Hirota Y, Kaji M, Ide S, Goto S, Oka T
Department of Public Health, Faculty of Medicine 60, Kyushu University, Fukuoka, Japan.
Vaccine. 1996 Dec;14(17-18):1597-602. doi: 10.1016/s0264-410x(96)00153-3.
The immunogenicity of the trivalent split-virus influenza vaccine was investigated among 70 healthy adults (mean age: 48.5, range: 36-68). The vaccine antigens were: A/Yamagata/32/89 (H1N1); A/Beijing/352/89 (H3N2); and B/Bangkok/163/90. Regarding the entire sample, the vaccine induced a tenfold or more rise on the average in the hemagglutination inhibition (HAI) antibody to each antigen. The response rates (greater than or equal to a fourfold rise) were about 90% or more among those with a prevaccination titer < or = 1:64 (equivalent to < or = 1:16 on the Western scale; in Japan, the HAI titers are expressed by the final, and not the initial, dilution of the serum; from hereon our findings will be expressed using the Japanese scale), whereas they were 0-50% at > or = 1:128. Thus, the prevaccination titer was negatively associated with antibody induction. The achievement rates (postvaccination titer > or = 1:128) among those with a prevaccination titer < 1:16 remained at 48-68%. Regarding the analysis of variance, a significant effect on antibody induction was indicated for the prevaccination titer (P < or = 0.002), but not for age (P > or = 0.425). The interaction between the prevaccination titer and age was significant for A/Yamagata (P = 0.030), while it was also suggestive for A/Beijing (P = 0.054): as age increased, those with no preexisting antibody (< 1:16) showed greater titer rises, in contrast to the smaller rises among those with a titer > or = 1:16. Based on the attack survey conducted separately, the vaccine efficacy on influenza-like illnesses with fever < or = 37 degrees C and > or = 37.5 degrees C was calculated to be 16% (95% confidence interval: -66% to 57%) and 37% (-55% to 74%), respectively.
在70名健康成年人(平均年龄:48.5岁,范围:36 - 68岁)中研究了三价裂解病毒流感疫苗的免疫原性。疫苗抗原为:A/山形/32/89(H1N1);A/北京/352/89(H3N2);以及B/曼谷/163/90。对于整个样本,疫苗使针对每种抗原的血凝抑制(HAI)抗体平均升高了10倍或更多。在接种前滴度≤1:64(相当于西方标准下≤1:16;在日本,HAI滴度用血清的最终稀释度表示,而非初始稀释度;此后我们的研究结果将采用日本标准表示)的人群中,应答率(升高≥4倍)约为90%或更高,而在≥1:128时应答率为0 - 50%。因此,接种前滴度与抗体诱导呈负相关。接种前滴度<1:16的人群中,接种后滴度≥1:128的达成率为48 - 68%。关于方差分析,接种前滴度对抗体诱导有显著影响(P≤0.002),但年龄无显著影响(P≥0.425)。接种前滴度与年龄之间的相互作用对A/山形毒株有显著意义(P = 0.030),对A/北京毒株也有提示意义(P = 0.054):随着年龄增加,无预先存在抗体(<1:16)的人群滴度升高幅度更大,而滴度≥1:16的人群升高幅度较小。基于单独进行的发病情况调查,针对体温≤37℃和≥37.5℃的流感样疾病,疫苗效力分别计算为16%(95%置信区间:-66%至57%)和37%(-55%至74%)。