Safety and immunogenicity of one and two doses of the live, attenuated oral ETEC candidate vaccine BB01 in healthy adults - a phase I, randomized, double-blind study

Completed

• Conditions: ETEC disease.; Infections and Infestations; Enterotoxigenic E. coli infection

• Registration Number: ISRCTN05087777
• Lead Sponsor: Berna Biotech Ltd (Switzerland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10-19
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Healthy adults between 18 and 45 years of age.

Exclusion Criteria

Any confirmed or suspected immunosuppressive or immunodeficient condition or prior exposure to ETEC.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety as measured by the incidence of adverse events reported post-vaccination.

Secondary Outcome Measures

Name	Time	Method
1. Seroconversion rates as determined by antibody titers pre- and post-vaccination against ETEC candidate vaccine antigens <br>2. Responder rates as determined by the number of antibody secreting cells pre- and post-vaccination against ETEC candidate vaccine antigens <br>3. Shedding of ETEC candidate vaccine strain post-vaccination as measured by duration and number of bacteria shedded