COVID-19 Vaccination in Oncologic Patients

Krankenhaus Barmherzige Schwestern Linz1,150 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

1,150

Conditions

Covid19 Oncologic Disorders

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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!

Locations (2)

Department of Radiooncology, Ordensklinikum Linz GmbH Barmherzige Schwestern

Linz, Upper Austria, Austria

Ordensklinikum Linz GmbH, Barmherzige Schwestern

Linz, Upper Austria, Austria

Outcomes

Primary Outcomes

Quantification of vaccination willingness

guided interview

Time frame: once directly after enrollment

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

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

Time frame: baseline and 7, 14,21,28,35, 182 and 365 days post first dose

Qualitive assessment of reasons to reject vaccination

guided interview

Time frame: 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

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)

guided interview, conducted again at day 35 after the first dose for patients who receive radiotherapy during the first dose of vaccination

Data from ClinicalTrials.gov

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