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

NCT07721649 | Not Yet Recruiting

• 1 other identifier: 26-1232
• Study Type: interventional
• Target: 482
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Acute Coronary Syndrome; Heart Failure; Influenza, Human; Cardiovascular Diseases; Vaccination Refusal

Keywords

Influenza vaccination; Vaccination rate; Intrahospital vaccination; Acute coronary syndrome; Congestive heart failure; Health services research; Vaccine hesitancy; 7C psychological antecedents of vaccination; Cardiovascular prevention

Outcome Measures

Primary Outcomes (1)

• Influenza vaccination rate at the end of the index influenza season

  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

Secondary Outcomes (3)

• Influenza vaccination rate at the end of the post-index influenza season

  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

  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

  During the index hospitalization, up to approximately 14 days

Study Arms (2)

Intrahospital vaccination offer

EXPERIMENTAL

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.

Biological: Intrahospital seasonal influenza vaccination offer; Behavioral: Standardized active influenza vaccination counseling

Active counseling alone (standard of care)

ACTIVE COMPARATOR

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.

Behavioral: Standardized active influenza vaccination counseling; Behavioral: Standard of care discharge recommendation for ambulatory vaccination

Interventions

Intrahospital seasonal influenza vaccination offer BIOLOGICAL

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.

Also known as: Seasonal influenza vaccine (high-dose or standard-dose according to STIKO recommendations)

Intrahospital vaccination offer

Standard of care discharge recommendation for ambulatory vaccination BEHAVIORAL

Current standard of care in Germany: the recommendation to obtain ambulatory influenza vaccination from the primary care physician, stated in the discharge papers.

Active counseling alone (standard of care)

Standardized active influenza vaccination counseling BEHAVIORAL

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.

Active counseling alone (standard of care); Intrahospital vaccination offer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stephan Baldus: lead
• Sanofi: collaborator

Study Sites (2)

Clinic III for Internal Medicine, University Hospital of Cologne

Cologne, 50937, Germany

Location

Department of Cardiology, University Heart and Vascular Centre Hamburg

Hamburg, 20246, Germany

Location

Related Publications (3)

• 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.

  PMID: 34459211 BACKGROUND

• 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.

  PMID: 36400090 BACKGROUND

• 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.

  PMID: 30532274 BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome; Heart Failure; Influenza, Human; Cardiovascular Diseases; Vaccination Refusal; Vaccination Hesitancy

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Vascular Diseases; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Treatment Refusal; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Stephan Baldus, Prof. Dr. med.

  Clinic III for Internal Medicine, University Hospital of Cologne

  PRINCIPAL INVESTIGATOR

• Sebastian Heyne, Dr. med.

  Clinic III for Internal Medicine, University Hospital of Cologne

  STUDY DIRECTOR

Central Study Contacts

Sebastian Heyne, Dr. med.

CONTACT

+49 221 478-82019; sebastian.heyne@uk-koeln.de

Stephan Baldus, Prof. Dr. med.

CONTACT

+49 221 478-32511; stephan.baldus@uk-koeln.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Director of Clinic III for Internal Medicine

Model Details: Two-arm parallel group design. All patients receive standardized active influenza vaccination counseling. Patients are randomized 1:1 to an additional offer of intrahospital influenza vaccination (intervention) or to the standard-of-care recommendation for ambulatory vaccination in the discharge papers (control). Fixed block randomization is stratified by study site (Cologne/Hamburg) and vaccination indication (ACS/CHF).

Study Record Dates

• First Submitted: July 18, 2026
• First Posted: July 23, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)