Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Vaccination with an oral live attenuated EnteroToxigenic Escherichia Coli (ETEC) candidate vaccine is safe and well tolerated and immunogenic.
Ethics approval(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study type
Prevention
Patient information sheet
Condition
ETEC disease.
Intervention
1. Single dose of ETEC candidate vaccine
2. Two doses of ETEC candidate vaccine
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Phase I
Drug/device/biological/vaccine name(s)
Vaccine
Primary outcome measure
Safety as measured by the incidence of adverse events reported post-vaccination.
Secondary outcome measures
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
Overall study start date
13/05/2005
Overall study end date
13/01/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Healthy adults between 18 and 45 years of age.
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
50
Participant exclusion criteria
Any confirmed or suspected immunosuppressive or immunodeficient condition or prior exposure to ETEC.
Recruitment start date
13/05/2005
Recruitment end date
13/01/2006
Locations
Countries of recruitment
Switzerland, United States of America
Study participating centre
Center for Immunization Research
Baltimore
21205
United States of America
Sponsor information
Organisation
Berna Biotech Ltd (Switzerland)
Sponsor details
Rehhagstrasse 79A
Bern
3018
Switzerland
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Berna Biotech Ltd (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|