RecruitingPhase 2NCT05672355

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

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

Sponsor

City of Hope Medical Center

Enrollment

80 participants

Start Date

Aug 1, 2023

Study Type

INTERVENTIONAL

Conditions

Chronic Lymphocytic Leukemia COVID-19 Infection

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new COVID-19 vaccine booster called GEO-CM04S1 in patients with chronic lymphocytic leukemia (CLL), a blood cancer that often weakens the immune system's response to standard vaccines. The goal is to see whether this specially designed booster generates a stronger immune response in this vulnerable group. **You may be eligible if...** - You are 18 or older - You have been diagnosed with CLL confirmed by a specialist - You have already received at least 2 prior COVID-19 vaccines (Pfizer or Moderna), with the last dose at least 3 months ago - Your white blood cell count is adequate and your general health is good (ECOG 0–1) **You may NOT be eligible if...** - You have active, uncontrolled infections - You are currently receiving active CLL treatment that significantly suppresses immunity - You have had a severe allergic reaction to prior COVID-19 vaccines - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREBiospecimen Collection

Undergo blood sample collection

BIOLOGICALmRNA COVID-19 Vaccine

Given IM

BIOLOGICALSynthetic MVA-based SARS-CoV-2 Vaccine COH04S1

Given IM

Locations(1)

City of Hope Medical Center

Duarte, California, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05672355

Related Trials

Testing Early Treatment for Patients With High-Risk Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), EVOLVE CLL/SLL Study

NCT04269902629 locations

A Prospective Observational Trial to Assess Treatment Sequences and Factors That Impact Overall Sur-vival in Patients With Chronic Lymphocytic Leukaemia (CLL) Treated Within First-line Studies of the GCLLSG

NCT067929942 locations

A Study of Nemtabrutinib (MK-1026) Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in First Line (1L) Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) (MK-1026-011/BELLWAVE-011)

NCT06136559196 locations

A Study to Learn About the Study Medicine Ibuzatrelvir in Adults With COVID-19 Who Are Severely Immunocompromised

NCT07013474132 locations

A Study to Investigate Progression-Free Survival With Sonrotoclax Plus Obinutuzumab Or Sonrotoclax Plus Rituximab Compared With Venetoclax Plus Rituximab Treatment In Patients With Relapsed and/or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CELESTIAL-RRCLL)

NCT06943872167 locations