口服或肌内注射一种甲型肝炎减毒活候选疫苗后的临床和实验室观察结果。

Clinical and laboratory observations following oral or intramuscular administration of a live attenuated hepatitis A vaccine candidate.

作者信息

Sjogren M H, Purcell R H, McKee K, Binn L, Macarthy P, Ticehurst J, Feinstone S, Caudill J, See A, Hoke C

机构信息

Division of Medicine, United States Army Medical Research Institute of Infectious Diseases, Fort Detrick, Frederick, MD 21702.

出版信息

Vaccine. 1992;10 Suppl 1:S135-7. doi: 10.1016/0264-410x(92)90568-5.

DOI:10.1016/0264-410x(92)90568-5

PMID:1335645

Abstract

Clinical observations made after immunising volunteers with a live attenuated hepatitis A vaccine are described. The candidate vaccine was prepared with the HM175 strain of hepatitis A virus and shown to be safe, immunogenic and efficacious in experimental animals. When the candidate vaccine was tested by oral administration in humans at increasing doses--10(4), 10(5), 10(6) and 10(7) median tissue culture infective doses (TCID50)--an antibody response was not observed at any dose. Volunteers who received similar doses by the intramuscular route developed antibody to hepatitis A three weeks after immunization with 10(6) or 10(7) TCID50. The antibody response was sustained for the 12 weeks of the observation period. All volunteers remained healthy with normal results from liver tests throughout the monitoring period. Further clinical observations of this product are in progress.

摘要

本文描述了用减毒活甲型肝炎疫苗对志愿者进行免疫后的临床观察结果。候选疫苗是用甲型肝炎病毒HM175株制备的，在实验动物中显示出安全、具有免疫原性且有效。当通过口服途径以递增剂量——10⁴、10⁵、10⁶和10⁷半数组织培养感染剂量（TCID50）——在人体中测试候选疫苗时，任何剂量下均未观察到抗体反应。通过肌肉注射途径接受相似剂量的志愿者，在用10⁶或10⁷ TCID50免疫后三周产生了甲型肝炎抗体。在观察期的12周内，抗体反应持续存在。在整个监测期内，所有志愿者均保持健康，肝功能测试结果正常。该产品的进一步临床观察正在进行中。