Condition category
Infections and Infestations
Date applied
17/06/2010
Date assigned
23/07/2010
Last edited
06/11/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Anu Kantele

ORCID ID

Contact details

Helsinki University Central Hospital
Department of Medicine
Division of Infectious Diseases
Aurora Hospital
Building 5
Floor 3
POB 348
Helsinki
00029
Finland

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

  1. 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.

  2. 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.

Additional files

Editorial Notes