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Trial registered on ANZCTR


Registration number
ACTRN12621000024842p
Ethics application status
Submitted, not yet approved
Date submitted
13/11/2020
Date registered
14/01/2021
Date last updated
14/01/2021
Date data sharing statement initially provided
14/01/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Seroconversion with Japanese encephalitis vaccine via intradermal route in healthy individuals
Scientific title
Seroconversion with Japanese encephalitis vaccine via intradermal route in healthy individuals
Secondary ID [1] 302744 0
None
Universal Trial Number (UTN)
Trial acronym
JEVID - Japanese Encephalitis Vaccination via IntraDermal route
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Japanese encephalitis 319682 0
Condition category
Condition code
Infection 317611 317611 0 0
Other infectious diseases
Neurological 317979 317979 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
0.1 ml of Imojev® (live attenuated Japanese encephalitis vaccine) once via intradermal administration.
Each 0.5 mL reconstituted dose of Imojev® contains 4.0–5.8 log plaque-forming units of live attenuated recombinant Japanese encephalitis, mannitol, lactose, glutamic acid, potassium hydroxide, histidine, and human serum albumin.
Intervention code [1] 319028 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325658 0
Seroconversion measured using Japanese encephalitis virus neutralizing antibody response using plaque reduction neutralization 50%. Participants will return to the clinic and peripheral venous blood samples (~5ml) will be collected by the nurses.
Timepoint [1] 325658 0
56 days post-vaccine administration
Secondary outcome [1] 388702 0
Seroconversion measured using Japanese encephalitis virus neutralizing antibody response using plaque reduction neutralization 50%. Participants will return to the clinic and peripheral venous blood samples (~5ml) will be collected by the nurses.
Timepoint [1] 388702 0
28 days post-vaccine administration
Secondary outcome [2] 388703 0
Self-reported adverse events as documented by the nurses in the follow-up using a study-specific questionnaire
Timepoint [2] 388703 0
10 days post-vaccine administration

Eligibility
Key inclusion criteria
Able to give written informed consent after all aspects of the protocol have been explained.
Between 18 and 45 years of age.
No prior history of Japanese encephalitis vaccination.
No serious uncontrolled medical conditions (as determined by a travel medicine doctor).
Minimum age
18 Years
Maximum age
45 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Previous Japanese encephalitis vaccine.
Previous dengue and/or yellow fever vaccine, or planning to have any of these vaccines during the next two months.
Live vaccine in the month prior, or planning to have during the next two months.
Contraindication for Japanese encephalitis vaccine.
Contraindication for live vaccines.
History of dengue fever.
Taking medications (e.g. TNF inhibitors, methotrexate, or steroids) or medical conditions that impair the normal functioning of the immune system.
Pregnancy or planning pregnancy.
Breastfeeding.
Lived in Japanese encephalitis risk area for more than a year.
Travelling or planning to travel to areas of high risk for Japanese encephalitis within the next two months.

Study design
Purpose of the study
Treatment
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 31938 0
4000 - Brisbane City

Funding & Sponsors
Funding source category [1] 307167 0
Other
Name [1] 307167 0
Dr Deb The Travel Doctor Pt Ltd
Address [1] 307167 0
5/247 Adelaide St, Brisbane City QLD 4000
Country [1] 307167 0
Australia
Primary sponsor type
Individual
Name
Luis Furuya-Kanamori
Address
Research School of Population Health
Australian National University
62 Mills Road
Acton, ACT 2601
Country
Australia
Secondary sponsor category [1] 307762 0
None
Name [1] 307762 0
Address [1] 307762 0
Country [1] 307762 0
Other collaborator category [1] 281530 0
Individual
Name [1] 281530 0
Deborah Mills
Address [1] 281530 0
Dr Deb The Travel Doctor Pt Ltd
5/247 Adelaide St, Brisbane City QLD 4000
Country [1] 281530 0
Australia
Other collaborator category [2] 281531 0
Individual
Name [2] 281531 0
Colleen Lau
Address [2] 281531 0
Australian National University
Research School of Population Health
62 Mills Road
Acton, ACT 2601
Country [2] 281531 0
Australia
Other collaborator category [3] 281532 0
Individual
Name [3] 281532 0
Gregor Devine
Address [3] 281532 0
QIMR Berghofer
300 Herston Road, Herston, Queensland 4006
Country [3] 281532 0
Australia
Other collaborator category [4] 281533 0
Individual
Name [4] 281533 0
Leon Hugo
Address [4] 281533 0
QIMR Berghofer
300 Herston Road, Herston, Queensland 4006
Country [4] 281533 0
Australia
Other collaborator category [5] 281534 0
Individual
Name [5] 281534 0
Narayan Gyawali
Address [5] 281534 0
QIMR Berghofer
300 Herston Road, Herston, Queensland 4006
Country [5] 281534 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 307281 0
Australian National University Human Research Ethics Committee
Ethics committee address [1] 307281 0
Level 1, Geography Building, Building 48A
Linnaeus Way,The Australian National University
Acton ACT 2601
Ethics committee country [1] 307281 0
Australia
Date submitted for ethics approval [1] 307281 0
10/11/2020
Approval date [1] 307281 0
Ethics approval number [1] 307281 0

