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    Summary
    EudraCT Number:2016-002690-35
    Sponsor's Protocol Code Number:OEV123
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-03-20
    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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFinland - Fimea
    A.2EudraCT number2016-002690-35
    A.3Full title of the trial
    A randomized, placebo-controlled phase IIb (OEV 123) study to evaluate safety, immunogenicity, diagnostic methodology, and estimate vaccine efficacy of an oral enterotoxigenic Escherichia coli (ETEC) Vaccine (ETVAX) for prevention of clinically significant ETEC diarrhea in healthy adult travelers visiting West Africa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase IIb study to evaluate an oral vaccine in prevention of diarrhea in healthy adult travelers visiting West Africa.
    A.4.1Sponsor's protocol code numberOEV123
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorScandinavian Biopharma AB
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportScandinavian Biopharma AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHelsinki University Hospital
    B.5.2Functional name of contact pointPrincipal Investigator
    B.5.3 Address:
    B.5.3.1Street AddressAuroran sairaala, PL 348
    B.5.3.2Town/ cityHelsinki
    B.5.3.3Post code00029
    B.5.3.4CountryFinland
    B.5.4Telephone number+358503097640
    B.5.6E-mailanu.kantele@hus.fi
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameETVAX
    D.3.4Pharmaceutical form Oral suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot known
    D.3.9.3Other descriptive nameESCHERICHIA COLI (INACTIVATED)
    D.3.9.4EV Substance CodeSUB25629
    D.3.10 Strength
    D.3.10.1Concentration unit million organisms million organisms
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number80000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral solution
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Healthy voluteers (prevention of diarrheal disease due to infection with enterotoxigenic E. coli [ETEC])
    E.1.1.1Medical condition in easily understood language
    Healthy volunteers (prevention of diarrhea caused by certain bacteria [ETEC])
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10054242
    E.1.2Term Escherichia coli infection
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10044552
    E.1.2Term Traveller's diarrhea
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Safety: To evaluate safety and tolerability of orally administered ETVAX vaccine in a two dose regimen.
    Immunogenicity: To evaluate the immune response in serum against LTB and O78 LPS.
    Diagnostic Tools: To elucidate the agreement between culture based and non-culture based diagnostic tools for identifying ETEC and other enteric pathogens in stool samples from travelers meeting pre-defined clinical end-points for moderate or severe Traveller's Diarrhea (TD). Culture-based diagnostics are performed on bacterial colonies isolated from stool samples and analyzed by biochemical, mass-spectrometric and immunological methods, and non-culture based methods are performed on frozen bacteriological cell line samples using a validated multiplex quantitative PCR developed by Mobidiag Oy, Finland and a modified TaqMan array developed by UVA and NMRC in the US.
    E.2.2Secondary objectives of the trial
    Efficacy: To evaluate the protective efficacy (PE) of the vaccine against moderate or severe, culture confirmed, Vaccine Preventable Outcome (VPO) ETEC-induced diarrhea in Finnish travelers to Benin.
    Immunogenicity: To evaluate the relationship between serum IgA/IgG anti-LTB levels approx. one week after the second dose and the risk of developing moderate or severe ETEC TD.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female age ≥18 and ≤ 65 years.
    2. General good health at the time of first vaccination.
    3. Female participants of childbearing potential must declare that they are not pregnant.
    4. Females of childbearing potential must agree to use an efficacious hormonal or barrier method of birth control during the study.
    5. Willingness to participate in the study after all aspects of the protocol have been explained and written informed consent obtained.
    6. Availability for the study duration, including all planned follow-up visits.
    7. Intake of atovaquone+proguanil (Malarone/Rumbacor) as anti-malaria profylax according to prescription guidelines mandatory before, during and after travel to Benin.
    E.4Principal exclusion criteria
    1. Presence of a significant medical or psychiatric condition, which in the opinion of the investigator precludes participation in the study.
    2. Known or suspected history of drug, chemical or alcohol abuse, as deemed by the investigator/physician
    3. Known recent history of impaired immune function which, according to the judgement of the investigator could influence the immune response.
