DiarrheaPhase 2NCT03729219

Prevention of Diarrheal Disease Due to Infection With Enterotoxigenic E. Coli (ETEC)

A Phase 2 study testing E. coli ETVAX in people with Diarrhea, run by Scandinavian Biopharma AB at 1 site in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Diarrhea
What is being tested?: E. coli ETVAX
Type of treatment: Vaccines, Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 749 participants
Where: 1 siteFinland
Study dates: 12 Jun 2017to 15 Apr 2019
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Male or female age ≥18 and ≤ 65 years
General good health at the time of first vaccination
Female participants of childbearing potential must not be pregnant
Females of childbearing potential must agree to use an efficacious hormonal or barrier method of birth control during the study
Willingness to participate in the study after all aspects of the protocol have been explained and written informed consent obtained
Availability for the study duration, including all planned follow-up visits
Intake of atovaquone + proguanil (Malarone) as anti-malaria prophylax according to prescription guidelines mandatory before, during and after travel to Benin

Who cannot join

Presence of a significant medical or psychiatric condition, which in the opinion of the investigator precludes participation in the study
Known or suspected history of drug, chemical or alcohol abuse, as deemed by the investigator/physician; AUDIT > 13 points
Known recent history of impaired immune function which, according to the judgement of the investigator could influence the immune response
Intends to receive any other investigational vaccine during the study period, or within two weeks prior to study vaccination
Intends to donate blood at any time during the study.
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

Show all 14Show fewer

Any history of psychosis or bipolar disorder or on-going significant mental disorder
Regular (daily) use of laxatives or agents which lower stomach acidity (antacids, proton pump inhibitors) less than one week before visit V1
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
Traveled to ETEC-endemic areas within the last year or visit for > two months in ETEC endemic areas during the last 10 years
Receipt of Dukoral or other ETEC or cholera vaccines within 3 years or planned receipt of such vaccine except ETVAX during the study
Antibiotic therapy within two weeks prior to the vaccination
History of diarrhea in the 7 days prior to vaccination (defined as ≥ 3 unformed loose stools in 24 hours)
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

Trial locations and contacts

1 site in 1 country.

Finland1 site

Lääkärikeskus Aava, matkailuklinikka
Helsinki

Other trials in Finland

About this study

Official title: A Randomized, Placebo-controlled Phase II b(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

This is a Phase II b, double-blind, randomized, placebo-controlled study in healthy adults (age 18-65 years) to evaluate the safety, immunogenicity, different diagnostic tools and efficacy of ETVAX. Participants will travel to Grand Popo, Africa for 12 days. Prior travelling participants will be vaccinated with two doses of vaccine or placebo. Vaccine Preventable Outcome will be identified and then characterized as to incidence, duration, severity and frequency of Moderate or Severe Travellers diarrhea. Health related information and assessments will be recorded during the travel.

Read the detailed description

This is a Phase II b, double-blind, randomized, placebo-controlled study in healthy adults (age 18-65 years) to evaluate the safety, immunogenicity, different diagnostic tools and efficacy of two doses of ETVAX. Study participants will be recruited among students, and personnel at the University of Helsinki and Helsinki University Hospital and among those responding to recruitment advertisements. To be eligible, the participants have to commit themselves to comply with the study protocol which involves in addition to vaccination, study visits and sampling, and commitment to travel to Grand Popo, Benin and stay there for 12 days. After providing written informed consent, eligible participants will be randomized (ratio 1:1, and block randomization in groups of 6) and immunized with two doses of vaccine or placebo, given 14±7 days apart while in Finland. The last dose of vaccine will be administered at least one week before departure (and no more than 30 days prior to travel) to Benin. Eligible participants will pay four pre-travel visits (V0 + V 1-3) to Aava Travel Clinic / University of Helsinki prior to travel. They will be asked to fill in pre-travel questionnaire latest at visit 1 (Q1) and fill in an Adverse Event Form (AEF1 and AEF2) after each dose, and give blood and fecal samples and saliva before travel. The participants will go together to Benin in groups of 25-35 individuals at a time.

In Benin, the participants will be seen within 48 hours of arrival to the study site in Grand Popo. Once the participants arrive at the study site in Grand Popo, they will be provided with practical information and contact details of the study personnel. They will receive the health card (HC1) and a stool collection kit with instructions.

Diarrhea reporting, stool collection, and stool submission procedures will be reviewed with the study participants. One routine visit at day 4 is planned for review of the participant's health status and collection of a routine stool sample. Other visits will take place when and if the participant gets Travelers Diarrhea (TD) episodes for collection of study specific stool samples and health related information and assessments. If more than one diarrhea episode occurs, 48 diarrhea and symptom (TD defined symptoms) free hours must have passed between the episodes for the new episode to be counted as a separate one. One or two days prior to departure from the Grand Popo site, all participants will have a final review of their HC1s. Health Card ( HC2) will be given. After 1-6 days back in Finland the participant has to give blood and a routine stool sample and they fill in Questionnaire 2 (Q2), HC2 will be reviewed. Approx. 30 days after return to Finland the last stool and blood sample will be collected and the post-travel questionnaire (Q3) filled and HC2 reviewed. Participants who get urinary tract infection will fill in Urinary questionnaire 4 (QU4) form at the time of infection. This follow-up is valid until V5.

Conditions: Diarrhea
Being tested: E. coli ETVAX, Placebo
Medical subject headings: Diarrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

E. coli ETVAXBiological
Oral suspension Sterile water is added to dmLT . Vaccine is poured to the effervescent solution and needed amount of dmLT is added.
PlaceboOther
Oral suspension

Study groups in NCT03729219
Study group	Role	What they receive
ETVAX	Experimental	Contains inactivated Tetravalent ETEC vaccine, 10 ug Double-mutant heat-labile toxin (dmLT) and effervescent power for oral solution administered twice 14 (plus minus 7) days intervals. Receives: Biological: E. coli ETVAX
Placebo	Placebo comparator	Effervescent power for oral solution administered wice 14 (plus-minus 7) days intervals Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety: Number of vaccine attributable adverse events
Number of vaccine attributable adverse events
Measured: From first vaccination until leave for Benin, approximately 13-50 days
Immunogenicity: Fold change of serum titers of IgA and IgG against LTB
Fold change of serum titers of Immunoglobulin A (IgA) and Immunoglobulin G (IgG) against heat-labile toxin (LTB)
Measured: Change from baseline (just before first vaccination) to Visit 3 (5-6 days after second vaccination), an average of 20 days
Immunogenicity: Number of subjects responding to heat-labile toxin (LTB)
Number of subjects responding to heat-labile toxin (LTB) based on serum Immunoglobulin A (IgA) and Immunoglobulin G (IgG) (i.e. fold change at least 2)
Measured: Change from baseline (just before first vaccination) to Visit 3 (5-6 days after second vaccination), an average of 20 days
Immunogenicity: Fold change of serum titers of Immunoglobulin A (IgA) and Immunoglobulin G (IgG) against O78 lipopolysaccharide (LPS)
Fold change of serum titers of Immunoglobulin A (IgA) and Immunoglobulin G (IgG) against O78 lipopolysaccharide (LPS)
Measured: Change from baseline (just before first vaccination) to Visit 3 (5-6 days after second vaccination), an average of 20 days
Immunogenicity: Number of subjects responding to O78 lipopolysaccharide (LPS)
Number of subjects responding to O78 lipopolysaccharide (LPS) based on serum Immunoglobulin A (IgA) and Immunoglobulin G (IgG) (i.e. fold change at least 2)
Measured: Change from baseline (just before first vaccination) to Visit 3 (5-6 days after second vaccination), an average of 20 days
Diagnostic Tools:To set the optimal threshold limits of the two quantitativePolymerase chain reaction (PCR ) procedures
To set the optimal threshold limits of the two quantitative Polymerase chain reaction (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 clinically significant ETEC TD cases, as well as cases associated with other enteric pathogens using the culture based bacterial detection method as the "Gold standard" for comparison.
Measured: 12 days in Benin and 30 days post-travel in Finland, approximately 42 days

Secondary outcomes (3)

Efficacy: The incidence of Vaccine Preventable Outcomes (VPO)
The incidence of cases with moderate or severe ETEC VPO diarrhea in the vaccinated and placebo groups of travelers.
Measured: 12 days in Benin and 30 days post-travel in Finland, approximately 42 days
Diagnostic Tools:Extent to which the non-culture based PCR assays can help resolve mixed ETEC infections
Percentage of clinically significant Traveller's Diarrhea cases with mixed infection where decision about what is the primary causative agent is concordant between Amphidial qPCR method and culture-based antigen detection method
Measured: 12 days in Benin and 30 days post-travel in Finland, approximately 42 days
Diagnostic Tools:The extent to which the TaqMan array yields results for ETEC colonization factor that are comparable to those obtained by culture based methods.
Percentage of clinically significant Traveller's Diarrhea cases with mixed infection where decision about what is the primary causative agent is concordant between TaqMan arrays qPCR method and culture-based antigen detection method
Measured: 12 days in Benin and 30 days post-travel in Finland, approximately 42 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Jun 201715 Apr 2019

