Safety and Immunogenicity of Two Dose Levels of OVX836 Influenza Vaccine as a Booster on Participants Previously Administered With OVX836

NCT06582277 | Completed Phase 2

• 1 other identifier: OVX836-007
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

Brief Summary

This phase 2a is designed to evaluate the anamnestic response of a booster dose (either 180 µg or 480 µg) of OVX836 influenza vaccine administered intramuscularly to participants vaccinated three to five years ago in OVX836-002 or OVX836-003 studies. Participants who had received a placebo or Influvac Tetra® in previous studies would serve as controls and would receive the highest dose of OVX836 vaccine (480 µg) as a primary vaccination.

Conditions

Vaccine-Preventable Diseases; Influenza

Outcome Measures

Primary Outcomes (1)

• Safety evaluation of OVX836 (180µg and 480µg)

  Description: Proportion of subjects reporting: - solicited local and systemic symptoms within 7 days after vaccine administration - unsolicited AEs within 29 days after vaccine administration - SAEs during the entire study duration - ILIs and RT-PCR confirmed influenza A or B (overall and occurring more than 14 days post-vaccination, i.e., vaccine failure), RSV and/or SARS-CoV-2.

  From enrollment to the end of trial at 180 days.

Secondary Outcomes (7)

• Cell-mediated immune response to OVX836 (180μg and 480μg) in term of NPspecific IFNγ spot forming cells frequencies in peripheral blood (ELISPOT)

  at Days 1, 8 and 29

• Frequencies of NP-specific CD4+ and CD8+T-cells expressing IL-2, TNFα and/or IFNγ, measured by flow cytometry, following in vitro stimulation of PBMC

  at Days 1, 8 and 29

• Cross-reactivity of the NP influenza-specific responses by IFNγ ELISPOT against selected circulating and emerging strains of influenza

  at Days 1, 8 and 29

• Geometric mean titers (GMTs) of anti-NP Immunoglobulin G (IgG) (ELISA, serum)

  at Days 1, 8 and 29

• Number and percentage of subjects with an increase (two-fold and four-fold) in anti-NP IgG (ELISA, serum)

  at Days 1, 8 and 29

Study Arms (2)

OVX836 - 180μg dose level

EXPERIMENTAL

180 µg dose of an adjuvant-free recombinant influenza candidate vaccine based on the Nucleoprotein (NP) of the influenza virus.

Biological: OVX836 shot

OVX836 - 480μg dose level

EXPERIMENTAL

480 µg dose of an adjuvant-free recombinant influenza candidate vaccine based on the Nucleoprotein (NP) of the influenza virus.

Biological: OVX836 shot

Interventions

OVX836 shot BIOLOGICAL

One single administration intramuscularly at Day 1.

OVX836 - 180μg dose level; OVX836 - 480μg dose level

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subject who voluntarily provides written informed consent to participate in the study.
• Healthy male or female subjects, as determined by medical history and medical examination
• Subject compliant with the reproductive criteria for female participants
• Subjects who participated in the OVX836-002 or OVX836-003 studies.
• Subjects aged 20 and 64 years, inclusive.
• Reliable and willing to commit to participating for the duration of the study, and capable of following study procedures diligently.
• Ability and technical capability to complete an eDiary.

You may not qualify if:

• Subjects with a body mass index (BMI) ≤18 kg/m² or ≥35 kg/m² on the day of vaccination.
• Previous influenza vaccination within 6 months before the day of vaccination or planned to receive during the whole study period.
• vaccination with an mRNA-based influenza vaccine including NP in its composition.
• Any known or suspected immunodeficient conditions.
• Past or current history of significant autoimmune diseases, as judged by the Investigator.
• Current history of uncontrolled medical illness such as diabetes, hypertension, heart, renal or hepatic diseases.
• Known or suspected infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV).
• Pregnant or lactating woman.
• Female planning to become pregnant or planning to discontinue contraceptive precautions until the end of the trial.
• Participants with extensive tattoos covering deltoid regions on both arms that would preclude the assessment of local reactogenicity.
• Other vaccination within 3 months prior to the day of study vaccination for live attenuated vaccines, or within 1 month prior to the day of study vaccination for non-live vaccines, at the exception of COVID vaccines which can be administered within 14 days before or after study vaccine administration.
• Planning to receive other vaccines during the first 28 days following the study vaccine administration.
• Administration of any investigational or non-registered drug or vaccine within 3 months prior to the administration of study vaccines, or planned administration of any such product during the entire study period.
• History of receiving blood, blood components or immunoglobulins within 3 months prior to the day of vaccination or planned to receive such product during the whole study period.
• Past or current history of any progressive or severe neurological disorder, seizure disorder or Guillain-Barré syndrome.

Sponsors & Collaborators

• Osivax: lead
• Harmony Clinical Research BVBA: collaborator
• Clinfidence: collaborator
• Inferential: collaborator
• University Hospital, Ghent: collaborator
• KCAS Bio: collaborator

Study Sites (1)

Centre for Vaccinology (CEVAC) Ghent University Hospital

Ghent, Belgium

Location

MeSH Terms

Conditions

Vaccine-Preventable Diseases; Influenza, Human

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Nicola Groth, MD

  Osivax

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized assignement to 2 dose-level of experimental vaccine (180µg and 480µg) in a 1:1 ratio for the booster group and open label assignement to 480µg dose of the experimental vaccine for the control group.

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: September 3, 2024
• Study Start: October 22, 2024
• Primary Completion: June 2, 2025
• Study Completion: June 2, 2025
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)