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
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 vacc...
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BMJ Publishing Group
2023-12-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/12/e070903.full |
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| author | Mendwas Dzingina James H Stark Bradford D Gessner Kristen E Allen Elizabeth Begier Andreas Pilz Alexandra Loew-Baselli Lisa R Harper Molly Bowdery Kate Halsby Nicole Bézay Ben Parslow |
| author_facet | Mendwas Dzingina James H Stark Bradford D Gessner Kristen E Allen Elizabeth Begier Andreas Pilz Alexandra Loew-Baselli Lisa R Harper Molly Bowdery Kate Halsby Nicole Bézay Ben Parslow |
| author_sort | Mendwas Dzingina |
| collection | DOAJ |
| description | 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.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.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. |
| format | Article |
| id | doaj-art-80ee6ea2b8f34e5d85267b9febfb655e |
| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2023-12-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-80ee6ea2b8f34e5d85267b9febfb655e2025-08-20T03:11:10ZengBMJ Publishing GroupBMJ Open2044-60552023-12-01131210.1136/bmjopen-2022-070903Prospective 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 countriesMendwas Dzingina0James H Stark1Bradford D Gessner2Kristen E Allen3Elizabeth Begier4Andreas Pilz5Alexandra Loew-Baselli6Lisa R Harper7Molly Bowdery8Kate Halsby9Nicole Bézay10Ben Parslow11Pfizer Ltd, Tadworth, UKPfizer Biopharma Group, Collegeville, Pennsylvania, USA9 Global Biopharmaceutical Business, Pfizer Inc, Collegeville, Pennsylvania, USAPfizer Biopharma Group, Collegeville, Pennsylvania, USAPfizer Vaccines, Pfizer Inc, Collegeville, Pennsylvania, USAPfizer Corporation Austria GmbH, Wien, AustriaPfizer Corporation Austria GmbH, Wien, AustriaPfizer Biopharma Group, Collegeville, Pennsylvania, USAUniversity of London, London, UKPfizer Ltd, Tadworth, UKValneva Austria GmbH, Vienna, AustriaUniversity of Exeter, Exeter, UKIntroduction 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.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.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.https://bmjopen.bmj.com/content/13/12/e070903.full |
| spellingShingle | Mendwas Dzingina James H Stark Bradford D Gessner Kristen E Allen Elizabeth Begier Andreas Pilz Alexandra Loew-Baselli Lisa R Harper Molly Bowdery Kate Halsby Nicole Bézay Ben Parslow 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 BMJ Open |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/13/12/e070903.full |
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