To assess immune response and adverse events after administration of one approved vaccine against COVID-19 in patients with cancer treated with immunotherapy and/or chemotherapy
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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. The percentage of responders of each patient
cohort will be compared with the percentage responders in the group without
cancer.
Secondary outcome
• Safety assessment through:
- Incidence and severity of solicited AEs during 7 days after each
vaccination (see Appendix 1)
- Incidence and nature of SAEs during 7 days after each vaccination
- 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)
- Incidence, nature and severity of AESIs (see Appendix 2) graded
according to CTCAEv5.0
• In depth assessment of immune response through:
- Measurement of SARS-CoV2 specific antibodies before the second
vaccination to analyze initial response, and at 6 and 12 11 and 18 months after
the second vaccination to measure longevity
- Measurement of SARS-CoV2 specific antibodies at day 28 after the
third vaccination if applicable
- Assessment of SARS-CoV2 specific T cells response at 28 days after
the second and third vaccination and at 6, 11 and 18 months after the second
vaccination using a high throughput Interferon * ELIspot
Background summary
Patients with cancer have an increased risk of adverse outcome of COVID-19,
which is determined by their underlying disease and/or cancer treatment.
Therefore, vaccination of cancer patients against COVID-19 is recommended.
However, phase III studies do not provide robust information on efficacy and
safety in this vulnerable population. In patients with cancer, immunotherapy
and chemotherapy may have a significant impact on the ability to develop an
effective immune response to COVID-19 vaccination, and could evenalso increase
the risk of adverse events.
Study objective
To assess immune response and adverse events after administration of one
approved vaccine against COVID-19 in patients with cancer treated with
immunotherapy and/or chemotherapy
Study design
This is an observational prospective multicentre, multicohort study.
Intervention
Vaccination with COVID-19 Vaccine Moderna
Study burden and risks
Participants will have to visit the hospital at 6 time points, and participants
who receive a third vaccination will have 2 additional hospital visits. The
vaccine will be administered two times according to the standard of care, with
the option of a third vaccination for participants without an adequate response
after 2 vaccinations. Blood will be drawn (~373 ml in total for participants
receiving 2 vaccinations, and ~539 ml in participants receiving 3 vaccinations)
prior to both the vaccinations and at day 28 and 6, 11 and 18 months after the
second vaccination. Nasal mucosal lining fluid samples will be collected at
baseline and day 28 after the second vaccination in a subgroup of patients.
Blood sampling will give minor discomfort, mucosal lining fluid collection is a
non-invasive procedure. The vaccine will be administered at baseline, and a
booster with the interval specified by the manufacturer. Vaccination can cause
adverse events including fatigue, chills, headache, myalgia, and pain at the
injection site. Participants will be asked to record local and systemic
reactions using a memory aid, for 7 days after each vaccination. At baseline
and 3, 6 , 9, 12, 15 and 18 months after the second vaccination, patients will
be asked to complete questionnaires about potential subsequent diagnosis of
COVID-19, severity of COVID-19 and testing for SARS-CoV-2. Participation in
this trial allows early access to vaccination.
This study will collect information on immune response and adverse events after
vaccination against COVID-19 in a vulnerable patient cohort. It will also
explore immune response and safety of a third vaccination in participants
without an adequate antibody response after the second vaccination.
Understanding the ability or disability to mount a protective immune response
after vaccination will help counsel patients during the pandemic and support
decisions on whom to vaccinate and to identify patients who require other
measures to protect them from COVID-19. Participants will be informed aboutof
their antibody titer in a letter that includes an explanation about what this
means to them. This will be done after antibody measurements have been
completed for day 28 after the second vaccination, and again after completion
of measurements for 6 months and 28 days after third vaccination, and 11 and 18
months after the second vaccination.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
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
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
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
• 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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2021-000872-13-NL |
| ClinicalTrials.gov | NCT04715438 |
| CCMO | NL76095.042.21 |