Maupas P, Goudeau A, Coursaget P, Drucker J, Bagros P
Intervirology. 1978;10(3):196-208. doi: 10.1159/000148983.
A formalin-treated hepatitis B vaccine in the form of purified hepatitis B surface antigen (HBsAg) was prepared from asymptomatic human HBsAg carriers. Its safety and potency were tested in 5 chimpanzees. The vaccine was administered to 264-individuals. The results of the first 173 immunizations--46 hemodialysis patients and 127 staff members--are presented. Potency was ascertained and efficacy assessed by the development of humoral immune responses to HBsAg (anti-HBs antibody) and seroepidemiologic studies of vaccinated and nonvaccinated subjects. The results, 2 years after immunization, suggest that the vaccine was protective against hepatitis B infection in high-risk hemodialysis settings. Preliminary studies with an inactivated hepatitis B vaccine similarly prepared, but with aluminum hydroxide as adjuvant, indicate that a such a preparation induces a more rapid and stronger anti-HBs response.
一种由无症状乙肝表面抗原（HBsAg）携带者制备的纯化乙肝表面抗原形式的福尔马林处理乙肝疫苗。在5只黑猩猩身上测试了其安全性和效力。该疫苗接种给了264人。呈现了前173次免疫接种的结果——46名血液透析患者和127名工作人员。通过对HBsAg的体液免疫反应（抗-HBs抗体）的发展以及对接种和未接种疫苗受试者的血清流行病学研究来确定效力并评估疗效。免疫接种2年后的结果表明，该疫苗在高风险血液透析环境中对乙肝感染具有保护作用。用类似方法制备但以氢氧化铝作为佐剂的灭活乙肝疫苗进行的初步研究表明，这样一种制剂可诱导更快更强的抗-HBs反应。
