ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12621000024842

Ethics application status

Approved

Date submitted

13/11/2020

Date registered

14/01/2021

Date last updated

1/11/2022

Date data sharing statement initially provided

14/01/2021

Date results provided

1/11/2022

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]

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

Condition category

Condition code

Infection

Other infectious diseases

Neurological

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]

Treatment: Drugs

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

56 days post-vaccine administration

Secondary outcome [1]

Timepoint [1]

28 days post-vaccine administration

Secondary outcome [2]

Self-reported adverse events as documented by the nurses in the follow-up using a study-specific questionnaire

Timepoint [2]

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

Sex

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

Completed

Date of first participant enrolment

Anticipated

1/04/2021

Actual

7/05/2021

Date of last participant enrolment

Anticipated

Actual

3/05/2022

Date of last data collection

Anticipated

29/07/2022

Actual

18/07/2022

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment postcode(s) [1]

4000 - Brisbane City

Funding & Sponsors

Funding source category [1]

Other

Name [1]

Dr Deb The Travel Doctor Pt Ltd

Address [1]

5/247 Adelaide St, Brisbane City QLD 4000

Country [1]

Australia

Primary sponsor type

University

Name

The University of Queensland

Address

The University of Queensland
Brisbane QLD 4072 Australia

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Individual

Name [1]

Deborah Mills

Address [1]

Dr Deb The Travel Doctor Pt Ltd
5/247 Adelaide St, Brisbane City QLD 4000

Country [1]

Australia

Other collaborator category [2]

Individual

Name [2]

Colleen Lau

Address [2]

Australian National University
Research School of Population Health
62 Mills Road
Acton, ACT 2601

Country [2]

Australia

Other collaborator category [3]

Individual

Name [3]

Gregor Devine

Address [3]

QIMR Berghofer
300 Herston Road, Herston, Queensland 4006

Country [3]

Australia

Other collaborator category [4]

Individual

Name [4]

Leon Hugo

Address [4]

QIMR Berghofer
300 Herston Road, Herston, Queensland 4006

Country [4]

Australia

Other collaborator category [5]

Individual

Name [5]

Narayan Gyawali

Address [5]

QIMR Berghofer
300 Herston Road, Herston, Queensland 4006

Country [5]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Australian National University Human Research Ethics Committee

Ethics committee address [1]

Level 1, Geography Building, Building 48A
Linnaeus Way,The Australian National University
Acton ACT 2601

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

10/11/2020

Approval date [1]

15/01/2021

Ethics approval number [1]

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

Dr Luis Furuya-Kanamori

Address

Australian National University
Research School of Population Health
62 Mills Road
Acton, ACT 2601

Country

Australia

Phone

+61 02 6125 2145

Fax

[email protected]

Contact person for public queries

Name

Luis Furuya-Kanamori

Address

Australian National University
Research School of Population Health
62 Mills Road
Acton, ACT 2601

Country

Australia

Phone

+61 02 6125 2145

Fax

[email protected]

Contact person for scientific queries

Name

Luis Furuya-Kanamori

Address

Australian National University
Research School of Population Health
62 Mills Road
Acton, ACT 2601

Country

Australia

Phone

+61 02 6125 2145

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
9677	Ethical approval				Once the ethics approval letter is received, it wi... [More Details]	380903-(Uploaded-27-01-2021-12-36-11)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	The Emergence of Japanese Encephalitis in Australia and the Implications for a Vaccination Strategy.	2022	https://dx.doi.org/10.3390/tropicalmed7060085
Embase	Immunogenicity of a single fractional intradermal dose of Japanese encephalitis live attenuated chimeric vaccine.	2023	https://dx.doi.org/10.1093/jtm/taac122

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically