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InfluenzaPhase 2NCT04192500

Safety and Immune Response of One Dose of OVX836 at Two Dose Levels, in Comparison to Influvac TetraTM, After Intramuscular Administration in Healthy Subjects Aged 18-65 Years

A Phase 2 study testing OVX836 and Quadrivalent seasonal influenza vaccine (Influvac TetraTM) in people with 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 clinical study is designed to evaluate the immunogenicity and the safety of one dose of OVX836 influenza vaccine administered IM, confirm the dose level and regimen, and expand immunogenicity and safety data to adults through age 65. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Influenza
What is being tested?
OVX836 and Quadrivalent seasonal influenza vaccine (Influvac TetraTM)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteBelgium
Study dates
11 Dec 2019to 7 Sep 2020
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 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Written informed consent.
  • Healthy male or female subjects, as determined by medical history and medical examination.
  • Between the ages of 18 and 65 years, inclusive.
  • Reliable and willing to make themselves available for the duration of the study, and willing and able to follow study procedures.

Who cannot join

  • Subject with a body mass index (BMI) ≥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 significant uncontrolled medical illness such as diabetes, hypertension, heart, renal or hepatic diseases, as judged by the Investigator.
  • 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 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 hormone-releasing system), bilateral tubal occlusion, vasectomized partner and/or sexual abstinence (refraining from heterosexual intercourse)."
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  • 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.
  • 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 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.
  • 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.
  • 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.
  • Treatment that can affect immune response such as systemic or high dose inhaled corticosteroids (>800 μg/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.
  • Subjects with known or suspected anemia.
  • Recent blood or platelets donation (less than 3 months before enrolment). History of plasma donation is authorized.
  • History of severe allergic reactions and/or anaphylaxis, or serious adverse reactions to vaccines or allergy to kanamycin, or to any component that may be present in the comparator vaccine, as traces such as eggs (ovalbumin, chicken proteins), formaldehyde, cetyltrimethylammonium bromide, polysorbate 80, or gentamicin.
  • Any contraindication to intramuscular administration, as judged by the Investigator.
  • Individuals with history of any illness that, in the opinion of the Investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study.
  • Technical difficulties in the use of an e-diary.
  • 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.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Centre for Vaccinology (CEVAC)

    Ghent, 9000

Other trials in Belgium

About this study

Official title: A Phase 2a, Single Center, Randomized, Double-blind, Controlled Study to Evaluate the Immunogenicity and the Safety of One Dose of OVX836 Influenza Vaccine at Two Dose Levels (90 µg and 180 μg), in Comparison to Influvac TetraTM, Quadrivalent Seasonal Influenza Sub-unit Vaccine, After Intramuscular Administration in Healthy Subjects Aged 18-65 Years

This Phase 2a clinical study is designed to evaluate the immunogenicity and the safety of one dose of OVX836 influenza vaccine administered IM, confirm the dose level and regimen, and expand immunogenicity and safety data to adults through age 65.

Read the detailed description

This is a Phase 2a, randomised, double-blind study in 300 adults to compare the safety and immunogenicity of OVX836 to QIV (Influvac TetraTM). One dose of OVX836 at two dose levels will be administered intramuscularly, in comparison to Influvac TetraTM, quadrivalent seasonal influenza sub-unit vaccine in healthy subjects aged 18-65 years.

Conditions
Influenza
Being tested
OVX836, Quadrivalent seasonal influenza vaccine (Influvac TetraTM)
Medical subject headings
Influenza, Human

What participants receive

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

  • OVX836Biological

    One single administration intramuscularly at Day 1.

  • Quadrivalent seasonal influenza vaccine (Influvac TetraTM)Biological

    One single administration intramuscularly at Day 1.

Study groups in NCT04192500
Study groupRoleWhat they receive
OVX836 - 90µg doseExperimentalAdjuvant-free recombinant influenza candidate vaccine based on the Nucleoprotein (NP) of the influenza virus. One single administration intramuscularly of a 90µg dose on Day 1.
Receives: Biological: OVX836
OVX836 - 180µg doseExperimentalAdjuvant-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.
Receives: Biological: OVX836
Quadrivalent seasonal influenza vaccine (Influvac TetraTM)Active comparatorLicensed quadrivalent seasonal influenza subunit vaccine for season 2019-2020. One full dose to be administered at Day 1
Receives: Biological: Quadrivalent seasonal influenza vaccine (Influvac TetraTM)

What is being measured

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

  1. NP-specific IFNγ T-cell increase measured by ELISPOT at Day 8 versus pre-injection baseline (Day 1) in the pooled age strata

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

Secondary outcomes (8)

  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) using an electronic Diary

    Measured: during 7 days after vaccine administration

  2. Proportion of subjects reporting unsolicited Adverse Events

    Measured: during 28 days after vaccine administration

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

    Measured: during the whole study duration, 180 days

  4. Severity scores of Influenza-Like-Illness cases (as per Flu-PRO® questionnaire)

    Measured: during the whole study duration, 180 days

  5. Proportion of subjects reporting Serious Adverse Events

    Measured: during the whole study duration, 180 days

  6. NP-specific IFNγ T-cell activity measured by ELISPOT in the pooled age strata and by age stratum (18-49 years; 50-65 years)

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

  7. NP T-cell phenotype and functionality by flow cytometry in the pooled age strata and by age stratum (18-49 years; 50-65 years)

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

  8. Anti-NP Immunoglobulin G (IgG) titers by ELISA at each time point in the pooled age strata and by age stratum (18-49 years; 50-65 years)

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

Timeline

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

  1. First posted10 Dec 2019
  2. Study start11 Dec 2019
  3. Primary completion7 Sep 2020
  4. Study completion7 Sep 2020

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 assignment to experimental vaccine (2 dosage levels or active control (commercial influenza vaccine) in a 1:1:1 ratio.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04192500
Sponsor's protocol ID
OVX836-002
Status last verified
Sep 2022
First submitted
3 Dec 2019
Last updated
22 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Leroux-Roels I, Waerlop G, Tourneur J, De Boever F, Maes C, Bruhwyler J, Guyon-Gellin D, Moris P, Del Campo J, Willems P, Leroux-Roels G, Le Vert A, Nicolas F. Randomized, Double-Blind, Reference-Controlled, Phase 2a Study Evaluating the Immunogenicity and Safety of OVX836, A Nucleoprotein-Based Influenza Vaccine. Front Immunol. 2022 Apr 7;13:852904. doi: 10.3389/fimmu.2022.852904. eCollection 2022.

    PubMed 35464450

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing OVX836 and Quadrivalent seasonal influenza vaccine (Influvac TetraTM) in people with 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 4 inclusion and 22 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 22 Sep 2022. 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?

NP-specific IFNγ T-cell increase measured by ELISPOT at Day 8 versus pre-injection baseline (Day 1) in the pooled age strata (time frame: at Day 8 versus pre-injection baseline (Day 1)). 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 NCT04192500, which also lists 1 linked publication.

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 22 Sep 2022.

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