Otago Medical School, University of Otago, Christchurch, New Zealand.
College of Education, Health and Human Development, University of Canterbury, Christchurch, New Zealand.
BMJ Open. 2021 May 25;11(5):e050114. doi: 10.1136/bmjopen-2021-050114.
Vaccination is a public health strategy that aims to reduce the burden of viral illness, especially important for populations known or likely to be at increased risk for inequitable outcomes due to the disease itself or disparities in care accessed and received. The role of weight status in COVID-19 susceptibility and disease burden remains unclear. Despite this, higher weight is frequently described as a definitive risk factor for both susceptibility and disease severity. Therefore, COVID-19 vaccine trials should recruit a study group representative of the full weight spectrum, and undertake appropriate subgroup analysis by weight status to evaluate response and titrate dose regimes where indicated to ensure equitable outcomes for higher weight people.
We aim to review inclusion and exclusion criteria of clinical trial protocols registered with ClinicalTrials.gov, ISRCTN Register, the WHO official vaccine trial register, and 'The COVID-19 Vaccine Tracker'. To determine the number of trials including higher weight (body mass index >30 kg/m) individuals and the number of trials conducting efficacy subgroup analyses by weight status. Screening, data extraction and quality appraisal of trial protocols will be completed independently by a minimum of two reviewers. Clinical trials will be assessed for risk of bias using the Risk of Bias-2 tool. We will conduct a descriptive analysis of extracted data. The following subsets are proposed: participation of higher weight people in COVID-19 vaccine trials by trial phase, country and vaccine platform.
Ethical approval was not required for this review. The results of this rapid review will be presented at appropriate conferences and published in a suitable peer reviewed journal.
CRD42020226573.
接种疫苗是一种旨在减轻病毒疾病负担的公共卫生策略，对于那些由于疾病本身或获得和接受护理的差异而处于不平等结果风险增加的人群，尤其重要。体重状况在 COVID-19 易感性和疾病负担中的作用尚不清楚。尽管如此，较高的体重通常被描述为对易感性和疾病严重程度的明确危险因素。因此，COVID-19 疫苗试验应招募一个代表整个体重谱的研究组，并根据体重状况进行适当的亚组分析，以评估反应并在需要时调整剂量方案，以确保较高体重人群的公平结果。
我们旨在审查 ClinicalTrials.gov、ISRCTN 登记处、世界卫生组织官方疫苗试验登记处和“COVID-19 疫苗追踪器”中注册的临床试验方案的纳入和排除标准。以确定纳入较高体重（体重指数>30 kg/m）个体的试验数量以及按体重状况进行疗效亚组分析的试验数量。试验方案的筛选、数据提取和质量评估将由至少两名评审员独立完成。使用风险偏倚-2 工具评估临床试验的风险偏倚。我们将对提取的数据进行描述性分析。提出了以下子集：按试验阶段、国家和疫苗平台划分，较高体重人群参与 COVID-19 疫苗试验的情况。
本综述不需要伦理批准。该快速审查的结果将在适当的会议上提交，并在合适的同行评议期刊上发表。
PROSPERO 注册号：CRD42020226573。
