solid tumors
Conditions
Interventions
Trade Name: COVID-19 Vaccine Moderna
Product Name: COVID-19 Vaccine Moderna
Pharmaceutical Form: Dispersion for injection
INN or Proposed INN: COVID-19 mRNA vaccine Moderna
Other descriptive name: CO
Sponsors
University Medical Center Groningen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible to participate in this study, a subject must meet all of the following criteria: • Age of 18 years or older • Life expectancy > 12 months • Ability to provide informed consent Additional criteria for cohort A: • Partner of a participating patient Additional criteria for cohort B: • Histological diagnosis of a solid malignancy • Treatment with monotherapy immune checkpoint inhibitor (ICI) against Programmed Death 1 (PD1) or its ligand PD-L1 (in curative or non-curative setting) • Last ICI administration within 3 months of vaccination Additional criteria for cohort C: • Histological diagnosis of a solid malignancy • Treatment with cytotoxic chemotherapy (monotherapy and combination chemotherapy is allowed, as well as a combination with radiotherapy, in curative or non-curative setting) • Last chemotherapy administration within 4 weeks of vaccination Additional criteria for cohort D: • Histological diagnosis of a solid malignancy • Treatment with a PD1 or PD-L1 antibody in combination with cytotoxic chemotherapy (in curative or non-curative setting) • Last chemotherapy administration within 4 weeks of vaccination • Last ICI administration within 3 months of vaccination 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 436 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 435
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • Confirmed SARS-CoV-2 infection (current or previous) • Women who are pregnant or breastfeeding •Active hematologic malignancy • Any immune deficiency not related to cancer or cancer treatment (e.g. inherited immune deficiency or known infection with Human Immunodeficiency Virus) • Systemic treatment with corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medication within 14 days of vaccination. Inhaled or topical steroids, and adrenal replacement steroids (> 10 mg daily prednisone equivalent) are permitted. In addition, standard of care with short course steroids to prevent nausea and allergic reactions from chemotherapy or iodinated CT contrast is allowed. Additional criteria for cohort A: • Current or previous diagnosis of a solid malignancy, unless treated with curative intent >5 years before enrolment and without signs of recurrence during proper follow-up • Previous history of a hematologic malignancy Additional criteria for cohort B: • Treatment with cytotoxic chemotherapy within 4 weeks of vaccination Additional criteria for cohort C: • Treatment with an ICI within 3 months of vaccination
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary endpoint is the antibody based immune response to vaccination against COVID-19 on day 28 after the second vaccination in patients receiving cancer treatment as compared to individuals without cancer. Participants will be classified as responders or non-responders. The definition of response is seroconversion defined as presence of SARS-CoV-2 spike S1-specific IgG antibodies in individuals without measurable anti-S antibodies at baseline. Participants who are seropositive at baseline will not be included in the analysis of the primary endpoint (see paragraph 10.1). The percentage of responders of each patient cohort will be compared with the percentage responders in the group without cancer.;Main Objective: Primary Objective: • To assess the antibody based immune response after vaccination against COVID-19 in patients with cancer treated with immunotherapy and/or chemotherapy as compared to controls ;Secondary Objective: Secondary Objectives: • To assess adverse events (AEs) after vaccination against COVID-19 in patients with cancer treated with immunotherapy and/or chemotherapy • To assess durability of the antibody response in patients with cancer treated with immunotherapy and/or chemotherapy • To analyze the SARS-CoV-2 specific T cell response after vaccination in patients with cancer treated with immunotherapy and/or chemotherapy ;Timepoint(s) of evaluation of this end point: 28 days after the second vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Safety assessment through: o Incidence and severity of solicited AEs during 7 days after each vaccination (see Appendix 1) o Incidence and nature of SAEs during 7 days after each vaccination o Incidence and nature of newly occurring irAEs [36] grade = 3 in cohort B and D up to 28 days after the last vaccination graded according to the Common Terminology Criteria for Adverse Events version 5.0 (CTCAEv5.0) o Incidence, nature and severity of AESIs (see Appendix 2) graded according to CTCAEv5.0 • In depth assessment of immune response through: o Measurement of SARS-CoV2 specific antibodies before the second vaccination to analyze initial response, and at 6 and 12 months after the second vaccination to measure longevity o Assessment of SARS-CoV2 specific T cells response at 28 days and 6 months after the second vaccination using a high throughput Interferon ? ELIspot;Timepoint(s) of evaluation of this end point: Before the second vaccination and at 6 and 12 months after the second vaccination | — |
Countries
Netherlands
Contacts
Public ContactResearch Coordinator Medical Oncolo
University Medical Center Groningen
Outcome results
None listed