Symvivo has enrolled and dosed the first healthy volunteer in a Phase I trial in Australia to evaluate its oral Covid-19 vaccine candidate, bacTRL-Spike.
Each oral dose of the vaccine candidate has bacterial medium with either one billion, three billion or ten billion colony-forming units of live Bifidobacterium longum.
BacTRL-Spike is designed to deliver plasmids containing synthetic DNA encoding spike protein from SARS-CoV-2.
The Phase I trial, ‘Evaluating the Safety, Tolerability and Immunogenicity of bacTRL-Spike Vaccine for Prevention of COVID-19 (NCT04334980)’, will analyse the safety, tolerability and preliminary evidence of immunogenicity to SARS CoV-2 elicited by the vaccine among healthy adults.
It is being conducted in collaboration with Nucleus Network in Brisbane, Australia for 18 months and plans to enrol 12 healthy participants.
Each participant will remain in the trial for 12-13 months. This will include a screening phase of up to 28 days, intervention phase of one day and follow-up phase of 12 months.
The primary investigator of the trial is Nucleus Network infectious diseases physician and microbiologist Paul Griffin.
Preliminary data from the trial is anticipated early next year.
Setting itself apart from the traditional vaccines that are delivered by intramuscular injection, bacTRL-Spike is taken orally and helps people to self-administer with no trained medical professional required to carry out the process.
Symvivo chief medical officer Eric Sievers said: “We are exceptionally pleased to commence dosing of our oral DNA vaccine for Covid-19 as we continue scale-up and manufacturing activities for future clinical development.
“The rapidly advancing pandemic mandates innovative scientific approaches and we believe a safe, protective oral vaccine could transform the landscape of traditional vaccination approaches, eliminating the need for syringes, needles, and trained vaccinators.”