University of Antwerp, Wilrijk, Belgium.
BMC Infect Dis. 2010 May 26;10:134. doi: 10.1186/1471-2334-10-134.
Although seasonal influenza vaccine is effective in the elderly, immune responses to vaccination are lower in the elderly than in younger adults. Strategies to optimise responses to vaccination in the elderly include using an adjuvanted vaccine or using an intradermal vaccination route. The immunogenicity of an intradermal seasonal influenza vaccine was compared with that of an adjuvanted vaccine in the elderly.
Elderly volunteers (age > or = 65 years) were randomised to receive a single dose of trivalent seasonal influenza vaccine: either a split-virion vaccine containing 15 microg haemagglutinin [HA]/strain/0.1-ml dose administered intradermally, or a subunit vaccine (15 microg HA/strain/0.5-ml dose) adjuvanted with MF59C.1 and administered intramuscularly. Blood samples were taken before and 21 +/- 3 days post-vaccination. Anti-HA antibody titres were assessed using haemagglutination inhibition (HI) and single radial haemolysis (SRH) methods. We aimed to show that the intradermal vaccine was non-inferior to the adjuvanted vaccine.
A total of 795 participants were enrolled (intradermal vaccine n = 398; adjuvanted vaccine n = 397). Non-inferiority of the intradermal vaccine was demonstrated for the A/H1N1 and B strains, but not for the A/H3N2 strain (upper bound of the 95% CI = 1.53) using the HI method, and for all three strains by the SRH method. A post-hoc analysis of covariance to adjust for baseline antibody titres demonstrated the non-inferiority of the intradermal vaccine by HI and SRH methods for all three strains. Both vaccines were, in general, well tolerated; the incidence of injection-site reactions was higher for the intradermal (70.1%) than the adjuvanted vaccine (33.8%) but these reactions were mild and of short duration.
The immunogenicity and safety of the intradermal seasonal influenza vaccine in the elderly was comparable with that of the adjuvanted vaccine. Intradermal vaccination to target the immune properties of the skin appears to be an appropriate strategy to address the challenge of declining immune responses in the elderly.
ClinicalTrials.gov: NCT00554333.
尽管季节性流感疫苗对老年人有效，但老年人对疫苗的免疫反应低于年轻人。优化老年人对疫苗的反应的策略包括使用佐剂疫苗或使用皮内接种途径。本研究比较了皮内季节性流感疫苗与佐剂疫苗在老年人中的免疫原性。
老年志愿者（年龄≥65 岁）被随机分配接受一剂三价季节性流感疫苗：皮内接种单价裂解疫苗（含 15 μg 血凝素 [HA]/株/0.1 ml 剂量）或肌内接种佐剂 MF59C.1 的亚单位疫苗（15 μg HA/株/0.5 ml 剂量）。在接种前和接种后 21 ± 3 天采集血样。使用血凝抑制（HI）和单放射免疫溶血（SRH）方法评估抗-HA 抗体滴度。我们旨在证明皮内疫苗不劣于佐剂疫苗。
共纳入 795 名参与者（皮内疫苗组 n = 398；佐剂疫苗组 n = 397）。使用 HI 法，皮内疫苗在 A/H1N1 和 B 株中具有非劣效性，但在 A/H3N2 株中不具有非劣效性（95%CI 的上限为 1.53），而使用 SRH 法则在所有三株中均具有非劣效性。对调整基线抗体滴度的协方差分析表明，皮内疫苗在 HI 和 SRH 方法中对所有三株均具有非劣效性。两种疫苗总体上均具有良好的耐受性；皮内（70.1%）比佐剂疫苗（33.8%）的注射部位反应发生率更高，但这些反应较轻且持续时间短。
皮内季节性流感疫苗在老年人中的免疫原性和安全性与佐剂疫苗相当。针对皮肤免疫特性的皮内接种似乎是解决老年人免疫反应下降挑战的一种合适策略。
ClinicalTrials.gov：NCT00554333。
