InfluenzaPhase 2NCT05060887
Immunogenicity and Safety of Three Dose Levels of OVX836 Candidate Vaccine Against Influenza in Healthy Volunteers.
A Phase 2 study testing OVX836-003 and Saline solution in people with Influenza, run by Osivax at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- OVX836-003 and Saline solution
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 239 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Nov 2021to 7 Dec 2022
- 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 years and older
- 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 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.
Who cannot join
- 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).
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- 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.
- 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, 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.
- History of severe allergic reactions and/or anaphylaxis, or serious adverse reactions to vaccines or allergy to kanamycin.
- Any contraindication to IM 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.
- 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.
- Previous administration with OVX836 candidate 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.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2a, Single Center, Randomized, Double-blind, Controlled Study to Evaluate the Immunogenicity and the Safety of One Single Administration of OVX836 Influenza Vaccine at Two Dose Levels (300μg and 480μg) Given Intramuscularly (IM), in Comparison to OVX836 Influenza Vaccine at 180μg and Placebo Given IM in Healthy Subjects Aged 18-55 Years and in Healthy Subjects Aged 65 Years and Older.
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.
Read the detailed description
This trial is a Phase 2a, randomized, double-blind, controlled study in 138 adult subjects to compare the immunogenicity and the safety of OVX836 influenza vaccine at two dose levels (300μg and 480μg) to lower dose level (180µg) and to placebo.
One single dose of OVX836 influenza vaccine (180µg or 300µg or 480µg) or of placebo will be administered intramuscularly in healthy subjects aged 18-55 years and in healthy subjects aged 65 years and older.
- Conditions
- Influenza
- Being tested
- OVX836-003, Saline solution
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OVX836-003Biological
One single administration intramuscularly at Day 1.
Saline solutionBiological
One single administration intramuscularly at Day 1.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Biological: Saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of NP-specific T-cell frequencies in peripheral blood, measured by IFNγ ELISPOT, at Day 8 versus pre-injection baseline (Day 1).
Measured: 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)
Measured: during 7 days after vaccine administration
Proportion of subjects reporting unsolicited Adverse Events
Measured: during 29 days after vaccine administration
Proportion of subjects with Influenza-Like-Illness cases associated with laboratory-confirmed influenza
Measured: during the whole study duration, 180 days
Severity scores of Influenza-Like-Illness cases (as per Flu-PRO® questionnaire)
Measured: during the whole study duration, 180 days
Proportion of subjects reporting Serious Adverse Events
Measured: during the whole study duration, 180 days
Secondary outcomes (3)
NP-specific IFNγ T-cell activity measured by ELISPOT
Measured: 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.
Measured: at Day 1 (pre-injection baseline), Day 8 and Day 180
Anti-NP Immunoglobulin G (IgG) titers by ELISA at each time point
Measured: at Day 1 (pre-injection baseline), 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.
- First posted29 Sep 2021
- Study start15 Nov 2021
- Primary completion1 Feb 2022
- Study completion7 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 (three dose levels) or placebo in a 1:1:1:1 ratio.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osivax
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Ghent
- Responsible party
- Sponsor
- Investigators
- Isabel Leroux-Roels, MD, PhD, Principal investigator, Centre for Vaccinology (CEVAC), Ghent University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05060887
- Sponsor's protocol ID
- OVX836-003
- Status last verified
- Aug 2023
- First submitted
- 20 Sep 2021
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37517422
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2a, Single Center, Randomized, Double-blind, Controlled Study to Evaluate the Immunogenicity and the Safety of One Single Administration of OVX836 Influenza Vaccine at Two Dose Levels (300μg and 480μg) Given Intramuscularly (IM), in Comparison to OVX836 Influenza Vaccine at 180μg and Placebo Given IM in Healthy Subjects Aged 18-55 Years and in Healthy Subjects Aged 65 Years and Older.
- ClinicalTrials.gov ID
- NCT05060887
- Acronym / sponsor ID
- OVX836-003
- Conditions
- Influenza
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- OsivaxIndustry (pharma, biotech, devices)
- Collaborators
- University Ghent
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 7 Dec 2022 (actual)
- First posted
- 29 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This trial is a Phase 2a, randomized, double-blind, controlled study in 138 adult subjects to compare the immunogenicity and the safety of OVX836 influenza vaccine at two dose levels (300μg and 480μg) to lower dose level (180µg) and to placebo.
One single dose of OVX836 influenza vaccine (180µg or 300µg or 480µg) or of placebo will be administered intramuscularly in healthy subjects aged 18-55 years and in healthy subjects aged 65 years and older.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Randomized assignment to experimental vaccine (three dose levels) or placebo in a 1:1:1:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| OVX836 - 180µg dose level | Experimental | Biological: OVX836-003Adjuvant-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. |
| OVX836 - 300µg dose level | Experimental | Biological: OVX836-003Adjuvant-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. |
| OVX836 - 480µg dose level | Experimental | Biological: OVX836-003Adjuvant-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. |
| Saline solution (B. Braun Ecoflac® Plus) | Placebo comparator | Biological: Saline solutionSaline solution (NaCl 0.9%), B. Braun Ecoflac® Plus 50mL. One single administration intramuscularly of a 0.8mL dose on Day 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OVX836-003One single administration intramuscularly at Day 1. | Biological | OVX836 - 180µg dose level, OVX836 - 300µg dose level, OVX836 - 480µg dose level |
| Saline solutionOne single administration intramuscularly at Day 1. | Biological | Saline solution (B. Braun Ecoflac® Plus) |
Primary outcome
Change of NP-specific T-cell frequencies in peripheral blood, measured by IFNγ ELISPOT, at Day 8 versus pre-injection baseline (Day 1).
Time frame: 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)
Time frame: during 7 days after vaccine administration
Proportion of subjects reporting unsolicited Adverse Events
Time frame: during 29 days after vaccine administration
Proportion of subjects with Influenza-Like-Illness cases associated with laboratory-confirmed influenza
Time frame: during the whole study duration, 180 days
Severity scores of Influenza-Like-Illness cases (as per Flu-PRO® questionnaire)
Time frame: during the whole study duration, 180 days
Proportion of subjects reporting Serious Adverse Events
Time frame: during the whole study duration, 180 days
3 secondary outcomes
NP-specific IFNγ T-cell activity measured by ELISPOT
Time frame: 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.
Time frame: at Day 1 (pre-injection baseline), Day 8 and Day 180
Anti-NP Immunoglobulin G (IgG) titers by ELISA at each time point
Time frame: at Day 1 (pre-injection baseline), Day 8, Day 29 and Day 180
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Derived from this study: PubMed 37517422Leroux-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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabel Leroux-Roels, MD, PhD principal investigator
Centre for Vaccinology (CEVAC), Ghent University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OVX836-003 and Saline solution 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 6 inclusion and 23 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 31 Aug 2023. 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. Some participants in this study may receive a placebo. 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?
Change of NP-specific T-cell frequencies in peripheral blood, measured by IFNγ ELISPOT, at Day 8 versus pre-injection baseline (Day 1). (time frame: at Day 8 versus pre-injection baseline (Day 1)). The study lists 6 primary outcomes in all. 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 NCT05060887, 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 31 Aug 2023.