Immunogenicity and Safety of Three Dose Levels of OVX836 Candidate Vaccine Against Influenza in Healthy Volunteers.

Summary

This Phase 2a clinical trial is designed to evaluate the immunogenicity and the safety of one administration of OVX836 influenza vaccine at different dose levels (180µg, 300μg and 480μg) in order to assess the dose response of the OVX836 influenza vaccine.

Timeline

Start

2021-11-15

Primary completion

2022-02-01

Completion

2022-12-07

Outcome

Met primary endpoint

paper by 124 SFCs per 106 PMBCs (95% CI 67 to 180; p=0·002) at 180 μg PMID 37517422 ↗

paper by 202 SFCs per 106 PMBCs (95% CI 138 to 267; p<0·0001) at 300 μg PMID 37517422 ↗

paper by 223 SFCs per 106 PMBCs (95% CI 147 to 299; p<0·0001) at 480 μg PMID 37517422 ↗

Publications

• Leroux-Roels I, Willems P, Waerlop G, Janssens Y, Tourneur J, De Boever F, Bruhwyler J, Alhatemi A, Jacobs B, Nicolas F, Leroux-Roels G, Le Vert A. Immunogenicity, safety, and preliminary efficacy evaluation of OVX836, a nucleoprotein-based universal influenza A vaccine candidate: a randomised, double-blind, placebo-controlled, phase 2a trial. Lancet Infect Dis. 2023 Dec;23(12):1360-1369. doi: 10.1016/S1473-3099(23)00351-1. Epub 2023 Jul 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	OVX836	Vaccine	180 ug	Intramuscular
Subject	OVX836	Vaccine	300 ug	Intramuscular
Subject	OVX836	Vaccine	480 ug	Intramuscular

Indications