NCT03594890

Safety and Immune Response of Increasing Doses of OVX836 After Intramuscular or Intranasal Administrations in Healthy Subjects

A First-in-human Phase I, Single Center, Randomized, Observer-blind, Placebo-controlled Study to Evaluate the Safety and Immune Response of Increasing Doses of OVX836 Vaccine After Intramuscular (IM) or Intranasal (IN) Administrations in Healthy Subjects Aged 18-49 Years.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Osivax · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

The present study is a first-in-man clinical trial evaluating OVX836, a recombinant broad spectrum vaccine for Influenza. This clinical trial will evaluate the safety and the immune response of increasing doses of OVX836 after intramuscular or intranasal administrations in healthy volunteers.

Detailed description

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.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	OVX836 (Intramuscular)	2 consecutive administrations of OVX836 vaccine at Day 1 and Day 29.
BIOLOGICAL	Placebo (Intramuscular)	2 consecutive administrations of placebo at Day 1 and Day 29.
BIOLOGICAL	OVX836 (Intranasal)	2 consecutive administrations of OVX836 vaccine at Day 1 and Day 29.
BIOLOGICAL	Placebo (Intranasal)	2 consecutive administrations of placebo at Day 1 and Day 29.

Timeline

• Start date: 2018-06-12
• Primary completion: 2019-08-07
• Completion: 2019-08-07
• First posted: 2018-07-20
• Last updated: 2022-09-22

Locations

1 site across 1 country: Belgium