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Vaccine-Preventable DiseasesPhase 2NCT06582277

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

A Phase 2 study testing OVX836 shot in people with Vaccine-Preventable Diseases and Influenza, run by Osivax at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 64 yearsHealthy volunteers can take part
Conditions the study is for
Vaccine-Preventable Diseases, Influenza
What is being tested?
OVX836 shot
Could I receive a placebo?
No, everyone receives an active treatment
How many people
117 participants
Where
1 siteBelgium
Study dates
22 Oct 2024to 2 Jun 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.
  • Presence of an acute febrile illness on the day of vaccination (oral temperature >38.0°C, temporary exclusion criterion).
  • 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.
  • History of alcohol or drug abuse that ceased less than 6 months before enrolment, current alcohol or drug abuse according to the Investigator's judgement), smoking habit of more than 10 cigarettes/day, or current vaping (nicotine consumption corresponding to more than 10 cigarettes/day).
  • Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months before the study vaccine administration. For corticosteroids, this will mean prednisone equivalent ≥20 mg/day. Inhaled, topical and intra-articular steroids are allowed.
  • Current or past malignancy, unless completely resolved for >5 years (except non-metastatic basal cell carcinoma which has been completely resected).
  • History of severe allergic reactions and/or anaphylaxis, or serious adverse reactions to vaccines or allergy to kanamycin or any other component of the vaccine.
  • Any contraindication to IM administration, as judged by the Investigator.
  • Individuals with a history of any illness that, in the opinion of the Investigator, could potentially interfere with the results of the study or pose additional risk to the subjects by participating in the study.
  • Sponsor employees or Investigator site personnel directly affiliated with this study and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted, including children of newly composed families.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Centre for Vaccinology (CEVAC) Ghent University Hospital

    Ghent

Other trials in Belgium

About this study

Official title: Phase 2a, Single Center, Randomized, Double-blind, Study to Evaluate the Immunogenicity and Safety of One Single Administration of OVX836 Influenza Vaccine at Two Dose Levels (180µg or 480μg) Given Intramuscularly (IM), Either as a Booster or a Primary Vaccination in Healthy Adults Previously Administered With OVX836, Influvac Tetra® or Placebo in the OVX836-002 (EudraCT Number: 2019-002939-28) and OVX836-003 (EudraCT Number: 2021-002535-39) Studies.

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.

Read the detailed description

This is a phase 2a, single center, randomized, double-blind study designed to evaluate the immunogenicity and safety of one single administration of OVX836 influenza vaccine at two dose levels (180μg or 480μg) given intramuscularly, either as a booster or a primary vaccination in approximately 160 to 220 healthy participants (aged 20-64 years) previously administered with OVX836, Influvac Tetra® or placebo in the OVX836-002 (EudraCT number: 2019-002939-28) and OVX836-003 (EudraCT number: 2021-002535-39) studies. This includes OVX836-002 participants who had received 180μg OVX836 during the influenza season 2019-2020 and OVX836-003 participants who had received 180μg, 300μg or 480μg OVX836 before the influenza season 2021-2022. Volunteers who received either Influvac Tetra® in the OVX836-002 study or a placebo in the OVX836-003 study will serve as controls and will receive a primary single dose of OVX836 480μg.

Being tested
OVX836 shot
Medical subject headings
Vaccine-Preventable Diseases, Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OVX836 shotBiological

    One single administration intramuscularly at Day 1.

Study groups in NCT06582277
Study groupRoleWhat they receive
OVX836 - 180μg dose levelExperimental180 µg dose of an adjuvant-free recombinant influenza candidate vaccine based on the Nucleoprotein (NP) of the influenza virus.
Receives: Biological: OVX836 shot
OVX836 - 480μg dose levelExperimental480 µg dose of an adjuvant-free recombinant influenza candidate vaccine based on the Nucleoprotein (NP) of the influenza virus.
Receives: Biological: OVX836 shot

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From enrollment to the end of trial at 180 days.

Secondary outcomes (7)

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

    Measured: at Days 1, 8 and 29

  2. 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

    Measured: at Days 1, 8 and 29

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

    Measured: at Days 1, 8 and 29

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

    Measured: at Days 1, 8 and 29

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

    Measured: at Days 1, 8 and 29

  6. GMTs of anti-OVX313 tag (Oligodom®) IgG level (ELISA, serum)

    Measured: at Days 1, 8 and 29

  7. Anti-C4bp (C4b-binding protein) oligomerization domain IgG titers (ELISA, serum) in subjects with positive result for anti-OVX313 (anti-OVX313 titer >12.5).

    Measured: at Days 1, 8 and 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2024
  2. Study start22 Oct 2024
  3. Primary completion2 Jun 2025
  4. Study completion2 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
117 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06582277
Sponsor's protocol ID
OVX836-007
Status last verified
Jun 2025
First submitted
26 Aug 2024
Last updated
6 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing OVX836 shot in people with Vaccine-Preventable Diseases and Influenza, run by Osivax at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety evaluation of OVX836 (180µg and 480µg) (time frame: From enrollment to the end of trial at 180 days.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06582277.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.

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