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AuthorCampbell, Jessica
AuthorHobbs, Matthew
AuthorO’Hara, Lily
AuthorBallantyne, Angela
AuthorHeywood, Anita
AuthorGray, Lesley
Available date2021-08-19T09:05:01Z
Publication Date2021-05-25
Publication NameBMJ Open
Identifierhttp://dx.doi.org/10.1136/bmjopen-2021-050114
CitationCampbell J, Hobbs M, O’Hara L, et al. Equity in vaccine trials for higher weight people? Protocol for a rapid review of inclusion and exclusion criteria for higher weight people in clinical trials for COVID-19. BMJ Open 2021;11:e050114. doi:10.1136/ bmjopen-2021-050114
Identifiere050114
URIhttps://pubmed.ncbi.nlm.nih.gov/34035111/
URIhttp://hdl.handle.net/10576/22081
AbstractIntroduction 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. Methods and analysis 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/m2 ) 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. Ethics and dissemination Ethical approval was not required for this review. The results of this rapid review will be presented at appropriate conferences and published in ma suitable peer reviewed journal. PROSPERO registration number CRD42020226573
Languageen
PublisherBMJ Publishing Group
SubjectCOVID-19
Vaccine
Vaccination
Trial
Higher weight
Critical weight studies
TitleEquity in vaccine trials for higher weight people ? Protocol for a rapid review of inclusion and exclusion criteria for higher weight people in clinical trials for COVID-19
TypeArticle
Issue Number5
Volume Number11
dc.accessType Open Access


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