Covid19VINCINCT04918888
COVID-19 Vaccination in Oncologic Patients
An observational study of Covid19 and Oncologic Disorders, run by Krankenhaus Barmherzige Schwestern Linz at 2 sites in Austria.
Trial summary
Evaluating the vaccination willingness in oncologic patients over six months as well as estimating the effects of radiotherapy/systemic anticancer treatment on the efficacy and toxicity of currently approved SARS-CoV-2 vaccines Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Covid19, Oncologic Disorders
- Type of treatment
- Vaccines
- How many people
- 1,150 participants
- Where
- 2 sitesAustria
- Study dates
- 19 Apr 2021to 30 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: new patients of the department for radiooncology at the Ordensklinikum Barmherzige Schwestern Linz
Who may be able to join
- Study population for the cross-sectional study (patients with previous SARS-CoV-2 infection of previous vaccination, evaluation of willingness to get vaccinated:
- Patients with solid tumors/haematooncologic diseases regardless of stage that seek treatment in the outpatient clinic of the department of radiooncology from April to September 2021 who will undergo active treatment.
- Age: 18-120 years Patients that undergo radiotherapy, radio-chemotherapy, radio-hormonotherapy or radio-immunotherapy during the investigation period.
- Longitudinal study:
- Patients that have not yet received SARS-CoV-2 vaccination, but are scheduled to get the first dose during or up to six weeks after active therapy.
- Age: 18-120 years
Who cannot join
- Lack of written consent
- Patients, that are mentally or physically incapable of completing a questionnaire
- Age: < 18 years
- A previous SARS-CoV-2 infection is no exclusion criteria!
Trial locations and contacts
2 sites in 1 country.
Austria2 sites
Department of Radiooncology, Ordensklinikum Linz GmbH Barmherzige Schwestern
Linz, Upper Austria, 4010
Ordensklinikum Linz GmbH, Barmherzige Schwestern
Linz, Upper Austria, 4010
About this study
Official title: SARS-CoV-2 Vaccination in Oncologic Patients: A Prospective, Explorative Study
Evaluating the vaccination willingness in oncologic patients over six months as well as estimating the effects of radiotherapy/systemic anticancer treatment on the efficacy and toxicity of currently approved SARS-CoV-2 vaccines
Read the detailed description
All patients that present themselves newly at the outpatient-clinic of the Department of Radiooncology at the Ordensklinikum Linz GmbH, Barmherzige Schwestern during a period of six months are eligible for participation. After being informed about the study, the participants answer a short structured interview regarding vaccination status and vaccination willingness. Patients who already received one or two doses of SARS-CoV-2 vaccine are eligible for the study's subpopulation 1, with the main focus of quantifying SARS-CoV-2 S binding antibody titres after at least 35 days from initial vaccination. Patients who are to receive at least one dose of vaccine during or up to six weeks after radiotherapy are eligible for subpopulation 2, comprising serial measurements of SARS-CoV-2 S binding antibody titres before and after vaccination.
- Conditions
- Covid19, Oncologic Disorders
- Keywords
- radiotherapy, SARS-CoV-2 vaccine, immune response, oncologic therapies, immunosuppression, SARS-CoV-2 S binding antibodies, vaccination willingness, vaccination side effects
- Medical subject headings
- COVID-19
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 |
|---|---|---|
| Overall study population | All new oncologic patients of the outpatient-clinic of the department of radiooncology | |
| First dose received (Subpopulation 1) | Patients, who received one or two doses of SARS-CoV-2 vaccine prior to radiotherapy | |
| Vaccination during therapy (Subpopulation 2) | Patients, who will receive at least one dose of SARS-CoV-2 vaccine during or up to 6 weeks after radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of vaccination willingness
guided interview
Measured: once directly after enrollment
Secondary outcomes (9)
SARS-CoV-2 antibody titre in already vaccinated patients
Measured: >= 35 days post first dose
SARS-CoV-2 antibody titre in patients vaccinated during antineoplastic treatment
Development of antibody titre in patients who received the first or second dose of SARS-CoV-2 vaccine during radiotherapy, Longitudinal quantification of binding antibodies
Measured: baseline and 7, 14,21,28,35, 182 and 365 days post first dose
Qualitive assessment of reasons to reject vaccination
guided interview
Measured: once directly after enrollment
Qualitive assessment of comorbidities
(in respect of the gravity of a SARS-CoV-2 infection corresponding to the WHO-grading), guided interview
Measured: once after enrollment prior to vaccination
Kind and dosage of accompanying systemic therapies
Measured: once after enrollment
Modalities and duration of the radiotherapy (irradiated region, single dose overall dose)
Measured: once after enrollment
Previous SARS-CoV-2 infection (Rate of undetected cases via antibody detection, for known previous disease: evaluation of severity)
guided interview, conducted again at day 35 after the first dose for patients who receive radiotherapy during the first dose of vaccination
Measured: once directly after enrollment and ev. at >= 35 days after first dose
Qualitative and quantitative assessment of local/systemic side effects of the SARS-CoV-2 vaccination
questionnaire
Measured: 35 days after vaccination
incidence of a symptomatic SARS-CoV-2 infection (duration, extent and severity)
questionnaire
Measured: 35 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start19 Apr 2021
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Krankenhaus Barmherzige Schwestern Linz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hans Geinitz, Univ.-Prof., Principal investigator, Ordensklinikum Linz GmbH, Barmherzige Schwestern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04918888
- Sponsor's protocol ID
- ECS 1048/2021
- Acronym
- VINCI
- Status last verified
- Nov 2021
- First submitted
- 4 Jun 2021
- Last updated
- 23 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Geinitz H, Silberberger E, Spiegl K, Feichtinger J, Wagner H, Hermann P, Brautigam E, Track C, Weis EM, Venhoda C, Huppert R, Spindelbalker-Renner B, Zauner-Babor G, Nyiri DV, Karasek N, Erdei M, Gheju R, Gruber G, Egger M, Dieplinger B. SARS-CoV-2 vaccination willingness and humoral vaccination response in radiation oncology patients. Vaccine. 2024 Feb 6;42(4):945-959. doi: 10.1016/j.vaccine.2024.01.006. Epub 2024 Jan 20.
