Contact information
Type
Scientific
Primary contact
Prof David Warrell
ORCID ID
Contact details
John Radcliffe Hospital
Nuffield Department of Clinical Medicine
Headington
Oxford
OX3 9DU
United Kingdom
+44 (0)1865 220968
david.warrell@ndm.ox.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
065947
Study information
Scientific title
A randomised comparative study of the immunogenicity of a modified intradermal post-exposure rabies vaccine regimen
Acronym
Study hypothesis
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
After temporary recruitment problems, approval for the smaller study was received from the Oxfordshire Clinical Research Ethics Committee (ref: C01.078).
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
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
Phase
Not Applicable
Drug names
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 trial start date
01/01/2005
Overall trial end date
30/07/2006
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
220
Participant 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
Recruitment start date
01/01/2005
Recruitment end date
30/07/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom
Sponsor information
Organisation
University of Oxford (UK)
Sponsor details
University Offices
Wellington Square
Oxford
OX1 2JD
United Kingdom
+44 (0)1865 270143
research.services@admin.ox.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
The Wellcome Trust (UK) (grant ref: 065947)
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
Basic results (scientific)
Publication list
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18431444
Publication citations
-
Results
Warrell MJ, Riddell A, Yu LM, Phipps J, Diggle L, Bourhy H, Deeks JJ, Fooks AR, Audry L, Brookes SM, Meslin FX, Moxon R, Pollard AJ, Warrell DA, A simplified 4-site economical intradermal post-exposure rabies vaccine regimen: a randomised controlled comparison with standard methods., PLoS Negl Trop Dis, 2008, 2, 4, e224, doi: 10.1371/journal.pntd.0000224.