GeoVax Labs has commenced subject dosing in the Phase II segment of its Phase I/II clinical trial to analyse the potential of experimental Covid-19 vaccine, COH04S1, as a universal booster.
Developed at the City of Hope Medical Center, COH04S1 is a synthetic, attenuated modified vaccinia Ankara (sMVA) vector expressing the SARS-CoV-2 virus’ spike (S) and nucleocapsid (N) antigens.
Under an exclusive licence agreement signed last month, the company obtained global rights to the vaccine patents, as well as develop and market it in City of Hope.
The booster could be used following vaccination with vaccines approved by the US Food and Drug Administration (FDA).
Carried out at City of Hope, the Phase I/II dose-escalation trial is designed to analyse the safety and will identify the biologically effective dose of the vaccine for administration.
The Phase I segment is currently in the follow-up stage with trial results anticipated to be reported early next year.
The Phase II trial will enrol 60 healthy adult subjects aged 18 years and above, who have already received an FDA-approved Covid-19 vaccine.
This dose-escalation trial will assess the safety and immunogenicity of COH04S1 when given as a booster.
The Covid-19 neutralising antibody levels against various viral variants of concern, including the Omicron variant, and specific T-cell responses will also be analysed in the trial.
GeoVax chief scientific officer Mark Newman said: “We believe that the COH04S1 vaccine, when administered as a heterologous booster, targeting both the S and N proteins, will provide additional beneficial elements for immune system recognition versus a homologous boost using a vaccine based solely on the SARS-CoV-2 S protein.
“The COH04S1 vaccine’s MVA backbone should also be more effective at inducing SARS-CoV-2 cellular immunity, since MVA strongly induces T cell responses, even in immunocompromised individuals.”
Last month, Clover Biopharmaceuticals started a Phase II clinical trial for evaluating SCB-2019 (CpG 1018/Alum), its vaccine candidate for Covid-19, as a heterologous booster shot in individuals who received an initial vaccine regimen.