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Response to Covid-19 vaccination in patients with cancer

Immune response to Covid-19 vaccination in patients with immune modulatory treatment for cancer - CoVaCan

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2021-000905-26-SE
Enrollment
150
Registered
2021-03-12
Start date
2021-03-31
Completion date
Unknown
Last updated
2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immune response to Covid-19 vaccination of patients with immune modulatory treatment for cancer

Interventions

Trade Name: Comirnaty Pharmaceutical Form: Concentrate for dispersion for infusion Trade Name: COVID-19 Vaccine Moderna Pharmaceutical Form: Concentrate for solution for injection Trade Name: COVID-

Sponsors

Department of Oncology, Uppsala University Hospita
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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 SARS-CoV2-antigen induced T cell responses ;Timepoint(s) of evaluation of this end point: 1, 3, 6, 9, 12 months after vaccination

Secondary

MeasureTime frame
Secondary end point(s): Incidence and severity of Covid-19 infection after vaccination ;Timepoint(s) of evaluation of this end point: 12 and 24 month after vaccination

Countries

Sweden

Contacts

Public ContactDepartment of Oncology

Department of Oncology, Uppsala University Hospita

gunilla.enblad@igp.uu.se

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026