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

ISRCTN	ISRCTN05087777
DOI	https://doi.org/10.1186/ISRCTN05087777
Protocol serial number	N/A
Sponsor	Berna Biotech Ltd (Switzerland)
Funder	Berna Biotech Ltd (Switzerland)

Submission date: 14/09/2005
Registration date: 19/10/2005
Last edited: 14/02/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Robin McKenzie
Scientific

Center for Immunization Research
Department of International Health
Johns Hopkins University
Bloomberg School of Public Health
Baltimore
21205
United States of America

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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
Health condition(s) or problem(s) studied	ETEC disease.
Intervention	1. Single dose of ETEC candidate vaccine 2. Two doses of ETEC candidate vaccine
Intervention type	Drug
Phase	Phase I
Drug / device / biological / vaccine name(s)	Vaccine
Primary outcome measure(s)	Safety as measured by the incidence of adverse events reported post-vaccination.
Key secondary outcome measure(s)	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
Completion date	13/01/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	50
Key inclusion criteria	Healthy adults between 18 and 45 years of age.
Key exclusion criteria	Any confirmed or suspected immunosuppressive or immunodeficient condition or prior exposure to ETEC.
Date of first enrolment	13/05/2005
Date of final enrolment	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan