Condition category
Infections and Infestations
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
25/04/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.lumc.nl/

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

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/18431480

Publication citations

  1. 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.

Additional files

Editorial Notes