Hederstedt B, Granström M
Department of Bacteriology, National Bacteriological Laboratory, Stockholm, Sweden.
Vaccine. 1989 Aug;7(4):349-50. doi: 10.1016/0264-410x(89)90200-4.
A monovalent pertussis toxoid vaccine (JNIH-7, Biken, Japan) was evaluated for reactogenicity and immunogenicity in 20 healthy adults (phase 1 study). Fever of greater than or equal to 38 degrees C was recorded in 2/20; local reactions started in 2/20 on day 1 (early onset) and in 3/20 on day 7 (late onset). All 15/15 subjects tested showed a significant antibody response to pertussis toxin by neutralization or enzyme-linked immunosorbent assay. Significantly elevated antibodies were still detected in 12/13 subjects 32 months after the single subcutaneous dose of vaccine.
在20名健康成年人中评估了单价百日咳类毒素疫苗（JNIH-7，日本比肯公司）的反应原性和免疫原性（1期研究）。20人中有2人记录到体温≥38℃；20人中有2人在第1天出现局部反应（早发型），3人在第7天出现局部反应（迟发型）。通过中和试验或酶联免疫吸附测定，所有15名受试对象均显示出对百日咳毒素的显著抗体反应。单次皮下注射疫苗32个月后，13名受试者中有12人仍检测到抗体显著升高。
