Contact information
Type
Scientific
Primary contact
Dr A.H.E. Roukens
ORCID ID
Contact details
Leiden University Medical Centre (LUMC)
Albinusdreef 2
C5-P
Leiden
2333 ZA
Netherlands
a.h.e.roukens@lumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study 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.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Yellow Fever
Intervention
Subcutaneous of intradermal yellow fever vaccination.
Intervention type
Drug
Phase
Not Specified
Drug names
Yellow fever vaccination
Primary outcome measure
1. Protective humoral immune response
2. For first time vaccinees measured 4 and 8 weeks post-vaccination, for revaccinees measured 2 weeks post-vaccination.
3. All sera will be analysed by ELISA, Immunofluorescence and plaque reduction assay.
Secondary outcome measures
Adverse events measured for three weeks post-vaccination by keeping a diary, viremia measured 5 days post-vaccination by RT-PCR.
Overall trial start date
15/06/2005
Overall trial end date
15/06/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Healthy volunteers, greater than 18 years (previously and not previously vaccinated with yellow fever vaccine)
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
120
Participant exclusion criteria
1. Pregnancy
2. Diabetes mellitus
3. Use of immunomodulating medication, e.g. corticosteroids
4. Cytostatica
5. Use of chloroquine
Recruitment start date
15/06/2005
Recruitment end date
15/06/2006
Locations
Countries of recruitment
Netherlands
Trial participating centre
Leiden University Medical Centre (LUMC)
Leiden
2333 ZA
Netherlands
Sponsor information
Organisation
Leiden University Medical Centre (LUMC) (Netherlands)
Sponsor details
Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Leiden University Medical Centre (LUMC) (The Netherlands) - Department of Infectious Diseases
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
Results in http://www.ncbi.nlm.nih.gov/pubmed/18431480
Publication citations
-
Results
Roukens AH, Vossen AC, Bredenbeek PJ, van Dissel JT, Visser LG, Intradermally administered yellow fever vaccine at reduced dose induces a protective immune response: a randomized controlled non-inferiority trial., PLoS ONE, 2008, 3, 4, e1993, doi: 10.1371/journal.pone.0001993.