Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619000946112
Ethics application status
Approved
Date submitted
20/06/2019
Date registered
5/07/2019
Date last updated
29/06/2021
Date data sharing statement initially provided
5/07/2019
Date results information initially provided
29/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Boostability of One priming dose intramuscular Rabies vaccine especially in Senior age groups
Scientific title
Boostability of One priming dose intramuscular Rabies vaccine especially in Senior age groups
Secondary ID [1] 298521 0
None
Universal Trial Number (UTN)
Trial acronym
BORS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rabies 313371 0
Condition category
Condition code
Infection 311813 311813 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intramuscular (deltoid) administration of 0.5ml of Verorab (containing not less than 2.5 international units of inactivated Wistar rabies virus strain per 0.5ml) at days 0, 60, and 63
Intervention code [1] 314803 0
Prevention
Comparator / control treatment
No control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320484 0
Antibodies titer levels to rabies virus (IU/mL) using serum assay (Platella Rabies II ELISA)
Timepoint [1] 320484 0
60 days post initial vaccination
Primary outcome [2] 320561 0
Antibodies titer levels to rabies virus (IU/mL) using serum assay (Platella Rabies II ELISA)
Timepoint [2] 320561 0
67 days post initial vaccination
Secondary outcome [1] 371776 0
Self-reported side effects of the vaccination (e.g. injection site reactions [pain, swelling, itching, or redness], headache, dizziness, muscle pain, nausea, pain)
Timepoint [1] 371776 0
74 days post initial vaccination
Secondary outcome [2] 372024 0
Antibodies titer levels to rabies virus (IU/mL) using serum assay (Platella Rabies II ELISA)
Timepoint [2] 372024 0
81 days post initial vaccination

Eligibility
Key inclusion criteria
1. No prior history of rabies vaccination
2. Able to give written Informed Consent and sign consent after all aspects of the protocol have been explained
3. Subject must agree to participate in three doses of vaccine, three to four blood tests and two questionnaires including the planned follow-up telephone review
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Taking medications that impair the normal functioning of the immune system
2. Pregnancy or planning pregnancy
3. Travelling to areas of high risk for rabies where an unusual pre-exposure prophylaxis schedule may cause difficulty in the event of an animal exposure that requires post-exposure prophylaxis

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2019
Actual
17/01/2020
Date of last participant enrolment
Anticipated
1/09/2020
Actual
2/10/2020
Date of last data collection
Anticipated
1/12/2020
Actual
4/12/2020
Sample size
Target
100
Accrual to date
Final
103
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 303065 0
Other
Name [1] 303065 0
Dr Deb The Travel Doctor Pt Ltd
Country [1] 303065 0
Australia
Primary sponsor type
Individual
Name
Luis Furuya-Kanamori
Address
Australian National University Research School of Population Health 62 Mills Road Acton, ACT 2601
Country
Australia
Secondary sponsor category [1] 303085 0
None
Name [1] 303085 0
Address [1] 303085 0
Country [1] 303085 0
Other collaborator category [1] 280749 0
Individual
Name [1] 280749 0
Colleen Lau
Address [1] 280749 0
Australian National University
Research School of Population Health
62 Mills Road
Acton, ACT 2601
Country [1] 280749 0
Australia
Other collaborator category [2] 280750 0
Individual
Name [2] 280750 0
Deborah Mills
Address [2] 280750 0
Dr Deb The Travel Doctor Pt Ltd
5/247 Adelaide St, Brisbane City QLD 4000
Country [2] 280750 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303615 0
Australian National University Human Research Ethics Committee
Ethics committee address [1] 303615 0
Level 1, Geography Building, Building 48A
Linnaeus Way,The Australian National University
Acton, ACT 2601
Ethics committee country [1] 303615 0
Australia
Date submitted for ethics approval [1] 303615 0
14/06/2019
Approval date [1] 303615 0
09/09/2019
Ethics approval number [1] 303615 0
2019/451

Summary
Brief summary
Rabies is a fatal disease, present in most countries outside Australia, so poses a risk to Australian travellers. Although deaths in travellers are rare (60 reported cases 1990 – 2012 ), rabies risk exposures are relatively common (2-13/1000 travellers per month). In travellers who are aware the horrors of this untreatable disease, a potential rabies exposure can be stressful, and cause major disruption to travel plans in the quest for appropriate treatment.

Pre-exposure rabies vaccination (PrEP) simplifies the treatment of animal exposures if they occur during travel. The standard recommendations for rabies PrEP is to give 2-3 doses of vaccine prior to departure.
The Australian guidelines recommend PrEP - one dose of Rabies vaccine given on day 0,7,and 21-28. Many travellers are leaving at short notice and do not have time to complete this pre departure rabies vaccine course. Recent research has suggested that two doses or even one dose may be sufficient to prime the immune system, and simplify the post exposure treatment of at risk animal exposures. Much of the research in the past has be done on young soldiers.

There is very limited research in persons over the age of 50 years to confirm that persons in this age group mount an adequate immune response to lower doses of rabies vaccine.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94270 0
Dr Luis Furuya-Kanamori
Address 94270 0
Australian National University
Research School of Population Health
62 Mills Road
Acton, ACT 2601
Country 94270 0
Australia
Phone 94270 0
+61 (02) 6125 2145
Fax 94270 0
Email 94270 0
[email protected]
Contact person for public queries
Name 94271 0
Dr Luis Furuya-Kanamori
Address 94271 0
Australian National University
Research School of Population Health
62 Mills Road
Acton, ACT 2601
Country 94271 0
Australia
Phone 94271 0
+61 (02) 6125 2145
Fax 94271 0
Email 94271 0
[email protected]
Contact person for scientific queries
Name 94272 0
Dr Luis Furuya-Kanamori
Address 94272 0
Australian National University
Research School of Population Health
62 Mills Road
Acton, ACT 2601
Country 94272 0
Australia
Phone 94272 0
+61 (02) 6125 2145
Fax 94272 0
Email 94272 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The dataset may contain personal and medical information from the participants' that could potentially be used for re-identification. Only aggregated or summary results will be shared.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2748Ethical approval    Once the ethics approval letter is received, it wi... [More Details] 377803-(Uploaded-10-09-2019-07-39-03)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Mills DJ, Lau CL, Mills C, Furuya-Kanamori L. Effi... [More Details] 377803-(Uploaded-28-06-2021-16-29-39)-Journal results publication.pdf

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEfficacy of one-dose intramuscular rabies vaccine as pre-exposure prophylaxis in travellers.2021https://dx.doi.org/10.1093/jtm/taab059
N.B. These documents automatically identified may not have been verified by the study sponsor.