Business
GeoVax Announces Initiation of Phase 2 Clinical Trial for COVID-19 Vaccine Booster
Ongoing Phase 1/2 Trial Advancing to Phase 2 Evaluation of Multi-Antigen Vaccine, Targeting both Spike and Nucleocapsid Proteins, as a Universal Booster to
About this update from Geovax Labs, Inc.
[{"type":"text","content":"Ongoing Phase 1/2 Trial Advancing to Phase 2 Evaluation of Multi-Antigen Vaccine, Targeting both Spike and Nucleocapsid Proteins, as a Universal Booster to Current FDA-Approved Vaccines ATLANTA, GA, Dec. 15, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company specializing in developing human vaccines and cancer immunotherapies, today announced the initiation of vaccine dosing in the Phase 2 portion of its Phase 1/2 clinical trial of COH04S1, a multi-antigenic SARS-CoV-2 investigational vaccine, designed to target both the spike (S) and nucleocapsid (N) proteins, to evaluate its use as a universal booster to current FDA-approved vaccines. The clinical trial, titled “Phase 1/2 Dose Escalation Study to Evaluate the Safety and Biologically Effective Dose of COH04S1, a Synthetic MVA-based SARS-CoV-2 Vaccine, Administered as One or Two Injections or as a Booster to Healthy Adult Volunteers” is being conducted at City of Hope, a world-renowned cancer research and treatment organization near Los Angeles. The Phase 1 portion of the trial was designed as a dose-escalation safety study in healthy individuals between the ages of 18 to 55, who had not been previously infected with SARS-CoV-2. The primary objectives were to evaluate the safety, tolerability and immunogenicity of the COH04S1 vaccine in healthy volunteers who were administered the vaccine at three different dose levels by intramuscular (IM) injection. Follow-up studies of the volunteers are continuing in order to better assess duration of immune responses and scientific presentations, and publications of results are planned for early 2022. The Phase 2 booster study, for which vaccination is now underway, will include 60 healthy individuals, 18 years of age and older, who were previously vaccinated with one of the FDA-approved SARS-CoV-2 mRNA vaccines. The study is designed as a dose-escalation trial to specifically evaluate the safety profile and immunogenicity of COH04S1 as a booster shot. The immunological responses measured throughout the study will include both the level of SARS-CoV-2 neutralizing antibodies against SARS-CoV-2 variants of concern (VOC), including the newly identified Omicron VOC, and specific T-cell responses. Mark Newman, PhD, GeoVax Chief Scientific Officer, commented, “Due to concerns with the duration o...