Equity in Vaccine Trials for Higher Weight People? A Rapid Review of Weight-Related Inclusion and Exclusion Criteria for COVID-19 Clinical Trials
Higher weight status, defined as body mass index (BMI) ≥ 30 kg/m<sup>2</sup>, is frequently described as a risk factor for severity and susceptibility to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) disease (known as COVID-19). Therefore, study groups in COVID-19 vaccine...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
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MDPI AG
2021-12-01
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| Series: | Vaccines |
| Subjects: | |
| Online Access: | https://www.mdpi.com/2076-393X/9/12/1466 |
| _version_ | 1797500071925776384 |
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| author | Jessica Campbell Juliet Sutherland Danielle Bucknall Lily O’Hara Anita Heywood Matthew Hobbs Angela Ballantyne Lesley Gray |
| author_facet | Jessica Campbell Juliet Sutherland Danielle Bucknall Lily O’Hara Anita Heywood Matthew Hobbs Angela Ballantyne Lesley Gray |
| author_sort | Jessica Campbell |
| collection | DOAJ |
| description | Higher weight status, defined as body mass index (BMI) ≥ 30 kg/m<sup>2</sup>, is frequently described as a risk factor for severity and susceptibility to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) disease (known as COVID-19). Therefore, study groups in COVID-19 vaccine trials should be representative of the weight spectrum across the global population. Appropriate subgroup analysis should be conducted to ensure equitable vaccine outcomes for higher weight people. In this study, inclusion and exclusion criteria of registered clinical trial protocols were reviewed to determine the proportion of trials including higher weight people, and the proportion of trials conducting subgroup analyses of efficacy by BMI. Eligibility criteria of 249 trial protocols (phase I, II, III and IV) were analysed; 51 protocols (20.5%) specified inclusion of BMI > 30, 73 (29.3%) specified exclusion of BMI > 30, and 125 (50.2%) did not specify whether BMI was an inclusion or exclusion criterion, or if BMI was included in any ‘health’ screenings or physical examinations during recruitment. Of the 58 protocols for trials in phase III and IV, only 2 (3.4%) indicated an intention to report subgroup analysis of vaccine efficacy by weight status. Higher weight people appear to be significantly under-represented in the majority of vaccine trials. This may result in reduced efficacy and acceptance of COVID-19 vaccines for higher weight people and exacerbation of health inequities within this population group. Explicit inclusion of higher weight people in COVID-19 vaccine trials is required to reduce health inequities. |
| first_indexed | 2024-03-10T03:56:35Z |
| format | Article |
| id | doaj.art-ef47c9f6292c4b77a9c9ee5fd5f2dcc3 |
| institution | Directory Open Access Journal |
| issn | 2076-393X |
| language | English |
| last_indexed | 2024-03-10T03:56:35Z |
| publishDate | 2021-12-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Vaccines |
| spelling | doaj.art-ef47c9f6292c4b77a9c9ee5fd5f2dcc32023-11-23T10:54:44ZengMDPI AGVaccines2076-393X2021-12-01912146610.3390/vaccines9121466Equity in Vaccine Trials for Higher Weight People? A Rapid Review of Weight-Related Inclusion and Exclusion Criteria for COVID-19 Clinical TrialsJessica Campbell0Juliet Sutherland1Danielle Bucknall2Lily O’Hara3Anita Heywood4Matthew Hobbs5Angela Ballantyne6Lesley Gray7Otago Medical School, University of Otago, Christchurch 8011, New ZealandOtago Medical School, University of Otago, Christchurch 8011, New ZealandOtago Medical School, University of Otago, Christchurch 8011, New ZealandDepartment of Public Health, College of Health Sciences, QU Health, Qatar University, Doha P.O. Box 2713, QatarSchool of Population Health, University of New South Wales, Sydney, NSW 2052, AustraliaSchool of Health Sciences, College of Education, Health and Human Development, University of Canterbury, Christchurch 8140, New ZealandDepartment of Primary Health Care & General Practice, University of Otago, Wellington 6021, New ZealandDepartment of Primary Health Care & General Practice, University of Otago, Wellington 6021, New ZealandHigher weight status, defined as body mass index (BMI) ≥ 30 kg/m<sup>2</sup>, is frequently described as a risk factor for severity and susceptibility to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) disease (known as COVID-19). Therefore, study groups in COVID-19 vaccine trials should be representative of the weight spectrum across the global population. Appropriate subgroup analysis should be conducted to ensure equitable vaccine outcomes for higher weight people. In this study, inclusion and exclusion criteria of registered clinical trial protocols were reviewed to determine the proportion of trials including higher weight people, and the proportion of trials conducting subgroup analyses of efficacy by BMI. Eligibility criteria of 249 trial protocols (phase I, II, III and IV) were analysed; 51 protocols (20.5%) specified inclusion of BMI > 30, 73 (29.3%) specified exclusion of BMI > 30, and 125 (50.2%) did not specify whether BMI was an inclusion or exclusion criterion, or if BMI was included in any ‘health’ screenings or physical examinations during recruitment. Of the 58 protocols for trials in phase III and IV, only 2 (3.4%) indicated an intention to report subgroup analysis of vaccine efficacy by weight status. Higher weight people appear to be significantly under-represented in the majority of vaccine trials. This may result in reduced efficacy and acceptance of COVID-19 vaccines for higher weight people and exacerbation of health inequities within this population group. Explicit inclusion of higher weight people in COVID-19 vaccine trials is required to reduce health inequities.https://www.mdpi.com/2076-393X/9/12/1466vaccinevaccinationCOVID-19higher weightBMIclinical trial |
| spellingShingle | Jessica Campbell Juliet Sutherland Danielle Bucknall Lily O’Hara Anita Heywood Matthew Hobbs Angela Ballantyne Lesley Gray Equity in Vaccine Trials for Higher Weight People? A Rapid Review of Weight-Related Inclusion and Exclusion Criteria for COVID-19 Clinical Trials Vaccines vaccine vaccination COVID-19 higher weight BMI clinical trial |
| title | Equity in Vaccine Trials for Higher Weight People? A Rapid Review of Weight-Related Inclusion and Exclusion Criteria for COVID-19 Clinical Trials |
| title_full | Equity in Vaccine Trials for Higher Weight People? A Rapid Review of Weight-Related Inclusion and Exclusion Criteria for COVID-19 Clinical Trials |
| title_fullStr | Equity in Vaccine Trials for Higher Weight People? A Rapid Review of Weight-Related Inclusion and Exclusion Criteria for COVID-19 Clinical Trials |
| title_full_unstemmed | Equity in Vaccine Trials for Higher Weight People? A Rapid Review of Weight-Related Inclusion and Exclusion Criteria for COVID-19 Clinical Trials |
| title_short | Equity in Vaccine Trials for Higher Weight People? A Rapid Review of Weight-Related Inclusion and Exclusion Criteria for COVID-19 Clinical Trials |
| title_sort | equity in vaccine trials for higher weight people a rapid review of weight related inclusion and exclusion criteria for covid 19 clinical trials |
| topic | vaccine vaccination COVID-19 higher weight BMI clinical trial |
| url | https://www.mdpi.com/2076-393X/9/12/1466 |
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