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ISRCTN
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ISRCTN05087777
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ClinicalTrials.gov identifier
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Public title
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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
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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Vaccination with an oral live attenuated EnteroToxigenic Escherichia Coli (ETEC) candidate vaccine is safe and well tolerated and immunogenic.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Switzerland
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Disease/condition/study domain
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ETEC disease.
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Participants - inclusion criteria
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Healthy adults between 18 and 45 years of age.
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Participants - exclusion criteria
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Any confirmed or suspected immunosuppressive or immunodeficient condition or prior exposure to ETEC.
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Anticipated start date
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13/05/2005
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Anticipated end date
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13/01/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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50
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Interventions
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1. Single dose of ETEC candidate vaccine
2. Two doses of ETEC candidate vaccine
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Primary outcome measure(s)
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Safety as measured by the incidence of adverse events reported post-vaccination.
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Secondary outcome measure(s)
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1. Seroconversion rates as determined by antibody titers pre- and post-vaccination against ETEC candidate vaccine antigens
2. Responder rates as determined by the number of antibody secreting cells pre- and post-vaccination against ETEC candidate vaccine antigens
3. Shedding of ETEC candidate vaccine strain post-vaccination as measured by duration and number of bacteria shedded
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Sources of funding
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Berna Biotech Ltd (Switzerland)
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Trial website
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Publications
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Contact name
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Dr
Robin
McKenzie
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Address
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Center for Immunization Research
Department of International Health
Johns Hopkins University
Bloomberg School of Public Health
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City/town
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Baltimore
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Zip/Postcode
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21205
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Country
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United States of America
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Sponsor
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Berna Biotech Ltd (Switzerland)
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Address
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Rehhagstrasse 79A
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City/town
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Bern
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Zip/Postcode
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3018
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Country
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Switzerland
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Sponsor website:
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http://www.bernabiotech.com
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Date applied
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14/09/2005
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Last edited
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14/02/2008
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Date ISRCTN assigned
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19/10/2005
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