Comparing the effectiveness of different vaccines in individuals with and without autoimmune diseases: a study protocol for a target trial emulation
AimThis article presents the study protocol of a retrospective cohort study designed to compare the effectiveness of herpes zoster, and influenza vaccines in individuals with multiple sclerosis (MS), chronic inflammatory bowel diseases (IBD), or chronic inflammatory rheumatic diseases (CIRD) to indi...
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Frontiers Media S.A.
2025-05-01
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| author | Robin Denz Heike van de Sand Jale Basten Katharina Meiszl Marianne Tokic Theresa Oganowski Thomas Grüter Thomas Grüter Stephanie Stock Dusan Simic Arim Shukri Uta Kiltz Uta Kiltz Maria Zacharopoulou Horst Christian Vollmar Ina Carola Otte Chantal Giehl Chantal Giehl Romy Lauer Romy Lauer Anastasia Suslow Andreas Stallmach Anika Franz Ursula Marschall Joachim Saam Catharina Schumacher Katja Blaschke Ingo Meyer Kerstin Hellwig Nina Timmesfeld The VAC-MAC Consortium |
| author_facet | Robin Denz Heike van de Sand Jale Basten Katharina Meiszl Marianne Tokic Theresa Oganowski Thomas Grüter Thomas Grüter Stephanie Stock Dusan Simic Arim Shukri Uta Kiltz Uta Kiltz Maria Zacharopoulou Horst Christian Vollmar Ina Carola Otte Chantal Giehl Chantal Giehl Romy Lauer Romy Lauer Anastasia Suslow Andreas Stallmach Anika Franz Ursula Marschall Joachim Saam Catharina Schumacher Katja Blaschke Ingo Meyer Kerstin Hellwig Nina Timmesfeld The VAC-MAC Consortium |
| author_sort | Robin Denz |
| collection | DOAJ |
| description | AimThis article presents the study protocol of a retrospective cohort study designed to compare the effectiveness of herpes zoster, and influenza vaccines in individuals with multiple sclerosis (MS), chronic inflammatory bowel diseases (IBD), or chronic inflammatory rheumatic diseases (CIRD) to individuals without these diseases, using claims data of one of the largest population based health insurances in Germany.BackgroundIndividuals with autoimmune diseases such as MS, IBD, and CIRD are more susceptible to vaccine preventable infectious diseases such as influenza and herpes zoster, due to the autoimmune disease itself, the presence of comorbidities and immunosuppressive therapies. Vaccines are the primary means to prevent such diseases. The efficacy of these vaccines is usually estimated using large randomized controlled trials, from which patients with MS, IBD, and CIRD are often excluded. It is therefore unclear whether these vaccines are also effective for these patients.DesignA target trial emulation based on observational claims data of a statutory health insurance company is proposed.MethodsThis study will aim to emulate multiple target trials to compare the effectiveness of herpes zoster and influenza vaccines in patients with and without MS, IBD and CIRD using data from a large German statutory health insurance provider (BARMER). The primary outcome for each vaccine effectiveness analysis is the disease itself. The analysis will be carried out using both time-dependent matching and a multivariable Cox proportional hazards model in conjunction with g-computation. Additionally, the moderating effect of immunosuppressive therapies on the vaccine effectiveness will be estimated using a stratified secondary analysis.DiscussionThis study will estimate and compare the effectiveness of influenza and herpes zoster vaccines in individuals with and without MS, IBD, and CIRD. Because of the large amount of data, this study will also be able to investigate the role of the immunosuppressive medication on vaccine effectiveness, which may provide guidance for vaccine administration guidelines. |
| format | Article |
| id | doaj-art-88032d2a028b4ba4a5a38575a244bf7f |
| institution | OA Journals |
| issn | 2296-2565 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | Frontiers Media S.A. |
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| series | Frontiers in Public Health |
| spelling | doaj-art-88032d2a028b4ba4a5a38575a244bf7f2025-08-20T02:34:10ZengFrontiers Media S.A.Frontiers in Public Health2296-25652025-05-011310.3389/fpubh.2025.15834341583434Comparing the effectiveness of different vaccines in individuals with and without autoimmune diseases: a study protocol for a target trial emulationRobin Denz0Heike van de Sand1Jale Basten2Katharina Meiszl3Marianne Tokic4Theresa Oganowski5Thomas Grüter6Thomas Grüter7Stephanie Stock8Dusan Simic9Arim Shukri10Uta Kiltz11Uta Kiltz12Maria Zacharopoulou13Horst Christian Vollmar14Ina Carola Otte15Chantal Giehl16Chantal Giehl17Romy Lauer18Romy Lauer19Anastasia Suslow20Andreas Stallmach21Anika Franz22Ursula Marschall23Joachim Saam24Catharina Schumacher25Katja Blaschke26Ingo Meyer27Kerstin Hellwig28Nina Timmesfeld29The VAC-MAC ConsortiumDepartment of Medical Informatics, Biometry and Epidemiology, Ruhr University Bochum, Bochum, GermanyPMV Research Group, Medical Faculty and University Hospital Cologne, University of Cologne, Cologne, GermanyDepartment of Medical Informatics, Biometry and Epidemiology, Ruhr University Bochum, Bochum, GermanyDepartment of Medical Informatics, Biometry and Epidemiology, Ruhr University Bochum, Bochum, GermanyDepartment of Medical Informatics, Biometry and Epidemiology, Ruhr University Bochum, Bochum, GermanyDepartment of Neurology, St. Josef Hospital, Ruhr University Bochum, Bochum, GermanyDepartment of Neurology, St. Josef Hospital, Ruhr University Bochum, Bochum, GermanyDepartment of Neurology and Stroke Unit, Evangelical Hospital Lippstadt, Lippstadt, GermanyFaculty of Medicine and University Hospital Cologne, Institute of Health Economics and Clinical Epidemiology (IGKE), University of Cologne, Cologne, GermanyFaculty of Medicine and University Hospital Cologne, Institute of Health Economics and Clinical Epidemiology (IGKE), University of Cologne, Cologne, GermanyFaculty of Medicine and University Hospital Cologne, Institute of Health Economics and Clinical Epidemiology (IGKE), University of Cologne, Cologne, GermanyRheumazentrum Ruhrgebiet, Herne, GermanyDepartment of Rheumatology, Ruhr University Bochum, Bochum, GermanyRheumazentrum Ruhrgebiet, Herne, GermanyMedical Faculty, Institute of General Practice and Family Medicine (AM RUB), Ruhr University Bochum, Bochum, GermanyMedical Faculty, Institute of General Practice and Family Medicine (AM RUB), Ruhr University Bochum, Bochum, GermanyMedical Faculty, Institute of General Practice and Family Medicine (AM RUB), Ruhr University Bochum, Bochum, GermanyDepartment of Geriatric Medicine, Marien Hospital Herne, Ruhr University Bochum, Herne, GermanyDepartment of Medical Informatics, Biometry and Epidemiology, Ruhr University Bochum, Bochum, GermanyMedical Faculty, Institute of General Practice and Family Medicine (AM RUB), Ruhr University Bochum, Bochum, GermanyMedical Faculty, Institute of General Practice and Family Medicine (AM RUB), Ruhr University Bochum, Bochum, Germany0Department of Internal Medicine IV (Gastroenterology, Hepatology and Infectious Diseases), Jena University Hospital, Jena, Germany0Department of Internal Medicine IV (Gastroenterology, Hepatology and Infectious Diseases), Jena University Hospital, Jena, Germany1Department Medicine and Health Services Research, BARMER Institute for Health System Research, Wuppertal, Germany1Department Medicine and Health Services Research, BARMER Institute for Health System Research, Wuppertal, Germany1Department Medicine and Health Services Research, BARMER Institute for Health System Research, Wuppertal, GermanyPMV Research Group, Medical Faculty and University Hospital Cologne, University of Cologne, Cologne, GermanyPMV Research Group, Medical Faculty and University Hospital Cologne, University of Cologne, Cologne, GermanyDepartment of Neurology, St. Josef Hospital, Ruhr University Bochum, Bochum, GermanyDepartment of Medical Informatics, Biometry and Epidemiology, Ruhr University Bochum, Bochum, GermanyAimThis article presents the study protocol of a retrospective cohort study designed to compare the effectiveness of herpes zoster, and influenza vaccines in individuals with multiple sclerosis (MS), chronic inflammatory bowel diseases (IBD), or chronic inflammatory rheumatic diseases (CIRD) to individuals without these diseases, using claims data of one of the largest population based health insurances in Germany.BackgroundIndividuals with autoimmune diseases such as MS, IBD, and CIRD are more susceptible to vaccine preventable infectious diseases such as influenza and herpes zoster, due to the autoimmune disease itself, the presence of comorbidities and immunosuppressive therapies. Vaccines are the primary means to prevent such diseases. The efficacy of these vaccines is usually estimated using large randomized controlled trials, from which patients with MS, IBD, and CIRD are often excluded. It is therefore unclear whether these vaccines are also effective for these patients.DesignA target trial emulation based on observational claims data of a statutory health insurance company is proposed.MethodsThis study will aim to emulate multiple target trials to compare the effectiveness of herpes zoster and influenza vaccines in patients with and without MS, IBD and CIRD using data from a large German statutory health insurance provider (BARMER). The primary outcome for each vaccine effectiveness analysis is the disease itself. The analysis will be carried out using both time-dependent matching and a multivariable Cox proportional hazards model in conjunction with g-computation. Additionally, the moderating effect of immunosuppressive therapies on the vaccine effectiveness will be estimated using a stratified secondary analysis.DiscussionThis study will estimate and compare the effectiveness of influenza and herpes zoster vaccines in individuals with and without MS, IBD, and CIRD. Because of the large amount of data, this study will also be able to investigate the role of the immunosuppressive medication on vaccine effectiveness, which may provide guidance for vaccine administration guidelines.https://www.frontiersin.org/articles/10.3389/fpubh.2025.1583434/fullclaims datamultiple sclerosischronic inflammatory rheumatoid diseaseschronic inflammatory bowel diseasesvaccine effectivenesstarget trial |
| spellingShingle | Robin Denz Heike van de Sand Jale Basten Katharina Meiszl Marianne Tokic Theresa Oganowski Thomas Grüter Thomas Grüter Stephanie Stock Dusan Simic Arim Shukri Uta Kiltz Uta Kiltz Maria Zacharopoulou Horst Christian Vollmar Ina Carola Otte Chantal Giehl Chantal Giehl Romy Lauer Romy Lauer Anastasia Suslow Andreas Stallmach Anika Franz Ursula Marschall Joachim Saam Catharina Schumacher Katja Blaschke Ingo Meyer Kerstin Hellwig Nina Timmesfeld The VAC-MAC Consortium Comparing the effectiveness of different vaccines in individuals with and without autoimmune diseases: a study protocol for a target trial emulation Frontiers in Public Health claims data multiple sclerosis chronic inflammatory rheumatoid diseases chronic inflammatory bowel diseases vaccine effectiveness target trial |
| title | Comparing the effectiveness of different vaccines in individuals with and without autoimmune diseases: a study protocol for a target trial emulation |
| title_full | Comparing the effectiveness of different vaccines in individuals with and without autoimmune diseases: a study protocol for a target trial emulation |
| title_fullStr | Comparing the effectiveness of different vaccines in individuals with and without autoimmune diseases: a study protocol for a target trial emulation |
| title_full_unstemmed | Comparing the effectiveness of different vaccines in individuals with and without autoimmune diseases: a study protocol for a target trial emulation |
| title_short | Comparing the effectiveness of different vaccines in individuals with and without autoimmune diseases: a study protocol for a target trial emulation |
| title_sort | comparing the effectiveness of different vaccines in individuals with and without autoimmune diseases a study protocol for a target trial emulation |
| topic | claims data multiple sclerosis chronic inflammatory rheumatoid diseases chronic inflammatory bowel diseases vaccine effectiveness target trial |
| url | https://www.frontiersin.org/articles/10.3389/fpubh.2025.1583434/full |
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