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Comparison of immune responses elicited by oral and parenteral typhoid fever vaccines
ISRCTN ISRCTN68125331
DOI 10.1186/ISRCTN68125331
ClinicalTrials.gov identifier
EudraCT number
Public title Comparison of immune responses elicited by oral and parenteral typhoid fever vaccines
Scientific title Comparison of immune responses elicited by oral and parenteral typhoid fever vaccines: a randomised controlled single centre study
Acronym N/A
Serial number at source Ty21a - ASC
Study hypothesis 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.
Lay summary Not provided at time of registration
Ethics approval Ethics Committee of Internal Medicine, Helsinki University Central Hospital, approved on the 8th April 2009. Amendment approved on the 4th September 2009.
Study design Randomised controlled single centre study
Countries of recruitment Finland
Disease/condition/study domain Prophylaxis of typhoid fever
Participants - inclusion criteria 1. Male or female subjects aged 18 to 65 years
2. Free of obvious health problems
3. Written informed consent
Participants - exclusion criteria 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.)
Anticipated start date 01/08/2010
Anticipated end date 30/06/2011
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 50
Interventions 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
Primary outcome measure(s) Measurement of specific IgA- IgG- and IgM-secreting antibody cells in peripheral blood using ELISPOT, measured at day 7.
Secondary outcome measure(s) 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.
Sources of funding Crucell Switzerland AG (Switzerland)
Trial website
Publications 2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/23084770
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23593253
Contact name Dr  Anu  Kantele
  Address Helsinki University Central Hospital
Department of Medicine
Division of Infectious Diseases
Aurora Hospital
Building 5, Floor 3
POB 348
  City/town Helsinki
  Zip/Postcode 00029
  Country Finland
Sponsor Helsinki University Central Hospital (Finland)
  Address c/o Dr Anu Kantele
Department of Medicine
Division of Infectious Diseases
Aurora Hospital
Building 5
Floor 3
POB 348
  City/town Helsinki
  Zip/Postcode 3018
  Country Finland
  Email anu.kantele@hus.fi
Date applied 17/06/2010
Last edited 06/11/2013
Date ISRCTN assigned 23/07/2010
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