Li Rong-Cheng, Fang Han-Hua, Li Yan-Ping, Liu You-Ping, Nong Yi, Huang Gui-Biao
Vaccine Clinical Trial Center, Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention, Nanning 530028, China.
Zhonghua Liu Xing Bing Xue Za Zhi. 2008 Jun;29(6):548-51.
To compare the safety and immunogenicity between a MF59-adjuvanted influenza subunit vaccine and a conventional non-adjuvanted influenza subunit vaccine.
A randomized, blind-designed controlled study was carried out, with 600 subjects (> or = 60 years of age) received MF59-adjuvanted influenza subunit vaccine (FLUAD, n = 400) or conventional non-adjuvanted influenza subunit vaccine (Agrippal, n = 200) respectively. The local and systemic reactions were observed on 0-7 days after vaccination. Haemagglutination inhibition (HI) titers of pre-and post-vaccination were detected by the HI assay. Seroconversion (4-fold increase) rate of subjects was calculated using baseline data when it was under naive level, and the protection rate when HI titer achieving the level of protection (> or = 1:40) after vaccination. Geometric mean titer (GMT) and its increasing folds were calculated. Differences between safety and immunogenicity were also calculated.
The local and systemic reaction rates were similar between both groups, but the duration in injection site was frequent for Agrippal (P < 0.05), while mild pain and fever in injection site were frequent for FLUAD. On immunogenicity test, for those subjects whose baseline was under naive level while the seroconversion rate against A/H3N2 viral strain after vaccination--FLUAD was significantly higher than Agrippal (P < 0.001). Aside from A/H1N1 viral strain, the rate of protection on both groups were significantly higher than those from baseline data, but for A/H3N2 viral strain, FLUAD was significantly higher than Agrippal (P < 0.001). GMT was higher than baseline (P < 0.001) after both groups being vaccinated but FLUAD group was significantly higher than Agrippal group.
FLUAD was well tolerated by Chinese elderly and its immunogenicity level induced by FLUAD was higher than that of Agrippal, showing that it would benefit the elderly with hypoimmunity.
比较含MF59佐剂的流感亚单位疫苗与传统非佐剂流感亚单位疫苗的安全性和免疫原性。
开展一项随机、盲法设计的对照研究，600名受试者（≥60岁）分别接种含MF59佐剂的流感亚单位疫苗（FLUAD，n = 400）或传统非佐剂流感亚单位疫苗（Agrippal，n = 200）。在接种后0至7天观察局部和全身反应。通过血凝抑制（HI）试验检测接种前后的HI滴度。当基线数据处于未免疫水平时，使用基线数据计算受试者的血清阳转（4倍增长）率，以及接种后HI滴度达到保护水平（≥1:40）时的保护率。计算几何平均滴度（GMT）及其增长倍数。还计算了安全性和免疫原性之间的差异。
两组的局部和全身反应率相似，但Agrippal在注射部位的持续时间更常见（P < 0.05），而FLUAD在注射部位的轻度疼痛和发热更常见。在免疫原性测试中，对于那些基线处于未免疫水平的受试者，接种后针对A/H3N2病毒株的血清阳转率——FLUAD显著高于Agrippal（P < 0.001）。除A/H1N1病毒株外，两组的保护率均显著高于基线数据，但对于A/H3N2病毒株，FLUAD显著高于Agrippal（P < 0.001）。两组接种疫苗后GMT均高于基线（P < 0.001），但FLUAD组显著高于Agrippal组。
中国老年人对FLUAD耐受性良好，其诱导的免疫原性水平高于Agrippal，表明它对免疫功能低下的老年人有益。
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