Clinical trial Recruiting at 2 sites Interventional Ages 18 and up

Intrahospital flu vaccine for adults with high cardiovascular risk when admitted for ACS or heart failure

Official title: 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

Run by University Hospital of Cologne · NCT07721649 · Data updated 2026-11-12

This study tests whether offering a flu vaccine at the bedside during a hospital stay, along with counseling, increases vaccination rates for adults with acute coronary syndrome or heart failure who are at high cardiovascular risk.

More Acute Coronary Syndrome trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment482 (estimated)
SponsorUniversity Hospital of Cologne
Academic / other
Locations2 sites (Cologne and 1 other locations)
StatusRecruiting
StartedSeptember 30, 2026
Main results expectedMarch 2028
Study endsJune 2029
Registry record updatedOctober 13, 2026
Trial IDNCT07721649 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults 18 years or older hospitalized for ACS or CHF who meet STIKO vaccination criteria and provide written informed consent.

Probably not a fit

Patients who have already received the seasonal flu vaccine for the current season, have a contraindication, or cannot provide consent may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults admitted for acute coronary syndrome or congestive heart failure are randomized to receive either an intrahospital influenza vaccination offer plus standardized counseling or counseling plus a discharge vaccine recommendation. The primary outcome is vaccination rate by the end of the influenza season. The intervention aligns with German STIKO recommendations and compares in-hospital vaccination to standard outpatient vaccination guidance. Safety, feasibility, and uptake are assessed within the index hospitalization period. The trial is conducted at two German centers and involves collaboration between an academic hospital and industry sponsor.

Why it matters

Potential benefit: If successful, more eligible patients may receive influenza vaccination during hospitalization, potentially reducing influenza-related complications in high-risk cardiovascular patients.

How similar studies have gone: Previous work suggests that in-hospital vaccination strategies can raise uptake, but results vary by setting and population; this study adds targeted evidence in high cardiovascular risk patients.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Clinic III for Internal Medicine, University Hospital of Cologne
    Cologne, Germany
    Recruiting
  • Department of Cardiology, University Heart and Vascular Centre Hamburg
    Hamburg, Germany
    Recruiting

Study contacts

  • Principal investigator: Stephan Baldus, Prof. Dr. med. — Clinic III for Internal Medicine, University Hospital of Cologne
  • Study coordinator: Sebastian Heyne, Dr. med.
  • Email: sebastian.heyne@uk-koeln.de
  • Phone: +49 221 478-82019

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.