SARS-CoV-2 Vaccine (GEO-CM04S1) Versus mRNA SARS-COV-2 Vaccine in Patients With Blood Cancer

Launched by GEOVAX, INC. · Jul 22, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new vaccine called GEO-CM04S1 to see how well it helps people with blood cancers, like leukemia and lymphoma, build immunity against COVID-19. The trial compares this new vaccine to the standard mRNA COVID-19 vaccine in patients who have received a stem cell transplant or other cellular therapies. The goal is to find out if GEO-CM04S1 can provide better protection against COVID-19, especially for those whose immune systems may be weaker due to their cancer treatments.

To participate in the trial, you need to be at least 18 years old and have had a stem cell transplant or CAR T-cell therapy at least three months before joining. You should also be in good health overall, with certain blood counts within a specific range. Participants will receive the vaccine and be monitored for their immune response. It's important to note that if you're pregnant, breastfeeding, or have certain health issues, you might not be able to join the study. This trial is currently recruiting participants, and taking part could help advance our understanding of how to protect vulnerable patients from COVID-19.

Gender

ALL

Eligibility 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