Comparison of immune responses elicited by oral and parenteral typhoid fever vaccines
| ISRCTN | ISRCTN68125331 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68125331 |
| Protocol serial number | Ty21a - ASC |
| Sponsor | Helsinki University Central Hospital (Finland) |
| Funder | Crucell Switzerland AG (Switzerland) |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled single centre study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Vivotif®, Typherix® |
| Primary outcome measure(s) |
Measurement of specific IgA- IgG- and IgM-secreting antibody cells in peripheral blood using ELISPOT, measured at day 7. |
| Key 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 |
| Completion date | 30/06/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
00029
Finland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
