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Evaluating the Effectiveness of Influenza Vaccine in People With At-Risk Medical Conditions: A Test-Negative Design Case-Control Study for the Seasonal Influenza Vaccine Effectiveness II (SIVE II) Project

24 Pages Posted: 11 Nov 2020

See all articles by Eleftheria Vasileiou

Eleftheria Vasileiou

University of Edinburgh - Asthma UK Centre for Applied Research

Tanya Englishby

University of Strathclyde - Department of Mathematics & Statistics

Kimberley Kavanagh

University of Strathclyde - Department of Mathematics & Statistics

Chris Robertson

University of Strathclyde - Department of Mathematics & Statistics; Government of the United Kingdom - Public Health Scotland

Nazir Lone

University of Edinburgh - Asthma UK Centre for Applied Research

Jim McMenamin

Public Health Scotland; Government of the United Kingdom - Public Health Scotland

Beatrix von Wissmann

Public Health Scotland

Rory Gunson

West of Scotland Specialist Virology Centre

Jürgen Schwarze

University of Edinburgh - Centre for Inflammation Research

Christopher Butler

University of Oxford - Nuffield Department of Primary Care Health Sciences

Sir Lewis D. Ritchie

University of Aberdeen - Centre of Academic Primary Care

Aziz Sheikh

University of Edinburgh - Usher Institute

Colin R. Simpson

Victoria University of Wellington - School of Health

More...

Abstract

Background: Seasonal trivalent inactivated influenza (TIV) vaccine effectiveness (VE) against laboratory confirmed influenza in adults with at-risk medical conditions is not well established. Previous studies have been hampered by small sample sizes to assess VE for each at-risk medical condition recommended for vaccination. Larger better powered studies investigating how influenza VE varied in those with specific risk factors associated with poor influenza outcomes is therefore required. 

Methods: A test-negative design case-control study of influenza VE was carried out in adults with at-risk medical conditions in Scotland between 2010/11 to 2015/16. We used individual patient-level health administrative data from 223 primary care practices linked with hospital and laboratory data (n=10275 swabs from n=9147 individuals). Generalised additive logistic regression was used to provide adjusted VE estimates between adults (aged >18 years) with laboratory-confirmed influenza compared to those with a negative test for influenza. 

Findings: Significant positive VE was found for all adults with chronic heart disease (31%; 95% confidence interval [CI]: 10 to 48), diabetes (34%; 95%CI: 12 to 51), impaired immune function (51%; 95%CI: 13 to 72), chronic kidney disease (40%; 95%CI: 17 to 57) and Body Mass Index (BMI) >30 to <40 kg/m2 (62%; 95%CI: 26 to 81). Significant VE was demonstrated for impaired immune function amongst most age groups including younger adults (18-54 years; 68%; 95%CI: 17 to 88) and those aged 85 years and over (42%; 95%CI: 4 to 65). The oldest adults aged 85 years and over had a significant positive VE for chronic respiratory disease (20%; 95%CI: 3 to 34), diabetes (34%; 95%CI: 11 to 51), and impaired immune function (42%; 95%CI: 4 to 65). Non-significant VE was found for those with chronic neurological disease (18%; 95%CI: -16 to 43). 

Interpretation: The amount of vaccine protection against laboratory-confirmed influenza varied amongst adults with at-risk medical conditions in different age groups. Seasonal influenza vaccination programmes should additionally consider those with BMI >30 to <40 kg/m2. Available alternate vaccines which aim to improve immune response should be considered for at-risk groups with consistently low TIV VE (e.g. neurological disease).

Funding Statement: National Institute for Health Research Health Technology Assessment Programme (project number 13/34/14), Health Data Research UK, Asthma UK

Declaration of Interests: The authors declare no competing interests.

Ethics Approval Statement: The Privacy Advisory Committee of the Information Services Division, NSS, approved the linkage and the statistical analysis of the anonymised data used in this study. Ethical permission was granted from the National Research Ethics Service Committee, West Midlands - Edgbaston [15/WM/0035].

Keywords: Influenza, vaccination, immunisation, laboratory confirmed influenza, at-risk condition

Suggested Citation

Vasileiou, Eleftheria and Englishby, Tanya and Kavanagh, Kimberley and Robertson, Chris and Lone, Nazir and McMenamin, Jim and von Wissmann, Beatrix and Gunson, Rory and Schwarze, Jürgen and Butler, Christopher and Ritchie, Sir Lewis D. and Sheikh, Aziz and Simpson, Colin R., Evaluating the Effectiveness of Influenza Vaccine in People With At-Risk Medical Conditions: A Test-Negative Design Case-Control Study for the Seasonal Influenza Vaccine Effectiveness II (SIVE II) Project. Available at SSRN: https://ssrn.com/abstract=3716865 or http://dx.doi.org/10.2139/ssrn.3716865

Eleftheria Vasileiou (Contact Author)

University of Edinburgh - Asthma UK Centre for Applied Research ( email )

Edinburgh
United Kingdom

Tanya Englishby

University of Strathclyde - Department of Mathematics & Statistics

26 Richmond Street
Glasgow G1 1XH
United Kingdom

Kimberley Kavanagh

University of Strathclyde - Department of Mathematics & Statistics

26 Richmond Street
Glasgow G1 1XH
United Kingdom

Chris Robertson

University of Strathclyde - Department of Mathematics & Statistics ( email )

26 Richmond Street
Glasgow G1 1XH
United Kingdom

Government of the United Kingdom - Public Health Scotland ( email )

Nazir Lone

University of Edinburgh - Asthma UK Centre for Applied Research ( email )

Edinburgh
United Kingdom

Jim McMenamin

Public Health Scotland

Glasgow, Scotland
United Kingdom

Government of the United Kingdom - Public Health Scotland

Beatrix Von Wissmann

Public Health Scotland

Glasgow, Scotland
United Kingdom

Rory Gunson

West of Scotland Specialist Virology Centre

Glasgow, Scotland
United Kingdom

Jürgen Schwarze

University of Edinburgh - Centre for Inflammation Research ( email )

Edinburgh BioQuarter
47 Little France Crescent
Edinburgh, EH16 4TJ
United Kingdom

Christopher Butler

University of Oxford - Nuffield Department of Primary Care Health Sciences ( email )

Oxford
United Kingdom

Sir Lewis D. Ritchie

University of Aberdeen - Centre of Academic Primary Care

Dunbar Street
Aberdeen, Scotland AB24 3QY
United Kingdom

Aziz Sheikh

University of Edinburgh - Usher Institute ( email )

Colin R. Simpson

Victoria University of Wellington - School of Health

P.O. Box 600
Wellington, 6140
New Zealand

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