A randomized control trial comparing immunogenicity, safety, and preference for self- versus nurse-administered intradermal influenza vaccine
A randomized control trial comparing immunogenicity, safety, and preference for self- versus nurse-administered intradermal influenza vaccine
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DOI：
10.1016/j.vaccine.2012.08.006
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发表时间：
2012-09-28
期刊：
影响因子：
5.5
通讯作者：
McNeil, Shelly A.
中科院分区：
文献类型：
--
作者：
Coleman, Brenda L.;McGeer, Allison J.;McNeil, Shelly A.
背景：在较低单位剂量下，皮下注射流感疫苗与肌肉注射疫苗具有同样的免疫原性。新的显微注射系统可以允许自行注射疫苗，可能会降低成本和不便。目的：比较自行接种与护士接种三价季节性流感疫苗的免疫原性、反应原性、成功率和可接受性。方法：成人（18-59岁）随机分为两组，一组自行接种，另一组由护士接种。在接种疫苗之前，参与者完成一份调查问卷，并抽血检测血凝抑制效价。护士管理组的参与者由研究人员接种疫苗。自我注射组发给一份说明书，并注射自己的疫苗。所有参与者在接种疫苗后21天完成问卷调查和不良事件日记，然后再次采集血液。结果：228例患者中，115例自行给药，113例护士给药。各组在基线时没有性别、年龄或血清保护水平的差异。在114例完成自我给药的患者中，106例（93%）第一次尝试成功。在任何菌株的免疫原性测量中没有组间差异。自我注射的参与者报告接种疫苗时的平均疼痛等级较低，但接种后的红肿面积较大。70%的参与者表示，如果可以选择，他们将来会更喜欢皮内接种而不是肌肉接种。结论：与护士给药的皮内流感疫苗相比，自我给药疫苗在免疫学上不差，达到了EMA对A株的所有免疫原性标准，是非常成功的，并为研究参与者所接受。总之，这些数据为这种流感疫苗接种方法的可行性提供了初步证据，这可能会提高成人疫苗的吸收率，并提高疫情期间疫苗递送的效率。(C) 2012 Elsevier Ltd.版权所有。
Background: Intradermally administered influenza vaccine is as immunogenic as intramuscular vaccine at a lower unit dose. New microinjection systems could allow self-administration of vaccine, potentially reducing the cost and inconvenience.Objective: To compare the immunogenicity, reactogenicity, success rate, and acceptability of self- versus nurse-administered intradermal trivalent seasonal influenza vaccine.Methods: Adults (18-59 years old) were randomized to either self- or nurse-administered intradermal vaccine. Prior to vaccination, participants completed a questionnaire and had blood drawn for hemagglutination inhibition titres. Participants in the nurse-administered group were vaccinated by study personnel. The self-administered group were given an instruction sheet and administered their own vaccine. All participants completed a questionnaire and adverse event diaries for 21 days post vaccination, at which time blood was again collected.Results: Of the 228 participants, 115 were randomized to self-administration and 113 to nurse administration. Groups did not differ by sex, age, or levels of seroprotection at baseline. Of the 114 who completed self-administration, 106 (93%) were successful on the first attempt. There were no group differences in measures of immunogenicity for any of the strains. Self-administering participants reported a lower mean pain rating at vaccination but had larger areas of redness post-vaccination. Seventy percent of all participants said they would prefer intradermal over intramuscular vaccinations in the future, if given the choice.Conclusion: Compared to nurse-administered intradermal influenza vaccine, self-administered vaccine was immunologically non-inferior and reached all EMA immunogenicity criteria for the A strains, was highly successful and well-accepted by study participants. Together, these data provide preliminary evidence of feasibility for this method of influenza vaccine administration, which may improve vaccine uptake in adults and increase efficiency of vaccine delivery during outbreaks. (C) 2012 Elsevier Ltd. All rights reserved.