Evaluation of a prototype vaccine against enterotoxigenic Escherichia coli diarrhoea

Completed

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

• Registration Number: ISRCTN23764070
• Lead Sponsor: Gothenburg University Vaccine Research Institute (GUVAX) (Sweden)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03-18
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Males or females aged 18-55 years
2. Healthy constitution as established by medical history, medical examination and clinical chemistry and haematology testing
3. Give written informed consent to participate
4. Willing and able to communicate with the investigators and understand the requirements of the study
5. Sexually active females should unless being menopausal agree to use reliable contraception as assessed by the investigator, during 1 month prior to inclusion and one month after the last intake of study vaccine and should have a negative pregnancy test before each vaccination

Exclusion Criteria

1. Has received the oral cholera vaccine Dukoral® in the last 5 years
2. Travelled to ETEC-endemic area within the last 2 years
3. Concomitant intake of immunomodulating drugs during the study period or less than four weeks prior to the first immunisation
4. Vaccination with some other vaccine during the study period or within two weeks prior to trial vaccination
5. Any condition which would limit the subject?s ability to complete the study in the opinion of the investigator
6. History of drug or chemical abuse in the year before the study
7. Receipt of any other investigational product in the month before study entry
8. Concomitant participation in any other clinical study
9. Donation of blood 6 weeks before study entry or at any time during the study
10. Females who are pregnant
11. Females who are nursing
12. History of gastrointestinal or systemic inflammatory or autoimmune disease
13. Any known hypersensitivity to any ingredient in the vaccines
14. Gastroenteritis within two weeks prior to vaccination
15. Antibiotic therapy within six weeks prior to the vaccination

Study & Design

• Study Type: Interventional
• Study Design: Not specified