COVID-19 Vaccination in Oncologic Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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SARS-CoV-2 Vaccination in Oncologic Patients: A Prospective, Explorative Study

Conditions
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Covid19, Oncologic Disorders

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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!

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Overall study population<br>All new oncologic patients of the outpatient-clinic of the department of radiooncology | |
| First dose received (Subpopulation 1)<br>Patients, who received one or two doses of SARS-CoV-2 vaccine prior to radiotherapy | |
| Vaccination during therapy (Subpopulation 2)<br>Patients, who will receive at least one dose of SARS-CoV-2 vaccine during or up to 6 weeks after radiotherapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of vaccination willingness | guided interview | once directly after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SARS-CoV-2 antibody titre in already vaccinated patients |  | >= 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 | baseline and 7, 14,21,28,35, 182 and 365 days post first dose | 
| Qualitive assessment of reasons to reject vaccination | guided interview | 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 | once after enrollment prior to vaccination | 
| Kind and dosage of accompanying systemic therapies |  | once after enrollment | 
| Modalities and duration of the radiotherapy (irradiated region, single dose overall dose) |  | 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 | 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 | 35 days after vaccination | 
| incidence of a symptomatic SARS-CoV-2 infection (duration, extent and severity) | questionnaire | 35 days after vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radiotherapy, SARS-CoV-2 vaccine, immune response, oncologic therapies, immunosuppression, SARS-CoV-2 S binding antibodies, vaccination willingness, vaccination side effects