Immunogenicity and Safety of the Concomitant Administration of OVX836 and Quadrivalent Influenza Vaccine in Healthy Volunteers.

NCT05284799 | Completed Phase 2

• 1 other identifier: OVX836-004
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

The present study will evaluate the concomitant administration of a Quadrivalent Inactivated Influenza Vaccine with the highest dose level of OVX836 (480µg) tested in the clinic to date, for which the likelihood for interference with Quadrivalent Inactivated Influenza Vaccine is considered the highest.

Conditions

Influenza

Outcome Measures

Primary Outcomes (8)

• Number of seroconversion determined using Hemagglutination-Inhibition assay, for the four influenza strains contained in the Quadrivalent Influenza Vaccine.

  Seroconversion is defined as a negative pre-vaccination Hemagglutination-Inhibition assay titer and post-vaccination Hemagglutination-Inhibition assay titer ≥1:40, or a fourfold increase in Hemagglutination-Inhibition assay titer between pre- and post-vaccination timepoints.

  At Day 29 versus pre-injection baseline (Day 1)

• Proportion of subjects achieving a titer ≥1:40 at Day 29 determined using Hemagglutination-Inhibition assay, for the four influenza strains contained in the Quadrivalent Influenza Vaccine.

  At Day 29

• Number of Hemagglutination-Inhibition assay titers geometric mean ratios >2.5 for the four influenza strains contained in the Quadrivalent Influenza Vaccine.

  At Day 29 versus pre-injection baseline (Day 1)

• Proportion of subjects reporting solicited local (Injection site redness, Injection site swelling, Injection site pain) and systemic signs and symptoms (Fatigue, Headache, Arthralgia, Malaise, Myalgia, Fever)

  During 7 days after vaccine administration

• Proportion of subjects reporting unsolicited AEs

  During 29 days after vaccine administration

• Proportion of subjects with Influenza-Like-Illness cases

  During the whole study duration, 180 days

• Severity scores of Influenza-Like-Illness cases (as per Flu-PRO questionnaire)

  During the whole study duration, 180 days

• Proportion of subjects reporting Serious Adverse Events

  During the whole study duration, 180 days

Secondary Outcomes (4)

• Hemagglutination-Inhibition assay geometric mean titers for each of the four strains contained in the Quadrivalent Influenza Vaccine.

  At Day 1 (pre-injection baseline) and Day 29

• Cell-mediated immune response in terms of change of Nucleoprotein-specific T-cell frequencies in Peripheral Blood Mononuclear Cells, measured by Interferon Gamma Enzyme-Linked Immunospot Assay.

  At Day 8 versus pre-injection baseline (Day 1)

• Geometric Mean Titer of anti-Nucleoprotein immunoglobulin G (Enzyme-Linked Immunosorbent Assay, serum).

  At Day 1, Day 8 and Day 29

• Proportion of subjects with an increase (four-fold) in anti-Nucleoprotein Immunoglobulin G (Enzyme-Linked Immunosorbent Assay, serum) titer.

  At Day 29 with respect to pre-injection baseline (Day 1)

Study Arms (3)

OVX836 480µg + Quadrivalent Inactivated Influenza Vaccine (Fluarix® Tetra) at commercial dose

EXPERIMENTAL

OVX836: Adjuvant-free recombinant influenza candidate vaccine based on Nucleoprotein of the incluenza virus. One single administration intramuscularly of 480µg dose on Day 1 AND Fluarix® Tetra (GlaxoSmithKline Biologicals): Inactivated and purified split influenza vaccine.

Biological: OVX836 480µg; Biological: Quadrivalent Inactivated Influenza Vaccine (Fluarix® Tetra)

Quadrivalent Inactivated Influenza Vaccine (Fluarix® Tetra) at commercial dose + Placebo

ACTIVE COMPARATOR

Fluarix® Tetra (GlaxoSmithKline Biologicals): Inactivated and purified split influenza vaccine. AND Placebo Comparator: Saline solution (B. Braun Ecoflac Plus) Saline solution (NaCl 0,9%), B. Braun Ecoflac Plus 50mL. One single administration intrumuscularly of a 0.8mL dose on Day 1

Biological: Quadrivalent Inactivated Influenza Vaccine (Fluarix® Tetra); Biological: Placebo

OVX836 480µg + Placebo

PLACEBO COMPARATOR

OVX836: Adjuvant-free recombinant influenza candidate vaccine based on Nucleoprotein of the incluenza virus. One single administration intramuscularly of 480µg dose on Day 1 AND Placebo Comparator: Saline solution (B. Braun Ecoflac Plus) Saline solution (NaCl 0,9%), B. Braun Ecoflac Plus 50mL. One single administration intrumuscularly of a 0.8mL dose on Day 1

