mRNA VaccinationCoVaCheckNCT07341321
SARS-CoV-2 mRNA Vaccination in Patients With Hepatocellular Carcinoma Treated With Immune Checkpoint Inhibitors
An observational study of mRNA Vaccination and Hepatocellular Carcinoma, run by Medical University of Graz at 5 sites in Austria.
Trial summary
A multicenter retrospective cohort analysis in Austria Primary Objective: To assess whether receiving an mRNA COVID-19 vaccine within 3 months before starting ICI (Immune checkpoint inhibitors) therapy improves best overall response (mRECIST) in HCC (hepatocellular carcinoma). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- mRNA Vaccination, Hepatocellular Carcinoma, Checkpoint Inhibitor
- Type of treatment
- Vaccines
- How many people
- 200 participants
- Where
- 5 sitesAustria
- Study dates
- 1 Jan 2026to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study will include all eligible patients with HCC treated within the past 5 years (January 2021 - December 2025, depending on center availability) with one of the specified checkpoint inhibitors
Who may be able to join
- Age ≥ 18 years
- Radiologically or histologically confirmed hepatocellular carcinoma
- Treatment with immune checkpoint inhibitor-based therapy (mono- or combination therapy; e.g., atezolizumab/bevacizumab, durvalumab/tremelimumab, nivolumab, pembrolizumab)
- Complete electronic medical records available
- At least one imaging-based response assessment using mRECIST
Who cannot join
- Missing key clinical data required for main analyses (e.g. survival status, date of progression, Child-Pugh class, BCLC stage)
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Austria5 sites, 5 recruiting
- Recruiting
Medical University of Graz
Graz, 8010
Florian Rainer, MD, +43 316 385, florian.rainer@medunigraz.at
- Not yet recruiting
Ordensklinikum Linz
Linz
Stephanie Hametner-Schreil, +43 732 7677, Stephanie.Hametner-Schreil@ordensklinikum.at
- Not yet recruiting
University Hospital St. Pölten
Sankt Pölten
Anderas Maieron, MD, +43 27429004, andreas.maieron@stpoelten.lknoe.at
- Recruiting
Krankenhaus der Barmherzigen Brüder St Veit an der Glan
Sankt Veit an der Glan
Ute Enökl-Tomantschger, MD, +43 4212 499, Ute.Enoekl-Tomantschger@bbstveit.at
- Not yet recruiting
Klinikum Wels-Grieskirchen
Wels
Harald Hofer, MD, +43 7242 415 - 2181, harald.hofer@klinikum-wegr.at
About this study
Official title: SARS-CoV-2 mRNA Vaccination in Patients With Hepatocellular Carcinoma Treated With Immune Checkpoint Inhibitors (CoVaCheck) A Multicenter Retrospective Cohort Analysis in Austria
A multicenter retrospective cohort analysis in Austria
Primary Objective:
To assess whether receiving an mRNA COVID-19 vaccine within 3 months before starting ICI (Immune checkpoint inhibitors) therapy improves best overall response (mRECIST) in HCC (hepatocellular carcinoma).
Secondary Objectives:
Evaluate whether vaccination within 1 or 3 months affects OS (overall survival) , PFS (Progression free survival)), or TTP (Time to progression); compare outcomes by vaccination status, vaccine type, and prior infection; explore modification by cirrhosis severity and tumor characteristics; and assess safety (irAEs, steroid use, toxicity-related discontinuation).
Read the detailed description
Immune checkpoint inhibitors (ICIs) have become a cornerstone of systemic therapy for advanced hepatocellular carcinoma (HCC). Their efficacy, however, varies substantially between patients, and factors that modulate immunotherapy response remain incompletely understood .
Recent mechanistic and clinical data have raised the hypothesis that SARS-CoV-2 mRNA vaccines might augment responsiveness to ICIs. A landmark study by Grippin et al. demonstrated that mRNA vaccines induce a systemic surge of type-I interferons, activate antigen-presenting cells, increase PD-L1 expression on tumor cells, and ultimately sensitize tumors to ICIs across various malignancies including NSCLC (non-small cell lung cancer) and melanoma. In their retrospective cohorts, receiving a COVID-19 mRNA vaccine within 100 days before starting ICI was associated with significantly improved overall survival and progression-free survival While these findings suggest that COVID-19 mRNA vaccines may act as potent immune modulators in the context of immunotherapy, no data exist for HCC, a tumor entity that is characterized by an immunosuppressive, 'immune-cold' microenvironment that limits effective anti-tumor immune responses.
Given the widespread implementation of COVID-19 vaccination programs in Austria since 2021, and the large number of HCC patients receiving ICI-based therapies at tertiary centers, a rigorous retrospective analysis is now feasible.
