| - candidate number | 1407 |
| - NTR Number | NTR231 |
| - ISRCTN | ISRCTN46326316 |
| - Date ISRCTN created | 20-dec-2005 |
| - date ISRCTN requested | 18-okt-2005 |
| - Date Registered NTR | 6-sep-2005 |
| - Secondary IDs | N/A |
| - Public Title | Comparison between immune response to different modes of vaccination; intradermal and subcutaneous yellow fever vaccination. |
| - Scientific Title | Comparison between immune response to different modes of vaccination; antibody response to intradermal and subcutaneous yellow fever vaccination, measured by ELISA, IF and plaque reduction assay. |
| - ACRONYM | N/A |
| - hypothesis | Intradermal yellow fever vaccination with a reduced dose will induce a sufficient protective immunological response comparable to the response elicited by subcutaneous yellow fever vaccination. |
| - Healt Condition(s) or Problem(s) studied | Yellow Fever |
| - Inclusion criteria | Healthy volunteers, >18yrs (previously and not previously vaccinated with yellow fever vaccine). |
| - Exclusion criteria | 1. Pregnancy; 2. Diabetes mellitus; 3. Use of immunomodulating medication e.g. corticosteroids; 4. Cytostatica; 5. Use of chloroquine. |
| - mec approval received | yes |
| - multicenter trial | no |
| - randomised | yes |
| - masking/blinding | None |
| - control | Active |
| - group | Parallel |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 15-jun-2005 |
| - planned closingdate | 15-jun-2006 |
| - Target number of participants | 120 |
| - Interventions | Subcutaneous of intradermal yellow fever vaccination. |
| - Primary outcome | Protective humoral immune response. For first time vaccinees measured 4 and 8 weeks post-vaccination, for revaccinees measured 2 weeks post-vaccination. All sera will be analysed by ELISA, Immunofluorescence and plaque reduction assay. |
| - Secondary outcome | Adverse events measured for three weeks post-vaccination by keeping a diary, viremia measured 5 days post-vaccination by RT-PCR. |
| - Timepoints | N/A |
| - Trial web site | N/A |
| - status | stopped: trial finished |
| - CONTACT FOR PUBLIC QUERIES | MD. A.H.E. Roukens |
| - CONTACT for SCIENTIFIC QUERIES | MD. PhD. L.G. Visser |
| - Sponsor/Initiator | Leiden University Medical Center (LUMC), Department of Infectious Diseases |
| - Funding (Source(s) of Monetary or Material Support) | Leiden University Medical Center (LUMC), Department of Infectious Diseases |
| - Publications | PLoS ONE. 2008 Apr 23;3(4):e1993. |
| - Brief summary | Comparison between effectivity of different methods of vaccination; antibody response to intradermal and subcutaneous yellow fever vaccination, measured by ELISA, IF and plaque reduction assay. Furthermore adverse events will be studied by keeping a diary, and viremia will be measured in a subgroup of the first time vaccinees and the revaccinees. |
| - Main changes (audit trail) | |
| - RECORD | 6-sep-2005 - 26-nov-2008 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl