No registrations found.
ID
Source
Brief title
Health condition
(Prevention of) yellow fever.
Sponsors and support
Intervention
Outcome measures
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.
Background 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.
Study objective
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.
Study design
N/A
Intervention
Subcutaneous of intradermal yellow fever vaccination.
P.O. Box 9600
A.H.E. Roukens
Albinusdreef 2
Leiden 2300 RC
The Netherlands
a.h.e.roukens@lumc.nl
P.O. Box 9600
A.H.E. Roukens
Albinusdreef 2
Leiden 2300 RC
The Netherlands
a.h.e.roukens@lumc.nl
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL194 |
| NTR-old | NTR231 |
| Other | : N/A |
| ISRCTN | ISRCTN46326316 |