Department of Epidemiology and Biostatistics, School of Public Health and Family Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, Western Cape, South Africa.
Cochrane South Africa, South African Medical Research Council, Tygerberg, Western Cape, South Africa.
BMJ Open. 2019 Mar 9;9(3):e023308. doi: 10.1136/bmjopen-2018-023308.
WHO recommends the introduction of at least one single dose of inactivated polio vaccine (IPV) in routine immunisation schedules. Thus, there has been an increased demand and concurrent supply shortages of IPV worldwide. One of the strategies to improve access is the use of fractional instead of full doses of IPV. We aim to compare the effects of fractional with standard doses of IPV.
We will include randomised trials, non-randomised trials, case-control studies and cohort studies that compared fractional with full doses of IPV among children aged 5 years or younger. We will search for eligible studies among published and grey literature. Two authors will independently screen the results of the search, select studies, extract data and assess risk of bias. We will stratify analyses by study design, type of poliovirus, type of outcome measure and number of IPV doses given. For each type of poliovirus, we will pool the outcome data from studies using random-effects meta-analyses. Statistical heterogeneity will be assessed using the χ test of homogeneity and quantified using the I statistic. To investigate statistical heterogeneity, subgroup analyses will be performed based on the timing of the first fractional dose, age of administration, immunisation schedules and country income status. Sensitivity analyses will be used to assess if the effect of IPV fractional dosing is affected by study design, risk of bias and methods of meta-analysis.
We obtained approval from the University of Cape Town Human Research Ethics Committee (HREC REF: 412/2018). The findings of this review will provide evidence for decision-making with regards to IPV dosage, eventually improving access to the vaccine by stretching vaccine supplies. The results will be published in the University of Cape Town online library and in a peer reviewed journal.
CRD42018092647.
世界卫生组织（WHO）建议在常规免疫计划中至少引入一剂灭活脊髓灰质炎疫苗（IPV）。因此，全球范围内对 IPV 的需求增加，同时供应短缺。改善获取途径的策略之一是使用 IPV 的部分剂量而不是全剂量。我们旨在比较部分剂量与标准剂量 IPV 的效果。
我们将纳入比较 5 岁或以下儿童使用部分剂量与全剂量 IPV 的随机试验、非随机试验、病例对照研究和队列研究。我们将在已发表和灰色文献中搜索合格的研究。两位作者将独立筛选搜索结果、选择研究、提取数据并评估偏倚风险。我们将根据研究设计、脊髓灰质炎病毒类型、结果测量类型和给予的 IPV 剂量数对分析进行分层。对于每种脊髓灰质炎病毒类型，我们将使用随机效应荟萃分析汇总来自研究的结果数据。使用 χ 检验同质性和 I 统计量来评估统计异质性。为了研究统计异质性，将根据第一剂部分剂量的时间、管理年龄、免疫计划和国家收入状况进行亚组分析。敏感性分析将用于评估 IPV 部分剂量给药的效果是否受到研究设计、偏倚风险和荟萃分析方法的影响。
我们已获得开普敦大学人类研究伦理委员会（HREC REF：412/2018）的批准。该审查的结果将为关于 IPV 剂量的决策提供证据，最终通过扩大疫苗供应来改善疫苗的获取。结果将在开普敦大学的在线图书馆和同行评议期刊上发表。
PROSPERO 注册号：CRD42018092647。
