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Prospective incidence epidemiology study protocol: conducting active surveillance to assess the burden of Lyme disease (BOLD) in primary care practices in endemic areas of six European countries.
- Source :
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BMJ open [BMJ Open] 2023 Dec 10; Vol. 13 (12), pp. e070903. Date of Electronic Publication: 2023 Dec 10. - Publication Year :
- 2023
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Abstract
- Introduction: Lyme disease (LD) is the most frequent tick-borne disease in the moderate climates of Europe. This study will inform the phase III efficacy study for Pfizer and Valneva's investigational Lyme disease vaccine, VLA15. VLA15 phase III will be conducted in the USA and Europe due to the vaccine's serotype coverage and public health burden of LD. In Europe, the existence and location of sites that have access to populations with high LD annual incidence is uncertain. This active, prospective surveillance study assesses annual LD incidence at general practice (GP)/primary care sites, allowing for phase III site vetting and better characterisation of LD burden in selected regions for study size calculations.<br />Methods and Analysis: This burden of Lyme disease (BOLD) study will assess LD incidence overall and by site at 15 GP/primary care practices in endemic areas of 6 European countries from Spring 2021 to December 2022 and will be summarised with counts (n), percentages (%) and associated 95% CIs. Suspected LD cases identified from site's practice panels are documented on screening logs, where clinical LD manifestations, diagnoses and standard of care diagnostic results are recorded. In the initial 12-month enrolment phase, suspected LD cases are offered enrolment. Participants undergo interview and clinical assessments to establish medical history, final clinical diagnosis, clinical manifestations and quality of life impact. Study-specific procedures include LD serology, skin punch biopsies and Lyme manifestation photographs. For every enrolled participant diagnosed with LD, 6-10 age-matched controls are randomly selected and offered enrolment for an embedded LD risk factor analysis. Persistent symptoms or post-treatment LD will be assessed at follow-up visits up to 2 years after initial diagnosis, while patients remain symptomatic.<br />Ethics and Dissemination: This study has been approved by all sites' local ethics committees. The results will be presented at conferences and published in peer-reviewed journals.<br />Competing Interests: Competing interests: EB, AL-B, AP, JHS, KH, LRH, BDG and KEA are employees of Pfizer and may own Pfizer stock. NB is an employee of Valneva Austria GmbH. BP and MB were University students on placement at Pfizer UK during the BOLD study.<br /> (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Details
- Language :
- English
- ISSN :
- 2044-6055
- Volume :
- 13
- Issue :
- 12
- Database :
- MEDLINE
- Journal :
- BMJ open
- Publication Type :
- Academic Journal
- Accession number :
- 38072499
- Full Text :
- https://doi.org/10.1136/bmjopen-2022-070903