Response to Covid-19 vaccination in patients with cancer

Phase 1

• Conditions: Immune response to Covid-19 vaccination of patients with immune modulatory treatment for cancer; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2021-000905-26-SE
• Lead Sponsor: Department of Oncology, Uppsala University Hospita

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-12
• Last Update Posted: 12 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Age 18 years or older
Treatment for cancer within 6 month with CD20-depleting therapy and/or check-point inhibitors and/or chemotherapy

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

Unable to give informed consent

Subject is not eligible to receive Covid-19 vaccine according to current reccommendations from the Public Health Agency of Sweden.

Subject has a known hypersensitivity to the active substance or to any of the components of the investigational medical product, as specified in the product’s Summary of Product Characteristics, SmPC .

Estimated life expectancy of less than three months.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the immunological response to Covid-19 vaccines in cancer patients treated with CD20 depleting therapy, check point inhibitors and/or chemotherapy;Secondary Objective: To determine the incidence and severity of Covid-19 infection after Covid-19 vaccination in cancer patients treated with CD20 depleting therapy, check point inhibitors and/or chemotherapy;Primary end point(s): SARS-CoV2 specific immunoglobulin responses <br>SARS-CoV2-antigen induced T cell responses<br><br>;Timepoint(s) of evaluation of this end point: 1, 3, 6, 9, 12 months after vaccination

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Incidence and severity of Covid-19 infection after vaccination<br>;Timepoint(s) of evaluation of this end point: 12 and 24 month after vaccination