What is the mechanism of action of this treatment?

The GEO-CM04S1 vaccine uses a modified vaccinia virus (MVA) backbone to strongly induce T cell expansion, which is crucial for fighting infections, especially in patients with suppressed immune systems like those with chronic lymphocytic leukemia (CLL). This mechanism is particularly important because it enhances the immune response even in immunocompromised individuals. Other common COVID-19 treatments, such as antiviral drugs (e.g., remdesivir) and monoclonal antibodies (e.g., tocilizumab), work by inhibiting viral replication or modulating the immune response to reduce inflammation. These treatments are essential for managing COVID-19 because they target different aspects of the disease, helping to reduce viral load and mitigate severe immune reactions, thereby improving patient outcomes.

What side effects are associated with this type of intervention?

Common treatments for COVID-19 include convalescent plasma, sulodexide, metformin, hydroxychloroquine, ivermectin, and fluvoxamine. Convalescent plasma can cause allergic reactions, fever, and transfusion-related acute lung injury. Sulodexide may lead to gastrointestinal issues and bleeding. Metformin's side effects include gastrointestinal upset and lactic acidosis. Hydroxychloroquine can cause gastrointestinal symptoms and cardiac arrhythmias. Ivermectin is associated with gastrointestinal distress and neurologic adverse effects. Fluvoxamine may cause nausea, dizziness, and sleep disturbances. The GEO-CM04S1 vaccine, which uses a modified vaccinia virus backbone, may have side effects similar to other vaccines, such as injection site reactions, fever, and fatigue.

What prior FDA approvals exist?

The FDA has granted Emergency Use Authorization (EUA) for several COVID-19 vaccines and treatments. Notably, the Pfizer-BioNTech and Moderna mRNA vaccines have been approved for their efficacy in preventing COVID-19. These vaccines work by inducing an immune response through mRNA technology. Additionally, monoclonal antibodies like casirivimab and imdevimab have been approved for their ability to reduce the risk of COVID-19 infection. These treatments, while different in mechanism from the GEO-CM04S1 vaccine, which uses a modified vaccinia virus to boost T cell immunity, represent significant advancements in the fight against COVID-19.

What other types of research exist?

Promising novel alternatives to the GEO-CM04S1 vaccine for COVID-19 patients include: 1) mRNA vaccines such as those developed by Pfizer-BioNTech and Moderna, which have shown high efficacy and adaptability to new variants. 2) Recombinant protein vaccines like Novavax, which use nanoparticle technology to elicit strong immune responses. 3) Viral vector vaccines such as Johnson & Johnson's Ad26.COV2.S, which use a different virus to deliver SARS-CoV-2 genetic material and induce immunity. 4) Oral vaccines using vectors like the Sabin 1 poliovirus-based system, which are in development and aim to provide mucosal immunity. These alternatives offer diverse mechanisms of action and potential benefits for different patient populations.

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Virus Therapy

Vaccine Booster GEO-CM04S1 for Chronic Lymphocytic Leukemia

Phase 2

Recruiting

Led By Alexey V Danilov

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically confirmed diagnosis of CLL according to World Health Organization (WHO) classification

Eastern Cooperative Oncology Group (ECOG) =< 1

Must not have

History of pericarditis or myocarditis

Any MVA vaccine or poxvirus vaccine in the last 12 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial compares a new COVID-19 vaccine, GEO-CM04S1, with the standard vaccine in patients with chronic lymphocytic leukemia (CLL). The new vaccine aims to boost the immune system more effectively in these patients. It works by helping the body produce more infection-fighting cells.

Who is the study for?

Adults diagnosed with chronic lymphocytic leukemia (CLL) who have had at least two Pfizer or Moderna COVID-19 vaccines over three months ago can join. They should be in good health otherwise, not pregnant, and willing to use birth control. People with recent intensive cancer treatments, certain allergies, a history of heart inflammation, or those on high-dose steroids cannot participate.

What is being tested?

The trial is testing the GEO-CM04S1 vaccine booster against standard COVID-19 vaccines for CLL patients. The new vaccine uses a modified virus that might better stimulate immune cells even when the immune system is weakened by CLL.

What are the potential side effects?

Potential side effects are not detailed but may include typical vaccine reactions like soreness at the injection site, fatigue, fever, and allergic responses due to components similar to other vaccines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My diagnosis of CLL is confirmed by lab tests.

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I am fully active and can carry on all pre-disease activities without restriction.

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I am 18 years old or older.

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I have recovered from side effects of cancer treatment, except for hair loss.

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My liver enzyme (ALT) levels are within the normal range.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had pericarditis or myocarditis in the past.

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I have not received a poxvirus vaccine in the last year.

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I have an infection that isn't getting better with treatment.

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I am not pregnant or breastfeeding.

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I currently have COVID-19.

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I take more than 0.5mg/kg/day of steroids for a chronic condition.

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I have not had a bone marrow transplant or CAR T cell therapy in the last year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Incidence of AEs unacceptable toxicity (UT)

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

Incidence of myocarditis or pericarditis

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (GEO-CM04S1)Experimental Treatment2 Interventions

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.

Group II: Arm II (mRNA Covid-19 Vaccine)Active Control2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2030

Synthetic MVA-based SARS-CoV-2 Vaccine COH04S1

2020

Completed Phase 2

~120

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The GEO-CM04S1 vaccine uses a modified vaccinia virus (MVA) backbone to strongly induce T cell expansion, which is crucial for fighting infections, especially in patients with suppressed immune systems like those with chronic lymphocytic leukemia (CLL). This mechanism is particularly important because it enhances the immune response even in immunocompromised individuals. Other common COVID-19 treatments, such as antiviral drugs (e.g., remdesivir) and monoclonal antibodies (e.g., tocilizumab), work by inhibiting viral replication or modulating the immune response to reduce inflammation. These treatments are essential for managing COVID-19 because they target different aspects of the disease, helping to reduce viral load and mitigate severe immune reactions, thereby improving patient outcomes.

A bibliometric analysis of research related Chinese Medicine in the prevention and treatment of corona virus disease 2019.TLR4 as a therapeutic target for respiratory and neurological complications of SARS-CoV-2.