Intrahospital Influenza Vaccination in Patients at High Cardiovascular Risk (VACC-UP) (VACC-UP)
18 juillet 2026 mis à jour par: Stephan Baldus
Intrahospital Vaccination and Active Counseling Versus Active Counseling Alone to Increase Seasonal Influenza immUnization in Patients at High Cardiovascular Risk in Germany: The Randomized Controlled VACC-UP Study
The aim of this study is to evaluate the effect of offering intrahospital influenza vaccination as an adjunct to active counseling during the index hospitalization to adult patients hospitalized for acute coronary syndrome (ACS) or congestive heart failure (CHF), compared with active counseling alone, on influenza vaccination rates in patients at high cardiovascular risk.
Patients are randomized 1:1 to either an offer of bedside intrahospital influenza vaccination according to the recommendations of the German Standing Vaccination Committee (STIKO) in addition to standardized active counseling (intervention group), or standardized active counseling plus the standard-of-care recommendation for ambulatory vaccination in the discharge papers (control group). The primary endpoint is the influenza vaccination rate at the end of the index season (March 31).
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Type d'étude
Interventionnel
Inscription (Estimé)
482
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Sebastian Heyne, Dr. med.
- Numéro de téléphone: +49 221 478-82019
- E-mail: sebastian.heyne@uk-koeln.de
Sauvegarde des contacts de l'étude
- Nom: Stephan Baldus, Prof. Dr. med.
- Numéro de téléphone: +49 221 478-32511
- E-mail: stephan.baldus@uk-koeln.de
Lieux d'étude
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Cologne, Allemagne, 50937
- Clinic III for Internal Medicine, University Hospital of Cologne
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Contact:
- Sebastian Heyne, Dr. med.
- Numéro de téléphone: +49 221 478-82019
- E-mail: sebastian.heyne@uk-koeln.de
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Chercheur principal:
- Stephan Baldus, Prof. Dr. med.
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Hamburg, Allemagne, 20246
- Department of Cardiology, University Heart and Vascular Centre Hamburg
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Chercheur principal:
- Natalie Arnold, Dr. med.
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
Inclusion Criteria:
- Age 18 years or older
- Hospitalized due to acute coronary syndrome (ACS) or congestive heart failure (CHF) and fulfilling the criteria for influenza vaccination according to the recommendations of the German Standing Vaccination Committee (STIKO)
- Written informed consent
Exclusion Criteria:
- Already received seasonal influenza vaccination in the current season, based on self-reported vaccination status and/or vaccination certificate
- Laboratory-confirmed active influenza infection during the index hospitalization
- Contraindication for vaccination (e.g., known allergy)
- Inability to provide written informed consent
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Intrahospital vaccination offer
Patients receive standardized active influenza vaccination counseling and are additionally offered bedside intrahospital vaccination against seasonal influenza according to the latest STIKO recommendations at any time prior to discharge during the index hospitalization.
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Offer of bedside vaccination against seasonal influenza during the index hospitalization, administered in a standardized manner by trained treating physicians according to the latest STIKO recommendations and the respective product information.
The appropriate vaccine is selected according to current recommendations (e.g., high-dose quadrivalent vaccine for patients aged 60 years and older, standard-dose quadrivalent vaccine otherwise).
Vaccination is offered from September 1 to February 28 of the respective influenza season.
Autres noms:
Standardized active counseling on influenza vaccination using a cardiovascular gain-framed information sheet, including the recommendation to be vaccinated and the opportunity to discuss vaccination with the treating physician.
Counseling is provided to all patients in both arms after completion of the baseline 7C questionnaire and prior to randomization.
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Comparateur actif: Active counseling alone (standard of care)
Patients receive standardized active influenza vaccination counseling and the current standard of care in Germany, i.e., the recommendation to obtain ambulatory influenza vaccination as stated in the discharge papers.
No intrahospital influenza vaccination is administered during the index hospitalization.
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Standardized active counseling on influenza vaccination using a cardiovascular gain-framed information sheet, including the recommendation to be vaccinated and the opportunity to discuss vaccination with the treating physician.
Counseling is provided to all patients in both arms after completion of the baseline 7C questionnaire and prior to randomization.
Current standard of care in Germany: the recommendation to obtain ambulatory influenza vaccination from the primary care physician, stated in the discharge papers.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Influenza vaccination rate at the end of the index influenza season
Délai: From randomization to the end of the index influenza season (March 31), up to approximately 7 months
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Proportion of patients vaccinated against seasonal influenza at the end of the index season (defined as March 31).
For intervention group patients vaccinated during the index hospitalization, vaccination status is documented from inpatient medical records.
For control group patients and intervention group patients who declined intrahospital vaccination, self-reported vaccination status is assessed by telephone interview beginning April 1 and cross-validated with data from the treating general practitioner.
