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ISRCTN
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ISRCTN30087513
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DOI
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10.1186/ISRCTN30087513
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Research to improve economical anti-rabies treatment
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Scientific title
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A randomised comparative study of the immunogenicity of a modified intradermal post-exposure rabies vaccine regimen
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Acronym
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N/A
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Serial number at source
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065947
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Study hypothesis
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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.
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Lay summary
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Not provided at time of registration
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Ethics approval
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After temporary recruitment problems, approval for the smaller study was received from the Oxfordshire Clinical Research Ethics Committee (ref: C01.078).
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Rabies vaccine
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/01/2005
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Anticipated end date
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30/07/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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220
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Interventions
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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.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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No secondary outcome measures
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Sources of funding
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The Wellcome Trust (UK) (grant ref: 065947)
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Trial website
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Publications
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2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18431444
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Contact name
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Prof
David
Warrell
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Address
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John Radcliffe Hospital
Nuffield Department of Clinical Medicine
Headington
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City/town
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Oxford
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Zip/Postcode
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OX3 9DU
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Country
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United Kingdom
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Tel
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+44 (0)1865 220968
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Fax
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+44 (0)1865 220984
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Email
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david.warrell@ndm.ox.ac.uk
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Sponsor
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University of Oxford (UK)
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Address
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University Offices
Wellington Square
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City/town
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Oxford
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Zip/Postcode
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OX1 2JD
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Country
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United Kingdom
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Tel
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+44 (0)1865 270143
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Fax
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+44 (0)1865 280467
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Email
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research.services@admin.ox.ac.uk
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Sponsor website:
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http://www.ox.ac.uk
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Date applied
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22/07/2005
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Last edited
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12/12/2012
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Date ISRCTN assigned
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22/07/2005
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