First posted2 Nov 2018
Study start12 Jun 2017
Primary completion15 Apr 2019
Study completion15 Apr 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for DiarrheaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: A randomized, placebo-controlled phase IIb
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 749 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03729219
Sponsor's protocol ID: OEV 123
Status last verified: Nov 2019
First submitted: 16 Oct 2017
Last updated: 8 Nov 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Mlangeni T, Jian C, Hakkinen HK, de Vos WM, Salonen A, Kantele A. Travel to the tropics: Impact on gut microbiota. Travel Med Infect Dis. 2025 Jul-Aug;66:102869. doi: 10.1016/j.tmaid.2025.102869. Epub 2025 May 21.
PubMed 40409390
Liu J, Jokiranta TS, Carlin N, Stroup S, Zhang J, Sjostrand B, Svennerholm A-M, Houpt ER, Kantele A. Use of a TaqMan Array Card for identification of enterotoxins and colonization factors directly from stool samples in an enterotoxigenic E. coli vaccine study. Microbiol Spectr. 2025 Mar 4;13(3):e0187024. doi: 10.1128/spectrum.01870-24. Epub 2025 Feb 11.
PubMed 39932427

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Placebo-controlled Phase II b(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
ClinicalTrials.gov ID: NCT03729219
Acronym / sponsor ID: OEV 123
Conditions: Diarrhea
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 749 participants (actual)
Lead sponsor: Scandinavian Biopharma ABIndustry (pharma, biotech, devices)
Collaborators: Göteborg University, United Medix Laboratories Ltd., Oy Medfiles Ltd, University of Helsinki, University of Virginia
Study start: 12 Jun 2017 (actual)
Primary completion: 15 Apr 2019 (actual)
Study completion: 15 Apr 2019 (actual)
First posted: 2 Nov 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a Phase II b, double-blind, randomized, placebo-controlled study in healthy adults (age 18-65 years) to evaluate the safety, immunogenicity, different diagnostic tools and efficacy of ETVAX. Participants will travel to Grand Popo, Africa for 12 days. Prior travelling participants will be vaccinated with two doses of vaccine or placebo. Vaccine Preventable Outcome will be identified and then characterized as to incidence, duration, severity and frequency of Moderate or Severe Travellers diarrhea. Health related information and assessments will be recorded during the travel.

Detailed description

This is a Phase II b, double-blind, randomized, placebo-controlled study in healthy adults (age 18-65 years) to evaluate the safety, immunogenicity, different diagnostic tools and efficacy of two doses of ETVAX. Study participants will be recruited among students, and personnel at the University of Helsinki and Helsinki University Hospital and among those responding to recruitment advertisements. To be eligible, the participants have to commit themselves to comply with the study protocol which involves in addition to vaccination, study visits and sampling, and commitment to travel to Grand Popo, Benin and stay there for 12 days. After providing written informed consent, eligible participants will be randomized (ratio 1:1, and block randomization in groups of 6) and immunized with two doses of vaccine or placebo, given 14±7 days apart while in Finland. The last dose of vaccine will be administered at least one week before departure (and no more than 30 days prior to travel) to Benin. Eligible participants will pay four pre-travel visits (V0 + V 1-3) to Aava Travel Clinic / University of Helsinki prior to travel. They will be asked to fill in pre-travel questionnaire latest at visit 1 (Q1) and fill in an Adverse Event Form (AEF1 and AEF2) after each dose, and give blood and fecal samples and saliva before travel. The participants will go together to Benin in groups of 25-35 individuals at a time.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2
Model description: A randomized, placebo-controlled phase IIb

Arm	Type	Receives
ETVAX	Experimental	Biological: E. coli ETVAXContains inactivated Tetravalent ETEC vaccine, 10 ug Double-mutant heat-labile toxin (dmLT) and effervescent power for oral solution administered twice 14 (plus minus 7) days intervals.
Placebo	Placebo comparator	Other: PlaceboEffervescent power for oral solution administered wice 14 (plus-minus 7) days intervals

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Male or female age ≥18 and ≤ 65 years
General good health at the time of first vaccination
Female participants of childbearing potential must not be pregnant
Females of childbearing potential must agree to use an efficacious hormonal or barrier method of birth control during the study
Willingness to participate in the study after all aspects of the protocol have been explained and written informed consent obtained

Key exclusion criteria (14 listed)

