Hepatitis A vaccination coverage amongst people with Chronic Liver Disease in England (HEALD): protocol for a retrospective cohort study
| ISRCTN | ISRCTN11919759 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11919759 |
| Secondary identifying numbers | GSK ISS: 14309 |
- Submission date
- 11/09/2023
- Registration date
- 12/10/2023
- Last edited
- 27/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Hepatitis A outbreaks in the United Kingdom are uncommon. Most people develop mild-to-moderate symptoms that resolve, without sequelae, within months. However, in high-risk groups, including those with underlying chronic liver disease, hepatitis A infection can be severe, with higher risk of mortality and morbidity.
The UK’s public health body, the Health Security Agency and the English guidelines organisation, the National Institute of Health and Care Excellence, recommend pre-exposure hepatitis A vaccination given as two doses to people with chronic liver disease, regardless of its cause. There are currently no published reports of vaccination coverage in people with chronic liver disease in England, or internationally.
The study aims to describe hepatitis A vaccination coverage in adults with chronic liver disease in a UK primary care setting. To compare liver disease aetiology, sociodemographic characteristics and comorbidities in people who are and are not exposed to hepatitis A vaccine.
Who can participate?
Data used for the study will include all the individuals in England.
What does the study involve?
During the study GP data will be retrospectively analysed to get an understanding of hepatitis A vaccination coverage in adults with chronic liver disease in a UK primary care setting, comparing liver disease aetiology, sociodemographic characteristics and comorbidities in people who are and are not exposed to hepatitis A vaccine.
What are the possible benefits and risks of participating?
The results of the study will give a better understanding about how to administer the hepatitis A vaccine to people with chronic liver disease in the English population in the future.
Where is the study run from?
Nuffield Department of Primary Health Care Sciences of the University of Oxford (UK)
When is the study starting and how long is it expected to run for?
March 2022 to August 2024
Who is funding the study?
GlaxoSmithKline (Belgium)
Who is the main contact?
Prof. Simon de Lusignan, simon.delusignan@phc.ox.ac.uk
Contact information
Scientific
Radcliffe Primary Care Building
Radcliffe Observatory Quarter
Woodstock Road
Oxford
OX2 6GG
United Kingdom
 ORCID ID |
0000-0001-6551-5484 |
|---|---|
| Phone | +44 1865 617855 |
| bernardo.meza-torres@phc.ox.ac.uk |
Principal Investigator
Radcliffe Primary Care Building
Radcliffe Observatory Quarter
Woodstock Road
Oxford
OX2 6GG
United Kingdom
| Phone | +44 1865 617855 |
|---|---|
| simon.delusignan@phc.ox.ac.uk |
Public
Radcliffe Primary Care Building
Radcliffe Observatory Quarter
Woodstock Road
Oxford
OX2 6GG
United Kingdom
| Phone | +44 1865 617855 |
|---|---|
| bernardo.meza-torres@phc.ox.ac.uk |
Study information
| Study design | Retrospective cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Retrospective cohort study |
| Study setting(s) | Medical and other records |
| Study type | Other |
| Participant information sheet | Not applicable (retrospective study) |
| Scientific title | Hepatitis A vaccination coverage amongst people with Chronic Liver Disease in England (HEALD): protocol for a retrospective cohort sentinel network database study |
| Study acronym | HEALD |
