Condition category
Infections and Infestations
Date applied
22/07/2005
Date assigned
22/07/2005
Last edited
12/12/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.ox.ac.uk

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

Results - basic reporting

Publication summary

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18431444

Publication citations

  1. 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.

Additional files

Editorial Notes