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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
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Trial registered on ANZCTR
Registration number
ACTRN12613000831785
Ethics application status
Approved
Date submitted
22/07/2013
Date registered
29/07/2013
Date last updated
4/02/2015
Type of registration
Prospectively registered
Titles & IDs
Public title
A Phase I, Proof of Concept, Open Label, Escalating Dose Study to Assess the Safety, Tolerability and Immunogenicity of a Herpes Simplex Virus (HSV) Deoxyribonucleic Acid (DNA) Vaccine
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Scientific title
A Phase I, Proof of Concept, Open Label, Escalating Dose Study to Assess the Safety, Tolerability and Immunogenicity of a Herpes Simplex Virus (HSV) Deoxyribonucleic Acid (DNA) Vaccine in Healthy Volunteers
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Secondary ID [1]
282878
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Genital Herpes
289697
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Condition category
Condition code
Infection
290019
290019
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0
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Sexually transmitted infections
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
HSV-2 DNA Vaccine
There are 5 treatment arms with the first dose being the lowest dose given to Arm 1 and then Arm 2 receives dose 3x greater than Arm 1 and then Arm 3 receives dose 10x greater than Arm 1 and then Arm 4 receives 30x greater than Arm 1 and then Arm 5 receives 100x greater than Arm 1. Each dose is given intradermally 3 times 3 weeks apart. The subject will be monitored 3 weeks post the last vaccination.
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Intervention code [1]
287580
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Prevention
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Comparator / control treatment
Immunological response post vaccination compared to baseline prior to vaccination
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Safety and tolerability. The investigator will solicit for adverse events and a diary card will be used by the subjects.
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Assessment method [1]
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Timepoint [1]
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First vaccination until study completion. Monitoring visits will take place 24h and 48h after vaccination and thereafter the subject will keep a diary card for another 5 days.
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Secondary outcome [1]
303883
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Antibody response will be measured by ELISA
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Assessment method [1]
303883
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Timepoint [1]
303883
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Antibody titres will be evaluated immediately pre vaccination and 3 weeks post vaccination after completion of dosing
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Eligibility
Key inclusion criteria
HSV-1 and 2 seronegative
Generally healthy
No birthmarks, tattoos, wounds or skin conditions on either forearm
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Minimum age
18
Years
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Maximum age
45
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Suffering acute or chronic disease
Pregant or nursing females
HSV, Hepatitis B or C, or HIV seropositive
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
5 groups receive escalating doses of the vaccine
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Phase
Phase 1
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Type of endpoint/s
Safety
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
26/08/2013
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Actual
5/08/2013
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Date of last participant enrolment
Anticipated
30/09/2013
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Actual
23/09/2013
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Funding & Sponsors
Funding source category [1]
287665
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Commercial sector/Industry
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Name [1]
287665
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Coridon Pty Ltd
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Address [1]
287665
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PO BOX 6132
BURANDA QLD 4102
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Country [1]
287665
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
Coridon Pty Ltd
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Address
PO BOX 6132
BURANDA QLD 4102
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Country
Australia
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Secondary sponsor category [1]
286401
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None
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Name [1]
286401
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Address [1]
286401
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Country [1]
286401
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
289629
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QIMR Human Research Ethics Committee
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Ethics committee address [1]
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QIMR Locked Bag 2000
Royal Brisbane and Women's Hospital
Qld 4029
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Ethics committee country [1]
289629
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Australia
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Date submitted for ethics approval [1]
289629
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14/05/2013
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Approval date [1]
289629
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21/06/2013
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Ethics approval number [1]
289629
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P1531
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Summary
Brief summary
Safety, Tolerability and Immunogenicity of a HSV DNA Vaccine
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Trial website
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Trial related presentations / publications
None
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Public notes
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Contacts
Principal investigator
Name
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Dr Paul Griffin
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Address
41634
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Q-Pharm Pty Ltd
QIMR-Clive Berghofer Cancer Research Centre
Level 5, 300 Herston Road
Herston QLD 4006
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Country
41634
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Australia
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Phone
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+61738453636
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Fax
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+61738453630
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Email
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[email protected]
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Contact person for public queries
Name
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Mr Neil Finlayson
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Address
41635
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Coridon Pty Ltd
PO BOX 6132
BURANDA QLD 4102
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Country
41635
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Australia
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Phone
41635
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+61734436996
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Fax
41635
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+61734437779
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Email
41635
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[email protected]
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Contact person for scientific queries
Name
41636
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Mr Neil Finlayson
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Address
41636
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Coridon Pty Ltd
PO BOX 6132
BURANDA QLD 4102
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Country
41636
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Australia
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Phone
41636
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+61734436996
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Fax
41636
0
+61734437779
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Email
41636
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[email protected]
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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
Source
Title
Year of Publication
DOI
Dimensions AI
Antibiotic-Free Gene Vectors: A 25-Year Journey to Clinical Trials
2024
https://doi.org/10.3390/genes15030261
N.B. These documents automatically identified may not have been verified by the study sponsor.
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