OVX836 is a Universal Influenza Vaccine candidate which targets the NucleoProtein (NP), a highly conserved internal antigen, much less prone to mutations than the traditional surface antigens targeted by current flu vaccines, thus alleviating the need for annual updates.
oligoDOM® technology enables the transformation of the NucleoProtein into a highly immunogenic antigen to trigger powerful B- and T-cells immune responses
OVX836 is being tested in healthy adults 18-49 to prevent seasonal influenza.
The phase 1 clinical trial is determining the proper dosage. The vaccine is being administered intramuscularly or intranasally.
Clinical Trial NCT03594890: Safety and Immune Response of Increasing Doses of OVX836 After Intramuscular or Intranasal Administrations in Healthy Subjects
- This study is a single-center, randomized, sequential dose-escalation, placebo-controlled, observer-blind study conducted in healthy subjects aged 18-49 years.
- The OVX836 recombinant vaccine is based on the well-conserved nucleoprotein of the Influenza virus.
- Three different dose levels of OVX836 (30µg, 90µg, 180µg) will be assessed sequentially and administered either by the intramuscular route (Study Part A) or by the intranasal route (Study Part B).
- There will be 6 cohorts in total with one cohort testing one dose level and one route of administration. Each study cohort will be composed of 12 subjects, with 9 subjects receiving the OVX836 vaccine and 3 subjects receiving the placebo. Each subject will receive one administration of OVX836 or placebo on Day 1 and one administration on Day 29.
- The study duration for each subject is approximately 5 months.