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
ACTRN12619000945123
Ethics application status
Approved
Date submitted
20/06/2019
Date registered
5/07/2019
Date last updated
30/05/2022
Date data sharing statement initially provided
5/07/2019
Date results information initially provided
30/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Travellers Rabies Intra Dermal Later testing & boosting of blood antibodies
Scientific title
Travellers Rabies Intra Dermal Later testing & boosting of blood antibodies
Secondary ID [1] 298554 0
None
Universal Trial Number (UTN)
Trial acronym
TRIDL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rabies 313381 0
Condition category
Condition code
Infection 311816 311816 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intradermal (deltoid) administration of a booster dose of 0.1ml of Merieux Inactivated Rabies Vaccine (lyophilised, stabilised suspension containing not less than 2.5 international units of inactivated Wistar rabies virus strain per 1ml) to participants that received a modified intradermal course of rabies vaccine more than 5 years ago
Intervention code [1] 314809 0
Prevention
Comparator / control treatment
Intradermal (deltoid) administration of a booster dose of 0.1ml of Merieux Inactivated Rabies Vaccine (lyophilised, stabilised suspension containing not less than 2.5 international units of inactivated Wistar rabies virus strain per 1ml) to participants that received a standard course of rabies vaccine more than 5 years ago
Control group
Active

Outcomes
Primary outcome [1] 320488 0
Antibodies titer levels to rabies virus (IU/mL) using serum assay (Platelia Rabies II ELISA)
Timepoint [1] 320488 0
14 days after the intradermal booster
Secondary outcome [1] 371778 0
Antibodies titer levels to rabies virus (IU/mL) using serum assay (Platelia Rabies II ELISA)
Timepoint [1] 371778 0
7 days after the intradermal booster
Secondary outcome [2] 372023 0
Self-reported side effects of the intradermal booster (e.g. injection site reactions [pain, swelling, itchining, or redness], headache, dizziness, muscle pain, nausea)
Timepoint [2] 372023 0
14 days after the intradermal booster

Eligibility
Key inclusion criteria
1. Intradermal rabies course more than 5 years ago, and no further boosters during that time
2. Able to give written Informed Consent and sign consent after all aspects of the protocol explained
3. Subject must agree to receive a booster dose, have two blood tests and a planned follow-up telephone review.
4. Subjects need to be enrolled at least 14 days prior to departure
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Previous adverse reactions to rabies vaccine
2. Taking medications that impair the normal functioning of the immune system
3. Pregnancy or planning pregnancy

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
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2019
Actual
2/04/2020
Date of last participant enrolment
Anticipated
30/07/2021
Actual
22/06/2021
Date of last data collection
Anticipated
31/08/2021
Actual
29/06/2021
Sample size
Target
215
Accrual to date
Final
158
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 303097 0
Other
Name [1] 303097 0
Dr Deb The Travel Doctor Pt Ltd
Country [1] 303097 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] 303150 0
None
Name [1] 303150 0
Address [1] 303150 0
Country [1] 303150 0
Other collaborator category [1] 280751 0
Individual
Name [1] 280751 0
Colleen Lau
Address [1] 280751 0
Australian National University
Research School of Population Health
62 Mills Road
Acton, ACT 2601
Country [1] 280751 0
Australia
Other collaborator category [2] 280752 0
Individual
Name [2] 280752 0
Deborah Mills
Address [2] 280752 0
Dr Deb The Travel Doctor Pt Ltd
5/247 Adelaide St, Brisbane City QLD 4000
Country [2] 280752 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303641 0
Australian National University Human Research Ethics Committee
Ethics committee address [1] 303641 0
Level 1, Geography Building, Building 48A
Linnaeus Way,The Australian National University
Acton ACT 2601
Ethics committee country [1] 303641 0
Australia
Date submitted for ethics approval [1] 303641 0
14/06/2019
Approval date [1] 303641 0
09/09/2019
Ethics approval number [1] 303641 0
2019/453

Summary
Brief summary
The use of Intradermal (ID) rabies vaccine was described in 1976, with the promise of allowing cheaper protection from a disease, which has been feared throughout history. 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.

The standard Pre Exposure Rabies vaccination course (PrEP) of one dose ID vaccine on day 0,7,21-28 has been recommended for some time. A modified ID course of two doses of ID rabies vaccine on day 0, and 7 with one dose on day 21-28 has been documented in our clinic and published in 2011 [Mills et al. Journal of Travel Medicine. 2011;18(5):327–332].

This project aims to document the long term persistence and boostability of rabies antibodies in travellers who have had a course of ID rabies vaccine.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94366 0
Dr Luis Furuya-Kanamori
Address 94366 0
Australian National University
Research School of Population Health
62 Mills Road
Acton, ACT 2601
Country 94366 0
Australia
Phone 94366 0
+61 (02) 6125 2145
Fax 94366 0
Email 94366 0
[email protected]
Contact person for public queries
Name 94367 0
Dr Luis Furuya-Kanamori
Address 94367 0
Australian National University
Research School of Population Health
62 Mills Road
Acton, ACT 2601
Country 94367 0
Australia
Phone 94367 0
+61 (02) 6125 2145
Fax 94367 0
Email 94367 0
[email protected]
Contact person for scientific queries
Name 94368 0
Dr Luis Furuya-Kanamori
Address 94368 0
Australian National University
Research School of Population Health
62 Mills Road
Acton, ACT 2601
Country 94368 0
Australia
Phone 94368 0
+61 (02) 6125 2145
Fax 94368 0
Email 94368 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
2749Ethical approval    Once the ethics approval letter is received, it wi... [More Details] 377827-(Uploaded-10-09-2019-07-42-59)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Long-term persistence of antibodies and boostabili... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseLong-term persistence of antibodies and boostability after rabies intradermal pre-exposure prophylaxis.2022https://dx.doi.org/10.1093/jtm/taab188
N.B. These documents automatically identified may not have been verified by the study sponsor.