COVID-19 Vaccination in Oncologic Patients

Covid19 Clinical Trial

— VINCI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04918888
• Other study ID #: ECS 1048/2021
• Status: Completed
• Start date: April 19, 2021
• Est. completion date: September 30, 2021

Study information

• Verified date: November 2021
• Source: Krankenhaus Barmherzige Schwestern Linz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1150
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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!

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Oncologic Disorders

Locations

Country	Name	City	State
Austria	Department of Radiooncology, Ordensklinikum Linz GmbH Barmherzige Schwestern	Linz	Upper Austria
Austria	Ordensklinikum Linz GmbH, Barmherzige Schwestern	Linz	Oberösterreich

Sponsors (1)

Lead Sponsor	Collaborator
Krankenhaus Barmherzige Schwestern Linz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantification of vaccination willingness	guided interview	once directly after enrollment
Secondary	SARS-CoV-2 antibody titre in already vaccinated patients		>= 35 days post first dose
Secondary	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
Secondary	Qualitive assessment of reasons to reject vaccination	guided interview	once directly after enrollment
Secondary	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
Secondary	Kind and dosage of accompanying systemic therapies		once after enrollment
Secondary	Modalities and duration of the radiotherapy (irradiated region, single dose overall dose)		once after enrollment
Secondary	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
Secondary	Qualitative and quantitative assessment of local/systemic side effects of the SARS-CoV-2 vaccination	questionnaire	35 days after vaccination
Secondary	incidence of a symptomatic SARS-CoV-2 infection (duration, extent and severity)	questionnaire	35 days after vaccination