    4. Intends to receive any other investigational vaccine during the study period, or within two weeks prior to study vaccination.
    5. Intends to donate blood at any time during the study.
    6. 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 requiring treatment.
    7. Regular (daily) use of laxatives or agents which lower stomach acidity (antacids, proton pump inhibitors) less than one week before inclusion.
    8. Use of any oral or parenteral medication known to affect the immune function (e.g., corticosteroids and others) within 30 days preceding the first vaccination or planned use during the active study period.
    9. Traveled to ETEC-endemic areas within the last year or visit for > two months in ETEC endemic areas during the last 10 years.
    10. Receipt of Dukoral or other ETEC or cholera vaccines within 3 years or planned receipt of such vaccine except ETVAX during the study.
    11. Antibiotic therapy within two weeks prior to the vaccination.
    12. History of diarrhea in the 7 days prior to vaccination (defined as ≥ 3 unformed loose stools in 24 hours).
    13. Any other criteria which, in the investigator's opinion, would compromise the ability of the traveler to participate in the study, the safety of the study, or the results of the study
    E.5 End points
    E.5.1Primary end point(s)
    Safety: Number of vaccine attributable events.
    Immunogenicity: Frequencies and magnitudes of serum IgA and IgG antibody responses to LTB and/or O78 LPS following immunization.
    Diagnostic Tools: To set the optimal threshold limits of the two quantitative PCR procedures by setting limits for the number of amplification cycles (Cq values) which best allows (in terms of sensitivity, specificity, and positive predictive value) for identification of moderate or severe ETEC TD cases, as well as cases associated with other enteric pathogens using the culture based antigen detection methods as the “Gold-standard” for comparison.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety: Immediate Adverse Events (AEs) 15 minutes after first and second dose. AE form 1 collected from participants 7-21 days after first vaccination and AE form 2 collected 7-30 days after second vaccination. AEs are followed actively 5 days after immunisation. Thereafter passively.
    Immunogenicity: Serum collected prior first vaccination, 5-6 days post second vaccination and 1-2 days after travel (20-44 days post second vaccination) for LTB, O78-specific IgA in serum.
    Diagnostic Tools: Routine stool samples collected prior first vaccination, on day 4-7 during travel (11-37 days after second vaccination), 1-2 days after travel (20-44 days post second vaccination) and 25-35 days after travel. Stool samples also collected during travel in case of diarrhea episodes.
    E.5.2Secondary end point(s)
    Efficacy: The incidence of cases with moderate or severe ETEC VPO diarrhea in the vaccinated and placebo groups of travelers.
    Immunogenicity : The incidence of cases with moderate or severe ETEC VPO diarrhea in relation to the serum antibody response against LTB.
    Diagnostic tools: The extent to which the non-culture based PCR assays can help resolve mixed enteric infections and enable attribution to be reasonably assigned to ETEC as the causative pathogen, against more traditional culture-based or antigen detection methods. Also, the extent to which the TaqMan array yields results for ETEC colonizatiom factor that are comparable to those obtained by culture based methods.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy: Routine stool samples collected on day 4-7 during travel (11-37 days after second vaccination) and 1-2 days after travel (20-44 days after second vaccination). Stool samples also collected during travel in case of diarrhea episodes. Travel-questionnaire, Q2 reviewed 1-2 days after travel and travel-questinnaire Q3 reviewed 25-35 days after travel. Diarrhea reporting form (DFR) reviewed 1-2 days after travel, if applicable.
    Immunogenicity: Serum collected prior first vaccination, 5-6 days post second vaccination and 1-2 days after travel (20-44 days post second vaccination) for LTB, O78-specific IgA in serum.
    Diagnostic tools: as specified in timepoints for primary end points.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Benin
    E.8.7Trial has a data monitoring committee No
    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.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 800
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state800
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 800
    F.4.2.2In the whole clinical trial 800
    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)
    Healthy voluteer study. No follow up after the subject has ended participation in the trial, unless the subject experiences unresolved AEs deemed to be related to vaccination by study physician. Subjects with unresolved AEs deemed to be related to vaccination will be followed by the study clinician until the AE has resolved.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-05-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-04-15
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