Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2024

Open Access 01-12-2024 | COVID-19 Vaccination | Review

How inclusive were UK-based randomised controlled trials of COVID-19 vaccines? A systematic review investigating enrolment of Black adults and adult ethnic minorities

Published in: Trials | Issue 1/2024

Login to get access

Abstract

Objectives

To establish if Black adults and adult ethnic minorities, defined as any group except White British, were represented in UK-based COVID-19 vaccination randomised controlled trials (RCTs) when compared to corresponding UK population proportions, based on 2011 census data.

Design

Systematic review of COVID-19 Randomised Controlled Vaccine Trials

Setting

United Kingdom

Participants

Randomised Controlled Trials of COVID-19 vaccines conducted in the UK were systematically reviewed following PRISMA guidelines. MeSH terms included “Covid-19 vaccine”, “Ad26COVS1”, and “BNT162 Vaccine” with keywords such as [covishield OR coronavac OR Vaxzevria OR NVX-CoV2373] also used. Studies that provided (A) participant demographics and (B) full eligibility criteria were included. The following key data was extracted for analysis: number of participants analysed, number of Black adults and number of adult minority ethnicity participants.

Primary and Secondary Outcome Measures

The primary outcome is the mean percentage of Black adults randomised to COVID-19 vaccine trials deemed eligible within this review. The secondary outcome is the mean percentage of adult ethnic minorities randomised.

Results

The final review included 7 papers and a total of 87 sets of data collated from trial sites across the UK. The standard mean percentage of Black adults included in the trials (0.59%, 95% CI: 0.13% - 1.05%) was significantly lower compared to the recorded Black adult population (2.67%) indicating that they were under-served in UK based COVID-19 vaccine RCTs (p < 0.001). Adult ethnic minority presence (8.94%, 95% CI: 2.07% - 15.80%) was also lower than census data (16.30%), indicating they were also under-served (p = 0.039).

