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Intrahospital Influenza Vaccination in Patients at High Cardiovascular Risk (VACC-UP) (VACC-UP)

18. juli 2026 opdateret af: 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).

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

482

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Tyskland
      • Cologne, Tyskland, 50937
        • Clinic III for Internal Medicine, University Hospital of Cologne
        • Kontakt:
        • Ledende efterforsker:
          • Stephan Baldus, Prof. Dr. med.
      • Hamburg, Tyskland, 20246
        • Department of Cardiology, University Heart and Vascular Centre Hamburg
        • Ledende efterforsker:
          • Natalie Arnold, Dr. med.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Biologisk: Intrahospital seasonal influenza vaccination offer
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.
Andre navne:
  • Seasonal influenza vaccine (high-dose or standard-dose according to STIKO recommendations)
Adfærdsmæssigt: Standardized active influenza vaccination counseling
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.
Aktiv komparator: 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.
Adfærdsmæssigt: Standardized active influenza vaccination counseling
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.
Adfærdsmæssigt: Standard of care discharge recommendation for ambulatory vaccination
Current standard of care in Germany: the recommendation to obtain ambulatory influenza vaccination from the primary care physician, stated in the discharge papers.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Influenza vaccination rate at the end of the index influenza season
Tidsramme: From randomization to the end of the index influenza season (March 31), up to approximately 7 months
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.
From randomization to the end of the index influenza season (March 31), up to approximately 7 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Influenza vaccination rate at the end of the post-index influenza season
Tidsramme: From randomization to the end of the post-index influenza season (March 31 of the following year), up to approximately 19 months
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.
From randomization to the end of the post-index influenza season (March 31 of the following year), up to approximately 19 months
Association of the individual components of the 7C psychological antecedents of vaccination questionnaire with vaccination status
Tidsramme: Baseline (prior to counseling and randomization) and end of the index influenza season (March 31), up to approximately 7 months
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.
Baseline (prior to counseling and randomization) and end of the index influenza season (March 31), up to approximately 7 months
Patient satisfaction with the offer of intrahospital influenza vaccination
Tidsramme: During the index hospitalization, up to approximately 14 days
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.
During the index hospitalization, up to approximately 14 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Stephan Baldus

Samarbejdspartnere

Sanofi

Efterforskere

  • Ledende efterforsker: Stephan Baldus, Prof. Dr. med., Clinic III for Internal Medicine, University Hospital of Cologne
  • Studieleder: Sebastian Heyne, Dr. med., Clinic III for Internal Medicine, University Hospital of Cologne

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

1. marts 2028

Studieafslutning (Anslået)

1. juni 2029

Datoer for studieregistrering

Først indsendt

18. juli 2026

Først indsendt, der opfyldte QC-kriterier

18. juli 2026

Først opslået (Faktiske)

23. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 26-1232

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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