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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05734040




Registration number
NCT05734040
Ethics application status
Date submitted
9/02/2023
Date registered
17/02/2023
Date last updated
25/01/2024

Titles & IDs
Public title
Immunogenicity and Safety of the Concomitant Administration of OVX836 Influenza Vaccine, Quadrivalent Inactivated Influenza Vaccines and Placebo in Healthy Subjects.
Scientific title
Phase 2a, Randomized, Double-blind (Double-dummy), Double Placebo-controlled, Parallel-group Study to Evaluate the Immunogenicity and the Safety of the Concomitant Administration of OVX836 Influenza Vaccine and Quadrivalent Inactivated Influenza Vaccines (QIVs: Fluarix Tetra and Afluria Quad) Given Intramuscularly as 2 Separate Injections Into Opposite Arms, in Comparison to the Concomitant Administration of Quadrivalent Inactivated Influenza Vaccines and Placebo, and OVX836 and Placebo Given the Same Way in Healthy Subjects Aged 18 to 60 Years.
Secondary ID [1] 0 0
OVX836-006
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - OVX836 480µg
Other interventions - Fluarix Tetra
Other interventions - Afluria Quad
Other interventions - Placebo

Experimental: OVX836 480µg + Fluarix Tetra at commercial dose - OVX836: Adjuvant-free recombinant influenza candidate vaccine based on Nucleoprotein of the influenza virus. One single administration intramuscularly of 480µg dose on Day 1 AND Fluarix Tetra: Inactivated and purified split influenza vaccine. One single administration intramuscularly in the opposite arm on Day 1.

Experimental: OVX836 480µg + Afluria Quad at commercial dose - OVX836: Adjuvant-free recombinant influenza candidate vaccine based on Nucleoprotein of the influenza virus. One single administration intramuscularly of 480µg dose on Day 1 AND Afluria Quad: Inactivated and purified split influenza vaccine. One single administration intramuscularly in the opposite arm on Day 1.

Active Comparator: Fluarix Tetra at commercial dose + Placebo - Fluarix Tetra: Inactivated and purified split influenza vaccine. One single administration intramuscularly in the opposite arm on Day 1.
AND Placebo Comparator: Saline solution (B. Braun Ecoflac Plus) Saline solution (NaCl 0,9%), B. Braun Ecoflac Plus 50 milliliter. One single administration intramuscularly of a 0.8 milliliter dose in the opposite arm on Day 1.

Active Comparator: Afluria Quad at commercial dose + Placebo - Afluria Quad: Inactivated and purified split influenza vaccine. One single administration intramuscularly on Day 1.
AND Placebo Comparator: Saline solution (B. Braun Ecoflac Plus) Saline solution (NaCl 0,9%), B. Braun Ecoflac Plus 50 milliliter. One single administration intramuscularly of a 0.8 milliliter dose in the opposite arm on Day 1.

Placebo Comparator: OVX836 480µg + Placebo - OVX836: Adjuvant-free recombinant influenza candidate vaccine based on Nucleoprotein of the influenza virus. One single administration intramuscularly of 480µg dose on Day 1 AND Placebo Comparator: Saline solution (B. Braun Ecoflac Plus) Saline solution (NaCl 0,9%), B. Braun Ecoflac Plus 50 milliliter. One single administration intramuscularly of a 0.8 milliliter dose in the opposite arm on Day 1.

Placebo Comparator: Placebo + Placebo - Placebo Comparator: Saline solution (B. Braun Ecoflac Plus) Saline solution (NaCl 0,9%), B. Braun Ecoflac Plus 50 milliliter. One single administration intramuscularly of a 0.8 milliliter dose on Day 1 AND Placebo Comparator: Saline solution (B. Braun Ecoflac Plus) Saline solution (NaCl 0,9%), B. Braun Ecoflac Plus 50 milliliter. One single administration intramuscularly of a 0.8 milliliter dose in the opposite arm on Day 1.


