Safety and Immunogenicity of Two Dose Levels of OVX836 Influenza Vaccine as a Booster on Participants Previously Administered With OVX836
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.
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 2
Contacts and Locations
Study Contact
Study Contact
- Name: Isabel Leroux-Roels, MD, PhD
- Phone Number: +32 9 332 20 68
- Email: Isabel.LerouxRoels@uzgent.be
Study Locations
-
-
-
Ghent, Belgium
- Centre for Vaccinology (CEVAC) Ghent University Hospital
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: OVX836 - 180μg dose level
180 µg dose of an adjuvant-free recombinant influenza candidate vaccine based on the Nucleoprotein (NP) of the influenza virus.
|
One single administration intramuscularly at Day 1.
|
|
Experimental: OVX836 - 480μg dose level
480 µg dose of an adjuvant-free recombinant influenza candidate vaccine based on the Nucleoprotein (NP) of the influenza virus.
|
One single administration intramuscularly at Day 1.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Safety evaluation of OVX836 (180µg and 480µg)
Time Frame: From enrollment to the end of trial at 180 days.
|
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.
|
From enrollment to the end of trial at 180 days.
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Cell-mediated immune response to OVX836 (180μg and 480μg) in term of NPspecific IFNγ spot forming cells frequencies in peripheral blood (ELISPOT)
Time Frame: at Days 1, 8 and 29
|
at Days 1, 8 and 29
|
|
Geometric mean titers (GMTs) of anti-NP Immunoglobulin G (IgG) (ELISA, serum)
Time Frame: at Days 1, 8 and 29
|
at Days 1, 8 and 29
|
|
Number and percentage of subjects with an increase (two-fold and four-fold) in anti-NP IgG (ELISA, serum)
Time Frame: at Days 1, 8 and 29
|
at Days 1, 8 and 29
|
|
Cross-reactivity of the NP influenza-specific responses by IFNγ ELISPOT against selected circulating and emerging strains of influenza
Time Frame: at Days 1, 8 and 29
|
at Days 1, 8 and 29
|
|
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
Time Frame: at Days 1, 8 and 29
|
at Days 1, 8 and 29
|
|
GMTs of anti-OVX313 tag (Oligodom®) IgG level (ELISA, serum)
Time Frame: at Days 1, 8 and 29
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at Days 1, 8 and 29
|
|
Anti-C4bp (C4b-binding protein) oligomerization domain IgG titers (ELISA, serum) in subjects with positive result for anti-OVX313 (anti-OVX313 titer >12.5).
Time Frame: at Days 1, 8 and 29
|
at Days 1, 8 and 29
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Study Director: Nicola Groth, MD, Osivax
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- OVX836-007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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