Summary
Brief summary
Japanese encephalitis (JE) is a mosquito-borne disease caused by Japanese encephalitis virus (JEV), an arbovirus from the flavivirus genus, family flaviviridae. It is estimated that in 2015 JEV caused more than 100,000 JE cases and 25,000 deaths worldwide. JE is endemic in Asia and Papua New Guinea, and outbreaks have occurred in the Torres Strait Islands. Although the current recommendation is that travellers spending one month or more in endemic regions during the wet season consider vaccination against JEV, there have been many reports of JEV infection in travellers after much shorter trips, including those limited to popular tourist destinations.
Effective JE vaccines with low rates of local and systemic adverse events have become available in recent years (e.g. Imojev® [live attenuated recombinant JE vaccine, Sanofi-Aventis], JEspect® [inactivated vero cell vaccine, Valneva). Despite this, the uptake of JE vaccines by travellers remain low. An internal clinical audit of over 1000 medical records at an Australian travel medicine clinic revealed that less than 30% of travellers to JE endemic areas received the vaccine. The high cost of the main vaccine used in Australia (approx. AU$ 300 for Imojev®) is likely to be one of the main reasons for the low uptake.
JE vaccines are administered via subcutaneous (SC) or intramuscular (IM) injections; however, intradermal (ID) administration of other vaccines using smaller doses have been shown to be as effective as SC administration for other viruses, e.g. yellow fever (another flavivirus) and rabies. ID administration is widely used for rabies vaccines, and is now recommended by the World Health Organization for both pre- and post-exposure prophylaxis. We conducted a systematic review and meta-analysis and found that the odds of seroconversion after JE vaccine were similar when administered SC or ID (using 20% of SC dose). However, none of the vaccines used in studies included in the meta-analysis are currently available in Australia.
The ID route would be certainly less expensive than the SC and IM routes of administration, and potentially increase vaccination uptake among travellers. Therefore, we aim to explore whether ID could potentially be an economical yet effective route of administration for JE vaccine.
Our hypothesis is that the seroconversion rate with 0.1ml ID Imojev® (i.e. 20% of the standard SC dose) would be similar to the standard dose of 0.5ml via SC.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106670 0
Dr Luis Furuya-Kanamori
Address 106670 0
Australian National University
Research School of Population Health
62 Mills Road
Acton, ACT 2601
Country 106670 0
Australia
Phone 106670 0
+61 02 6125 2145
Fax 106670 0
Email 106670 0
Luis.Furuya-Kanamori@anu.edu.au
Contact person for public queries
Name 106671 0
Dr Luis Furuya-Kanamori
Address 106671 0
Australian National University
Research School of Population Health
62 Mills Road
Acton, ACT 2601
Country 106671 0
Australia
Phone 106671 0
+61 02 6125 2145
Fax 106671 0
Email 106671 0
Luis.Furuya-Kanamori@anu.edu.au
Contact person for scientific queries
Name 106672 0
Dr Luis Furuya-Kanamori
Address 106672 0
Australian National University
Research School of Population Health
62 Mills Road
Acton, ACT 2601
Country 106672 0
Australia
Phone 106672 0
+61 02 6125 2145
Fax 106672 0
Email 106672 0
Luis.Furuya-Kanamori@anu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 9677 0
Ethical approval
Citation [1] 9677 0
Link [1] 9677 0
Email [1] 9677 0
Other [1] 9677 0
Once the ethics approval letter is received, it will be made available on ANZCTR.
Attachment [1] 9677 0
Summary results
No Results