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Comparison between immune response to different modes of vaccination; intradermal and subcutaneous yellow fever vaccination.


- candidate number1407
- NTR NumberNTR231
- ISRCTNISRCTN46326316
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR6-sep-2005
- Secondary IDsN/A 
- Public TitleComparison between immune response to different modes of vaccination; intradermal and subcutaneous yellow fever vaccination.
- Scientific TitleComparison 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.
- ACRONYMN/A
- hypothesisIntradermal 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) studiedYellow Fever
- Inclusion criteriaHealthy volunteers, >18yrs (previously and not previously vaccinated with yellow fever vaccine).
- Exclusion criteria1. Pregnancy;
2. Diabetes mellitus;
3. Use of immunomodulating medication e.g. corticosteroids;
4. Cytostatica;
5. Use of chloroquine.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-jun-2005
- planned closingdate15-jun-2006
- Target number of participants120
- InterventionsSubcutaneous of intradermal yellow fever vaccination.
- Primary outcomeProtective 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 outcomeAdverse events measured for three weeks post-vaccination by keeping a diary, viremia measured 5 days post-vaccination by RT-PCR.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMD. A.H.E. Roukens
- CONTACT for SCIENTIFIC QUERIESMD. 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
- PublicationsPLoS ONE. 2008 Apr 23;3(4):e1993.
- Brief summaryComparison 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)
- RECORD6-sep-2005 - 26-nov-2008


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