- Keywords
- hepatocellular carcinoma, mRNA vaccination, response, immune checkpoint inhibitor
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Vaccinated | Patients with hepatocellular carcinoma, undergoing checkpoint inhibitor therapy, vaccinated with mRNA vaccine within last 100 days | |
| not vaccinated | Patients with hepatocellular carcinoma, undergoing checkpoint inhibitor therapy, not vaccinated with mRNA vaccine within last 100 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best overall response
according to mRECIST criteria
Measured: up to 4 years
Secondary outcomes (3)
Overall survival
death yes/no
Measured: up to 4 years
Progression free survival
Progression according to RECIST yes/no
Measured: up to 4 years
Time to progression
Time until progression occurs according to RECIST
Measured: up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start1 Jan 2026
- Primary completionJul 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for mRNA VaccinationStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- Klinikum Wels-Grieskirchen, University Hospital St. Polten, Ordensklinikum Linz GmbH Krankenhaus Barmherzige Schwestern, Krankenhaus der Barmherzigen Brüder St. Veit/Glan
- Responsible party
- Sponsor
- Investigators
- Florian Rainer, MD, Principal investigator, Medizinische Universität GrazVanessa Stadlbauer, Univ Prof, Principal investigator, Medizinische Universität GrazWalter Spindelböck, MD, Principal investigator, Medizinische Universität Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07341321
- Sponsor's protocol ID
- CoVaCheck
- Acronym
- CoVaCheck
- Status last verified
- Oct 2026
- First submitted
- 15 Dec 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon request and after having a data sharing agreement in place, pseudonymized IPD can be shared.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SARS-CoV-2 mRNA Vaccination in Patients With Hepatocellular Carcinoma Treated With Immune Checkpoint Inhibitors (CoVaCheck) A Multicenter Retrospective Cohort Analysis in Austria
- ClinicalTrials.gov ID
- NCT07341321
- Acronym / sponsor ID
- CoVaCheck / CoVaCheck
- Keywords
- hepatocellular carcinoma, mRNA vaccination, response, immune checkpoint inhibitor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Collaborators
- Klinikum Wels-Grieskirchen, University Hospital St. Polten, Ordensklinikum Linz GmbH Krankenhaus Barmherzige Schwestern, Krankenhaus der Barmherzigen Brüder St. Veit/Glan
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicenter retrospective cohort analysis in Austria
Primary Objective:
To assess whether receiving an mRNA COVID-19 vaccine within 3 months before starting ICI (Immune checkpoint inhibitors) therapy improves best overall response (mRECIST) in HCC (hepatocellular carcinoma).
Secondary Objectives:
Evaluate whether vaccination within 1 or 3 months affects OS (overall survival) , PFS (Progression free survival)), or TTP (Time to progression); compare outcomes by vaccination status, vaccine type, and prior infection; explore modification by cirrhosis severity and tumor characteristics; and assess safety (irAEs, steroid use, toxicity-related discontinuation).
Detailed description
Immune checkpoint inhibitors (ICIs) have become a cornerstone of systemic therapy for advanced hepatocellular carcinoma (HCC). Their efficacy, however, varies substantially between patients, and factors that modulate immunotherapy response remain incompletely understood .
Recent mechanistic and clinical data have raised the hypothesis that SARS-CoV-2 mRNA vaccines might augment responsiveness to ICIs. A landmark study by Grippin et al. demonstrated that mRNA vaccines induce a systemic surge of type-I interferons, activate antigen-presenting cells, increase PD-L1 expression on tumor cells, and ultimately sensitize tumors to ICIs across various malignancies including NSCLC (non-small cell lung cancer) and melanoma. In their retrospective cohorts, receiving a COVID-19 mRNA vaccine within 100 days before starting ICI was associated with significantly improved overall survival and progression-free survival While these findings suggest that COVID-19 mRNA vaccines may act as potent immune modulators in the context of immunotherapy, no data exist for HCC, a tumor entity that is characterized by an immunosuppressive, 'immune-cold' microenvironment that limits effective anti-tumor immune responses.
Given the widespread implementation of COVID-19 vaccination programs in Austria since 2021, and the large number of HCC patients receiving ICI-based therapies at tertiary centers, a rigorous retrospective analysis is now feasible.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccinated | – | –Patients with hepatocellular carcinoma, undergoing checkpoint inhibitor therapy, vaccinated with mRNA vaccine within last 100 days |
| not vaccinated | – | –Patients with hepatocellular carcinoma, undergoing checkpoint inhibitor therapy, not vaccinated with mRNA vaccine within last 100 days |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will include all eligible patients with HCC treated within the past 5 years (January 2021 - December 2025, depending on center availability) with one of the specified checkpoint inhibitors
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Radiologically or histologically confirmed hepatocellular carcinoma
- Treatment with immune checkpoint inhibitor-based therapy (mono- or combination therapy; e.g., atezolizumab/bevacizumab, durvalumab/tremelimumab, nivolumab, pembrolizumab)
- Complete electronic medical records available
- At least one imaging-based response assessment using mRECIST
Key exclusion criteria (1 listed)
- Missing key clinical data required for main analyses (e.g. survival status, date of progression, Child-Pugh class, BCLC stage)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Best overall response
Time frame: up to 4 years
according to mRECIST criteria
3 secondary outcomes
Overall survival
Time frame: up to 4 years
Progression free survival
Time frame: up to 4 years
Time to progression
Time frame: up to 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: Yes. Upon request and after having a data sharing agreement in place, pseudonymized IPD can be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Florian Rainer, MD principal investigator
Medizinische Universität Graz
Vanessa Stadlbauer, Univ Prof principal investigator
Medizinische Universität Graz
Walter Spindelböck, MD principal investigator
Medizinische Universität Graz
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of mRNA Vaccination and Hepatocellular Carcinoma, run by Medical University of Graz at 5 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Florian Rainer, MD (+43 316 385 ext. 30164, florian.rainer@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best overall response (time frame: up to 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.