COVID-19 Vaccination in Oncologic Patients (VINCI)

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

Study Overview

• Status: Completed
• Conditions: Covid19; Oncologic Disorders

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 Type: Observational
• Enrollment (Actual): 1150

Contacts and Locations

Study Locations

• Austria
  • Oberösterreich
    • Linz, Oberösterreich, Austria, 4010
      • Ordensklinikum Linz GmbH, Barmherzige Schwestern
  • Upper Austria
    • Linz, Upper Austria, Austria, 4010
      • Department of Radiooncology, Ordensklinikum Linz GmbH Barmherzige Schwestern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

new patients of the department for radiooncology at the Ordensklinikum Barmherzige Schwestern Linz

Description

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!

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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 the study measuring?

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

Collaborators and Investigators

• Sponsor: Krankenhaus Barmherzige Schwestern Linz
• Investigators: Principal Investigator: Hans Geinitz, Univ.-Prof., Ordensklinikum Linz GmbH, Barmherzige Schwestern

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2021
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: June 4, 2021
• First Submitted That Met QC Criteria: June 8, 2021
• First Posted (Actual): June 9, 2021

Study Record Updates

• Last Update Posted (Actual): November 23, 2021
• Last Update Submitted That Met QC Criteria: November 22, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: immunosuppression; radiotherapy; SARS-CoV-2 vaccine; immune response; oncologic therapies; SARS-CoV-2 S binding antibodies; vaccination willingness; vaccination side effects
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: ECS 1048/2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No