CancerVOICENCT04715438
Vaccination Against COVID-19 in Cancer
A study testing mRNA-1273 SARS-CoV-2 vaccine from Moderna in people with Cancer, run by University Medical Center Groningen at 3 sites in Netherlands.
Trial summary
This study will collect information on immune response and adverse events after vaccination against coronavirus disease (COVID-19) in a vulnerable patient cohort. Understanding the ability or disability to mount a protective immune response after vaccination will help to counsel patients during the pandemic and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- mRNA-1273 SARS-CoV-2 vaccine from Moderna
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 791 participants
- Where
- 3 sitesNetherlands
- Study dates
- 8 Jan 2021to Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 19Show fewer
- 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
Who cannot join
- 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:
Show all 12Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
NKI-AvL
Amsterdam
UMCG
Groningen, 9700 RB
Erasmus MC
Rotterdam
About this study
Official title: Vaccination Against cOvid In CancEr
This study will collect information on immune response and adverse events after vaccination against coronavirus disease (COVID-19) in a vulnerable patient cohort. Understanding the ability or disability to mount a protective immune response after vaccination will help to 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.
Read the detailed description
Rationale:
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, the disease itself, but also immunotherapy and chemotherapy, may have a significant impact on the ability to develop an effective immune response to COVID-19 vaccination, and could even increase the risk of adverse events.
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 a prospective multicenter, multicohort study.
Study population:
Four cohorts will receive vaccination against COVID-19:
- Individuals without cancer (N=246, i.e., partners of patients in cohort B, C, and D) B. Patients with cancer treated with immunotherapy (N=135) C. Patients with cancer treated with chemotherapy (N=246) D. Patients with cancer treated with chemo-immunotherapy (N=246)
Intervention:
Participants will be vaccinated against COVID-19 with an approved vaccine. Blood will be drawn at different time points by venipuncture and mucosal lining fluid will be collected at 2 time points.
Main study parameters/endpoints:
The primary endpoint is the antibody based immune response on day 28 after the second vaccination. 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 control group. Safety is a secondary endpoint which will be reported in terms of percentage of solicited local and systemic adverse events (AEs) graded according to severity. Other secondary endpoints include longevity at 6 months and levels of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) specific T cell responses.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
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 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 ~539ml in participants receiving 3 vaccinations) prior to the vaccinations and at day 28 and 6 months, 11 months 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. Vaccination can cause AEs including fatigue, chills, headache, myalgia, and pain at the injection site. For seven days after each vaccination, participants will be asked to record local and systemic reactions using a questionnaire. At baseline and at 3, 6, 9, 12, 15 and 18 months after the second vaccination, patients will be asked to complete questionnaires about potential subsequent testing for SARS-CoV-2, diagnosis of COVID-19, and severity of COVID-19.
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 to 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 about 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 second vaccination, and again after completion of measurements for 6 months and 28 days after third vaccination, and 11 months and 18 months after the second vaccination.
