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一种新型MF59佐剂流感疫苗可增强患有慢性病的老年人的免疫反应:免疫原性荟萃分析结果

A new MF59-adjuvanted influenza vaccine enhances the immune response in the elderly with chronic diseases: results from an immunogenicity meta-analysis.

作者信息

Banzhoff Angelika, Nacci Pantaleo, Podda Audino

机构信息

Clinical Research and Medical Affairs, Chiron Vaccines, Marburg, Germany.

出版信息

Gerontology. 2003 May-Jun;49(3):177-84. doi: 10.1159/000069172.

Abstract

BACKGROUND

The elderly are at a higher risk of morbidity and mortality associated with influenza infection than younger adults, but get less protection from conventional vaccination.

OBJECTIVE

We conducted a meta-analysis of all available data from clinical trials in the elderly on a recently introduced MF59-adjuvanted influenza vaccine to determine its immunogenicity and safety in subjects with underlying chronic disease who are at highest risk of influenza infection.

METHODS

Data on immunogenicity and safety from 3600 subjects immunized with either the MF59-adjuvanted or conventional comparator influenza vaccine in 13 clinical trials were analyzed by disease history. Geometric mean haemagglutination inhibition titres (GMTs) and differences between the vaccine groups were compared using two-way analysis of variance. Differences between vaccine groups in the percentages with post-immunization reactions were assessed using chi-squared test and Fischer's exact test.

RESULTS

At 28 days the adjuvanted:comparator GMT ratio for the A/H3N2 antigen was 1.18 in healthy elderly subjects and 1.43 in elderly subjects with chronic disease (p = 0.004). The respective GMT ratios were 1.17 versus 1.37 for the B antigen (p = 0.065) and 1.10 versus 1.17 for the A/H1N1 antigen (p = 0.41). Although post-immunization reactions were more common in the group receiving the adjuvanted vaccine, these were predominantly mild and transient, and none were serious.

CONCLUSIONS

The MF59-adjuvanted influenza vaccine is more immunogenic in elderly subjects than conventional non-adjuvanted influenza vaccines and especially so in those with chronic disease. Therefore, since its safety profile is clinically acceptable, this adjuvanted vaccine represents an excellent option for influenza immunization of elderly subjects at highest risk of complications.

摘要

背景

与年轻成年人相比,老年人因流感感染而发病和死亡的风险更高,但从传统疫苗接种中获得的保护较少。

目的

我们对近期引入的含 MF59 佐剂流感疫苗在老年人中的所有临床试验可用数据进行了荟萃分析,以确定其在患流感感染风险最高的慢性疾病患者中的免疫原性和安全性。

方法

通过疾病史分析了 13 项临床试验中 3600 名接种含 MF59 佐剂或传统对照流感疫苗的受试者的免疫原性和安全性数据。使用双向方差分析比较几何平均血凝抑制滴度(GMTs)和疫苗组之间的差异。使用卡方检验和费舍尔精确检验评估疫苗组之间免疫后反应百分比的差异。

结果

在 28 天时,健康老年人中 A/H3N2 抗原的佐剂组与对照 GMT 比值为 1.18,慢性病老年人中为 1.43(p = 0.004)。B 抗原的相应 GMT 比值分别为 1.17 对 1.37(p = 0.065),A/H1N1 抗原为 1.10 对 1.17(p = 0.41)。虽然免疫后反应在接受佐剂疫苗的组中更常见,但这些反应主要是轻微和短暂的,没有严重反应。

结论

含 MF59 佐剂的流感疫苗在老年人中比传统非佐剂流感疫苗具有更强的免疫原性,在患有慢性病的老年人中尤其如此。因此,由于其安全性在临床上是可接受的,这种佐剂疫苗是对并发症风险最高的老年人进行流感免疫接种的极佳选择。

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