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NCT04977024 · ClinicalTrials.gov registry record · Phase 2
SARS-CoV-2 Vaccine (GEO-CM04S1) Versus mRNA SARS-COV-2 Vaccine in Patients With Blood Cancer
A Phase 2 study of Lymphoma and Leukemia, sponsored by GeoVax.
- Active
- Registry status
- Phase 2
- Development phase
- 63
- Enrollment target
- 6
- Study locations
NCT04977024: Active Phase 2 study of Lymphoma and Leukemia, sponsored by GeoVax.
NCT04977024 is a Phase 2 study of Lymphoma and Leukemia that is active but no longer recruiting, run by GeoVax. The registered enrollment target is 63 participants, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (87% lower). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04977024, a Phase 2 study of Lymphoma and Leukemia, is active but no longer recruiting, sponsored by GeoVax.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 63 participants
- Enrollment target
- 6
- Study locations
Study Summary
This phase 2 trial studies the immune response to GEO-CM04S1 (previously designated as COH04S1) compared to standard of care (SOC) mRNA SARS-COV-2 vaccine in patients with blood cancer who have received stem cell transplant or cellular therapy. GEO-CM04S1 belongs to a category called modified vaccinia Ankara (MVA) vaccines, created from a new version of MVA, called synthetic MVA. GEO-CM04S1 works by inducing immunity (the ability to recognize and fight against an infection) to SARS-CoV-2. The immune system is stimulated to produce antibodies against SARS-CoV-2 that would block the virus from entering healthy cells. The immune system also grows new disease fighting T cells that can recognize and destroy infected cells. Giving GEO-CM04S1 after cellular therapy may work better in reducing the chances of contracting coronavirus disease 2019 (COVID-19) or developing a severe form of COVID-19 disease in patients with blood cancer compared to SOC mRNA SARS-CoV-2 vaccine.
Primary Outcome
Based on at least a 3-fold increase in severe acute respiratory syndrome coronavirus 2 (SARSCoV-2)- neutralizing antibodies or interferon (IFN)-gamma levels. Will compare the immune response at day 28 post the second injection between GEO-CM04S1 and SOC mRNA SARS-CoV-2 vaccine using a one-sided stratified Cochran-Mantel-Haenszel test. The point estimate and 95% confidence interval will be calculated per arm for immune response at day 28 post the second injection. Bar charts will be generated to
Conditions Studied
Interventions
- OTHER Diagnostic Laboratory Biomarker Analysis
- BIOLOGICAL COVID-19 Vaccine
- BIOLOGICAL Synthetic MVA-based SARS-CoV-2 Vaccine GEO-CM04S1
Study Locations (6)
California
- City of Hope Medical Center - Duarte
Maryland
- Johns Hopkins University - Baltimore
Massachusetts
- U Mass Chan Medical School - Worcester
New York
- SUNY-Stony Brook - Stony Brook
North Carolina
- Atrium Health Wake Forest Baptist - Winston-Salem
Washington
- Fred Hutchinson Cancer Center - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2021-09-27 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 2 |
What the registry record for NCT04977024 still lists
NCT04977024 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (87% lower).
The record links to 5 conditions, with Lymphoma appearing as the primary indexed condition, and to 3 interventions - of which Diagnostic Laboratory Biomarker Analysis is the first listed.
NCT04977024 lists 6 locations in 6 states (California, Maryland, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT04977024 about?
NCT04977024 is a clinical study titled "SARS-CoV-2 Vaccine (GEO-CM04S1) Versus mRNA SARS-COV-2 Vaccine in Patients With Blood Cancer". This phase 2 trial studies the immune response to GEO-CM04S1 (previously designated as COH04S1) compared to standard of care (SOC) mRNA SARS-COV-2 vaccine in patients with blood cancer who have received stem cell transplant or cellular therapy. GEO-CM04S1 belongs to a category called modified vacci...
What is the current status of trial NCT04977024?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 63 participants. The study started on 2021-09-27. Estimated completion is 2027-12-31.
What conditions does trial NCT04977024 study?
This clinical trial studies the following conditions: Lymphoma, Leukemia, Plasma Cell Myeloma, Hematopoietic and Lymphoid System Neoplasm, COVID-19 Infection.
What interventions are being tested in trial NCT04977024?
The interventions under investigation include: Diagnostic Laboratory Biomarker Analysis (OTHER), COVID-19 Vaccine (BIOLOGICAL), Synthetic MVA-based SARS-CoV-2 Vaccine GEO-CM04S1 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04977024?
This trial is sponsored by GeoVax, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04977024 being conducted?
This trial has 6 study locations across California, Maryland, Massachusetts, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04977024's enrollment target sits among peer trials
63 125th of 299 higher than 175 of 299 other Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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