Clinical trial · Interventional
Booster Dose Trial
Safety and Efficacy of Booster Doses of COVID-19 Vaccine in Immunocompromised Patients With a Cancer Diagnosis
NCT05016622CI-TRIAL-00079277terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to decreased level of engagement and available funding, PI determined it appropriate to close the study prior to visit occurring. IRB approved.
Summary
Brief summary (as posted)
The goal of this study is to assess the safety and effectiveness of COVID vaccine booster doses in patients with cancer who have not developed an antibody after the U.S. Food and Drug Administration (FDA) Emergency Use Authorized COVID primary vaccination series.
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 |
|---|---|---|---|
| BNT162b2 vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Booster dose
- interventionNames
- Biological: BNT162b2 vaccine
Primary outcomes (2)
- measure
- Rate of Seroconversion for SARS-CoV-2 Spike Antibody Among Patients Who Were Seronegative After Primary Series of COVID-19 Vaccinations
- timeFrame
- 4 weeks after administration of 1st booster dose
- description
- Rate will be determined as the percentage of patients demonstrating booster-induced seroconversion, as evidenced by anti-Spike antibody testing, who were seronegative after the primary series of FDA authorized COVID-19 vaccinations.
- measure
- Percentage of Patients Who Were 'Responders' After 2nd Booster Dose
- timeFrame
- 4 weeks after administration of 2nd booster dose
- description
- A patient was classified as a responder if they either (1) had positive anti-S antibody at 4 weeks if seronegative at baseline (following 1st booster dose) or (2) if they achieved a titer of \>1000 AU/mL at 4 weeks if they were sero-low at baseline (following 1st booster dose)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria (Cohort 1): * Above the age of 18 * Meet one of the sub-criteria below: * Meet the CDC definition for immunocompromised status for cancer patients, i.e patients receiving active treatment for solid tumor or hematologic malignancy OR * Be a recipient of stem cell transplant or CAR-T cell therapy in the last 2 years OR * Have a negative SARS-CoV-2 spike IgG despite standard vaccination series, irrespective of active/inactive cancer status, on observation, or active therapy. * Underwent an in-person encounter at a study facility during the study period * Have received the second of the mRNA-based vaccines BNT162b2 and mRNA-1273 (Pfizer/BioNTech or Moderna, respectively) or one dose of the adenoviral Ad26CoV2.S (Johnson \& Johnson) vaccine at least 28 days before the booster dose. Exclusion Criteria (Cohort 1): * Patients who have had a serious adverse reaction to any prior COVID-19 vaccines resulting in emergency room visit or hospitalization, had events related to myocarditis, thrombosis and thrombocytopenia syndrome or anaphylaxis to any prior dose of the COVID-19 vaccines. * Patients who have had a documented COVID-19 infection in the 90 days prior to starting the study Inclusion Criteria (Cohort 2): * Above the age of 18 * Have a diagnosis of prior or active malignancy, either hematological or solid tumor * Have a negative or low-level SARS-CoV-2 spike IgG after 14 days of booster vaccination series irrespective of active/inactive cancer status, on observation, or active therapy. * Have received an FDA-authorized booster dose of mRNA (BNT162b2 and mRNA-1273) vaccine at least 28 days before study enrollment. Exclusion Criteria (Cohort 2): * Patients who have had a serious adverse reaction to any prior COVID-19 vaccines resulting in emergency room visit or hospitalization, had events related to myocarditis, thrombosis and thrombocytopenia syndrome or anaphylaxis to any prior dose of the COVID-19 vaccines. * Patients who have had a documented COVID-19 infection in the 90 days prior to study enrollment
References
Publications (1)
- DERIVEDThakkar A, Pradhan K, Duva B, Carreno JM, Sahu S, Thiruthuvanathan V, Campbell S, Gallego S, Bhagat TD, Rivera J, Choudhary G, Olea R, Sabalza M, Shapiro LC, Lee M, Quinn R, Mantzaris I, Chu E, Will B, Pirofski LA, Krammer F, Verma A, Halmos B. Study of efficacy and longevity of immune response to third and fourth doses of COVID-19 vaccines in patients with cancer: A single arm clinical trial. Elife. 2023 Mar 28;12:e83694. doi: 10.7554/eLife.83694. PMID 36975207