Vaccination against cOvid In CancEr
- Conditions
- solid tumors10027656
- Registration Number
- NL-OMON52037
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 873
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
An additional criteria for cohort B:
• Histologic 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
An additional criteria for cohort C:
• Histologic 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
An additional criteria for cohort D:
• Histologic 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
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
• 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 steroid > 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 tumor, unless treated with curative
intent >5 years before enrolment and with no signs of recurrence during proper
follow-up
• Previous history of a hematologic malignancy
An additional criteria for cohort B:
• Treatment with cytotoxic chemotherapy within 4 weeks of vaccination
An additional criteria for cohort C:
• Treatment with an ICI within 3 months of vaccination
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is the antibody based immune response to vaccination<br /><br>against COVID-19 on day 28 after the second vaccination in patients receiving<br /><br>cancer treatment as compared to individuals without cancer. Participants will<br /><br>be classified as responders or non-responders. The definition of response is<br /><br>seroconversion defined as presence of SARS-CoV-2 spike S1-specific IgG<br /><br>antibodies in individuals without measurable anti-S antibodies at baseline.<br /><br>Participants who are seropositive at baseline will not be included in the<br /><br>analysis of the primary endpoint. The percentage of responders of each patient<br /><br>cohort will be compared with the percentage responders in the group without<br /><br>cancer.</p><br>
- Secondary Outcome Measures
Name Time Method