Comparison of immune responses elicited by oral and parenteral typhoid fever vaccines
| ISRCTN | ISRCTN68125331 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68125331 |
| Secondary identifying numbers | Ty21a - ASC |
- Submission date
- 17/06/2010
- Registration date
- 23/07/2010
- Last edited
- 06/11/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Anu Kantele
Scientific
Scientific
Helsinki University Central Hospital
Department of Medicine
Division of Infectious Diseases
Aurora Hospital
Building 5, Floor 3
POB 348
Helsinki
00029
Finland
Study information
| Study design | Randomised controlled single centre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Comparison of immune responses elicited by oral and parenteral typhoid fever vaccines: a randomised controlled single centre study |
| Study objectives | 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(s) | Ethics Committee of Internal Medicine, Helsinki University Central Hospital, approved on the 8th April 2009. Amendment approved on the 4th September 2009. |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Vivotif®, Typherix® |
| Primary outcome measure | 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 study start date | 01/08/2010 |
| Completion date | 30/06/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 50 |
| Key inclusion criteria | 1. Male or female subjects aged 18 to 65 years 2. Free of obvious health problems 3. Written informed consent |
| Key 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.) |
| Date of first enrolment | 01/08/2010 |
| Date of final enrolment | 30/06/2011 |
Locations
Countries of recruitment
- Finland
Study participating centre
Helsinki University Central Hospital
Helsinki
00029
Finland
00029
Finland
Sponsor information
Helsinki University Central Hospital (Finland)
Hospital/treatment centre
Hospital/treatment centre
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 | |
"ROR" |
https://ror.org/02e8hzf44 |
Funders
Funder type
Industry
Crucell Switzerland AG (Switzerland)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 26/11/2012 | Yes | No | |
| Results article | results | 08/04/2013 | Yes | No |
