A phase IIb study to evaluate an oral vaccine in prevention of diarrhea in healthy adult travelers visiting West Africa.

Phase 1

• Conditions: Healthy voluteers (prevention of diarrheal disease due to infection with enterotoxigenic E. coli [ETEC]); MedDRA version: 19.1Level: LLTClassification code 10054242Term: Escherichia coli infectionSystem Organ Class: 100000004862; MedDRA version: 19.1Level: LLTClassification code 10044552Term: Traveller's diarrheaSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2016-002690-35-FI
• Lead Sponsor: Scandinavian Biopharma AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-20
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 800

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 800
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified