Evaluation of the safety and immunogenicity of a prototype enterotoxigenic Escherichia coli (ETEC) vaccine: a three-armed, double-blinded, randomised, single-centre study

Gothenburg University Vaccine Research Institute (GUVAX) (Sweden)0 sites60 target enrollmentMarch 18, 2011

Overview

No summary available.

Registry

who.int

Start Date

March 18, 2011

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional

Sex

All

Sponsor

Gothenburg University Vaccine Research Institute (GUVAX) (Sweden)

•1\. Males or females aged 18\-55 years
•2\. Healthy constitution as established by medical history, medical examination and clinical chemistry and haematology testing
•3\. Give written informed consent to participate
•4\. Willing and able to communicate with the investigators and understand the requirements of the study
•5\. Sexually active females should unless being menopausal agree to use reliable contraception as assessed by the investigator, during 1 month prior to inclusion and one month after the last intake of study vaccine and should have a negative pregnancy test before each vaccination

•1\. Has received the oral cholera vaccine Dukoral® in the last 5 years
•2\. Travelled to ETEC\-endemic area within the last 2 years
•3\. Concomitant intake of immunomodulating drugs during the study period or less than four weeks prior to the first immunisation
•4\. Vaccination with some other vaccine during the study period or within two weeks prior to trial vaccination
•5\. Any condition which would limit the subject?s ability to complete the study in the opinion of the investigator
•6\. History of drug or chemical abuse in the year before the study
•7\. Receipt of any other investigational product in the month before study entry
•8\. Concomitant participation in any other clinical study
•9\. Donation of blood 6 weeks before study entry or at any time during the study
•10\. Females who are pregnant