Research to improve economical anti-rabies treatment
| ISRCTN | ISRCTN30087513 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30087513 |
| Secondary identifying numbers | 065947 |
- Submission date
- 22/07/2005
- Registration date
- 22/07/2005
- Last edited
- 12/12/2012
- 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
Prof David Warrell
Scientific
Scientific
John Radcliffe Hospital
Nuffield Department of Clinical Medicine
Headington
Oxford
OX3 9DU
United Kingdom
| Phone | +44 (0)1865 220968 |
|---|---|
| david.warrell@ndm.ox.ac.uk |
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 | A randomised comparative study of the immunogenicity of a modified intradermal post-exposure rabies vaccine regimen |
| Study objectives | To find a single economical post-exposure rabies vaccine regimen suitable for use with all vaccines currently recommended by the World Health Organisation (WHO), by testing the initial immunogenicity of a new variation of current intradermal post-exposure treatment regimens. Any new method must induce a rapid initial immune response, in comparison with control regimens. |
| Ethics approval(s) | After temporary recruitment problems, approval for the smaller study was received from the Oxfordshire Clinical Research Ethics Committee (ref: C01.078). |
| Health condition(s) or problem(s) studied | Rabies vaccine |
| Intervention | 220 healthy volunteers in the UK between the ages of 18 and 50 years will be recruited and randomised into one of four treatment groups of 55 people each. The standard intramuscular rabies post-exposure vaccine regimen will be compared with two current economical intradermal regimens and a new improved intradermal regimen. Unfortunately, recruitment was badly affected by a general anti vaccination sentiment in UK resulting from the media campaign against MMR. Our intention to recruit from the armed forces was thwarted by bad experiences with multiple vaccinations, in particular against anthrax, in preparation for the Iraq war. The funds for the trial ran out last year and while seeking an extension of the grant, recruitment was stopped temporarily. We have re-evaluated what can be achieved using internal funds and honorary staff, and have now restarted recruiting. The strategy has been changed to carry out a smaller study. The size is reduced by elimination of three of the seven study arms. The remaining groups will still provide data on the most important objectives, and may give results which could alter routine rabies post-exposure treatment. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Rabies vaccine regimes |
| Primary outcome measure | Blood samples are taken to measure the level of rabies virus-neutralising antibody by the Rabies antibody responses (RIFFIT) method. The serological results of the test regimen will be compared with those of control reference regimens of proven clinical efficacy. |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/01/2005 |
| Completion date | 30/07/2006 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 220 |
| Key inclusion criteria | 1. Healthy volunteers in Oxfordshire between the ages of 18 and 50 years, either sex 2. Have never had rabies vaccine before 3. Able to attend all appointments |
| Key exclusion criteria | 1. Any previous rabies immunisation 2. Treatment with human immunoglobulins or blood transfusion within the past three months 3. The use of immunosuppressive drugs 4. Pregnancy 5. Uncertainty about returning for appointments during the year 6. Chloroquine cannot be taken for two weeks prior to vaccination at day zero until two weeks after vaccination at day 90 |
| Date of first enrolment | 01/01/2005 |
| Date of final enrolment | 30/07/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom
OX3 9DU
United Kingdom
Sponsor information
University of Oxford (UK)
University/education
University/education
University Offices
Wellington Square
Oxford
OX1 2JD
England
United Kingdom
| Phone | +44 (0)1865 270143 |
|---|---|
| research.services@admin.ox.ac.uk | |
| Website | http://www.ox.ac.uk |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Charity
The Wellcome Trust (UK) (grant ref: 065947)
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 |