Other interventions: OVX836 480µg
One single administration intramuscularly at Day 1

Other interventions: Fluarix Tetra
One single administration intramuscularly at Day 1

Other interventions: Afluria Quad
One single administration intramuscularly at Day 1

Other interventions: Placebo
One single administration intramuscularly at Day 1
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of seroconversion determined using Hemagglutination-Inhibition assay, for the four influenza strains contained in the Quadrivalent Inactivated Influenza Vaccines.
Timepoint [1] 0 0
At Day 29 versus pre-injection baseline (Day 1)
Primary outcome [2] 0 0
Proportion of subjects achieving a titer =1:40 at Day 29 determined using Hemagglutination-Inhibition assay, for the four influenza strains contained in the Quadrivalent Inactivated Influenza Vaccine.
Timepoint [2] 0 0
At Day 29
Primary outcome [3] 0 0
Number of Hemagglutination-Inhibition assay titers geometric mean ratios >2.5 for the four influenza strains contained in the Quadrivalent Inactivated Influenza Vaccines.
Timepoint [3] 0 0
At Day 29 versus pre-injection baseline (Day 1)
Primary outcome [4] 0 0
Proportion of subjects reporting solicited local (Injection site redness, Injection site swelling, Injection site pain) and systemic signs and symptoms (Fatigue, Headache, Arthralgia, Malaise, Myalgia, Fever)
Timepoint [4] 0 0
During 7 days after vaccine administration
Primary outcome [5] 0 0
Proportion of subjects reporting unsolicited Adverse Events
Timepoint [5] 0 0
During 29 days after vaccine administration
Primary outcome [6] 0 0
Proportion of subjects reporting Serious Adverse Events
Timepoint [6] 0 0
During the whole study duration, 180 days
Secondary outcome [1] 0 0
Hemagglutination-Inhibition assay geometric mean titers for each of the four strains contained in the Quadrivalent Inactivated Influenza Vaccines.
Timepoint [1] 0 0
At Day 1 (pre-injection baseline) and Day 29
Secondary outcome [2] 0 0
Number of laboratory-confirmed influenza A or B cases.
Timepoint [2] 0 0
During the whole study duration, 180 days
Secondary outcome [3] 0 0
Severity scores of Influenza-Like-Illness cases (as per Flu-PRO questionnaire)
Timepoint [3] 0 0
During the whole study duration, 180 days
Secondary outcome [4] 0 0
Cell-mediated immune response in terms of change of Nucleoprotein-specific T-cell frequencies in Peripheral Blood Mononuclear Cells, measured by Interferon Gamma Enzyme-Linked Immunospot Assay.
Timepoint [4] 0 0
At Day 8 versus pre-injection baseline (Day 1)
Secondary outcome [5] 0 0
Geometric Mean Titer of anti-Nucleoprotein immunoglobulin G (Enzyme-Linked Immunosorbent Assay, serum).
Timepoint [5] 0 0
At Day 1, Day 8 and Day 29
Secondary outcome [6] 0 0
Proportion of subjects with an increase (four-fold) in anti-Nucleoprotein Immunoglobulin G (Enzyme-Linked Immunosorbent Assay, serum) titer.
Timepoint [6] 0 0
At Day 29 with respect to pre-injection baseline (Day 1)

Eligibility
Key inclusion criteria
1. Written informed consent.

2. Healthy male or female subjects, as determined by medical history and medical
examination.

3. Aged 18 to 60 years.

4. Subjects who have received at least two doses of a licensed severe acute respiratory
syndrome Coronavirus 2 vaccine.

5. Reliable and willing to make themselves available for the duration of the study, and
willing and able to follow study procedures.

6. Able to read, understand and complete an electronic diary and electronic patient
reported outcome, and availability of a person who can complete the electronic
diary/electronic patient reported outcome in case of illness.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Subjects with a body mass index =19 kg/m² or =40 kg/m² on the day of vaccination.

2. Previous influenza vaccination within 6 months before the day of vaccination or
planned to receive influenza vaccination during the whole study period.

3. Any known or suspected immunodeficient conditions.

4. Past or current history of significant autoimmune diseases, as judged by the
Investigator.

5. Known or suspected infection with human immunodeficiency virus, hepatitis C virus, or
hepatitis B virus.

6. Current history of significant uncontrolled medical illness such as diabetes,
hypertension, heart, renal or hepatic diseases, as judged by the Investigator.

7. Planned, recent (<6 months since completion) or ongoing gender reassignment during the
study.

8. 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 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 progestogencontaining) 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)."

9. 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 Coronavirus Disease 2019 vaccine.

10. Planning to receive other vaccines during the first 28 days following the study
vaccine administration.

11. Having received a Coronavirus Disease 2019 vaccination within 2 weeks prior to the day
of study vaccination.

12. Planning to receive Coronavirus Disease 2019 vaccine during the first week (within 7
days) following the study vaccine administration. An interval of preferably 14 days is
recommended.

