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GeoVax Announces Initiation of Phase 2 Clinical Trial of COVID-19 Vaccine Booster in Patients with Chronic Lymphocytic Leukemia
Seeking Improved Immune Response vs mRNA Vaccine ATLANTA, GA, July 20, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire - GeoVax Labs, Inc. (Nasdaq: GOVX), a
About this update from Geovax Labs, Inc.
[{"type":"text","content":" Seeking Improved Immune Response vs mRNA Vaccine ATLANTA, GA, July 20, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire - GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced the start of an investigator-initiated clinical trial (ClinicalTrials.gov Identifier: NCT05672355), titled “Randomized observer-blinded phase 2 trial of COVID-19 booster with GEO-CM04S1 or Pfizer-BioNTech Bivalent vaccine in patients with chronic lymphocytic leukemia,” at City of Hope National Medical Center, led by Alexey Danilov, M.D., PhD as principal investigator. GEO-CM04S1, a multi-antigenic SARS-CoV-2 vaccine that targets the spike (S) and nucleocapsid (N) proteins of SARS-CoV-2, is actively under clinical study by GeoVax in severely immunocompromised individuals, as well as in healthy adults for use as a universal heterologous booster. Despite a high vaccination rate, chronic lymphocytic leukemia (CLL) patients may be at high risk for lethal COVID-19 infection due to poor immune response to COVID-19 infections or vaccination. The GEO-CM04S1 vaccine uses a modified vaccinia virus (MVA) backbone that may be more effective at inducing COVID-19 immunity in patients with poor humoral immune responses since MVA strongly induces T cell expansion even in the background of immunosuppression. Targeting both the spike and nucleocapsid protein antigens broaden the specificity of the immune responses and protects against the loss of efficacy associated with the significant sequence variation observed with the spike antigen. The study will examine the use of two injections of GEO-CM04S1 three months apart to assess immune responses in these vulnerable patients, with the Pfizer-BioNTech Bivalent vaccine as the control arm. Participants will be randomized 1:1 to receive two boosters with either the GEO-CM04S1 or the control vaccine. The primary immune response outcome will be 56 days following the first booster injection. Up to 40 participants will be treated in each arm, with immune responses evaluated at the interim and final analyses in each arm. Brian Koffman, M.D.C.M., FCFP DABFP (retired) MS Ed, Executive Vice President and Chief Medical Officer of the CLL Society, a nonprofit dedicated to the unmet needs of those diagnosed with CLL/small lymphocytic lymphoma (SLL)...