A study of arbovirus-infected individuals that have travelled from outside of the UK
| ISRCTN | ISRCTN98882766 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98882766 |
| IRAS number | 306309 |
| Secondary identifying numbers | UoL001705, IRAS 306309, CPMS 54505 |
- Submission date
- 06/06/2024
- Registration date
- 13/06/2024
- Last edited
- 01/08/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
This study aims to gather samples and clinical data from individuals who have recently travelled from outside of the UK who have been infected by an arbovirus, including viruses like Japanese encephalitis, dengue, West Nile, yellow fever, and Zika. Arboviruses are transmitted by insects such as mosquitoes, sandflies, midges or ticks which then go on to infect humans. Diagnosis of arboviruses relies on clinical suspicion and slow diagnostic tests. By collecting samples from non-immune individuals with confirmed arbovirus infection, this study will help develop and validate new diagnostic tests.
Who can participate?
Anyone aged 18 years old and over suspected or confirmed to be infected with an arbovirus by their clinical team
What does the study involve?
Participants' clinical data will be collected on admission, including blood pressure and tests. Samples will be collected at admission and on days 30 and 180 post-infection. Participants will also complete a quality of life questionnaire at these time points.
What are the possible benefits and risks of participating?
Participants won't directly benefit, but their involvement will contribute to the development of new arbovirus diagnostics, potentially benefiting future patients. There are minimal risks to participating, as data collection occurs as part of routine clinical practice. The only additional risk is minimal discomfort from venepuncture.
Where is the study run from?
The University of Liverpool (sponsor) in conjunction with the Global Health Trials unit at the Liverpool School of Tropical Medicine.
When is the study starting and how long is it expected to run for?
May 2022 to May 2030. The ARBO-UK study will end when either the Health Protection Research Unit (HPRU) funding has been exhausted or the maximum sample size has been reached. Each participant will be followed up for a maximum of 240 days from the presentation.
Who is funding the study?
The National Institute for Health and Care Research (NIHR) HPRU
Who is the main contact?
Dr Lance Turtle (Chief Investigator), arbo@liverpool.ac.uk
Contact information
Scientific, Principal Investigator
University of Liverpool, Department of Clinical Infection, Microbiology and Immunology
Liverpool
L69 7ZX
United Kingdom
 ORCID ID |
0000-0002-0778-1693 |
|---|---|
| Phone | +44 (0)151 795 7554 |
| lturtle@liverpool.ac.uk |
Public
Department of Clinical Sciences, Liverpool School of Tropical Medicine, Room 1st Floor W1-036, Wolfson Building, LSTM, Pembroke Place
Liverpool
L3 5QA
United Kingdom
| Phone | +44 (0)151 705 3364 |
|---|---|
| ravi.lad@lstmed.ac.uk |
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital, Laboratory, Medical and other records |
| Study type | Diagnostic, Quality of life, Screening |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | UK multicentre prospective observational study of imported arboviral infections |
| Study acronym | ARBO-UK |
| Study objectives | This observational study aims to construct a platform to develop arbovirus diagnostics. As a result, there is no primary endpoint specified. The primary objective of this study is to establish a multi-centre initiative to enrol patients diagnosed with arbovirus infections across the UK. Recruitment will be conducted at designated sentinel sites, where clinical admission and follow-up data, along with samples, will be collected from participants. The approach will generate an invaluable resource to support current and future arbovirus diagnostic development. |
| Ethics approval(s) |
Approved 16/05/2023, North West - Greater Manchester South Research Ethics Committee (3rd Floor, Barlow House 4 Minshull Street, Manchester, M1 3DZ, United Kingdom; +44 (0)2071048143; gmsouth.rec@hra.nhs.uk), ref: 23/NW/0008 |
| Health condition(s) or problem(s) studied | Humans infected with an arbovirus |
| Intervention | This observational cohort study aims to recruit 100-200 participants who are followed up for up to 6 months post arboviral infection. Participants will complete a quality-of-life questionnaire (EQ-5D-5L) at admission and on days 30 and 180. Additionally, serum samples, throat swab samples, and human peripheral blood mononuclear cells (PBMC) samples (not collected from all participants) will be collected at these time points. These samples will contribute to the development and testing of new diagnostic assays and assist in further characterizing immune responses, particularly in a non-endemic setting. |
