Osivax Announces Last Participant Last Visit in its Phase 1 Clinical Trial of OVX836 Universal Influenza Vaccine Candidate
– Full safety and immunogenicity results expected for end 2019 —
Lyon, France – September 26th, 2019 – Osivax announced today that all participants have completed their final visit in the first-in-human clinical trial of OVX836 universal Influenza vaccine candidate conducted by the Centre for the Evaluation of Vaccination (CEV) at the University of Antwerp (Belgium).
This first-in-human study is a randomized, observer-blind, placebo-controlled dose escalating trial (NCT03594890). The 72-subject clinical trial began enrolment in June 2018 and ended on-time with the last participant completing final visit on 7th August 2019. The 72 healthy subjects from 18 to 49 years old were enrolled and followed for 150 days to evaluate the safety and the immune response of increasing doses of OVX836 vaccine. Safety and immunogenicity will be assessed and compared between the groups receiving OVX836 and placebo. Laboratory analyses of vaccine immunogenicity are being performed at ABL Lyon. Full Results are anticipated by the end of 2019.
Alexandre LE VERT, CEO and co-founder of Osivax, commented: “We are pleased with the progress of our first-in-human trial, and excited to announce that the last patient’s last visit has taken place according to the planned calendar. With the unblinding and data readout imminent, we hope to demonstrate that our universal flu vaccine OVX836 is safe and well tolerated and induces strong immune responses”.
The trial took place at the Centre for the Evaluation of Vaccination (CEV) of the University of Antwerp, which was founded in 1994 by Prof Pierre Van Damme, full professor at the University of Antwerp, Faculty of Medicine and Health Sciences. The CEV is recognized as a ‘Centre of Excellence’ of the University of Antwerp and functions as a WHO Collaborating Centre for the WHO European Region for the control and prevention of infectious diseases. The centre also works in collaboration with PATH, CDC, ECDC, EU and the Bill & Melinda Gates Foundation.
Osivax’s mission is to revolutionize influenza prevention with a universal flu vaccine for both current and future Influenza infections by leveraging its unique oligoDOM® technology platform. OVX836, its candidate universal flu vaccine is in Phase 1 clinical development. Osivax is focused on providing proof-of-concept in Influenza firstly to save lives and secondly to apply the OligoDOM® platform to other infectious and immune system-associated diseases.
For further information: www.osivax.com