Presence of a significant medical or psychiatric condition, which in the opinion of the investigator precludes participation in the study
Known or suspected history of drug, chemical or alcohol abuse, as deemed by the investigator/physician; AUDIT > 13 points
Known recent history of impaired immune function which, according to the judgement of the investigator could influence the immune response
Intends to receive any other investigational vaccine during the study period, or within two weeks prior to study vaccination
Intends to donate blood at any time during the study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
E. coli ETVAXOral suspension Sterile water is added to dmLT . Vaccine is poured to the effervescent solution and needed amount of dmLT is added.	Biological	ETVAX
PlaceboOral suspension	Other	Placebo

Primary outcome

Safety: Number of vaccine attributable adverse events
Time frame: From first vaccination until leave for Benin, approximately 13-50 days
Number of vaccine attributable adverse events
Immunogenicity: Fold change of serum titers of IgA and IgG against LTB
Time frame: Change from baseline (just before first vaccination) to Visit 3 (5-6 days after second vaccination), an average of 20 days
Fold change of serum titers of Immunoglobulin A (IgA) and Immunoglobulin G (IgG) against heat-labile toxin (LTB)
Immunogenicity: Number of subjects responding to heat-labile toxin (LTB)
Time frame: Change from baseline (just before first vaccination) to Visit 3 (5-6 days after second vaccination), an average of 20 days
Number of subjects responding to heat-labile toxin (LTB) based on serum Immunoglobulin A (IgA) and Immunoglobulin G (IgG) (i.e. fold change at least 2)
Immunogenicity: Fold change of serum titers of Immunoglobulin A (IgA) and Immunoglobulin G (IgG) against O78 lipopolysaccharide (LPS)
Time frame: Change from baseline (just before first vaccination) to Visit 3 (5-6 days after second vaccination), an average of 20 days
Fold change of serum titers of Immunoglobulin A (IgA) and Immunoglobulin G (IgG) against O78 lipopolysaccharide (LPS)
Immunogenicity: Number of subjects responding to O78 lipopolysaccharide (LPS)
Time frame: Change from baseline (just before first vaccination) to Visit 3 (5-6 days after second vaccination), an average of 20 days
Number of subjects responding to O78 lipopolysaccharide (LPS) based on serum Immunoglobulin A (IgA) and Immunoglobulin G (IgG) (i.e. fold change at least 2)
Diagnostic Tools:To set the optimal threshold limits of the two quantitativePolymerase chain reaction (PCR ) procedures
Time frame: 12 days in Benin and 30 days post-travel in Finland, approximately 42 days
To set the optimal threshold limits of the two quantitative Polymerase chain reaction (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 clinically significant ETEC TD cases, as well as cases associated with other enteric pathogens using the culture based bacterial detection method as the "Gold standard" for comparison.

3 secondary outcomes

Efficacy: The incidence of Vaccine Preventable Outcomes (VPO)
Time frame: 12 days in Benin and 30 days post-travel in Finland, approximately 42 days
Diagnostic Tools:Extent to which the non-culture based PCR assays can help resolve mixed ETEC infections
Time frame: 12 days in Benin and 30 days post-travel in Finland, approximately 42 days
Diagnostic Tools:The extent to which the TaqMan array yields results for ETEC colonization factor that are comparable to those obtained by culture based methods.
Time frame: 12 days in Benin and 30 days post-travel in Finland, approximately 42 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2019.
Derived from this study: PubMed 40409390Mlangeni T, Jian C, Hakkinen HK, de Vos WM, Salonen A, Kantele A. Travel to the tropics: Impact on gut microbiota. Travel Med Infect Dis. 2025 Jul-Aug;66:102869. doi: 10.1016/j.tmaid.2025.102869. Epub 2025 May 21.
Derived from this study: PubMed 39932427Liu J, Jokiranta TS, Carlin N, Stroup S, Zhang J, Sjostrand B, Svennerholm A-M, Houpt ER, Kantele A. Use of a TaqMan Array Card for identification of enterotoxins and colonization factors directly from stool samples in an enterotoxigenic E. coli vaccine study. Microbiol Spectr. 2025 Mar 4;13(3):e0187024. doi: 10.1128/spectrum.01870-24. Epub 2025 Feb 11.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anu Kantele principal investigator

University of Helsinki, Dept. of Infectious Diseases

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing E. coli ETVAX in people with Diarrhea, run by Scandinavian Biopharma AB at 1 site in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety: Number of vaccine attributable adverse events (time frame: From first vaccination until leave for Benin, approximately 13-50 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03729219, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2019.