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From randomization to the end of the index influenza season (March 31), up to approximately 7 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Influenza vaccination rate at the end of the post-index influenza season
Délai: From randomization to the end of the post-index influenza season (March 31 of the following year), up to approximately 19 months
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Proportion of patients vaccinated against seasonal influenza at the end of the post-index season.
For all patients, self-reported vaccination status is assessed by telephone interview beginning April 1 of the post-index season and cross-validated with data from the treating general practitioner.
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From randomization to the end of the post-index influenza season (March 31 of the following year), up to approximately 19 months
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Association of the individual components of the 7C psychological antecedents of vaccination questionnaire with vaccination status
Délai: Baseline (prior to counseling and randomization) and end of the index influenza season (March 31), up to approximately 7 months
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Association of the individual components of the 7C psychological antecedents of vaccination questionnaire (7-point scale, long version), assessed at baseline prior to active counseling, with vaccination status at the end of the index season.
Assessed using univariate and multivariable regression models reporting odds ratios with 95% confidence intervals.
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Baseline (prior to counseling and randomization) and end of the index influenza season (March 31), up to approximately 7 months
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Patient satisfaction with the offer of intrahospital influenza vaccination
Délai: During the index hospitalization, up to approximately 14 days
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Descriptive assessment of patient satisfaction with the intrahospital vaccination offer, based on a study-specific patient satisfaction questionnaire completed by patients in the intervention group.
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During the index hospitalization, up to approximately 14 days
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Stephan Baldus, Prof. Dr. med., Clinic III for Internal Medicine, University Hospital of Cologne
- Directeur d'études: Sebastian Heyne, Dr. med., Clinic III for Internal Medicine, University Hospital of Cologne
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Frobert O, Gotberg M, Erlinge D, Akhtar Z, Christiansen EH, MacIntyre CR, Oldroyd KG, Motovska Z, Erglis A, Moer R, Hlinomaz O, Jakobsen L, Engstrom T, Jensen LO, Fallesen CO, Jensen SE, Angeras O, Calais F, Karegren A, Lauermann J, Mokhtari A, Nilsson J, Persson J, Stalby P, Islam AKMM, Rahman A, Malik F, Choudhury S, Collier T, Pocock SJ, Pernow J. Influenza Vaccination After Myocardial Infarction: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial. Circulation. 2021 Nov 2;144(18):1476-1484. doi: 10.1161/CIRCULATIONAHA.121.057042. Epub 2021 Aug 30.
- Lawrence DS, Muthoga C, Meya DB, Tugume L, Williams D, Rajasingham R, Boulware DR, Mwandumba HC, Moyo M, Dziwani EN, Maheswaran H, Kanyama C, Hosseinipour MC, Chawinga C, Meintjes G, Schutz C, Comins K, Bango F, Muzoora C, Jjunju S, Nuwagira E, Mosepele M, Leeme T, Ndhlovu CE, Hlupeni A, Shamu S, Boyer-Chammard T, Molloy SF, Youssouf N, Chen T, Shiri T, Jaffar S, Harrison TS, Jarvis JN, Niessen LW; AMBITION Study Group. Cost-effectiveness of single, high-dose, liposomal amphotericin regimen for HIV-associated cryptococcal meningitis in five countries in sub-Saharan Africa: an economic analysis of the AMBITION-cm trial. Lancet Glob Health. 2022 Dec;10(12):e1845-e1854. doi: 10.1016/S2214-109X(22)00450-8.
- Betsch C, Schmid P, Heinemeier D, Korn L, Holtmann C, Bohm R. Beyond confidence: Development of a measure assessing the 5C psychological antecedents of vaccination. PLoS One. 2018 Dec 7;13(12):e0208601. doi: 10.1371/journal.pone.0208601. eCollection 2018.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 septembre 2026
Achèvement primaire (Estimé)
1 mars 2028
Achèvement de l'étude (Estimé)
1 juin 2029
Dates d'inscription aux études
Première soumission
18 juillet 2026
Première soumission répondant aux critères de contrôle qualité
18 juillet 2026
Première publication (Réel)
23 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
23 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
18 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies vasculaires
- Maladies cardiaques
- Infections des voies respiratoires
- Infections
- Infections à Orthomyxoviridae
- Infections par virus à ARN
- Maladies virales
- Maladies des voies respiratoires
- Ischémie myocardique
- Comportement
- Adhésion et conformité au traitement
- Comportement de santé
- Refus de traitement
- Insuffisance cardiaque
- Grippe humaine
- Maladies cardiovasculaires
- Syndrome coronarien aigu
- Refus de vaccination
- Hésitation à la vaccination
Autres numéros d'identification d'étude
- 26-1232
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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