Evaluation of a drinkable vaccine against enterotoxigenic E. coli diarrhoea

Phase 1

Completed

• Conditions: Enterotoxigenic E. coli (ETEC) diarrhoea; Infections and Infestations

• Registration Number: ISRCTN91363076
• Lead Sponsor: niversity of Gothenburg (Sweden)

Brief Summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25444830

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-12-12
• Study Completion: 2013-03-31
• Last Update Posted: 25 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Male or female aged 18-45 years
2. Healthy constitution as established by medical history, medical examination and clinical chemistry and haematology testing.
3. Willing and able to communicate with the investigators/physician and understand the requirements of the study
4. Give written informed consent to participate
5. Sexually active females should unless being menopausal agree to use reliable contraception as assessed by the investigator/physician, during 1 month prior to inclusion and one month after the last intake of study vaccine and should have a negative urine pregnancy test at screening and also negative urine pregnancy tests before each vaccination.

Exclusion Criteria

1. 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.
2. Gastroenteritis within two weeks prior to vaccination
3. Antibiotic therapy within two weeks prior to the vaccination
4. Known Hepatitis A, B, C, and/or HIV infection
5. Concomitant intake of immunomodulating drugs during the study period or less than four weeks prior to the first immunization
6. Psychiatric symptoms and treatments during the last year deemed by the investigator/physician to be relevant for participation in the OEV-121 study.
7. Intends to receive any other vaccine during the study period, or within two weeks prior to trial vaccination
8. Any known hypersensitivity to any ingredient in the vaccines
9. Has received Dukoral or other ETEC or cholera vaccines
10. Brought up in ETEC-endemic areas (e.g., urban and rural areas of Central and South America, Caribbean, most countries in Asia, Africa, etc.).
11. Has travelled to ETEC-endemic areas within the last 3 years or spent > two months in ETEC endemic areas during the last 10 years
12. Intends to travel to ETEC endemic countries during the study period
13. Known or suspected history of drug, chemical or alcohol abuse, as deemed by the investigator/physician
14. Receipt of any other investigational product in the month before study entry or during the study deemed by the investigator/physician to be relevant for the OEV-121 study
15. Concomitant participation in any other clinical study deemed by the investigator/physician to be relevant for the OEV-121 study
16. Intends to donate blood at any time during the study
17. Females who are pregnant
18. Females who are nursing
19. Unable to participate in all study visits
20. Any condition or circumstance which would make the subject unsuitable for participation in the study in the opinion of the investigator/physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified