Ennis F A, Mayner R E, Barry D W, Manischewitz J E, Dunlap R C, Verbonitz M W, Bozeman R M, Schild G C
J Infect Dis. 1977 Dec;136 Suppl:S397-406. doi: 10.1093/infdis/136.supplement_3.s397.
The large, uniformly performed clinical investigations with influenza A/New Jersey vaccines provided an opportunity to correlate results of laboratory tests of vaccine with human reactivity and antibody responses. These vaccines were given to large numbers of subjects under code, and significant differences in immunogenicity and reactivity were observed in unprimed individuals. A single, relatively large dose of intact virus was more immunogenic and reactive than split-virus vaccines in unprimed subjects. Differences in immunogenicity and reactivity in unprimed subjects correlated with the amount of intact virus in the vaccines (measured by column chromatography or electron microscopy) and with the amount of viral hemagglutinin in the vaccine (measured by immunodiffusion), but not with the number of chick cell-agglutinating units.
针对甲型/新泽西流感疫苗开展的大规模、统一实施的临床研究,为将疫苗的实验室检测结果与人体反应性及抗体反应进行关联提供了契机。这些疫苗在盲法状态下接种给大量受试者,在未接种过疫苗的个体中观察到了免疫原性和反应性的显著差异。在未接种过疫苗的受试者中,单次给予相对大剂量的完整病毒疫苗比裂解病毒疫苗更具免疫原性和反应性。未接种过疫苗的受试者在免疫原性和反应性上的差异,与疫苗中完整病毒的量(通过柱色谱法或电子显微镜测定)以及疫苗中病毒血凝素的量(通过免疫扩散测定)相关,但与鸡胚细胞凝集单位的数量无关。