Article Text
Abstract
Notwithstanding the success of conventional field trials for vaccines against COVID-19, human challenge trials (HCTs) that could obtain more information about these and about other vaccines and further strategies against it are about to start in the UK. One critique of COVID-19 HCTs is their distinct paucity of information on crucial population groups. For safety reasons, these HCTs will exclude candidate participants of advanced age or with comorbidities that worsen COVID-19, yet a vaccine should (perhaps especially) protect such populations. We turn this cliché on its head. The truth is that either an HCT or a field trial has intrinsic generalisability limitations, that an HCT can expedite protection of high-risk participants even without challenging them with the virus, and that an important route to obtaining results generalisable to high-risk groups under either strategy is facilitated by HCTs.
- biostatistics
- clinical trials
- COVID-19
- ethics
- research ethics
Data availability statement
There are no data in this work.
This article is made freely available for personal use in accordance with BMJ’s website terms and conditions for the duration of the covid-19 pandemic or until otherwise determined by BMJ. You may use, download and print the article for any lawful, non-commercial purpose (including text and data mining) provided that all copyright notices and trade marks are retained.
https://bmj.com/coronavirus/usageStatistics from Altmetric.com
Data availability statement
There are no data in this work.
Footnotes
Contributors Both authors contributed equally.
Funding NE receives funding from the US National Science Foundation, Award # 2039320 and from Open Philanthropy.
Competing interests NE serves on the Board of Advisor of 1DaySooner, an unpaid position.
Provenance and peer review Not commissioned; externally peer reviewed.
Read the full text or download the PDF:
Other content recommended for you
- COVID-19 controlled human infection studies: worries about local community impact and demands for local engagement
- Comparison of T-cell immune responses to SARS-CoV-2 spike (S) and nucleocapsid (N) protein using an in-house flow-cytometric assay in laboratory employees with and without previously confirmed COVID-19 in South Africa: nationwide cross-sectional study
- Human infection challenge studies in endemic settings and/or low-income and middle-income countries: key points of ethical consensus and controversy
- Vaccine ethics: an ethical framework for global distribution of COVID-19 vaccines
- Controlled human infection with SARS-CoV-2 to study COVID-19 vaccines and treatments: bioethics in Utopia
- Cohort profile: Stop the Spread Ottawa (SSO)—a community-based prospective cohort study on antibody responses, antibody neutralisation efficiency and cellular immunity to SARS-CoV-2 infection and vaccination
- UK Research Ethics Committee’s review of the global first SARS-CoV-2 human infection challenge studies
- Considerations for vaccinating children against COVID-19
- Effectiveness of BNT162b2 and mRNA-1273 covid-19 vaccines against symptomatic SARS-CoV-2 infection and severe covid-19 outcomes in Ontario, Canada: test negative design study
- Maternal mRNA covid-19 vaccination during pregnancy and delta or omicron infection or hospital admission in infants: test negative design study