PubMed 38246842
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SARS-CoV-2 Vaccination in Oncologic Patients: A Prospective, Explorative Study
- ClinicalTrials.gov ID
- NCT04918888
- Acronym / sponsor ID
- VINCI / ECS 1048/2021
- Conditions
- Covid19, Oncologic Disorders
- Keywords
- radiotherapy, SARS-CoV-2 vaccine, immune response, oncologic therapies, immunosuppression, SARS-CoV-2 S binding antibodies, vaccination willingness, vaccination side effects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,150 participants (actual)
- Lead sponsor
- Krankenhaus Barmherzige Schwestern LinzUniversity, hospital or other
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 9 Jun 2021 (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.
Evaluating the vaccination willingness in oncologic patients over six months as well as estimating the effects of radiotherapy/systemic anticancer treatment on the efficacy and toxicity of currently approved SARS-CoV-2 vaccines
Detailed description
All patients that present themselves newly at the outpatient-clinic of the Department of Radiooncology at the Ordensklinikum Linz GmbH, Barmherzige Schwestern during a period of six months are eligible for participation. After being informed about the study, the participants answer a short structured interview regarding vaccination status and vaccination willingness. Patients who already received one or two doses of SARS-CoV-2 vaccine are eligible for the study's subpopulation 1, with the main focus of quantifying SARS-CoV-2 S binding antibody titres after at least 35 days from initial vaccination. Patients who are to receive at least one dose of vaccine during or up to six weeks after radiotherapy are eligible for subpopulation 2, comprising serial measurements of SARS-CoV-2 S binding antibody titres before and after vaccination.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Overall study population | – | –All new oncologic patients of the outpatient-clinic of the department of radiooncology |
| First dose received (Subpopulation 1) | – | –Patients, who received one or two doses of SARS-CoV-2 vaccine prior to radiotherapy |
| Vaccination during therapy (Subpopulation 2) | – | –Patients, who will receive at least one dose of SARS-CoV-2 vaccine during or up to 6 weeks after radiotherapy |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- new patients of the department for radiooncology at the Ordensklinikum Barmherzige Schwestern Linz
Key inclusion criteria (6 listed)
- Study population for the cross-sectional study (patients with previous SARS-CoV-2 infection of previous vaccination, evaluation of willingness to get vaccinated:
- Patients with solid tumors/haematooncologic diseases regardless of stage that seek treatment in the outpatient clinic of the department of radiooncology from April to September 2021 who will undergo active treatment.
- Age: 18-120 years Patients that undergo radiotherapy, radio-chemotherapy, radio-hormonotherapy or radio-immunotherapy during the investigation period.
- Patients that have not yet received SARS-CoV-2 vaccination, but are scheduled to get the first dose during or up to six weeks after active therapy.
- Age: 18-120 years
Key exclusion criteria (4 listed)
- Lack of written consent
- Patients, that are mentally or physically incapable of completing a questionnaire
- Age: < 18 years
- A previous SARS-CoV-2 infection is no exclusion criteria!
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
Quantification of vaccination willingness
Time frame: once directly after enrollment
guided interview
9 secondary outcomes
SARS-CoV-2 antibody titre in already vaccinated patients
Time frame: >= 35 days post first dose
SARS-CoV-2 antibody titre in patients vaccinated during antineoplastic treatment
Time frame: baseline and 7, 14,21,28,35, 182 and 365 days post first dose
Qualitive assessment of reasons to reject vaccination
Time frame: once directly after enrollment
Qualitive assessment of comorbidities
Time frame: once after enrollment prior to vaccination
Kind and dosage of accompanying systemic therapies
Time frame: once after enrollment
Modalities and duration of the radiotherapy (irradiated region, single dose overall dose)
Time frame: once after enrollment
Previous SARS-CoV-2 infection (Rate of undetected cases via antibody detection, for known previous disease: evaluation of severity)
Time frame: once directly after enrollment and ev. at >= 35 days after first dose
Qualitative and quantitative assessment of local/systemic side effects of the SARS-CoV-2 vaccination
Time frame: 35 days after vaccination
incidence of a symptomatic SARS-CoV-2 infection (duration, extent and severity)
Time frame: 35 days after vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
- Derived from this study: PubMed 38246842Geinitz H, Silberberger E, Spiegl K, Feichtinger J, Wagner H, Hermann P, Brautigam E, Track C, Weis EM, Venhoda C, Huppert R, Spindelbalker-Renner B, Zauner-Babor G, Nyiri DV, Karasek N, Erdei M, Gheju R, Gruber G, Egger M, Dieplinger B. SARS-CoV-2 vaccination willingness and humoral vaccination response in radiation oncology patients. Vaccine. 2024 Feb 6;42(4):945-959. doi: 10.1016/j.vaccine.2024.01.006. Epub 2024 Jan 20.
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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. This study is not recruiting at the moment.
Hans Geinitz, Univ.-Prof. principal investigator
Ordensklinikum Linz GmbH, Barmherzige Schwestern
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Oncologic Disorders, run by Krankenhaus Barmherzige Schwestern Linz at 2 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of vaccination willingness (time frame: once directly after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04918888, which also lists 1 linked publication.
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 23 Nov 2021.