We are experiencing 4 week turn-around time in review of submissions and resubmissions. We recommend commencing this process concurrently with your ethics submission and allowing at least 8 weeks for registration to be completed from date of first submission. We currently do not have the capacity to expedite reviews.

Note also there are delays to review of updates. We appreciate your patience.

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
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
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
Secondary ID [1] 282878 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Genital Herpes 289697 0
Condition category
Condition code
Infection 290019 290019 0 0
Sexually transmitted infections

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 287580 0
Prevention
Comparator / control treatment
Immunological response post vaccination compared to baseline prior to vaccination
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290066 0
Safety and tolerability. The investigator will solicit for adverse events and a diary card will be used by the subjects.
Timepoint [1] 290066 0
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.
Secondary outcome [1] 303883 0
Antibody response will be measured by ELISA
Timepoint [1] 303883 0
Antibody titres will be evaluated immediately pre vaccination and 3 weeks post vaccination after completion of dosing

Eligibility
Key inclusion criteria
HSV-1 and 2 seronegative
Generally healthy
No birthmarks, tattoos, wounds or skin conditions on either forearm
Minimum age
18 Years
Maximum age
45 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Suffering acute or chronic disease
Pregant or nursing females
HSV, Hepatitis B or C, or HIV seropositive

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)
Allocation is not concealed
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
Other
Other design features
5 groups receive escalating doses of the vaccine
Phase
Phase 1
Type of endpoint(s)
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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

Funding & Sponsors
Funding source category [1] 287665 0
Commercial sector/Industry
Name [1] 287665 0
Coridon Pty Ltd
Address [1] 287665 0
PO BOX 6132
BURANDA QLD 4102
Country [1] 287665 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Coridon Pty Ltd
Address
PO BOX 6132
BURANDA QLD 4102
Country
Australia
Secondary sponsor category [1] 286401 0
None
Name [1] 286401 0
Address [1] 286401 0
Country [1] 286401 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289629 0
QIMR Human Research Ethics Committee
Ethics committee address [1] 289629 0
QIMR Locked Bag 2000
Royal Brisbane and Women's Hospital
Qld 4029
Ethics committee country [1] 289629 0
Australia
Date submitted for ethics approval [1] 289629 0
14/05/2013
Approval date [1] 289629 0
21/06/2013
Ethics approval number [1] 289629 0
P1531

Summary
Brief summary
Safety, Tolerability and Immunogenicity of a HSV DNA Vaccine
Trial website
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 41634 0
Dr Paul Griffin
Address 41634 0
Q-Pharm Pty Ltd
QIMR-Clive Berghofer Cancer Research Centre
Level 5, 300 Herston Road
Herston QLD 4006
Country 41634 0
Australia
Phone 41634 0
+61738453636
Fax 41634 0
+61738453630
Email 41634 0
p.griffin@qpharm.com.au
Contact person for public queries
Name 41635 0
Mr Neil Finlayson
Address 41635 0
Coridon Pty Ltd
PO BOX 6132
BURANDA QLD 4102
Country 41635 0
Australia
Phone 41635 0
+61734436996
Fax 41635 0
+61734437779
Email 41635 0
enquiries@coridon.com
Contact person for scientific queries
Name 41636 0
Mr Neil Finlayson
Address 41636 0
Coridon Pty Ltd
PO BOX 6132
BURANDA QLD 4102
Country 41636 0
Australia
Phone 41636 0
+61734436996
Fax 41636 0
+61734437779
Email 41636 0
neil.finlayson@coridon.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary