GeoVax Labs has engaged CATO SMS as the company’s clinical research organisation (CRO) partner to manage two Phase II clinical trials of its Covid-19 vaccine candidate, GEO-CM04S1.
The trials underway are analysing the vaccine in immunocompromised individuals and as a booster shot in healthy subjects.
GEO-CM04S1 is a synthetic, non-replicating modified vaccinia Ankara (MVA) vaccine vector.
It was designed as a double recombinant vectored vaccine for inducing humoral as well as cellular immune responses against the SARS-CoV-2 virus’ spike and nucleocapsid proteins.
The vaccine vector infects cells at the local injection site following vaccination resulting in the SARS-CoV-2 antigen expression visible to the immune system.
A Phase II trial is progressing to analyse GEO-CM04S1’s safety and immunogenicity versus the Pfizer-BioNTech’s mRNA-based Covid-19 vaccine in immunocompromised subjects.
These subjects will include those who had either an allogeneic hematopoietic cell transplant, an autologous hematopoietic cell transplant or chimeric antigen receptor (CAR) T cell therapy earlier.
This trial is the first to compare an investigational multi-antigenic Covid-19 vaccine to Food and Drug Administration (FDA)-approved Pfizer-BioNTech vaccine in immunocompromised individuals.
Another Phase II segment of a Phase I/II trial is analysing GEO-CM04S1 as a universal booster shot following administration of two doses of mRNA vaccines of either Pfizer-BioNTech or Moderna that are presently approved by the FDA.
The Phase II dose-escalation trial commenced enrolment of healthy subjects in December last year.
It will assess the safety and immunogenicity of the vaccine administered as a booster.
The SARS-CoV-2 neutralising antibody levels against the viral variants, including Omicron, and specific T-cell responses will be analysed as immunological responses in the trial.
The concluded Phase I segment of the trial was a dose-escalation safety study that enrolled healthy subjects who were not infected by Covid-19.
GeoVax Labs president and CEO David Dodd said: “We are excited to have engaged CATO SMS as our CRO partner for our advancing clinical studies of GEO-CM04S1.
“We previously announced the engagement of CATO to manage our Phase I/II trial of Gedeptin therapy in patients with recurrent head and neck squamous cell carcinoma and now look forward to working with them for our Covid-19 vaccine trials as well to achieve important clinical milestones including the expansion of clinical sites and acceleration of patient enrolment and evaluation.”
In December last year, the company started dosing of subjects in the Phase II portion of the Phase I/II trial to analyse its Covid-19 vaccine, COH04S1, as a universal booster.