Conclusion

The findings show that COVID-19 vaccine trials failed to adequately randomise proportionate numbers of Black adults and adult minority ethnicities. More inclusive practices must be developed and implemented in the recruitment of underserved groups to understand the true impact of COVID-19.
Appendix
Available only for authorised users
Literature
1.
2.
3.
4.
5.
Chaturvedi N, McKeigue PM, Marmot MG. Resting and ambulatory blood pressure differences in Afro-Caribbeans and Europeans. Hypertension [Internet]. 1993 Jul [cited 2022 Apr 20];22(1):90–6. Available from: https://​www.​ahajournals.​org/​doi/​10.​1161/​01.​hyp.​22.​1.​90
6.
7.
8.
Zhang R, Li Y, Zhang AL, et al. Identifying airborne transmission as the dominant route for the spread of COVID-19. Proc Natl Acad Sci. 2020;117(26):14857–63.CrossRefPubMedPubMedCentral
9.
10.
Razai MS, Osama T, McKechnie DGJ, et al. Covid-19 vaccine hesitancy among ethnic minority groups. BMJ. 2021;26:n513.CrossRef
11.
Robertson E, Reeve KS, Niedzwiedz CL, et al. Predictors of COVID-19 vaccine hesitancy in the UK household longitudinal study. Brain Behav Immun. 2021;94:41–50.CrossRefPubMedPubMedCentral
12.
13.
Witham MD, Anderson E, Carroll C, et al. Developing a roadmap to improve trial delivery for under-served groups: results from a UK multi-stakeholder process. Trials. 2020;21(1):694.CrossRefPubMedPubMedCentral
14.
15.
16.
National Record of Scotland. Scotland’s Census - Ethnicity, Identity, Language and Religion [Internet]. 2011 [cited 2022 May 7]. Available from: https://​www.​scotlandscensus.​gov.​uk/​search-the-census#/topics/list?topic=Ethnicity,%20Identity,%20Language%20and%20Religion&categoryId=4
17.
18.
Page MJ, Moher D, Bossuyt PM, et al. PRISMA 2020 explanation and elaboration: updated guidance and exemplars for reporting systematic reviews. BMJ. 2021;29:n160.CrossRef
19.
20.
21.
Ayiku L, Levay P, Hudson T, et al. The Embase UK filter: validation of a geographic search filter to retrieve research about the UK from OVID Embase. Health Inf Libr J. 2019;36(2):121–33.CrossRef
22.
23.
Munro APS, Janani L, Cornelius V, et al. Safety and immunogenicity of seven COVID-19 vaccines as a third dose (booster) following two doses of ChAdOx1 nCov-19 or BNT162b2 in the UK (COV-BOOST): a blinded, multicentre, randomised, controlled, phase 2 trial. Lancet. 2021;398(10318):2258–76.CrossRefPubMedPubMedCentral
24.
Ramasamy MN, Minassian AM, Ewer KJ, et al. Safety and immunogenicity of ChAdOx1 nCoV-19 vaccine administered in a prime-boost regimen in young and old adults (COV002): a single-blind, randomised, controlled, phase 2/3 trial. Lancet. 2020;396(10267):1979–93.CrossRefPubMedPubMedCentral
25.
Lazarus R, Baos S, Cappel-Porter H, et al. Safety and immunogenicity of concomitant administration of COVID-19 vaccines (ChAdOx1 or BNT162b2) with seasonal influenza vaccines in adults in the UK (ComFluCOV): a multicentre, randomised, controlled, phase 4 trial. Lancet. 2021;398(10318):2277–87.CrossRefPubMedPubMedCentral
26.
Liu X, Shaw RH, Stuart ASV, et al. Safety and immunogenicity of heterologous versus homologous prime-boost schedules with an adenoviral vectored and mRNA COVID-19 vaccine (Com-COV): a single-blind, randomised, non-inferiority trial. Lancet. 2021;398(10303):856–69.CrossRefPubMedPubMedCentral
27.
Stuart ASV, Shaw RH, Liu X, et al. Immunogenicity, safety, and reactogenicity of heterologous COVID-19 primary vaccination incorporating mRNA, viral-vector, and protein-adjuvant vaccines in the UK (Com-COV2): a single-blind, randomised, phase 2, non-inferiority trial. Lancet. 2022;399(10319):36–49.CrossRefPubMedPubMedCentral
28.
Heath PT, Galiza EP, Baxter DN, et al. Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine. N Engl J Med. 2021;385(13):1172–83.CrossRefPubMed
29.
Folegatti PM, Ewer KJ, Aley PK, et al. Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial. Lancet. 2020;396(10249):467–78.CrossRefPubMedPubMedCentral
30.
31.
Crawshaw AF, Deal A, Rustage K, et al. What must be done to tackle vaccine hesitancy and barriers to COVID-19 vaccination in migrants? J Travel Med. 2021;28(4)
32.
33.
Hayward SE, Deal A, Cheng C, et al. Clinical outcomes and risk factors for COVID-19 among migrant populations in high-income countries: A systematic review. J Migr Health. 2021;3:100041.CrossRefPubMedPubMedCentral
34.
Oakley A, Wiggins M, Turner H, et al. Including Culturally Diverse Samples in Health Research: A Case Study of an Urban Trial of Social Support. Ethn Health. 2003;8(1):29–39.CrossRefPubMed
35.
Witham MD, Anderson E, Carroll CB, et al. Ensuring that COVID-19 research is inclusive: guidance from the NIHR INCLUDE project. BMJ Open. 2020;10(11):e043634.CrossRefPubMed
Metadata
Title
How inclusive were UK-based randomised controlled trials of COVID-19 vaccines? A systematic review investigating enrolment of Black adults and adult ethnic minorities
Publication date
01-12-2024
Published in
Trials / Issue 1/2024
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-024-08054-4

Other articles of this Issue 1/2024

Trials 1/2024 Go to the issue

Update

Detailed statistical analysis plan for ALBINO: effect of Allopurinol in addition to hypothermia for hypoxic-ischemic Brain Injury on Neurocognitive Outcome — a blinded randomized placebo-controlled parallel group multicenter trial for superiority (phase III)

Methodology

Good Statistical Practice—development of tailored Good Clinical Practice training for statisticians

Study protocol

Safety and efficacy of ketorolac in improving the prognosis of acute type A aortic dissection patients: a protocol of a randomized, double-blinded, and placebo-controlled study

Study protocol

Effect of Postoperative Prolonged sedation with Dexmedetomidine after successful reperfusion with Endovascular Thrombectomy on long-term prognosis in patients with acute ischemic stroke (PPDET): study protocol for a randomized controlled trial

Study protocol

Effectiveness of a school-based Life Gatekeeper Training Program on suicide prevention in China: protocol for a randomized controlled trial

Study protocol

PeRsOnaliSed care Planning for oldER people with frailty (PROSPER): protocol for a randomised controlled trial