Biological: OVX836 480µg; Biological: Placebo

Interventions

OVX836 480µg BIOLOGICAL

One single administration intramuscularly at Day 1

OVX836 480µg + Placebo; OVX836 480µg + Quadrivalent Inactivated Influenza Vaccine (Fluarix® Tetra) at commercial dose

Quadrivalent Inactivated Influenza Vaccine (Fluarix® Tetra) BIOLOGICAL

One single administration intramuscularly at Day 1

OVX836 480µg + Quadrivalent Inactivated Influenza Vaccine (Fluarix® Tetra) at commercial dose; Quadrivalent Inactivated Influenza Vaccine (Fluarix® Tetra) at commercial dose + Placebo

Placebo BIOLOGICAL

One single administration intramuscularly at Day 1

OVX836 480µg + Placebo; Quadrivalent Inactivated Influenza Vaccine (Fluarix® Tetra) at commercial dose + Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Written informed consent.
• Healthy male or female subjects, as determined by medical history and medical examination.
• Between the age of 18 and 55 years, inclusive.
• Subjects who have fully been vaccinated with licensed Severe Acute Respiratory Syndrome Coronavirus-2 (COVID-19) vaccine(s) according to national recommendations for the corresponding population group, in vigor at the moment the study starts.
• Reliable and willing to make themselves available for the duration of the study, and willing and able to follow study procedures.
• Ability and technical possibility for completing an e-diary and ePRO.

You may not qualify if:

• Subjects with a body mass index ≤19 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 study duration.
• 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, hepatitis C virus, or hepatitis B virus, based upon medical history or physical examination findings.
• Female subjects: pregnant, breast-feeding or of childbearing potential without appropriate contraceptive methods in place for 2 months before enrolment, or with positive pregnancy test on the day of vaccination. Appropriate contraceptive methods are to be maintained until the end of the trial. Appropriate contraceptive methods are defined by the Clinical Trial Facilitation Group as follow: "Contraceptive methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods. Such methods include: combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable intrauterine device, intrauterine hormone-releasing system), bilateral tubal occlusion, vasectomized partner and/or sexual abstinence (refraining from heterosexual intercourse)."
• Having received another vaccination within 3 months prior to the day of study vaccination with live attenuated vaccines, or within 1 month prior to the day of study vaccination with inactivated vaccines, except COVID-19 vaccine.
• Planning to receive other vaccines during the first 28 days following the study vaccine administration, except COVID-19 vaccine.
• Having received a COVID-19 vaccination within 2 weeks prior to the day of study vaccination.
• Planning to receive COVID-19 vaccine during the first week (within 7 days) following the study vaccine administration. An interval of preferably 14 days is recommended. If for scheduling reasons, COVID-19 vaccine has to be given on Day 8, the vaccination should be administered after completion of the study procedures.
• 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 whole 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.
• Behavioral or cognitive impairment, or psychiatric disease that, in the opinion of the Investigator, may interfere with the subject's ability to participate in the study.

Sponsors & Collaborators

• Osivax: lead
• Northern Beaches Clinical Research: collaborator
• Novotech (Australia) Pty Limited: collaborator
• Harmony Clinical Research BVBA: collaborator

Study Sites (1)

Northern Beaches Clinical Research

Brookvale, New South Wales, 2100, Australia

Location

Related Publications (1)

• Groth N, Bruhwyler J, Tourneur J, Piat E, Moris P, Le Vert A, Nicolas F. Safety and Immunogenicity of OVX836, a Nucleoprotein-Based Universal Influenza Vaccine, Co-Administered with Fluarix(R) Tetra, a Seasonal Hemagglutinin-Based Vaccine. Vaccines (Basel). 2025 May 23;13(6):558. doi: 10.3390/vaccines13060558.

  PMID: 40573889 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Ross Aldrich, MBBS

  Northern Beaches Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Randomized assignment (1:1:1) into 3 groups of 60 subjects to receive: * First group: OVX836 480µg and Quadrivalent Inactivated Influenza Vaccine at commercial dose administered * Second group: Quadrivalent Inactivated Influenza Vaccine at commercial dose, concomitantly administered with placebo * Third group: OVX836 480µg, concomitantly administered with placebo

Study Record Dates

• First Submitted: March 10, 2022
• First Posted: March 17, 2022
• Study Start: May 9, 2022
• Primary Completion: July 19, 2022
• Study Completion: December 9, 2022
• Last Updated: October 31, 2024

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)