Responses to COVID-19 Vaccination in Patients With Cancer

NCT04745377 | Completed

• 1 other identifier: HE_42C/21 ReCOVer study
• Study Type: observational
• Target: 332
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

COVID-19 vaccination; Cancer patients; Immunity

Outcome Measures

Primary Outcomes (3)

• Clinical outcome post vaccination

  The primary outcome is the rate of COVID-19 infections post vaccination in cancer patients compared to individuals without cancer, measured as confirmed COVID-19 infections by positive PCR COVID-tests (in asymptomatic or symptomatic cases within a period of up to 12 months post vaccination)

  12 months

• Serological outcome post vaccination, immune response to vaccination against COVID-19 (measured as antibody titre 1 month after completion of vaccination

  This primary outcome includes the antibody based immune response to COVID-19 vaccination measured 1 month after the complete vaccination (2 doses) in patients with cancer as compared to individuals without cancer, expressed as antibody titres by means of ELISA

  1 month

• Serological outcome post vaccination, immune response to vaccination against COVID-19 (measured as antibody titre 3 months after completion of vaccination

  This outcome involves the persistence of antibody response to COVID-19 vaccination measured 3 months after the complete vaccination (2 doses) in patients with cancer as compared to individuals without cancer, expressed as antibody titres by means of ELISA

  3 months

Secondary Outcomes (2)

• Safety and Tolerance assessment - AEs; Incidence and severity of Adverse Events post vaccination

  12 months

• Correlation of factors that might affect immune response in patients with cancer compared to individuals without cancer

  12 months

Study Arms (2)

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

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

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 DIAGNOSTIC_TEST

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

Cancer patients; Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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. Also a group of healthy volunteers from the hospital personnel that have been vaccinated within the National Program of Vaccination and signed informed consent for 3 measurements of antibody titers in serum, at the timepoints described aboved.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hellenic Cooperative Oncology Group: lead

Study Sites (1)

Metropolitan Hospital

Athens, Attica, 18547, Greece

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum for neutralising IgG antibody titers against S1 and S2 proteins of SARS-COV-2 virus

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: February 9, 2021
• Study Start: January 12, 2021
• Primary Completion: October 14, 2021
• Study Completion: May 20, 2022
• Last Updated: August 17, 2022

Record last verified: 2022-08

Locations

GR (1)