13. Administration of any investigational (including OVX836) 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.

14. 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.

15. Presence of an acute febrile illness on the day of planned vaccination (oral
temperature >38.0°C; temporary exclusion criterion).

16. Long Coronavirus Disease, either ongoing or recently recovered.

17. Presence of a condition in the ear-nose-throat area, such as nasal septum deviation,
atrophic rhinitis, etc., that could render nasal and nasopharyngeal swabs more
difficult to perform, or increase the risk of bleeding; to be confirmed by medical
history question and inspection of nasal passage.

18. Presence of tattoos at the level of one of the deltoid muscle.

19. Past or current history of any progressive or severe uncontrolled neurological
disorder, seizure disorder or Guillain-Barré syndrome.

20. 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.

21. Past (stopped less than 6 months before enrolment) or current smoking habit above 10
cigarettes per day.

22. Past (stopped less than 6 months before enrolment) or current history of alcohol abuse
or use of recreational drugs.

23. 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, acetylsalicylic acid,
paracetamol, ibuprofen, interferon, immunomodulators, allergy shots, as judged by the
Investigator. Occasional, non-continuous use of acetylsalicylic acid, paracetamol,
ibuprofen or non-steroidal anti-inflammatory drugs on an as-needed basis is allowed.

24. Prophylactic or therapeutic use of any anti(retro)virals by systemic route during the
study. Topical application is allowed.

25. History of severe allergic reactions and/or anaphylaxis, or serious adverse reactions
to vaccines or allergy to kanamycin, eggs (especially ovalbumin and chicken proteins),
neomycin, polymyxin, formaldehyde and octoxinol-9 (triton-X-100).

26. Any contraindication to intramuscular administration, as judged by the Investigator.

27. 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, either directly or through any treatments
administered for that illness.

28. Sponsor employees or Investigator site personnel directly affiliated with this study,
and their immediate families. Immediate family is defined as a spouse (or
assimilated), parent, child or sibling, whether biological or legally adopted.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/05/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/01/2024
Sample size
Target
Accrual to date
Final
478
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Paratus Clinical Research Central Coast - Kanwal
Recruitment hospital [2] 0 0
Emeritus Research Sydney - Sydney
Recruitment hospital [3] 0 0
Paratus Clinical Research Western Sydney - Sydney
Recruitment hospital [4] 0 0
Paratus Clinical Research Brisbane - Brisbane
Recruitment hospital [5] 0 0
Mater Misericordiae Limited - Brisbane
Recruitment hospital [6] 0 0
UniSC Clinical Trials Moreton Bay - Morayfield
Recruitment hospital [7] 0 0
University of Sunshine Coast - Sippy Downs
Recruitment hospital [8] 0 0
CMAX Fusion Clinical Research - Adelaide
Recruitment hospital [9] 0 0
Emeritus - Melbourne
Recruitment postcode(s) [1] 0 0
2259 - Kanwal
Recruitment postcode(s) [2] 0 0
2019 - Sydney
Recruitment postcode(s) [3] 0 0
2148 - Sydney
Recruitment postcode(s) [4] 0 0
4010 - Brisbane
Recruitment postcode(s) [5] 0 0
4101 - Brisbane
Recruitment postcode(s) [6] 0 0
4506 - Morayfield
Recruitment postcode(s) [7] 0 0
4556 - Sippy Downs
Recruitment postcode(s) [8] 0 0
5000 - Adelaide
Recruitment postcode(s) [9] 0 0
3124 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Osivax
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Novotech (Australia) Pty Limited
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Mater Misericordiae Limited
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The present study OVX836-006 aims principally to:

- Confirm feasibility of the concomitant administration of the vaccines under normal
clinical conditions, i.e. as two separate concomitant injections into opposite arms;

- Introduce an additional representative brand of Quadrivalent Inactivated Influenza
Vaccines ;

- Demonstrate the absence of interaction between OVX836 and Quadrivalent Inactivated
Influenza Vaccines on the Hemagglutinin response;

- Demonstrate the absence of interaction between OVX836 and Quadrivalent Inactivated
Influenza Vaccines on the nucleoprotein response;

- Evaluate the absolute vaccine efficacy of OVX836 compared to placebo in order to
corroborate the efficacy signals previously detected in the OVX836 previous studies;

- Evaluate the combined vaccine efficacy of OVX836 + Quadrivalent Inactivated Influenza
Vaccines versus OVX836 + placebo, and versus double placebo.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05734040
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries