NCT04745377

Responses to COVID-19 Vaccination in Patients With Cancer

Mapping the Responses to COVID-19 Vaccination in Patients With Cancer - the ReCOVer Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 332 (actual)
• Sponsor: Hellenic Cooperative Oncology Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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

Timeline

• Start date: 2021-01-12
• Primary completion: 2021-10-14
• Completion: 2022-05-20
• First posted: 2021-02-09
• Last updated: 2022-08-17

Locations

1 site across 1 country: Greece