Condition category
Infections and Infestations
Date applied
14/09/2005
Date assigned
19/10/2005
Last edited
14/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Robin McKenzie

ORCID ID

Contact details

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

Additional identifiers

EudraCT 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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial 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

Phase

Phase I

Drug names

Vaccine

Primary outcome measures

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 trial start date

13/05/2005

Overall trial end date

13/01/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy adults between 18 and 45 years of age.

Participant type

Patient

Age group

Adult

Gender

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

Trial 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

http://www.bernabiotech.com

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes