Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001090909
Ethics application status
Approved
Date submitted
7/10/2011
Date registered
20/10/2011
Date last updated
20/10/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Safety and effectiveness of boosting healthy adults with new cell-culture-derived JE vaccine (JESPECT), where mouse-brain-derived vaccine (JEVAX) has previously been administered.
Scientific title
Safety and immunogenicity of inactivated vero-cell-derived Japanese encephalitis vaccine in military personnel previously vaccinated with inactivated mouse-brain-derived JE vaccine.
Secondary ID [1] 273176 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Japanese encephalitis 278928 0
Condition category
Condition code
Public Health 279108 279108 0 0
Other public health
Infection 279109 279109 0 0
Other infectious diseases
Inflammatory and Immune System 279144 279144 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Administration of TGA-approved vero-cell-derived JE vaccine (VCDV) in standard primary schedule of two 0.5 mL intramuscular doses 28 days apart, as recommended by the manufacturer. All participants had previously been vaccinated with mouse-brain-derived JE vaccine (MBDV), and were due for boosting.
Intervention code [1] 269507 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 279748 0
Tolerability of VCDV in prior MBDV recipients. This is assessed via questionairre addressing local and systemic effects at the time of the second VCDV dose, and by medical chart audit at 14 days post second dose.
Timepoint [1] 279748 0
Up to 14 days post second dose of VCDV.
Primary outcome [2] 279749 0
JE immunogenicity, as measured by PRNT50.
Timepoint [2] 279749 0
28 days post first dose of VCDV. Baseline immunogenicity is also assessed on serum taken at day 0.
Secondary outcome [1] 294361 0
Nil
Timepoint [1] 294361 0
Nil

Eligibility
Key inclusion criteria
1) Previous MBDV vaccinee, due for boosting (3-5 years post last dose).
2) Volunteer in 'short-notice-to-move' military unit which requires currency with JE vaccination.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Pregnancy
2) Lactation
3) Administration of any vaccine 30 days prior to VCDV administration
4) Serious ADR to a previous vaccine
5) Acute febrile illness
6) Known or suspected immune deficiency

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/09/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 270001 0
Self funded/Unfunded
Name [1] 270001 0
Nil
Country [1] 270001 0
Primary sponsor type
Individual
Name
Csongor Oltvolgyi
Address
1 Expeditionary Health Squadron - Detachment Townsville
RAAF Base Townsville
Ingham Rd
Townsville QLD 4814
Country
Australia
Secondary sponsor category [1] 268981 0
Individual
Name [1] 268981 0
Peter Nasveld
Address [1] 268981 0
Centre for Military and Veterans' Health
The University of Queensland
Mayne Medical School
Herston Road
Herston QLD 4006
Country [1] 268981 0
Australia
Other collaborator category [1] 252284 0
Individual
Name [1] 252284 0
John Aaskov
Address [1] 252284 0
Army Malaria Institute
Weary Dunlop Drive
Gallipoli Barracks
Enoggera QLD 4051
Country [1] 252284 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271961 0
Australian Defence Human Research Ethics Committee
Ethics committee address [1] 271961 0
ADHREC
CP2-6-104
Campbell Park Offices
Campbell ACT 2600
Ethics committee country [1] 271961 0
Australia
Date submitted for ethics approval [1] 271961 0
Approval date [1] 271961 0
10/08/2009
Ethics approval number [1] 271961 0
1/09/0548
Ethics committee name [2] 271962 0
University of Queensland Medical Research Ethics Committee
Ethics committee address [2] 271962 0
The University of Queensland MREC
Cumbrae-Stewart Building
Research Road
Brisbane QLD 4072
Ethics committee country [2] 271962 0
Australia
Date submitted for ethics approval [2] 271962 0
Approval date [2] 271962 0
21/08/2009
Ethics approval number [2] 271962 0
2009001368

Summary
Brief summary
With the cessation of manufacture of MBDV in 2005, alternative JE vaccines were developed, including the VCDV approved by the TGA in Jan 2009. This vaccine was selected by the Australian Defence Force to continue its program of JE vaccination of members on 'short-notice-to-move'. Prior to this study there were no published reports of tolerability and immunogenicity of VCDV in previous MBDV vaccinees.

Military volunteers who had previously received MBDV and were due for boosting were invited to take part in the study (the alternative was to have a single booster dose of MBDV from remaining stocks). The full primary course of two doses of VCDV 28 days apart was provided to each participant (shown by the manufacturer to be effective at inducing immunogenicity), and blood was drawn prior to each dose for PRNT50 assays of immunogenicity. This was done in order to determine whether a single dose of VCDV was effective as a 'booster' dose, as measured at 28 days. The aim of the study was to determine tolerability of the vaccine in this population, and to determine whether a single dose of VCDV would be adequate to boost immunogenicity in this population.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 33247 0
Address 33247 0
Country 33247 0
Phone 33247 0
Fax 33247 0
Email 33247 0
Contact person for public queries
Name 16494 0
Csongor Oltvolgyi
Address 16494 0
1 Expeditionary Health Squadron - Detachment Townsville
RAAF Base Townsville
Ingham Rd
Townsville QLD 4814
Country 16494 0
Australia
Phone 16494 0
+61(7)47521410
Fax 16494 0
Email 16494 0
[email protected]
Contact person for scientific queries
Name 7422 0
Csongor Oltvolgyi
Address 7422 0
1 Expeditionary Health Squadron - Detachment Townsville
RAAF Base Townsville
Ingham Rd
Townsville QLD 4814
Country 7422 0
Australia
Phone 7422 0
+61(7)47521410
Fax 7422 0
Email 7422 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.