A Vaccine Booster (GEO-CM04S1) for the Prevention of COVID-19 in Patients With Chronic Lymphocytic Leukemia

NCT05672355 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: 22416NCI-2022-10303P30CA033572
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Lymphocytic Leukemia; COVID-19 Infection

Outcome Measures

Primary Outcomes (1)

• T cell response

  Assessed by \>= 3-fold increase in S-specific or N-specific IFN-gamma-secreting T cells over baseline at day 56 (Primary Immune Analysis \[PIA\]), using Enzyme-linked Immunosorbent Spot (ELISPOT) assay to quantify SARS CoV-2 reactive T cells. \* Note: Missing immune response will not be imputed. Missing immune response will be categorized as no for intent-to-treat analysis but will be excluded in per-protocol analysis.

  Baseline to day 56

Secondary Outcomes (11)

• Incidence of adverse events (AEs) moderate toxicity (MOD)

  From each injection to Day 28 post injection

• Incidence of AEs unacceptable toxicity (UT)

  From each injection to Day 28 post injection

• Incidence of myocarditis or pericarditis

  Up to 42 days following final injection of study vaccine (GEO-CM04S1 or standard of care [SoC] mRNA-CoV-2 vaccine)

• Incidence of serious adverse events (SAEs)

  From each injection to Day 365 post injection

• T cell response

  Baseline to 28 days after the second booster injection

Study Arms (2)

Arm I (GEO-CM04S1)

EXPERIMENTAL

Patients receive GEO-CM04S1 vaccine IM on days 0 and 84 on study. Patients undergo blood sample collections throughout the study and are monitored for 1 year.

Procedure: Biospecimen Collection; Biological: Synthetic MVA-based SARS-CoV-2 Vaccine COH04S1

Arm II (mRNA Covid-19 Vaccine)

ACTIVE COMPARATOR

Patients receive mRNA vaccine injection IM on days 0 and 84 on study. Patients undergo blood sample collections throughout the study and are monitored for 1 year.

Procedure: Biospecimen Collection; Biological: mRNA COVID-19 Vaccine

Interventions

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Arm I (GEO-CM04S1); Arm II (mRNA Covid-19 Vaccine)

mRNA COVID-19 Vaccine BIOLOGICAL

Given IM

Also known as: COVID-19 mRNA Vaccine, mRNA-based COVID-19 Vaccine, SARS-CoV-2 mRNA Vaccine

Arm II (mRNA Covid-19 Vaccine)

Synthetic MVA-based SARS-CoV-2 Vaccine COH04S1 BIOLOGICAL

Given IM

Also known as: COH04S1, SARS-CoV-2 Vaccine COH04S1, sMVA-based SARS-CoV-2 Vaccine COH04S1

Arm I (GEO-CM04S1)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

RECRUITING

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; COVID-19

Interventions

Specimen Handling; CVnCoV COVID-19 vaccine; COH04S1 COVID-19 vaccine

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Alexey V Danilov

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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. The 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2023
• First Posted: January 5, 2023
• Study Start: August 1, 2023
• Primary Completion (Estimated): January 12, 2029
• Study Completion (Estimated): January 12, 2029
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

US (1)