- Conditions
- Cancer
- Being tested
- mRNA-1273 SARS-CoV-2 vaccine from Moderna
- Keywords
- vaccination, COVID-19, solid tumors, immune response
- Medical subject headings
- Neoplasms, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mRNA-1273 SARS-CoV-2 vaccine from ModernaBiological
All participants will receive two vaccinations against COVID-19 according to standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: Individuals without cancer | Experimental | A cohort of individuals without a cancer diagnosis is included for comparison. Because age is an important predictor of the ability to mount an effective immune response to vaccination, partners of patients in cohort B, C, and D. Receives: Biological: mRNA-1273 SARS-CoV-2 vaccine from Moderna |
| Cohort B: patients receiving immunotherapy | Experimental | Cancer patients receiving immunotherapy Receives: Biological: mRNA-1273 SARS-CoV-2 vaccine from Moderna |
| Cohort C: patients receiving chemotherapy | Experimental | Cancer patients receiving chemotherapy Receives: Biological: mRNA-1273 SARS-CoV-2 vaccine from Moderna |
| Cohort D: patients receiving chemo-immunotherapy | Experimental | Cancer patients receiving chemo-immunotherapy Receives: Biological: mRNA-1273 SARS-CoV-2 vaccine from Moderna |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune response to vaccination against COVID-19 measured as antibody response expressed as geometric mean concentration: arbitrary units (AU)/ml
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. Expressed as antibody response expressed as geometric mean concentration: arbitrary units (AU)/ml
Measured: Measured at 28 days after vaccination
Secondary outcomes (5)
Safety assessment (S)AEs; Incidence and severity of solicited AEs during 7 days after each vaccination with incidence and nature of SAEs reported during 7 days after each vaccination
- Incidence and severity of solicited AEs during 7 days after each vaccination
- Incidence and nature of SAEs during 7 days after each vaccination
Measured: During 7 days after vaccination
Safety assessment immune related (ir), with incidence and nature of newly occurring irAEs grade ≥ 3 in cohort B and D reported up to 28 days
- Incidence and nature of newly occurring irAEs grade ≥ 3 in cohort B and D up to 28 days after the last vaccination graded according to the Common Criteria for Adverse Events version 5.0 (CTCAE v5.0)
- Neutralizing capacity of antibodies to test functionality
- Assessment of SARS-CoV2 specific T cells response, 7 days, 28 days, and 6 months after vaccination using a high throughput Interferon ɣ ELIspot.
Measured: From start till 28 days after second vaccination
Safety assessment AE of special interest (SI)s with Incidence, nature and severity of AESIs graded according to CTCAE v5.0 reported up to 12 months after vaccination
- Incidence, nature and severity of AESIs graded according to CTCAE v5.0
Measured: From start till 12 months after vaccination
Assessment of immune response: expressed as geometric mean antibody concentration: arbitrary units (AU)/ml
Persistence of antibody response expressed as geometric mean concentration: arbitrary units (AU)/ml
Measured: measured at 6 to 18 months after vaccination
Assessment of immune response: measured as levels of SARS-CoV-2 specific T-cell responses expressed as number of IFNg producing T cells/ million peripheral blood mononuclear cells (PBMCs)
Levels of SARS-CoV-2 specific T-cell responses expressed as number of IFNg producing T cells/ million peripheral blood mononuclear cells (PBMCs)
Measured: measured 28 days to 18 months after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start8 Jan 2021
- Primary completion4 Jun 2021
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 791 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- E G de Vries, MD, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04715438
- Sponsor's protocol ID
- 202000865
- Acronym
- VOICE
- Status last verified
- May 2024
- First submitted
- 11 Jan 2021
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Alignment and reuse Our options for reusing data, biological materials, and/or other resources (from research or practice) in your project. * Data: Clinicopathological parameters as described in the protocol * Biological materials: Blood * Research software: R statistical package, Castor, MOLGENIS * Other resources, i.e.,Nederlandse Kankerregistratie (NKR), the Dutch Cancer Registry, electronic patient dossiers (EPDs) FAIR data within the COVID-19 research community * A COVID-19 related or other Findability, Accessibility, Interoperability, and Reuse (FAIR) data points * COVID-19 research platform for data sharing we will make protocol etc. available on the website soon voicetrial.nl
Publications
Piening A, Ebert E, Khojandi N, Alspach E, Teague RM. Immune responses to SARS-CoV-2 in vaccinated patients receiving checkpoint blockade immunotherapy for cancer. Front Immunol. 2022 Dec 13;13:1022732. doi: 10.3389/fimmu.2022.1022732. eCollection 2022.
PubMed 36582225Oosting SF, van der Veldt AAM, GeurtsvanKessel CH, Fehrmann RSN, van Binnendijk RS, Dingemans AC, Smit EF, Hiltermann TJN, den Hartog G, Jalving M, Westphal TT, Bhattacharya A, van der Heiden M, Rimmelzwaan GF, Kvistborg P, Blank CU, Koopmans MPG, Huckriede ALW, van Els CACM, Rots NY, van Baarle D, Haanen JBAG, de Vries EGE. mRNA-1273 COVID-19 vaccination in patients receiving chemotherapy, immunotherapy, or chemoimmunotherapy for solid tumours: a prospective, multicentre, non-inferiority trial. Lancet Oncol. 2021 Dec;22(12):1681-1691. doi: 10.1016/S1470-2045(21)00574-X. Epub 2021 Nov 9.
PubMed 34767759
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaccination Against cOvid In CancEr
- ClinicalTrials.gov ID
- NCT04715438
- Acronym / sponsor ID
- VOICE / 202000865
- Conditions
- Cancer
- Keywords
- vaccination, COVID-19, solid tumors, immune response
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 791 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 8 Jan 2021 (actual)
- Primary completion
- 4 Jun 2021 (actual)
- Study completion
- Apr 2025 (estimated)
- First posted
- 20 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will collect information on immune response and adverse events after vaccination against coronavirus disease (COVID-19) in a vulnerable patient cohort. Understanding the ability or disability to mount a protective immune response after vaccination will help to 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.
Detailed description
Rationale:
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, the disease itself, but also immunotherapy and chemotherapy, may have a significant impact on the ability to develop an effective immune response to COVID-19 vaccination, and could even increase the risk of adverse events.
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 a prospective multicenter, multicohort study.
Study population:
Four cohorts will receive vaccination against COVID-19:
- Individuals without cancer (N=246, i.e., partners of patients in cohort B, C, and D) B. Patients with cancer treated with immunotherapy (N=135) C. Patients with cancer treated with chemotherapy (N=246) D. Patients with cancer treated with chemo-immunotherapy (N=246)
Intervention:
Participants will be vaccinated against COVID-19 with an approved vaccine. Blood will be drawn at different time points by venipuncture and mucosal lining fluid will be collected at 2 time points.
Main study parameters/endpoints:
The primary endpoint is the antibody based immune response on day 28 after the second vaccination. 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 control group. Safety is a secondary endpoint which will be reported in terms of percentage of solicited local and systemic adverse events (AEs) graded according to severity. Other secondary endpoints include longevity at 6 months and levels of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) specific T cell responses.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
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 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 ~539ml in participants receiving 3 vaccinations) prior to the vaccinations and at day 28 and 6 months, 11 months 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. Vaccination can cause AEs including fatigue, chills, headache, myalgia, and pain at the injection site. For seven days after each vaccination, participants will be asked to record local and systemic reactions using a questionnaire. At baseline and at 3, 6, 9, 12, 15 and 18 months after the second vaccination, patients will be asked to complete questionnaires about potential subsequent testing for SARS-CoV-2, diagnosis of COVID-19, and severity of COVID-19.
