Clinical trial · Interventional
Immune Response to the COVID-19 Vaccine
NCT04936997CI-TRIAL-00058625completedEarly Phase 1ClinicalTrials.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)
Explore the effects on immune response to include a potential third vaccine for the cancer cohort.
Conditions
Conditions (4)
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 |
| Covid19 | — | UNRESOLVED | — |
| Malignancy | Malignant Neoplasm | ALIAS | 0.90 |
| Vaccine Response Impaired | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SARS-COV2 Pfizer Vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 3rd COVID-19 vaccine (2nd booster)
- description
- Patients who were a part of the non-interventional portion of the study are eligible to receive a third COVID-19 Pfizer vaccine.
- interventionNames
- Biological: SARS-COV2 Pfizer Vaccine
Primary outcomes (1)
- measure
- Immune response
- timeFrame
- 3 months
- description
- Evaluating immune response to a second COVID-19 vaccination booster (3rd vaccine) in patients with solid tumor malignancies on immunosuppressive cancer therapies by antibody quantification in blood samples.
Secondary outcomes (1)
- measure
- Adverse events
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients must have active solid tumor malignancy diagnosis 2. On active chemotherapy 3. Received two prior SARS-COV2 Pfizer vaccines 4. Age ≥ 18 years 5. Ability to understand and the willingness to sign a written informed consent 6. Agree to comply with study procedures 7. Subjects previously enrolled under the main study Exclusion Criteria: 1. History of HIV or organ/bone marrow transplant 2. Actively receiving immunotherapy 3. On active, chronic immunosuppression (\>10 mg daily dose of prednisone equivalent) 4. Currently incarcerated or residence of another state 5. Speaks a language other than English.
References
Publications (1)
- DERIVEDShroff RT, Chalasani P, Wei R, Pennington D, Quirk G, Schoenle MV, Peyton KL, Uhrlaub JL, Ripperger TJ, Jergovic M, Dalgai S, Wolf A, Whitmer R, Hammad H, Carrier A, Scott AJ, Nikolich-Zugich J, Worobey M, Sprissler R, Dake M, LaFleur BJ, Bhattacharya D. Immune responses to two and three doses of the BNT162b2 mRNA vaccine in adults with solid tumors. Nat Med. 2021 Nov;27(11):2002-2011. doi: 10.1038/s41591-021-01542-z. Epub 2021 Sep 30. PMID 34594036