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

ISRCTN	ISRCTN46326316
DOI	https://doi.org/10.1186/ISRCTN46326316
Protocol serial number	N/A
Sponsor	Leiden University Medical Centre (LUMC) (Netherlands)
Funder	Leiden University Medical Centre (LUMC) (The Netherlands) - Department of Infectious Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr A.H.E. Roukens
Scientific

Leiden University Medical Centre (LUMC)
Albinusdreef 2, C5-P
Leiden
2333 ZA
Netherlands

Email	a.h.e.roukens@lumc.nl

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Comparison between immune response to different modes of vaccination: intradermal and subcutaneous yellow fever vaccination
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Yellow Fever
Intervention	Subcutaneous of intradermal yellow fever vaccination.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Yellow fever vaccination
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	Adverse events measured for three weeks post-vaccination by keeping a diary, viremia measured 5 days post-vaccination by RT-PCR.
Completion date	15/06/2006

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	120
Total final enrolment	155
Key inclusion criteria	Healthy volunteers, greater than 18 years (previously and not previously vaccinated with yellow fever vaccine)
Key exclusion criteria	1. Pregnancy 2. Diabetes mellitus 3. Use of immunomodulating medication, e.g. corticosteroids 4. Cytostatica 5. Use of chloroquine
Date of first enrolment	15/06/2005
Date of final enrolment	15/06/2006

Leiden University Medical Centre (LUMC)

Leiden
2333 ZA
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	23/04/2008		Yes	No
Results article	results	04/12/2018	02/09/2019	Yes	No

02/09/2019: Publication reference and total final enrollment added.