lancet-header

Preprints with The Lancet is part of SSRN´s First Look, a place where journals identify content of interest prior to publication. Authors have opted in at submission to The Lancet family of journals to post their preprints on Preprints with The Lancet. The usual SSRN checks and a Lancet-specific check for appropriateness and transparency have been applied. Preprints available here are not Lancet publications or necessarily under review with a Lancet journal. These preprints are early stage research papers that have not been peer-reviewed. The findings should not be used for clinical or public health decision making and should not be presented to a lay audience without highlighting that they are preliminary and have not been peer-reviewed. For more information on this collaboration, see the comments published in The Lancet about the trial period, and our decision to make this a permanent offering, or visit The Lancet´s FAQ page, and for any feedback please contact preprints@lancet.com.

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

Nazir Lone

University of Edinburgh - Asthma UK Centre for Applied Research

Jim McMenamin

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 - Asthma UK Centre for Applied Research

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

Nazir Lone

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

Edinburgh
United Kingdom

Jim McMenamin

Public Health Scotland

Glasgow, Scotland
United Kingdom

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 )

Old College
South Bridge
Edinburgh, Scotland EH8 9JY
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 - Asthma UK Centre for Applied Research ( email )

Edinburgh
United Kingdom

Colin R. Simpson

Victoria University of Wellington - School of Health

P.O. Box 600
Wellington, 6140
New Zealand

Click here to go to TheLancet.com

Paper statistics

Abstract Views
194
Downloads
14
PlumX Metrics