Green M S, Cohen D, Lerman Y, Sjogren M, Binn L N, Zur S, Slepon R, Robin G, Hoke C, Bancroft W
Medical Corps, Israel Defense Forces.
Isr J Med Sci. 1994 May-Jun;30(5-6):485-8.
Purified, formaldehyde-inactivated and alum-adjuvanted hepatitis A virus (HAV) vaccines have recently become available for clinical trials. The vaccine is administered intramuscularly in a schedule of 0, 1, and 6 months. The aim of the study was to evaluate the reactogenicity and immunogenicity of an inactivated hepatitis A (HA) vaccine. Three groups of volunteers comprised the study population: 28 volunteers without antibody to HAV were given HA vaccine and, for comparison, 43 subjects received hepatitis B vaccine for possible adverse reactions to the HA vaccine; 12 other subjects received immunoglobulin alone. Each 1 ml dose of HA vaccine contained 720 enzyme units or about 100 ng of antigen. Anti-HAV was determined by means of a commercial assay (Abbott Laboratories: HAV-EIA), and by a more sensitive ELISA. No significant adverse reactions were reported. In the group that received HA vaccine, 4 weeks following the first dose all had detectable antibodies (> or = 20 mIU/ml) by the sensitive ELISA. By commercial HAV-EIA, at 20 weeks following the second dose 75.0% had detectable antibodies, and after the third vaccine all had detectable antibodies. This new inactivated HA vaccine is highly immunogenic and had no significant side effects.
纯化的、经甲醛灭活并添加明矾佐剂的甲型肝炎病毒（HAV）疫苗最近已可用于临床试验。该疫苗通过肌肉注射给药，接种程序为0、1和6个月。本研究的目的是评估一种灭活甲型肝炎（HA）疫苗的反应原性和免疫原性。三组志愿者构成了研究人群：28名无HAV抗体的志愿者接种了HA疫苗，作为对照，43名受试者接种了乙型肝炎疫苗以观察对HA疫苗可能的不良反应；另外12名受试者仅接受免疫球蛋白。每1毫升HA疫苗剂量含有720个酶单位或约100纳克抗原。通过商业检测法（雅培实验室：HAV-EIA）以及一种更灵敏的ELISA法测定抗-HAV。未报告有显著不良反应。在接种HA疫苗的组中，首剂接种4周后，通过灵敏ELISA法所有受试者均检测到抗体（≥20 mIU/ml）。通过商业HAV-EIA法，在第二剂接种20周后，75.0%的受试者检测到抗体，第三剂疫苗接种后所有受试者均检测到抗体。这种新型灭活HA疫苗具有高度免疫原性且无显著副作用。