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 to 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 about 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 second vaccination, and again after completion of measurements for 6 months and 28 days after third vaccination, and 11 months and 18 months after the second vaccination.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort A: Individuals without cancer | Experimental | Biological: mRNA-1273 SARS-CoV-2 vaccine from ModernaA cohort of individuals without a cancer diagnosis is included for comparison. Because age is an important predictor of the ability to mount an effective immune response to vaccination, partners of patients in cohort B, C, and D. |
| Cohort B: patients receiving immunotherapy | Experimental | Biological: mRNA-1273 SARS-CoV-2 vaccine from ModernaCancer patients receiving immunotherapy |
| Cohort C: patients receiving chemotherapy | Experimental | Biological: mRNA-1273 SARS-CoV-2 vaccine from ModernaCancer patients receiving chemotherapy |
| Cohort D: patients receiving chemo-immunotherapy | Experimental | Biological: mRNA-1273 SARS-CoV-2 vaccine from ModernaCancer patients receiving chemo-immunotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
- Partner of a participating patient
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mRNA-1273 SARS-CoV-2 vaccine from ModernaAll participants will receive two vaccinations against COVID-19 according to standard of care. | Biological | Cohort A: Individuals without cancer, Cohort B: patients receiving immunotherapy, Cohort C: patients receiving chemotherapy, Cohort D: patients receiving chemo-immunotherapy |
Primary outcome
Immune response to vaccination against COVID-19 measured as antibody response expressed as geometric mean concentration: arbitrary units (AU)/ml
Time frame: Measured at 28 days after vaccination
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. Expressed as antibody response expressed as geometric mean concentration: arbitrary units (AU)/ml
5 secondary outcomes
Safety assessment (S)AEs; Incidence and severity of solicited AEs during 7 days after each vaccination with incidence and nature of SAEs reported during 7 days after each vaccination
Time frame: During 7 days after vaccination
Safety assessment immune related (ir), with incidence and nature of newly occurring irAEs grade ≥ 3 in cohort B and D reported up to 28 days
Time frame: From start till 28 days after second vaccination
Safety assessment AE of special interest (SI)s with Incidence, nature and severity of AESIs graded according to CTCAE v5.0 reported up to 12 months after vaccination
Time frame: From start till 12 months after vaccination
Assessment of immune response: expressed as geometric mean antibody concentration: arbitrary units (AU)/ml
Time frame: measured at 6 to 18 months after vaccination
Assessment of immune response: measured as levels of SARS-CoV-2 specific T-cell responses expressed as number of IFNg producing T cells/ million peripheral blood mononuclear cells (PBMCs)
Time frame: measured 28 days to 18 months after vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Derived from this study: PubMed 36582225Piening A, Ebert E, Khojandi N, Alspach E, Teague RM. Immune responses to SARS-CoV-2 in vaccinated patients receiving checkpoint blockade immunotherapy for cancer. Front Immunol. 2022 Dec 13;13:1022732. doi: 10.3389/fimmu.2022.1022732. eCollection 2022.
- Derived from this study: PubMed 34767759Oosting SF, van der Veldt AAM, GeurtsvanKessel CH, Fehrmann RSN, van Binnendijk RS, Dingemans AC, Smit EF, Hiltermann TJN, den Hartog G, Jalving M, Westphal TT, Bhattacharya A, van der Heiden M, Rimmelzwaan GF, Kvistborg P, Blank CU, Koopmans MPG, Huckriede ALW, van Els CACM, Rots NY, van Baarle D, Haanen JBAG, de Vries EGE. mRNA-1273 COVID-19 vaccination in patients receiving chemotherapy, immunotherapy, or chemoimmunotherapy for solid tumours: a prospective, multicentre, non-inferiority trial. Lancet Oncol. 2021 Dec;22(12):1681-1691. doi: 10.1016/S1470-2045(21)00574-X. Epub 2021 Nov 9.
- Individual participant dataSharing planned: Yes. Alignment and reuse Our options for reusing data, biological materials, and/or other resources (from research or practice) in your project. * Data: Clinicopathological parameters as described in the protocol * Biological materials: Blood * Research software: R statistical package, Castor, MOLGENIS * Other resources, i.e.,Nederlandse Kankerregistratie (NKR), the Dutch Cancer Registry, electronic patient dossiers (EPDs) FAIR data within the COVID-19 research community * A COVID-19 related or other Findability, Accessibility, Interoperability, and Reuse (FAIR) data points * COVID-19 research platform for data sharing we will make protocol etc. available on the website soon voicetrial.nl
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
E G de Vries, MD, PhD principal investigator
University Medical Center Groningen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mRNA-1273 SARS-CoV-2 vaccine from Moderna in people with Cancer, run by University Medical Center Groningen at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune response to vaccination against COVID-19 measured as antibody response expressed as geometric mean concentration: arbitrary units (AU)/ml (time frame: Measured at 28 days after vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04715438, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.