Comparison between immune response to different modes of vaccination: intradermal and subcutaneous yellow fever vaccination
| ISRCTN | ISRCTN46326316 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46326316 |
| Secondary identifying numbers | N/A |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 02/09/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr A.H.E. Roukens
Scientific
Scientific
Leiden University Medical Centre (LUMC)
Albinusdreef 2, C5-P
Leiden
2333 ZA
Netherlands
| a.h.e.roukens@lumc.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 15/06/2005 |
| Completion date | 15/06/2006 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Leiden University Medical Centre (LUMC)
Leiden
2333 ZA
Netherlands
2333 ZA
Netherlands
Sponsor information
Leiden University Medical Centre (LUMC) (Netherlands)
University/education
University/education
Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands
| Website | http://www.lumc.nl/ |
|---|---|
"ROR" |
https://ror.org/027bh9e22 |
Funders
Funder type
Hospital/treatment centre
Leiden University Medical Centre (LUMC) (The Netherlands) - Department of Infectious Diseases
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| 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 |
Editorial Notes
02/09/2019: Publication reference and total final enrollment added.
