Intravacc has enrolled the first subject in a Phase I clinical trial analysing its intranasal subunit vaccine for Covid-19, Avacc 10, as a booster.
The double-blind, randomised, placebo and outer membrane vesicles (OMV) controlled, first-in-human trial was launched at a clinical centre in Australia.
It is designed to evaluate the safety, tolerability, and immunogenicity of booster doses of the intranasal vaccine, administered following prior Covid-19 vaccinations.
The trial will enrol 36 healthy male and female subjects aged 18 to 55 years, who are IgG seropositive for the SARS-CoV-2 virus.
These subjects will be given two intranasal doses of Avacc 10 at a gap of three weeks.
One group will be given a low dose of the vaccine while another group will receive a high dose.
Additionally, both these groups will be followed up for six months following inoculation.
The trial will analyse Avacc 10’s potential to elicit an immune response by assessing neutralising antibodies, IgA and IgG antibodies, and mucosal and cellular immunity.
The company intends to carry out the trial till June next year, with initial interim data anticipated by the end of the first quarter of next year.
Avacc 10 is based on the OMV platform of the company.
Intravacc CEO Dr Jan Groen said: “This is a very important milestone in the development of our intranasal OMV-based vaccine.
“We strongly believe that intranasal vaccines offer major advantages over injectable vaccines, and we are excited to take our vaccine concept to the next stage, supporting our CDMO business.”
In August 2020, the company reported positive data from a Phase I trial of its respiratory syncytial virus (RSV) vaccine candidate.