatitis A.
一种甲型肝炎灭活疫苗的临床试验涵盖了截至1993年12月在27个国家完成的104项研究。这些研究涉及50677名受试者，接种疫苗剂量超过120000剂。结果表明，该疫苗安全，临床耐受性良好，在所有年龄组中均具有高度免疫原性。初次接种疫苗1个月后血清转化率达到100%。成人单剂1440酶联免疫吸附测定单位（EL.U.）、儿童两剂360 EL.U.的初次接种疗程后，疫苗诱导的抗体滴度持续≥1年。在第一剂疫苗接种后6 - 12个月进行加强剂量接种可诱导非常高的抗体滴度，根据数学模型，预计可预防甲型肝炎超过20年。该疫苗与其他旅行者疫苗同时接种时免疫原性相同，因此能够灵活方便地接种甲型肝炎疫苗。
