Bilthoven, The Netherlands, 30 November 2022 – Intravacc, a world leader in translational research and development of preventive and therapeutic vaccines, today announced that it enrolled the first participant in a phase I first in-human clinical trial to test novel Avacc® 10, the company’s SARS-CoV-2 intranasal subunit vaccine, as a booster to previous COVID-19 vaccinations. Avacc® 10 is based on Intravacc’s proprietary outer membrane vesicles (OMV) platform.
The phase I clinical trial has just commenced in a clinical center in Australia, and will assess the tolerability, safety and immunogenicity of the intranasal Avacc® 10 vaccine. In a randomized, double-blind placebo and OMV control study, 36 healthy male and female volunteers aged 18-55, who are IgG seropositive for SARS-CoV-2, will receive two intranasal doses, three weeks apart. One group will receive a low dose and the second group a high dose. Both groups will be followed for a period of 6 months post vaccination. In addition, the study will evaluate the ability of Avacc® 1 to induce an immune response, by measuring IgA and IgG antibodies, neutralizing antibodies, mucosal immunity and cellular immunity. The trial will run from September 2022 through June 2023. The first interim results of the trial are expected end Q1 2023. Learn more about the trial at Clinicaltrials.gov.
“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.“