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Approval of Osivax’ First in Human Clinical Trial for its Universal Influenza Vaccine Candidate

 

Lyon, France – June 4, 2018 – Osivax, a clinical stage biopharmaceutical company currently focused on the development of a universal influenza vaccine candidate, announced today that the Belgian health authority approved the initiation of a first-in-human clinical trial evaluating the safety and immunogenicity of OVX836, a universal influenza vaccine candidate, in healthy volunteers.
 


This first-in-human phase I study is a randomized, observer-blind, placebo-controlled dose escalating trial, conducted in the Centre for the Evaluation of Vaccination (CEV) at the University of Antwerp. 72 healthy subjects between 18 to 49 years old will be enrolled and followed during 22 weeks to evaluate the safety and the immune response of OVX836. The recruitment is on schedule with the first volunteer starting mid June.


 
Preclinical immunogenicity studies conducted in different species including mice, ferrets and rabbits demonstrated that OVX836 vaccination induces both humoral and cellular responses specific of NP and especially robust CD8+ T cells responses. Pharmacology studies demonstrated OVX836 efficacy in protecting mice and ferrets against influenza challenges. OVX836 also showed an excellent safety and tolerance profile after intramuscular and intranasal administration in a rabbit’s toxicology study.

 

 

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