Clinical Trials Register

Summary
EudraCT Number:	2021-002535-39
Sponsor's Protocol Code Number:	OVX836-003
National Competent Authority:	Belgium - FPS Health-DGM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-09-06
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Belgium - FPS Health-DGM

A.2

EudraCT number

2021-002535-39

A.3

Full title of the trial

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.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A trial to evaluate the immunogenicity and safety of a vaccine against influenza at two dose levels (300µg and 480 µg) compared to the vaccin at 180µg and placebo in healthy volunteers between 18 and 55 years and in healthy subjects aged 65 years and older.

A.3.2

Name or abbreviated title of the trial where available

OVX836-003

A.4.1

Sponsor's protocol code number

OVX836-003

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Osivax
B.1.3.4	Country	Belgium
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Osivax
B.4.2	Country	Belgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Osivax
B.5.2	Functional name of contact point	Clinical Operations team
B.5.3	Address:
B.5.3.1	Street Address	Rue des Chasseurs Ardennais 7
B.5.3.2	Town/ city	Angleur
B.5.3.3	Post code	4031
B.5.3.4	Country	Belgium
B.5.4	Telephone number	003247244 96 18
B.5.6	E-mail	spenning@osivax.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	OVX836
D.3.2	Product code	OVX836
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	There is no recommended International Nonproprietary Name (INN)
D.3.9.1	CAS number	NA
D.3.9.2	Current sponsor code	OVX836
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	SUB192573
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	510 to 690
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	OVX836
D.3.2	Product code	OVX836
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	There is no recommended International Nonproprietary Name (INN)
D.3.9.1	CAS number	NA
D.3.9.2	Current sponsor code	OVX836
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	SUB192573
D.3.10	Strength
D.3.10.1	Concentration unit	µl/ml microlitre(s)/millilitre
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	510 to 690
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	OVX836
D.3.2	Product code	OVX836
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	There is no recommended International Nonproprietary Name (INN)
D.3.9.1	CAS number	NA
D.3.9.2	Current sponsor code	OVX836
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	SUB192573
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	510 to 690
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection
D.8.4	Route of administration of the placebo	Intramuscular use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

The study is being conducted in healthy volunteers for the prophylaxis of influenza infection.

E.1.1.1

Medical condition in easily understood language

The study is being conducted in healthy volunteers for the prevention of influenza infection.

E.1.1.2

Therapeutic area

Diseases [C] - Virus Diseases [C02]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	PT
E.1.2	Classification code	10059429
E.1.2	Term	Influenza immunisation
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

-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.

E.2.2

Secondary objectives of the trial

-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.

E.2.3

Trial contains a sub-study

E.3

Principal 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.

E.4

Principal 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.
21. Previous administration with OVX836 candidate vaccine.
22. Having received a COVID-19 vaccination within 2 weeks prior to the day of study vaccination.
23. 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.

E.5 End points

E.5.1

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 IFNγ 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).

E.5.1.1

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)

E.5.2

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 IFNγ ELISPOT, at Day 8 versus pre-injection baseline (Day 1) (in both age cohorts).
• NP-specific T-cell frequencies (measured by IFNγ 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, TNFα and/or IFNγ 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).

E.5.2.1

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)

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

To investigate the immunogenecity of one single administration of OVX836 against influenza virus

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

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

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

Yes

F.3.2

Patients

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

238

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2021-11-03

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-11-03

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2022-12-07

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