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FAQ: GeoVax's GEO-CM04S1 Vaccine Superior T-Cell Responses in CLL Patients
TL;DR
GeoVax's GEO-CM04S1 vaccine outperforms Pfizer-BioNTech's mRNA vaccine in immunocompromised patients, offering a competitive edge in the $30B+ market for vulnerable populations.
GEO-CM04S1 uses a dual-antigen MVA platform to generate durable T-cell responses, meeting primary endpoints in Phase 2 trials with 40% efficacy versus 14.3% for mRNA vaccines.
This vaccine addresses a critical gap for 40 million immunocompromised Americans and 400 million globally who remain vulnerable despite first-generation COVID-19 vaccines.
GeoVax's vaccine achieved 10-fold higher nucleocapsid-specific T-cell activation than mRNA vaccines, with responses maintained through 180 days in leukemia patients.
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GeoVax announced the publication of interim Phase 2 clinical data showing its next-generation COVID-19 vaccine, GEO-CM04S1, generated superior T-cell responses compared to Pfizer's BNT162b2 mRNA vaccine in patients with chronic lymphocytic leukemia (CLL).
This is significant because CLL patients typically respond poorly to vaccines, and GEO-CM04S1's ability to generate strong T-cell responses addresses a protection gap for immunocompromised patients, potentially benefiting 40 million U.S. and 400 million global patients underserved by current vaccines.
The publication reported that 40% of GEO-CM04S1 recipients met the primary endpoint (≥3-fold rise in antigen-specific T cells) versus 14.3% for BNT162b2, with GEO-CM04S1 showing higher Spike-specific responses and approximately 10-fold higher Nucleocapsid-specific CD4 T-cell activation maintained through Day 180.
The Data and Safety Monitoring Board (DSMB) discontinued the randomized, double-blind comparator arm after the mRNA vaccine (BNT162b2) failed to meet the predefined primary immunogenicity endpoint, and the trial is now proceeding exclusively with a single-arm cohort receiving GEO-CM04S1.
GEO-CM04S1 uses a dual-antigen (Spike + Nucleocapsid), MVA-based platform designed to promote robust, durable T-cell responses that are less impacted by immune dysfunction and viral variation, whereas mRNA vaccines primarily induce humoral (antibody) responses that are less effective in immunocompromised patients.
The Phase 2 study (NCT05672355) enrolled 31 CLL patients previously vaccinated with mRNA vaccines, with 27 evaluable for primary analysis, assessing T-cell responses, binding/neutralizing antibodies, and safety with no Grade ≥3 adverse events reported.
The target population is immunocompromised patients, particularly those with chronic lymphocytic leukemia (CLL), who represent part of the 40 million U.S. and 400 million global patients with compromised immunity who often fail to mount meaningful responses to currently authorized COVID-19 vaccines.
These findings reinforce GEO-CM04S1 as an important next-generation vaccine candidate for immunocompromised patients and demonstrate its ability to address immune limitations in CLL patients by inducing strong, durable T-cell responses to both spike and nucleocapsid proteins of SARS-CoV-2.
The announcement was made on December 15, 2025, with the Research Letter published in the British Journal of Haematology, following GeoVax's clinical update at the European Hematology Association (EHA) 2025 Conference.
No Grade greater than or equal to 3 adverse events were reported in the study, indicating favorable safety findings for GEO-CM04S1 in this patient population.
Curated from NewMediaWire
