Clinical trial · Interventional
Vaccination Against COVID-19 in Cancer
Vaccination Against cOvid In CancEr
NCT04715438CI-TRIAL-00076713VOICEunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| mRNA-1273 SARS-CoV-2 vaccine from Moderna | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Cohort A: Individuals without cancer
- description
- 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.
- interventionNames
- Biological: mRNA-1273 SARS-CoV-2 vaccine from Moderna
- type
- EXPERIMENTAL
- label
- Cohort B: patients receiving immunotherapy
- description
- Cancer patients receiving immunotherapy
- interventionNames
- Biological: mRNA-1273 SARS-CoV-2 vaccine from Moderna
- type
- EXPERIMENTAL
- label
- Cohort C: patients receiving chemotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 Exclusion criteria: * 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
References
Publications (2)
- DERIVEDPiening 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. PMID 36582225
- DERIVEDOosting 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. PMID 34767759