Intravacc launches phase I clinical trial of Avacc 10, an intranasal subunit booster vaccine for SARS-CoV-2   

Randomized, double blinded, placebo-controlled trial. Evaluation of two doses in 36 volunteers. Mid-term data expected by end Q1 2023

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Biovoice News vaccine
New Delhi/Bilthoven:  Intravacc, a world leader in preventive and therapeutic vaccines, has announced that it enrolled the first participant in a phase I first in-human clinical trial of 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 10 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.
Dr. Jan Groen, Intravacc’s CEO, says: “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.”