背景技术微针被定义为具有20至1500μm范围内的插入长度和高达300μm的外径的微米尺寸的突起。通过微针施用的药物通过皮肤的深层扩散,进入全身循环,对疼痛敏感的神经末梢有最小的刺激。真皮中树突细胞的丰富存在使得基于微针的疫苗递送成为有吸引力的选择。本系统评价将评估使用微针皮内递送疫苗的有效性和安全性。在人类中。
方法:我们将在以下数据库中搜索报告使用微针皮内递送疫苗的功效和/或安全性的研究:Epidemonikos和Cochrane图书馆进行系统评价和MEDLINE(通过PubMed),EMBASE,科克伦中部,LIVIVIVO,WebofScience,用于主要研究的Scopus和CINAHL数据库。我们还将搜索灰色文献数据库和相关研究的手动搜索参考列表。我们将包括在人类(任何年龄)的随机和准随机试验,使用微针(任何材料,长度或孔径)皮内递送疫苗,其中反映功效的结果,安全,疼痛反应,报告参与者满意度或成本。我们还将包括长期安全性结果的非随机观察性研究,这些研究未在试验中报告。入选资格将由两名审稿人独立确定。纳入研究的偏倚风险将使用CochraneRoB2工具(用于随机试验)和纽卡斯尔-渥太华量表(用于其他研究设计)进行评估。关于疗效和安全性的数据将通过荟萃分析汇总(如果可行)。我们将探索随机试验之间的异质性,使用希金斯和汤普森I2方法。我们将进行敏感性分析,以探讨研究质量和亚组分析的影响,根据参与者的年龄,微针长度和疫苗剂量。等级方法将用于估计证据的可信度。
结果:这是系统审查的方案;因此,现阶段没有结果。
结论:拟议的系统评价将提供关于疗效的证据,安全,疼痛反应,参与者对人类(成人和儿童)通过使用微针的皮内途径接种疫苗的可接受性和成本。由于使用微针的皮内注射由于它们的短长度和狭窄的孔而与较少的疼痛相关,我们预计使用这种方法递送疫苗抗原可能是安全的,与使用皮下注射针的常规注射相比,有效且疼痛较小的替代方案。这次审查中的证据将对决策者有用,疫苗制造商和医疗保健提供者在常规免疫计划中考虑将这种方法用于婴儿和儿童的疫苗接种。因此,我们计划通过同行评审的期刊出版物传播该评论,并将根据合理要求向任何人提供无法包含在已发布版本中的数据。
背景:PROSPEROCRD42020213608。
BACKGROUND: Microneedles are defined as micron-sized projections with an insertion length ranging from 20 to 1500 μm and an external diameter up to 300 μm. Medications administered through microneedles diffuse through the deeper layers of the skin, into the systemic circulation, with minimal stimulation of pain-sensitive nerve endings. The rich presence of dendritic cells in the dermis makes
microneedle-based vaccine delivery an attractive option. This systematic
review will evaluate the efficacy and safety of intradermal delivery of vaccines using microneedles, in human beings.
METHODS: We will search the following databases for studies reporting the efficacy and/or safety of intradermal delivery of vaccines using microneedles: Epistemonikos and the Cochrane Library for systematic reviews and MEDLINE (through PubMed), EMBASE, Cochrane CENTRAL, LIVIVO, Web of Science, Scopus and CINAHL databases for primary studies. We will also search grey literature databases and hand search reference lists of relevant studies. We will include randomised and quasi-randomised trials in human beings (any age), using microneedles (any material, length or bore) to deliver vaccines intradermally, wherein outcomes reflecting efficacy, safety, pain responses, participant satisfaction or cost are reported. We will additionally include non-randomised observational studies for long-term safety outcomes that are not reported in trials. Eligibility for inclusion will be independently determined by two reviewers. The risk of bias of the included studies will be assessed using the Cochrane RoB2 Tool (for randomised trials) and Newcastle-Ottawa Scale (for other study designs). Data on efficacy and safety will be pooled through meta-analysis (where feasible). We will explore the heterogeneity amongst randomised trials, using the Higgins and Thompson I2 method. We will undertake sensitivity analysis to explore the impact of study quality and subgroup analysis based on the age of participants, length of
microneedle and vaccine dosage. The GRADE approach will be used to estimate the confidence in the evidence.
RESULTS: This is a protocol for a systematic review; hence, there are no results at this stage.
CONCLUSIONS: The proposed systematic
review will provide evidence on efficacy, safety, pain responses, participant acceptability and cost in human beings (adults and children) for vaccines administered through the intradermal route using microneedles. Since intradermal injections using microneedles are associated with less pain due to their short lengths and narrow bores, we anticipate that delivery of vaccine antigens using this method could be a safe, efficacious and less painful alternative compared with conventional injections using hypodermic needles. The evidence in this review will be useful for policymakers, vaccine manufacturers and healthcare providers to consider this approach for the vaccination of infants and children in routine immunisation programmes. Therefore, we plan to disseminate the
review through a peer-reviewed journal publication and will also provide data that cannot be included in the published version to anyone upon reasonable request.
BACKGROUND: PROSPERO CRD42020213608.