Responses to COVID-19 Vaccination in Patients With Cancer

NCT ID: NCT04745377

Last Updated: 2022-08-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 332 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-12
• Study Completion Date: 2022-05-20

Brief Summary

This is an observational study that will prospectively record and monitor responses and clinical outcomes of patients with cancer after covid-19 vaccination, including measurements of antibody titers in serum and also record potential factors that affect immunity, such as type and stage of cancer, type and time of systemic therapy in relation to covid-19 vaccination.

Detailed Description

It is well recognised that patients with cancer are at an increased risk of severe COVID-19 disease and should be at high prioritisation for vaccination against SARS-CoV-2. In Greece the vaccination of healthcare workers has been initiated in January 2021, elderly citizens as well and for cancer patients of all ages will be initiated early February 2021. There are very little available data on the efficacy of immunisation with vaccines overall in cancer patients, with most existing data involving the influenza vaccine. The covid-19 vaccine trials have not included cancer patients, therefore, the efficacy and duration of immunity in patients with cancer are still unknown. Those patients are often immunocompromised due to their disease or the side-effects of their treatment.

Based on the above this study was designed to prospectively record and monitor patients with cancer after covid-19 vaccination. The study will record and measure clinical outcomes, such as possible infection from covid-19 despite vaccination, severity and mortality, but also possible side effects post vaccination. Within the study serological responses (IgG antibody titers) will also be monitored in three timepoints (prior to vaccination, one month and three months after completion of the two doses of vaccination). Potential factors that affect immunity, will be recorded, such as type and stage of cancer, type and time of systemic therapy in relation to covid-19 vaccination.

Conditions

Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Control Group

Healthy volunteers from hospital personnel vaccinated for covid-19, who sign informed consent for recording of outcomes and monitor of antibody titers in 3 timepoints

IgG neutralising antibody titers to S1 and S2 proteins of SARS-COV-2 virus

Intervention Type: DIAGNOSTIC_TEST

IgG neutralising antibody titers to S1 and S2 proteins of SARS-COV-2 virus

Cancer patients

Cancer patients with solid tumours, with active disease and/or undergoing active systemic treatment, who will be vaccinated for covid-19

IgG neutralising antibody titers to S1 and S2 proteins of SARS-COV-2 virus

Intervention Type: DIAGNOSTIC_TEST

IgG neutralising antibody titers to S1 and S2 proteins of SARS-COV-2 virus

Interventions

IgG neutralising antibody titers to S1 and S2 proteins of SARS-COV-2 virus

IgG neutralising antibody titers to S1 and S2 proteins of SARS-COV-2 virus

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Patients with solid tumours and potentially immunocompromised, ie. currently with active disease and/or undergoing active antineoplastic therapy of any type (chemotherapy, immunotherapy, biologic therapy, targeted therapy) that will be vaccinated for covid-19 within the National Program of Vaccination
• patients must sign informed consent for their data monitoring and also for serum antibody titers to covid-19 vaccination measured in three timepoints, prior to 1st dose and 1 and 3 months post completion of two doses

Exclusion Criteria

• patients with haematological malignancies are excluded
• patients with prior diagnosis of cancer and now on follow-up without active disease are excluded
• patients on adjuvant hormonal therapy are excluded

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hellenic Cooperative Oncology Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Metropolitan Hospital

Athens, Attica, Greece

Countries

Greece

Other Identifiers

HE_42C/21 ReCOVer study

Identifier Type: -

Identifier Source: org_study_id