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 |
| Secondary identifying numbers | N/A |
- 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
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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| 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 |
| 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 |
| Completion date | 13/01/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
21205
United States of America
Sponsor information
Berna Biotech Ltd (Switzerland)
Industry
Industry
Rehhagstrasse 79A
Bern
3018
Switzerland
| Website | http://www.bernabiotech.com |
|---|
Funders
Funder type
Industry
Berna Biotech Ltd (Switzerland)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
