Clinical Trials Register

Summary
EudraCT Number:	2021-001541-13
Sponsor's Protocol Code Number:	OEV-125
National Competent Authority:	Sweden - MPA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-06-04
Trial results	View 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

Sweden - MPA

A.2

EudraCT number

2021-001541-13

A.3

Full title of the trial

A Phase 2 immunological bridging study assessing the non-inferiority of a new formulation of ETVAX®. A prospective double-blind, randomized study in healthy volunteers

A.3.1

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

A phase 2 bridging study to assess that the new formulation of ETVAX is not inferior to the previous formulation

A.4.1

Sponsor's protocol code number

OEV-125

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT05178134

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	Scandinavian Biopharma Holding AB
B.1.3.4	Country	Sweden
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	Scandinavian Biopharma Holding AB
B.4.2	Country	Sweden
B.4.1	Name of organisation providing support	European and Developing Countries Clinical Trials Partnership (EDCTP)
B.4.2	Country	European Union
B.4.1	Name of organisation providing support	U.S. Army Medical Materiel Development Activity (USAMMDA)
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Scandinavian Biopharma Holding AB
B.5.2	Functional name of contact point	Chief Executive Officer
B.5.3	Address:
B.5.3.1	Street Address	Industrivagen 1
B.5.3.2	Town/ city	Solna
B.5.3.3	Post code	171 48
B.5.3.4	Country	Sweden
B.5.6	E-mail	bjorn.sjostrand@scandinavianbiopharma.se

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Comparator
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	ETVAX
D.3.2	Product code	Wet formulation
D.3.4	Pharmaceutical form	Oral suspension
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Not known
D.3.9.3	Other descriptive name	ESCHERICHIA COLI (INACTIVATED)
D.3.9.4	EV Substance Code	SUB25629
D.3.10	Strength
D.3.10.1	Concentration unit	billion organisms billion organisms
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	105
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Not known
D.3.9.3	Other descriptive name	DMLT
D.3.9.4	EV Substance Code	SUB188528
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.010
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Not known
D.3.9.3	Other descriptive name	LCTBA
D.3.9.4	EV Substance Code	SUB188527
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1
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	Yes
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	ETVAX
D.3.2	Product code	Partially dried
D.3.4	Pharmaceutical form	Oral suspension
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Not known
D.3.9.3	Other descriptive name	ESCHERICHIA COLI (INACTIVATED)
D.3.9.4	EV Substance Code	SUB25629
D.3.10	Strength
D.3.10.1	Concentration unit	billion organisms billion organisms
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	105
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Not known
D.3.9.3	Other descriptive name	DMLT
D.3.9.4	EV Substance Code	SUB188528
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.010
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Not known
D.3.9.3	Other descriptive name	LCTBA
D.3.9.4	EV Substance Code	SUB188527
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1
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	Yes
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Healthy volunteers (prevention of diarrheal disease due to infection with enterotoxigenic E. coli [ETEC])

E.1.1.1

Medical condition in easily understood language

Healthy volunteers (prevention of diarrhea caused by certain bacteria [ETEC])

E.1.1.2

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	26.0
E.1.2	Level	LLT
E.1.2	Classification code	10054983
E.1.2	Term	Prophylaxis against traveller's diarrhea
E.1.2	System Organ Class	100000004865

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.1
E.1.2	Level	LLT
E.1.2	Classification code	10022665
E.1.2	Term	Intestinal infection due to enterotoxigenic E. coli
E.1.2	System Organ Class	100000004862

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 demonstrate non-inferiority, in terms of immunogenicity, between
the wet formulation and the newly developed partially dried formulation of selected components of ETVAX®.