| Study objectives | This study fills this gap reporting ehpatitis A (Hep A) vaccine coverage in people with chronic liver disease (CLD), with a focus on whether there are disparities as to which people with CLD receive Hep A vaccination. The study aim is to report Hep A vaccination coverage in people with CLD in English primary care and the predictors of receiving a single dose or full vaccination course. With the folowing objectives: 1. To report Hep A vaccination coverage in people with CLD by: a. Sociodemographic characteristics (e.g. age, gender, ethnicity, deprivation, obesity, smoking, alcohol consumption) b. CLD disease type (e.g. alcholic liver disease, chronic hepatitis B and C, Non alcoholic fatty liver disease). c. CLD complications (e.g. renal disease, ascites, liver failure and transplant, cardio-metabolic disease) d. Comorbidities and exposures (e.g. Cambridge Multimorbidity Score (CMMS), bile duct and colon cancers, at least three doses of COVID-19 vaccine, flu vaccination). 2. To report the predictors of one- and two-doses of Hep A vaccination in people with CLD. |
| Ethics approval(s) |
Approved 09/06/2022, Central University Research Ethics Committee (CUREC) at the University of Oxford (Boundary Brook House, Churchill Drive, Headington, Oxford, OX3 7GB, United Kingdom; +44 1865 616577; ethics@medsci.ox.ac.uk), ref: R80951/RE001 |
| Health condition(s) or problem(s) studied | People with chronic liver disease, including alcohol-related liver disease (ALD), chronic hepatitis B infection (CH-B), chronic hepatitis C infection (CH-C), and non-alcoholic fatty liver disease (NAFLD) |
| Intervention | Using data from the Primary Care Sentinel Cohort (PCSC) of the Oxford-Royal College of General Practitioners (RCGP) Research and Surveillance centre (RSC) for the period between the 1st January 2012 and 31st December 2022. Data will be extracted retrospectively at the time of the start of the study. |
| Intervention type | Other |
| Primary outcome measure | Number of doses of hepatitis A vaccination measured using patient records at a single time point |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 31/03/2022 |
| Completion date | 31/08/2024 |
Eligibility
| Participant type(s) | Population |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 1,650 |
| Total final enrolment | 13875 |
| Key inclusion criteria | We will include adults registered in general practices within the RSC network, with a diagnosis of CLD, as defined by our ontology, within the period between the 1st January 2012 and 31st December 2022. The following inclusion criteria will be applied: People registered in the RSC general practices, aged 18 years of age and older, with a diagnosis of CLD. Our ontology for CLD includes: Alcoholic liver disease (ALD), chronic hepatitis B (CH-B), chronic hepatitis C (CH-C), non-alcoholic fatty liver disease, Wilson´s Disease, haemochromatosis, autoimmune hepatitis (AIH), primary sclerosing cholangitis (PSC) and primary biliary cholangitis (PBC). |
| Key exclusion criteria | 1. Patients with recorded contraindications to the Hep A vaccine (confirmed anaphylactic reaction to a previous dose of Hep A containing vaccine, or to any of its components). 2. Records of administration of post-infection or risk-of-infection immunoglobulins. |
| Date of first enrolment | 06/06/2023 |
| Date of final enrolment | 06/06/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
- Wales
Study participating centre
Radcliffe Observatory Quarter
Woodstock Road
Oxford
OX2 6GG
United Kingdom
Sponsor information
University/education
University Offices
Wellington Square
Oxford
OX1 2JD
England
United Kingdom
| Phone | +44 1865 280422 |
|---|---|
| kay.mcnamee@admin.ox.ac.uk | |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- GSK Belgium, GlaxoSmithKline Biologicals SA, GlaxoSmithKline Biologicals SAS, GlaxoSmithKline (GSK) Biologicals, GSK Biologicals, GSK
- Location
- Belgium
Results and Publications
| Intention to publish date | 01/03/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publicly available repository, at the ORCHID database hosted by the Nuffield Department of Primary Care Health Sciences at the University of Oxford (https://orchid.phc.ox.ac.uk/) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol (preprint) | 05/09/2023 | 15/09/2023 | No | No | |
| Basic results | version 5.2 | 04/12/2024 | 17/01/2025 | No | No |
Additional files
Editorial Notes
27/01/2025: Total final enrolment added. The intention to publish date was changed from 31/08/2024 to 01/03/2025.
17/01/2025: Basic results added.
15/09/2023: Trial's existence confirmed by University of Oxford.
