Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Ty21a - ASC
Study information
Scientific title
Comparison of immune responses elicited by oral and parenteral typhoid fever vaccines: a randomised controlled single centre study
Acronym
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.
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Prophylaxis of typhoid fever
Intervention
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
Intervention type
Drug
Phase
Not Applicable
Drug names
Vivotif®, Typherix®
Primary outcome measures
Measurement of specific IgA- IgG- and IgM-secreting antibody cells in peripheral blood using ELISPOT, measured at day 7.
Secondary outcome measures
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.
Overall trial start date
01/08/2010
Overall trial end date
30/06/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. Male or female subjects aged 18 to 65 years
2. Free of obvious health problems
3. Written informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50
Participant 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.)
Recruitment start date
01/08/2010
Recruitment end date
30/06/2011
Locations
Countries of recruitment
Finland
Trial participating centre
Helsinki University Central Hospital
Helsinki
00029
Finland
Sponsor information
Organisation
Helsinki University Central Hospital (Finland)
Sponsor details
c/o Dr Anu Kantele
Department of Medicine
Division of Infectious Diseases
Aurora Hospital
Building 5
Floor 3
POB 348
Helsinki
3018
Finland
anu.kantele@hus.fi
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Crucell Switzerland AG (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
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/23084770
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23593253
Publication citations
-
Results
Kantele A, Pakkanen SH, Siitonen A, Karttunen R, Kantele JM, Live oral typhoid vaccine Salmonella Typhi Ty21a - a surrogate vaccine against non-typhoid salmonella?, Vaccine, 2012, 30, 50, 7238-7245, doi: 10.1016/j.vaccine.2012.10.002.
-
Results
Kantele A, Pakkanen SH, Karttunen R, Kantele JM, Head-to-head comparison of humoral immune responses to Vi capsular polysaccharide and Salmonella Typhi Ty21a typhoid vaccines--a randomized trial., PLoS ONE, 2013, 8, 4, e60583, doi: 10.1371/journal.pone.0060583.