Osivax announces Last Subject Last Visit completed in Phase 2a Clinical Trial of OVX836 Universal Influenza Vaccine Candidate
— Full immunogenicity and safety results expected for early 2021 –Lyon, France – September 10, 2020 –
Osivax announced today that the Last Subject’s Last Visit (LSLV) occurred in the Phase 2a clinical trial of OVX836 universal Influenza vaccine candidate. The trial has been conducted by the Centre for Vaccinology (CEVAC) at the Ghent University Hospital (Belgium) under the oversight of the Professor Isabel Leroux-Roels.
This phase 2a is a randomized, double-blind clinical trial to assess the immunogenicity and safety of OVX836 universal flu vaccine candidate compared to a quadrivalent seasonal subunit flu vaccine (Influvac TetraTM) (NCT04192500). The 300-subject clinical trial began enrolment in December 2019 and ended on-time despite the coronavirus pandemic with the last participant completing final visit on September 7th 2020. The healthy subjects from 18 to 65 years old were enrolled and followed for 180 days to evaluate and compare the immunogenicity and safety of one intramuscular administration of OVX836 vaccine at two different dose levels (90μg and 180μg) to a quadrivalent seasonal influenza sub-unit vaccine.
Laboratory analyses of vaccine immunogenicity are being performed at ABL Lyon and CEVAC lab. Full Results are anticipated in early 2021.
Alexandre Le Vert, CEO and co-founder of Osivax, commented: “We are pleased with the progress of our phase 2a, and excited to announce that all participants have completed their final visit according to the planned calendar. With the advances made during this study, we hope to confirm in a larger population the results observed in Phase 1 clinical trial showing that our universal flu vaccine candidate OVX836 is well tolerated, safe, and induces strong cellular and antibody immune responses”.
Professor Isabel Leroux-Roels, the Principal Investigator, commented: “We are proud to have successfully completed OVX836’s Phase 2a clinical study in this epidemic context within the timeframe we had set. We are looking forward to review the study results expected for early 2021.”
About the Center of Vaccinology
The Center for Vaccinology of the Ghent University and Ghent University Hospital (CEVAC) has a large track record in conducting vaccine trials for numerous infectious diseases: hepatitis B, combined hepatitis A-B, influenza, HPV, HSV, VZV, RSV, CMV, HIV, tuberculosis, malaria, for a wide number of sponsors. CEVAC has developed a large portfolio of assays to measure humoral and cellular immune responses following rapid blood sample on-site processing.
Osivax’ mission is to prevent globally impactful infectious diseases. Leveraging its unique oligoDOM® technology platform, Osivax is developing a universal vaccine for both current and future influenza infections. The Company’s universal flu vaccine candidate, OVX836 is in Phase 2a clinical development. Osivax is leveraging the same platform technology for the
development of a universal vaccine against all existing and emerging coronavirus infections.
Osivax is focused on providing proof-of-concept in influenza and coronavirus, and to applying
its oligoDOM® platform broadly in other infectious and immune system-associated diseases.
Alexandre Le Vert, CEO
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|This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 961112|