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

NCT05060887 | Completed Phase 2

• 1 other identifier: OVX836-003
• Study Type: interventional
• Target: 239
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Influenza

Outcome Measures

Primary Outcomes (6)

• Change of NP-specific T-cell frequencies in peripheral blood, measured by IFNγ ELISPOT, at Day 8 versus pre-injection baseline (Day 1).

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

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

  during 7 days after vaccine administration

• Proportion of subjects reporting unsolicited Adverse Events

  during 29 days after vaccine administration

• Proportion of subjects with Influenza-Like-Illness cases associated with laboratory-confirmed influenza

  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 (3)

• NP-specific IFNγ T-cell activity measured by ELISPOT

  at Day 8 and Day 180 versus pre-injection baseline (Day 1)

• NP-specific CD4+ and CD8+T-cell frequencies measured by flow cytometry (on PBMCs) as expressing IL-2, TNFα and/or IFNγ upon in vitro stimulation at Day 1 (pre-injection baseline), Day 8 and Day 180.

  at Day 1 (pre-injection baseline), Day 8 and Day 180

• Anti-NP Immunoglobulin G (IgG) titers by ELISA at each time point

  at Day 1 (pre-injection baseline), Day 8, Day 29 and Day 180

Study Arms (4)

OVX836 - 180µg dose level

EXPERIMENTAL

Adjuvant-free recombinant influenza candidate vaccine based on the Nucleoprotein (NP) of the influenza virus. One single administration intramuscularly of a 180μg dose on Day 1.

Biological: OVX836-003

OVX836 - 300µg dose level

EXPERIMENTAL

Adjuvant-free recombinant influenza candidate vaccine based on the Nucleoprotein (NP) of the influenza virus. One single administration intramuscularly of a 300μg dose on Day 1.

Biological: OVX836-003

OVX836 - 480µg dose level

EXPERIMENTAL

Adjuvant-free recombinant influenza candidate vaccine based on the Nucleoprotein (NP) of the influenza virus. One single administration intramuscularly of a 480μg dose on Day 1.

Biological: OVX836-003

Saline solution (B. Braun Ecoflac® Plus)

PLACEBO COMPARATOR

Saline solution (NaCl 0.9%), B. Braun Ecoflac® Plus 50mL. One single administration intramuscularly of a 0.8mL dose on Day 1.

Biological: Saline solution

Interventions

OVX836-003 BIOLOGICAL

One single administration intramuscularly at Day 1.

OVX836 - 180µg dose level; OVX836 - 300µg dose level; OVX836 - 480µg dose level

Saline solution BIOLOGICAL

One single administration intramuscularly at Day 1.

Saline solution (B. Braun Ecoflac® Plus)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent.
• Healthy male or female subjects, as determined by medical history and medical examination.
• Between the ages of 18 and 55 years, inclusive in the pilot phase and the first, younger age cohort; aged 65 years and older in the second, older age cohort..
• Subject who has fully been vaccinated with licensed SARS-CoV-2 (COVID-19) vaccine(s) according to national recommendations for the corresponding population group.
• 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 in the pilot phase and the first, younger age cohort; ability for completing a paper diary in the second, older age cohort.

You may not qualify if:

• Subjects with a body mass index (BMI) ≤19 kg/m² or ≥35 kg/m² on the day of vaccination.
• In the pilot phase and the first younger age cohort only: 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 (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV).
• 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 \[CTFG\] 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 hormonereleasing 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 for live attenuated vaccines, or within 1 month prior to the day of study vaccination for 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.
• 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.
• Past (stopped less than 6 months before enrolment) or current history of alcohol or drug abuse, or current smoking habit above 10 cigarettes per day, or current vaping.
• Treatment that can affect immune response such as systemic or high dose inhaled corticosteroids (\>800μg/day beclomethasone or equivalent; occasional inhaled corticosteroids for asthma therapy are allowed), radiation treatment, cytotoxic drugs, or current or recent (within 30 days before study entry) chronic or prolonged (\>10 days) use of systemic non-steroidal anti-inflammatory drugs, interferon, immunomodulators, allergy shots, as judged by the Investigator.

Sponsors & Collaborators

• Osivax: lead
• University Ghent: collaborator

Study Sites (1)

Centre for Vaccinology (CEVAC)

Ghent, 9000, Belgium

Location

Related Publications (1)

• 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.

  PMID: 37517422 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Influenza, Human

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Isabel Leroux-Roels, MD, PhD

  Centre for Vaccinology (CEVAC), Ghent University Hospital

  PRINCIPAL INVESTIGATOR

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 assignment to experimental vaccine (three dose levels) or placebo in a 1:1:1:1 ratio.

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: September 29, 2021
• Study Start: November 15, 2021
• Primary Completion: February 1, 2022
• Study Completion: December 7, 2022
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)