Acute Coronary SyndromeVACC-UPNCT07721649
Intrahospital Influenza Vaccination in Patients at High Cardiovascular Risk (VACC-UP)
A study testing Intrahospital seasonal influenza vaccination offer and Standardized active influenza vaccination counseling in people with Acute Coronary Syndrome and Heart Failure, run by Stephan Baldus at 2 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Heart Failure, Influenza, Human
- What is being tested?
- Intrahospital seasonal influenza vaccination offer and Standardized active influenza vaccination counseling
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 482 participants
- Where
- 2 sitesGermany
- Study dates
- 30 Sep 2026to Jun 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 2 recruiting
- Recruiting
Clinic III for Internal Medicine, University Hospital of Cologne
Cologne, 50937
Sebastian Heyne, Dr. med., +49 221 478-82019, sebastian.heyne@uk-koeln.de
Stephan Baldus, Prof. Dr. med.
- Recruiting
Department of Cardiology, University Heart and Vascular Centre Hamburg
Hamburg, 20246
Natalie Arnold, Dr. med.
About this study
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
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
- Being tested
- Intrahospital seasonal influenza vaccination offer, Standardized active influenza vaccination counseling, Standard of care discharge recommendation for ambulatory vaccination
- 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
- Medical subject headings
- Acute Coronary Syndrome, Heart Failure, Influenza, Human, Cardiovascular Diseases, Vaccination Refusal, Vaccination Hesitancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrahospital seasonal influenza vaccination offerBiological
Also called Seasonal influenza vaccine (high-dose or standard-dose according to STIKO recommendations)
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.
Standardized active influenza vaccination counselingBehavioural
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.
Standard of care discharge recommendation for ambulatory vaccinationBehavioural
Current standard of care in Germany: the recommendation to obtain ambulatory influenza vaccination from the primary care physician, stated in the discharge papers.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standardized active influenza vaccination counseling; Behavioral: Standard of care discharge recommendation for ambulatory vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: During the index hospitalization, up to approximately 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start30 Sep 2026
- Primary completionMar 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 482 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stephan Baldus
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor-investigator, Stephan Baldus, University Hospital of Cologne
- Investigators
- Stephan Baldus, Prof. Dr. med., Principal investigator, Clinic III for Internal Medicine, University Hospital of CologneSebastian Heyne, Dr. med., Study director, Clinic III for Internal Medicine, University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07721649
- Sponsor's protocol ID
- 26-1232
- Acronym
- VACC-UP
- Status last verified
- Oct 2026
- First submitted
- 18 Jul 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34459211Lawrence 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.
PubMed 36400090Betsch 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.
PubMed 30532274