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ISRCTN
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ISRCTN68125331
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ClinicalTrials.gov identifier
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Public title
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Comparison of immune responses elicited by oral and parenteral typhoid fever vaccines
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Scientific title
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Comparison of immune responses elicited by oral and parenteral typhoid fever vaccines: a randomised controlled single centre study
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Acronym
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N/A
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Serial number at source
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Ty21a - ASC
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Study hypothesis
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Evaluation of the immune response as elicited by the oral Ty21a typhoid fever vaccine or a parenteral Vi-capsular polysaccharide vaccine using different immunological methods.
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Ethics approval
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Ethics Committee of Internal Medicine, Helsinki University Central Hospital, approved on the 8th April 2009. Amendment approved on the 4th September 2009.
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Study design
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Randomised controlled single centre study
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Countries of recruitment
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Finland
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Disease/condition/study domain
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Prophylaxis of typhoid fever
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Participants - inclusion criteria
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1. Male or female subjects aged 18 to 65 years
2. Free of obvious health problems
3. Written informed consent
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Participants - exclusion criteria
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1. Vaccination against typhoid fever within 5 years before dosing
2. History of clinical typhoid fever, clinical paratyphoid A or B fever
3. Current intake of antibiotics or end of antibiotic therapy less than 8 days before first investigative medicinal product (IMP) administration
4. Standard exclusion criteria (allergic to vaccine components, acute disease, immunosuppressed, serious chronic illness, pregancy or lactation, etc.)
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Anticipated start date
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01/08/2010
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Anticipated end date
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30/06/2011
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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50
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Interventions
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Biological:
Group A: Three oral doses of Vivotif®; administered with an interval of 1 day
Group B: one intramuscular dose of Typherix®; will be administered
Total duration of follow-up: approximately four weeks
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Primary outcome measure(s)
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Measurement of specific IgA- IgG- and IgM-secreting antibody cells in peripheral blood using ELISPOT, measured at day 7.
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Secondary outcome measure(s)
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1. To evaluate the expression of various homing receptors on antigen-specific antibody-secreting cells by separating the PBMCs with immunomagnetic cell sorting according to their HR expressions and by investigating specific ASC in the resulting subpopulations
2. Antibody analyses from serum (Widal test/ELISA)
3. Cell-mediated immune response
Measured at week 1 and 4.
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Sources of funding
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Crucell Switzerland AG (Switzerland)
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Trial website
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Publications
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Contact name
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Dr
Anu
Kantele
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Address
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Helsinki University Central Hospital
Department of Medicine
Division of Infectious Diseases
Aurora Hospital
Building 5, Floor 3
POB 348
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City/town
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Helsinki
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Zip/Postcode
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00029
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Country
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Finland
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Sponsor
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Helsinki University Central Hospital (Finland)
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Address
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c/o Dr Anu Kantele
Department of Medicine
Division of Infectious Diseases
Aurora Hospital
Building 5
Floor 3
POB 348
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City/town
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Helsinki
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Zip/Postcode
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3018
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Country
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Finland
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Email
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anu.kantele@hus.fi
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Date applied
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17/06/2010
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Last edited
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25/08/2010
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Date ISRCTN assigned
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23/07/2010
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