Comparing a new COVID-19 vaccine to standard mRNA vaccines in blood cancer patients
A Phase 2 Randomized, Multi-center Study of GEO-CMO4S1 (SARS-CoV-2 Vaccine) Versus mRNA SARS-CoV-2 Vaccine in Patients Post Cellular Therapy for Hematological Malignancies
This study is testing a new COVID-19 vaccine in blood cancer patients who have had a stem cell transplant to see if it works better than the standard mRNA vaccines.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | GeoVax, Inc. Industry-sponsored |
| Drugs / interventions | rituximab, chimeric antigen receptor, prednisone |
| Locations | 6 sites (Duarte, California and 5 other locations) |
| Trial ID | NCT04977024 on ClinicalTrials.gov |
What this trial studies
This phase 2 trial evaluates the immune response to the GEO-CM04S1 vaccine, a modified vaccinia Ankara vaccine, in patients with blood cancer who have undergone stem cell transplant or cellular therapy. Participants are randomized to receive either the GEO-CM04S1 vaccine or a standard mRNA SARS-CoV-2 vaccine, with the aim of assessing the biological activity, safety, and durability of immune responses. The study includes follow-up assessments to monitor immune responses and any incidental COVID-19 infections over a year.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with blood cancer who have received a stem cell transplant or cellular therapy at least three months prior.
Not a fit: Patients who are not eligible include those with active blood cancer or those who have not undergone the required therapies.
Why it matters
Potential benefit: If successful, this study could enhance protection against COVID-19 in patients with blood cancer, potentially reducing severe disease outcomes.
How similar studies have performed: Other studies have shown promise with similar vaccine approaches, but this specific vaccine is novel in this patient population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Documented informed consent of the participant * Age \>=18 years * Eastern Cooperative Oncology Group (ECOG) =\<1 * Allogeneic or autologous hematopoietic cell transplant (HCT), cellular therapy (chimeric antigen receptor \[CAR\] T-cell) recipients who are at \>= 3 months of infusion date of respective regimen * Platelets \>= 50,000/mm\^3 (to be performed within 30 days prior to day 0 of protocol therapy unless otherwise stated) * White blood cells (WBCs) \>= 1000/mm\^3 (to be performed within 30 days prior to day 0 of protocol therapy unless otherwise stated) * Total bilirubin \< 1.5 X upper limit of normal (ULN) (to be performed within 30 days prior to day 0 of protocol therapy unless otherwise stated) * Aspartate aminotransferase (AST) \< 2.5 X ULN (to be performed within 30 days prior to day 0 of protocol therapy unless otherwise stated) * Alanine aminotransferase (ALT) \< 2.5 X ULN (to be performed within 30 days prior to day 0 of protocol therapy unless otherwise stated) * Creatinine \< 1.5 X ULN (to be performed within 30 days prior to day 0 of protocol therapy unless otherwise stated) * Negative COVID-19 PCR test * Women of childbearing potential (WOCBP): negative urine or serum pregnancy test (to be performed within 30 days prior to day 0 of protocol therapy unless otherwise stated). If the urine pregnancy test is inconclusive a serum pregnancy test will be required * Agreement by females and males of childbearing potential\* to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 weeks after the last dose of protocol therapy * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only) Exclusion Criteria: * Systemic corticosteroids required for chronic conditions at doses \> 0.5mg/kg/day prednisone equivalent within 7 days of enrollment * Prior Evusheld or other anti-SARS CoV-2 prophylaxis \< 2 weeks prior to enrollment * Therapies that cause profound T-cell or B cell depletion within 30 days of enrollment * Maintenance therapies (e.g. rituximab, Bruton tyrosine kinase inhibitors, Janus kinase inhibitors) within 30 days of enrollment * Received investigational or licensed SARS-CoV-2 vaccines after their qualifying cellular therapy. Patients who received a SARS- CoV-2 vaccine prior to cellular therapy are eligible for this trial, as revaccination for these patients (e.g. flu and shingles vaccine) is standard of care. * Received a live vaccine ≤30 days prior to administration of study vaccine or subjects who are =\< 2 weeks within administration of inactivated vaccines (e.g. influenza vaccine). Flu shots are allowed \> 2 weeks before the first injection and \> 2 weeks post 2nd injection * History of allergic reactions attributed to compounds of similar chemical or biologic composition to vaccine agents * History of adverse event with a prior smallpox vaccination * Any MVA vaccine or poxvirus vaccine in the last 12 months * History (suspected or confirmed) of myocarditis or pericarditis * Clinically significant uncontrolled illness * Females only: Pregnant or breastfeeding * Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns with clinical study procedures * Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics) * Anyone considered to be in a vulnerable population as defined in 45 CFR §46.111 (a)(3) and 45 CFR §46, Subparts B-D
Where this trial is running
Duarte, California and 5 other locations
- City of Hope Medical Center — Duarte, California, United States (Active_not_recruiting)
- Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)
- U Mass Chan Medical School — Worcester, Massachusetts, United States (Recruiting)
- SUNY-Stony Brook — Stony Brook, New York, United States (Recruiting)
- Atrium Health Wake Forest Baptist — Winston-Salem, North Carolina, United States (Recruiting)
- Fred Hutchinson Cancer Center — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Chief Medical Officer — GeoVax, Inc.
- Study coordinator: Chief Medical Officer
- Email: info@geovax.com
- Phone: 678-384-7220
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.