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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/NCT05284799




Registration number
NCT05284799
Ethics application status
Date submitted
10/03/2022
Date registered
17/03/2022
Date last updated
16/12/2022

Titles & IDs
Public title
Immunogenicity and Safety of the Concomitant Administration of OVX836 and Quadrivalent Influenza Vaccine in Healthy Volunteers.
Scientific title
Phase 2a, Randomized, Double-blind (Double-dummy), Controlled, Parallel-group Study to Evaluate the Immunogenicity and the Safety of the Concomitant Administration of OVX836 Influenza Vaccine and a Quadrivalent Inactivated Influenza Vaccine Given Intramuscularly as 2 Separate Injections in the Same Arm, in Comparison to Co-administration of Quadrivalent Inactivated Influenza Vaccine and Placebo and to Co-administration of OVX836 and Placebo Given Intramuscularly in Healthy Subjects.
Secondary ID [1] 0 0
OVX836-004
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 - Quadrivalent Inactivated Influenza Vaccine (Fluarix® Tetra)
Other interventions - Placebo

Experimental: OVX836 480µg + Quadrivalent Inactivated Influenza Vaccine (Fluarix® Tetra) at commercial dose - OVX836: Adjuvant-free recombinant influenza candidate vaccine based on Nucleoprotein of the incluenza virus. One single administration intramuscularly of 480µg dose on Day 1
AND
Fluarix® Tetra (GlaxoSmithKline Biologicals): Inactivated and purified split influenza vaccine.

Active Comparator: Quadrivalent Inactivated Influenza Vaccine (Fluarix® Tetra) at commercial dose + Placebo - Fluarix® Tetra (GlaxoSmithKline Biologicals): Inactivated and purified split influenza vaccine.
AND
Placebo Comparator: Saline solution (B. Braun Ecoflac Plus) Saline solution (NaCl 0,9%), B. Braun Ecoflac Plus 50mL. One single administration intrumuscularly of a 0.8mL dose on Day 1

Placebo Comparator: OVX836 480µg + Placebo - OVX836: Adjuvant-free recombinant influenza candidate vaccine based on Nucleoprotein of the incluenza 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 50mL. One single administration intrumuscularly of a 0.8mL dose on Day 1


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

Other interventions: Quadrivalent Inactivated Influenza Vaccine (Fluarix® Tetra)
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 Influenza Vaccine.
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 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 Influenza Vaccine.
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 AEs
Timepoint [5] 0 0
During 29 days after vaccine administration
Primary outcome [6] 0 0
Proportion of subjects with Influenza-Like-Illness cases
Timepoint [6] 0 0
During the whole study duration, 180 days
Primary outcome [7] 0 0
Severity scores of Influenza-Like-Illness cases (as per Flu-PRO questionnaire)
Timepoint [7] 0 0
During the whole study duration, 180 days
Primary outcome [8] 0 0
Proportion of subjects reporting Serious Adverse Events
Timepoint [8] 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 Influenza Vaccine.
Timepoint [1] 0 0
At Day 1 (pre-injection baseline) and Day 29
Secondary outcome [2] 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 [2] 0 0
At Day 8 versus pre-injection baseline (Day 1)
Secondary outcome [3] 0 0
Geometric Mean Titer of anti-Nucleoprotein immunoglobulin G (Enzyme-Linked Immunosorbent Assay, serum).
Timepoint [3] 0 0
At Day 1, Day 8 and Day 29
Secondary outcome [4] 0 0
Proportion of subjects with an increase (four-fold) in anti-Nucleoprotein Immunoglobulin G (Enzyme-Linked Immunosorbent Assay, serum) titer.
Timepoint [4] 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. Between the age of 18 and 55 years, inclusive.

4. Subjects who have fully been vaccinated with licensed Severe Acute Respiratory
Syndrome Coronavirus-2 (COVID-19) vaccine(s) according to national recommendations for
the corresponding population group, in vigor at the moment the study starts.

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 ePRO.
Minimum age
18 Years
Maximum age
55 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 =35 kg/m² on the day of vaccination.

2. 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, hepatitis C virus, or
hepatitis B virus, based upon medical history or physical examination findings.

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. 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 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)."

8. Having received another vaccination within 3 months prior to the day of study
vaccination with live attenuated vaccines, or within 1 month prior to the day of study
vaccination with 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. Having received a COVID-19 vaccination within 2 weeks prior to the day of study
vaccination.

11. 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.

12. 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.

13. 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.

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

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

16. 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.

17. 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.

18. 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.

19. History of severe allergic reactions and/or anaphylaxis, or serious adverse reactions
to vaccines or allergy to any component of either of the study vaccines, including to
egg protein or to kanamycin.

20. Any contraindication to IM administration, as judged by the Investigator, including
bleeding disorders such as hemophilia or anticoagulant therapy.

21. 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.

22. Subjects with tattoos in the deltoid region bilaterally, which might interfere with
observation of local signs and symptoms or other adverse events at the injection
sites. In case of tattoos on one side, injections of study vaccines should be
performed in the contralateral arm.

23. 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 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
9/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/12/2022
Sample size
Target
Accrual to date
Final
180
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Northern Beaches Clinical Research - Brookvale
Recruitment postcode(s) [1] 0 0
2100 - Brookvale

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Osivax
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Northern Beaches Clinical Research
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Novotech (Australia) Pty Limited
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Harmony Clinical Research
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The present study will evaluate the concomitant administration of a Quadrivalent Inactivated
Influenza Vaccine with the highest dose level of OVX836 (480µg) tested in the clinic to date,
for which the likelihood for interference with Quadrivalent Inactivated Influenza Vaccine is
considered the highest.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05284799
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ross Aldrich, MBBS
Address 0 0
Northern Beaches Clinical Research
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