19th Oct 2020
Nucleus Networks announced today that Symvivo Corporation has received regulatory approval to initiate a Phase 1, first-in-human trial of bacTRL-Spike™, an orally-delivered, room-temperature stable DNA vaccine candidate for the prevention of COVID-19.
Symvivo has partnered with Nucleus Network, Australia’s largest Phase 1 clinical trials specialist, to initiate a Phase 1 trial evaluating the safety, tolerability, and immunogenicity of bacTRL-Spike™ in healthy adult volunteers.
“This unique approach delivers genetic material directly to the lining of the lower gastrointestinal tract, enabling both systemic and mucosal anti-SARS-CoV2 immune responses,” said Alexander Graves, president and CEO of Symvivo Corporation. “Results from this trial will provide valuable insight enabling the development of a room-temperature stable oral formulation, with the ultimate goal of delivering a COVID-19 vaccine directly into people’s homes throughout the world for self-administration and bypassing cold-chain supply logistics.”
The Phase 1 study of this vaccine will be conducted at the Nucleus Network Brisbane Clinic, under the supervision of Associate Professor Paul Griffin, infectious diseases physician and microbiologist at Nucleus Network, and principal investigator of the Phase 1 trial.
“The global pandemic has become the most visible example of the medical research sector for this generation,” said Assoc. Professor Griffin. “It’s inspiring to see the level of innovation and application that has gone into developing a safe and protective vaccine. The potential of this orally-delivered vaccine is particularly exciting, and we are enthusiastic about conducting this trial so that we may better understand this DNA vaccine.”
DNA vaccines work by introducing the immune system to a modified version or component of the infectious agent that has been altered to provoke an immune response without creating an infection.
For more information on the Symvivo clinical trial, see NCT04334980 study information on Clinicaltrials.gov.