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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-27

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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PRIMARY OBJECTIVE:

I. Evaluate the biological activity and the role of timing of 2 injections of GEO-CM04S1 vaccine administered at 2.5e8 PFU/dose compared to SOC mRNA vaccine.

SECONDARY OBJECTIVES:

I. Assess safety of GEO-CM04S1 vaccine. II. Evaluation of SARS-CoV-2 S and N-specific Th1 vs Th2 polarization. III. Evaluate T-cell levels and function. IV. Evaluate activated/cycling and memory phenotype markers. V. Evaluate durability of immune responses. VI. Evaluate maintenance of immunity that can be associated with protection over the study period.

EXPLORATORY OBJECTIVE:

I. Surveillance for incidental COVID-19 infection during follow-up (1 year).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I : Patients receive one dose of GEO-CM04S1 intramuscularly (IM) in the upper arm on days 0 and 28.

ARM II : Patients receive one dose of SOC mRNA SARS-CoV-2 vaccine IM in the upper arm on days 0 and 28.

After the completion of study treatment, patients are followed up at days 7, 90, 120, 180, and 365.

Conditions

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COVID-19 Infection Hematopoietic and Lymphoid System Neoplasm Leukemia Lymphoma Plasma Cell Myeloma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Arm I (GEO-CM04S1)

Patients receive one dose of GEO-CM04S1 IM in the upper arm on days 0 and 28.

Group Type EXPERIMENTAL

Diagnostic Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Synthetic MVA-based SARS-CoV-2 Vaccine GEO-CM04S1

Intervention Type BIOLOGICAL

Given IM

Arm II (SOC mRNA SARS-CoV-2 vaccine)

Patients receive one dose of SOC mRNA SARS-CoV-2 vaccine IM in the upper arm on days 0 and 28.

Group Type EXPERIMENTAL

COVID-19 Vaccine

Intervention Type BIOLOGICAL

Receive SOC mRNA SARS-CoV-2 vaccine IM

Diagnostic Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Interventions

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COVID-19 Vaccine

Receive SOC mRNA SARS-CoV-2 vaccine IM

Intervention Type BIOLOGICAL

Diagnostic Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Synthetic MVA-based SARS-CoV-2 Vaccine GEO-CM04S1

Given IM

Intervention Type BIOLOGICAL

Other Intervention Names

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COH04S1 SARS-CoV-2 Vaccine COH04S1 sMVA-based SARS-CoV-2 Vaccine COH04S1 GEO-CM04S1

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No