The study is being conducted in healthy volunteers for the prophylaxis of influenza infection. MedDRA version: 21.1 Level: PT Classification code 10059429 Term: Influenza immunisation System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Product Name: OVX836
Product Code: OVX836
Pharmaceutical Form: Solution for injection
INN or Proposed INN: There is no recommended International Nonproprietary Name (INN)
CAS Number: NA
Current Sponso
Sponsors
Osivax
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent. 2. Healthy male or female subjects, as determined by medical history and medical examination. 3. 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. 4. Subject who has fully been vaccinated with licensed SARS-CoV-2 (COVID-19) vaccine(s) according to national recommendations for the corresponding population group. 5. Reliable and willing to make themselves available for the duration of the study, and willing and able to follow study procedures. 6. Ability and technical possibility for completing an e-diary and e-PRO in the pilot phase and the first, younger age cohort; ability for completing a paper diary in the second, older age cohort. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 138 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: 1. Subjects with a body mass index (BMI) =19 kg/m² or =35 kg/m² on the day of vaccination 2. 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. 3. Any known or suspected immunodeficient conditions. 4. Past or current history of significant autoimmune diseases, as judged by the Investigator. 5. Current history of uncontrolled medical illness such as diabetes, hypertension, heart, renal or hepatic diseases. 6. Known or suspected infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV). 7. 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. 8. 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. 9. Planning to receive other vaccines during the first 28 days following the study vaccine administration, except COVID-19 vaccine. 10. 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. 11. 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. 12. Presence of an acute febrile illness on the day of vaccination (oral temperature >38.0°C, temporary exclusion criterion). 13. Past or current history of any progressive or severe neurological disorder, seizure disorder or Guillain-Barré syndrome. 14. 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. 15. 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. 16. 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. 17. History of severe allergic reactions and/or anaphylaxis, or serious adverse reactions to vaccines or allergy to kanamycin. 18. Any contraindication to IM administration, as judged by the Investigator. 19. 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. 20. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -To evaluate the immunogenicity of one single administration of OVX836 influenza vaccine at two dose levels (300µg and 480µg) given IM, in comparison to OVX836 influenza vaccine at 180µg given IM in healthy subjects aged 18-55 years. -To evaluate the safety and reactogenicity of the investigational vaccine at three dose levels (180µg, 300µg and 480µg) in the study, in comparison to placebo.;Secondary Objective: -To evaluate the immune responses to influenza virus NP of one single administration of OVX836 influenza vaccine at two dose levels (300µg and 480µg) given IM each in comparison to OVX836 influenza vaccine at 180µg given IM and to placebo. -To evaluate the immunogenicity of one single administration of OVX836 influenza vaccine at two dose levels (300µg and 480µg) given IM, in comparison to OVX836 influenza vaccine at 180µg given IM in healthy subjects aged 65 years and older.;Primary end point(s): Co-primary endpoints: -Cell-mediated immune response to OVX836 at three dose levels (180µg, 300µg and 480µg) in terms of change of NP-specific T-cell frequencies in peripheral blood, measured by IFN? ELISPOT, at Day 8 versus pre-injection baseline (Day 1) (in 18-55 year old cohort). Safety evaluation of the three dose levels of OVX836 administered by the IM route in comparison to placebo: •Number and percentage of subjects reporting solicited local and systemic symptoms during 7 days after vaccine administration (in both age cohorts). •Number and percentage of subjects reporting unsolicited AEs during 29 days after vaccine administration (in both age cohorts). •Number and severity of ILI cases during the whole study duration (in the 18-55 year-old cohort only). •Number and percentage of subjects reporting SAEs during the whole study duration (in both age cohorts). ;Timepoint(s) of evaluation of this end point: Day 1 (Visit 1), Day 8 (Visit 2), Day 29 (Visit 3) and Day 180 (Visit 4) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Cell-mediated immune response to OVX836 at three dose levels (180µg, 300µg and 480µg) and placebo in terms of change of NP-specific T-cell frequencies in PBMCs, measured by IFN? ELISPOT, at Day 8 versus pre-injection baseline (Day 1) (in both age cohorts). • NP-specific T-cell frequencies (measured by IFN? ELISPOT on PBMCs) at Day 1 (pre-injection baseline) (in both age cohorts), Day 8 (in both age cohorts) and Day 180 (in the 18-55 year-old cohort only). • NP-specific CD4+ and CD8+T-cell frequencies measured by flow cytometry (on PBMCs) as expressing IL-2, TNFa and/or IFN? upon in vitro stimulation at Day 1 (pre-injection baseline) (in both age cohorts), Day 8 (in both age cohorts) and Day 180 (in the 18-55 year-old cohort only). • Geometric mean titers (GMTs) of anti-NP Immunoglobulin G (IgG) (ELISA, serum) at Day 1 (pre-injection baseline) (in both age cohorts), Day 8 (in both age cohorts), Day 29 (in both age cohorts) and Day 180 (in the 18-55 year-old cohort only). • Number and percentage of subjects with an increase (two-fold and four-fold) in anti-NP Immunoglobulin G (IgG) (ELISA, serum) titer with respect to pre-injection baseline (Day 1) (in both age cohorts), at Day 8 (in both age cohorts), Day 29 (in both age cohorts) and Day 180 (in the 18-55 year-old cohort only).;Timepoint(s) of evaluation of this end point: Day 1 (Visit 1), Day 8 (Visit 2), Day 29 (Visit 3) and Day 180 (Visit 4) | — |
Countries
Belgium
Contacts
Public ContactClinical Operations team
Osivax
Outcome results
None listed