Clinical trial NCT04918888: COVID-19 Vaccination in Oncologic Patients
Official title: SARS-CoV-2 Vaccination in Oncologic Patients: A Prospective, Explorative Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Krankenhaus Barmherzige Schwestern Linz
Sponsor class: OTHER
First posted: 2021-06-09
Enrollment: 1150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: new patients of the department for radiooncology at the Ordensklinikum Barmherzige Schwestern Linz

Brief 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

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.

Eligibility criteria: 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!

Primary outcomes:
measure: Quantification of vaccination willingness
timeFrame: once directly after enrollment
Secondary outcomes:
measure: SARS-CoV-2 antibody titre in already vaccinated patients
timeFrame: >= 35 days post first dose
measure: SARS-CoV-2 antibody titre in patients vaccinated during antineoplastic treatment
timeFrame: baseline and 7, 14,21,28,35, 182 and 365 days post first dose
measure: Qualitive assessment of reasons to reject vaccination
timeFrame: once directly after enrollment
measure: Qualitive assessment of comorbidities
timeFrame: once after enrollment prior to vaccination
measure: Kind and dosage of accompanying systemic therapies
timeFrame: once after enrollment
measure: Modalities and duration of the radiotherapy (irradiated region, single dose overall dose)
timeFrame: once after enrollment
measure: Previous SARS-CoV-2 infection (Rate of undetected cases via antibody detection, for known previous disease: evaluation of severity)
timeFrame: once directly after enrollment and ev. at >= 35 days after first dose
measure: Qualitative and quantitative assessment of local/systemic side effects of the SARS-CoV-2 vaccination
timeFrame: 35 days after vaccination
measure: incidence of a symptomatic SARS-CoV-2 infection (duration, extent and severity)
timeFrame: 35 days after vaccination
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH, Barmherzige Schwestern
state: Oberösterreich
city: Linz
country: Austria
facility: Department of Radiooncology, Ordensklinikum Linz GmbH Barmherzige Schwestern
state: Upper Austria
Study officials:
affiliation: Ordensklinikum Linz GmbH, Barmherzige Schwestern
name: Hans Geinitz, Univ.-Prof.
role: PRINCIPAL_INVESTIGATOR
References: