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 个研究点目标入组 60 人开始时间: 2011年3月18日最近更新: 2015年1月13日

适应症

试验速览

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•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
•11. Females who are nursing
•12. History of gastrointestinal or systemic inflammatory or autoimmune disease
•13. Any known hypersensitivity to any ingredient in the vaccines
•14. Gastroenteritis within two weeks prior to vaccination
•15. Antibiotic therapy within six weeks prior to the vaccination

发起方

Gothenburg University Vaccine Research Institute (GUVAX) (Sweden)