Randomized Observer-Blinded Phase 2 Trial of COVID-19 Booster With GEO-CM04S1 or mRNA Vaccine in Patients With Chronic Lymphocytic Leukemia

22416

This phase II trial compares the effect of the GEO-CM04S1 vaccine with the current standard of care vaccine in preventing COVID-19 infections in patients with chronic lymphocytic leukemia (CLL). The GEO-CM04S1 vaccine uses a modified vaccinia virus (MVA) backbone that may be more effective at boosting COVID-19 immunity in patients with poor immune responses. MVA strongly induces T cell expansion (infection fighting blood cells) even in the background of a suppressed immune system, which is the case in the targeted CLL patient population. Using the GEO-CM04S1 vaccine may be more effective at preventing COVID-19 infection in patients diagnosed with CLL.

2023-08-01

2026-01-12

2026-01-12

Recruiting

Early phase I

80

Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative * Age: \>= 18 years * Eastern Cooperative Oncology Group (ECOG) =\< 1 * Histologically confirmed diagnosis of CLL according to World Health Organization (WHO) classification * Prior COVID-19 Vaccination (2 or more Pfizer or Moderna) with last injection \>= 3 months prior * Fully recovered from the acute toxic effects (except alopecia) to =\< Grade 1 to prior anti-cancer therapy * White Blood Cells (WBC) \>= 1,000/mm\^3 (To be performed within 14 days prior to Day 1 of protocol therapy) * Platelets \>= 50,000/mm\^3 (To be performed within 14 days prior to Day 1 of protocol therapy) * Total bilirubin =\< 1.5 X upper limit of normal (ULN) (unless has Gilbert's disease) (To be performed within 14 days prior to Day 1 of protocol therapy) * Aspartate aminotransferase (AST) =\< 2.5 x ULN (To be performed within 14 days prior to Day 1 of protocol therapy) * Alanine transaminase (ALT) =\< 2.5 x ULN (To be performed within 14 days prior to Day 1 of protocol therapy) * Creatinine clearance \<1.5 ULN (To be performed within 14 days prior to Day 1 of protocol therapy) * Women of childbearing potential (WOCBP): negative urine or serum pregnancy test (To be performed within 14 days prior to Day 1 of protocol therapy) * If the urine test is positive or cannot be confirmed as negative, 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 vaccine injection * 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: * Known current SARS CoV-2 infection * Prior Evusheld or other anti-SARS CoV-2 prophylaxis \< 2 weeks prior * Prior hematopoietic cell transplantation (HCT) or chimeric antigen receptor (CAR) T cell therapy within the previous year * Systemic corticosteroids required for chronic conditions at doses \> 0.5mg/kg/day prednisone equivalent within 7 days of enrollment * Intensive cytotoxic therapies, T-cell depleting therapies, within 30 days of enrollment; however, patients with stable disease on maintenance therapies are allowed (See ConMeds for lists of acceptable and contraindicated therapies) * Participants who have had a live vaccine =\< 30 days prior to administration of any dose 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 a study vaccine injection and \> 2 weeks post study vaccine injection * History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent (e.g., egg allergies) * Active infection not controlled on appropriate therapy * History of adverse event with a prior smallpox vaccination * History of pericarditis or myocarditis * Any MVA vaccine or poxvirus vaccine in the last 12 months * Females only: Pregnant or breastfeeding * Any other condition that would, in the Investigator's judgment, contraindicate the patient'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)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'This trial is observer-blinded because the physical appearance of GEO-CM04S1 and mRNA vaccine may vary. The investigators, treating clinicians, participants, and other study staff, including the nurses involved in soliciting or recording of AEs, will be blinded through the day 112 visit.\n\nThe study statisticians, pharmacists, and nurses who administer the vaccine injections will be unblinded. To avoid inadvertent unblinding of the participants at the time of injection, the syringe will be obscured from view by the nurse during injection.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}

2024-02-02