| Intervention type | Other |
| Primary outcome measure | To establish a multi-centre study to recruit up to 200 patients with confirmed arbovirus infections, recruiting from designated sentinel sites to store reference short-term and long-term biological material from across the UK. A participant has been recruited once they have signed an informed consent form, with each participant staying within the study for a maximum of 240 days from presentation. |
| Secondary outcome measures | 1. Collect clinical follow-up data and samples from participants measured using data collected in REDCap, to support the Health Protection Research Unit (HPRU) in Emerging and Zoonotic Infections (EZIs) arbovirus diagnostic development, via percentage CRF completion, at one month and 6 months post-diagnosis 2. Collect peripheral blood mononuclear cells (PBMC) from selected cases in sites with processes in place and the capability to do so, measured using sample collection, to study the natural history of immune responses in well-characterised single virus exposure, aiming to identify optimal epitopes for inclusion in second generation vaccines at Day 0, Day 30 and Day 180 3. To study epitope specificity and how the immune response may change over time from infection to 6 months post-infection Exploratory scientific objectives 1. To describe the burden of disease and resource utilisation of imported arbovirus infections in the UK, measured using collected medical data of length and type of stay, medication prescribed, and care provided at the end of the study 2. To develop a cohort as a resource for future studies, such as diagnostic studies, or vaccine trials in people with well-defined previous exposure measured using clear documentation and categorization of the exposure history at the end of the study 3. To examine the long-term post-infectious sequelae and effects on people post Arboviral infection, measured using the EQ-5D-5L quality of life questionnaire at Day 0, 30 and 180 |
| Overall study start date | 01/05/2022 |
| Completion date | 01/05/2030 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100-200 |
| Key inclusion criteria | 1. Adults aged 18 years old and above 2. Laboratory confirmed or clinically highly suspected arbovirus infection, defined by: a clinically highly suspected arbovirus is a compatible clinical syndrome in the opinion of the supervising clinician. For example but not exclusively, a patient presenting with a syndrome which may include: 2.1. CNS infection 2.2. Fever and rash 2.3. Fever and myalgia 2.4. Fever and arthralgia 2.5. Plus a negative malaria test 3. Recent travel from another country |
| Key exclusion criteria | Clinical syndrome incompatible with the positive diagnostic test |
| Date of first enrolment | 20/05/2024 |
| Date of final enrolment | 01/12/2029 |
Locations
Countries of recruitment
- England
- United Kingdom
- Wales
Study participating centres
Beckett Street
Leeds
LS9 7TF
United Kingdom
Prescot Street
Liverpool
L7 8XP
United Kingdom
University Hospital of Wales
Heath Park
Cardiff
CF14 4XW
United Kingdom
Herries Road
Sheffield
S5 7AU
United Kingdom
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Mindelsohn Way
Edgbaston
Birmingham
B15 2GW
United Kingdom
Pond Street
London
NW3 2QG
United Kingdom
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
London
NW1 2BU
United Kingdom
80 Newark Street
London
E1 2ES
United Kingdom
Southmead Road
Westbury-on-trym
Bristol
BS10 5NB
United Kingdom
Watford Road
Harrow
HA1 3UJ
United Kingdom
London
SE1 7EH
United Kingdom
Sponsor information
University/education
2nd Floor Block D Waterhouse Building, 3 Brownlow Street
Liverpool
L69 3GL
England
United Kingdom
| Phone | +44 (0)151 794 8739 |
|---|---|
| sponsor@liverpool.ac.uk | |
| Website | https://www.liverpool.ac.uk/ |
"ROR" |
https://ror.org/04xs57h96 |
Funders
Funder type
Government
Government organisation / Research institutes and centers
- Alternative name(s)
- NIHR Health Protection Research Unit, Health Protection Research Unit, NIHR HPRU
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/05/2028 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Dr Lance Turtle, lturtle@liverpool.ac.uk. The type of data that will be shared comprises admission clinical data, demographic data, and QoL EQ-5D-5L data at Day 0, 30 and 180. Data will be available within 3 months. Consent from participants was required and obtained. Data is pseudonymised. Any ethical or legal restrictions: Has to be within the UK |
Editorial Notes
01/08/2025: The following changes were made:
1. The completion date was changed from 01/05/2027 to 01/05/2030.
2. The date of final enrolment was changed from 01/12/2026 to 01/12/2029.
02/07/2024: Internal review.
07/06/2024: Study's existence confirmed by the Health Research Authority (HRA) and Health and Care Research Wales (HCRW)