E.2.2

Secondary objectives of the trial

To evaluate the safety and tolerability of the new formulation of the vaccine.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Male or female aged 18-50 years, inclusive at the time of signing the informed consent.
• Healthy constitution as established by medical history and physical examination.
• Willing and able to give written informed consent for participation in the study
• Able to comply with study activities, as judged by the Investigator.
• Female Participants: Women of child-bearing potential (for definition see Section 9.3.6):
- Have to agree to use an acceptable birth control method during participation in the investigation (see Section 9.3.6).
- A negative pregnancy test (beta human chorionic gonadotropin dipstick test in urine) at Visit 2/Day 1 will be required.
• Male Participants:
- Have to agree to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm.

E.4

Principal exclusion criteria

• An acute or chronic medical condition that, in the opinion of the investigator/physician, would render ingestion of the investigational products unsafe or would interfere with the evaluation of responses. This includes, but is not limited to gastrointestinal diseases, and autoimmune diseases.
• Current malignancy or history of malignancy during the last five years, based on anamnesis.
• Gastroenteritis within two weeks prior to vaccination.
• Regular use of laxatives, antacids or other agents that lower stomach acidity.
• Any planned major surgery during the duration of the study.
• After 10 minutes supine rest, any vital signs outside the following ranges:
-Systolic BP > 160 mm Hg
-Diastolic BP > 100 mm Hg
-Heart rate < 40 or >85 beats per minute
• Antibiotic therapy within two weeks prior to the vaccination.
• Known Hepatitis A, B, C, and/or HIV infection.
• Concomitant intake of immunomodulating drugs during the study period or less than three months prior to the first immunization. Local anti-histamine treatment is however allowed.
• Any other significant medical conditions (e.g. poorly controlled psychiatric condition) judged by the Investigator to preclude entry.
• Intends to receive any other vaccine during the study period, or within two weeks prior to trial vaccination.
• Has previously received Dukoral or any type of enterotoxigenic Escherichia coli (ETEC) or cholera vaccines.
• Brought up in ETEC-endemic areas (e.g., urban and rural areas of Central and South America, Caribbean, most countries in Asia, Africa, etc.).
• Has travelled to ETEC-endemic areas within the last 3 years OR spent > two months in ETEC endemic areas during the last 10 years.
• Intends to travel to ETEC endemic countries during the study period.
• Known or suspected history of drug, chemical or alcohol abuse, as deemed by the investigator/physician.
• History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to ETVAX®.
• Participation in any other clinical study that included drug treatment with the last administration within the past 3 months prior to administration of treatment in this study. Patients consented and screened but not dosed in previous clinical studies are not excluded
• Concomitant participation in any other clinical study.
• Females who are pregnant as determined by urine test at inclusion and prior to each vaccination.
• Females who are nursing.
• Unable to participate in all study visits.
• Any condition or circumstance which would make the subject unsuitable for participation in the study in the opinion of the investigator/physician.

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint to be measured for each patient in the study is response (yes/no) to a vaccine. A vaccine responder will be defined by a ≥2-fold increase in IgA and/or IgG antibody levels against LTB in serum between post- compared to pre-immunization samples. The response rates (seroconversion rates) of IgA and/or IgG anti-LTB antibodies in serum will be derived and compared between the two treatment groups.

E.5.1.1

Timepoint(s) of evaluation of this end point

Serum collected prior first vaccination and 6-10 days post second vaccination

E.5.2

Secondary end point(s)

Occurrence of solicited symptoms for six days after each vaccination (day of vaccination and five subsequent days).

E.5.2.1

Timepoint(s) of evaluation of this end point

Adverse events will be collected at each dosing visit (Day 1 and Day 15) and the following 5 days after each vaccination (i.e. day of vaccination and five subsequent days)

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

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

Assessment of non-inferior Immunogenicity of new formulation by comparing Seroconversion rates of IgA and/or IgG anti-LTB antibodies in serum in the two formulations

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

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Current wet formulation of the same vaccine

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:

280

F.1.3

Elderly (>=65 years)

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

280

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
G.4 Investigator Network to be involved in the Trial: 1

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2021-07-27

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-07-07

P. End of Trial
P.	End of Trial Status	Completed

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