Intradermal influenza vaccination of healthy adults using a new microinjection system: a 3-year randomised controlled safety and immunogenicity trial.
Intradermal influenza vaccination of healthy adults using a new microinjection system: a 3-year randomised controlled safety and immunogenicity trial.
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DOI：
10.1186/1741-7015-7-13
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发表时间：
2009-04-02
期刊：
影响因子：
9.3
通讯作者：
Salamand C
中科院分区：
文献类型：
--
作者：
Beran J;Ambrozaitis A;Laiskonis A;Mickuviene N;Bacart P;Calozet Y;Demanet E;Heijmans S;Van Belle P;Weber F;Salamand C
皮内疫苗接种通过专门的树突状细胞和引流淋巴管提供了直接且可能更有效地进入免疫系统的途径。我们连续三年研究了使用显微注射系统皮内注射的针对季节性流感的不同剂量的三价灭活裂解病毒颗粒疫苗与肌内对照疫苗的免疫原性和安全性。在一项随机、部分盲法对照研究中，健康志愿者（1150 名入组时年龄在 18 至 57 岁之间）每年接受三次皮内或肌内疫苗接种。在第一年，受试者被随机分配到三组中的一组：皮内注射 3 μg 或 6 μg 血凝素/菌株/剂量的灭活流感疫苗，或肌肉注射含有 15 μg/菌株/剂量的经许可的灭活流感疫苗。在第 2 年，受试者再次随机分为两组：9 μg/株/剂量皮内注射或 15 μg 肌内注射。在第 3 年，受试者第三次被随机分为两组：9 μg 皮内注射或 15 μg 肌肉注射。第一年的随机分组列表按地点进行分层。第 2 年和第 3 年的随机分组名单根据地点和前几年收到的疫苗进行分层，以确保每年每个中心的疫苗组中包含相当数量的受试者。每次疫苗接种后 21 天评估免疫原性。在整个研究过程中评估了安全性。在第 2 年和第 3 年，对于所有毒株，9 μg 皮内注射与 15 μg 肌肉注射的免疫原性相当，并且两种疫苗均符合欧洲流感疫苗年度许可要求。 3μg和6μg皮内制剂的免疫原性低于肌内注射15μg。在研究的每一年中，皮内和肌肉内疫苗接种的安全性相当。皮内途径注射部位红斑和肿胀更为常见。使用皮内显微注射系统注射的含有 9 μg 血凝素/菌株的流感疫苗显示出与许可的肌肉注射疫苗相当的免疫原性和安全性，并且为 60 岁以下成年人提供了一种有前途的肌肉注射流感疫苗替代方案。临床试验.gov NCT00703651。
Intradermal vaccination provides direct and potentially more efficient access to the immune system via specialised dendritic cells and draining lymphatic vessels. We investigated the immunogenicity and safety during 3 successive years of different dosages of a trivalent, inactivated, split-virion vaccine against seasonal influenza given intradermally using a microinjection system compared with an intramuscular control vaccine. In a randomised, partially blinded, controlled study, healthy volunteers (1150 aged 18 to 57 years at enrolment) received three annual vaccinations of intradermal or intramuscular vaccine. In Year 1, subjects were randomised to one of three groups: 3 μg or 6 μg haemagglutinin/strain/dose of inactivated influenza vaccine intradermally, or a licensed inactivated influenza vaccine intramuscularly containing 15 μg/strain/dose. In Year 2 subjects were randomised again to one of two groups: 9 μg/strain/dose intradermally or 15 μg intramuscularly. In Year 3 subjects were randomised a third time to one of two groups: 9 μg intradermally or 15 μg intramuscularly. Randomisation lists in Year 1 were stratified for site. Randomisation lists in Years 2 and 3 were stratified for site and by vaccine received in previous years to ensure the inclusion of a comparable number of subjects in a vaccine group at each centre each year. Immunogenicity was assessed 21 days after each vaccination. Safety was assessed throughout the study. In Years 2 and 3, 9 μg intradermal was comparably immunogenic to 15 μg intramuscular for all strains, and both vaccines met European requirements for annual licensing of influenza vaccines. The 3 μg and 6 μg intradermal formulations were less immunogenic than intramuscular 15 μg. Safety of the intradermal and intramuscular vaccinations was comparable in each year of the study. Injection site erythema and swelling was more common with the intradermal route. An influenza vaccine with 9 μg of haemagglutinin/strain given using an intradermal microinjection system showed comparable immunogenic and safety profiles to a licensed intramuscular vaccine, and presents a promising alternative to intramuscular vaccination for influenza for adults younger than 60 years. Clinicaltrials.gov NCT00703651.
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