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Trial registered on ANZCTR


Registration number
ACTRN12615000094572
Ethics application status
Approved
Date submitted
14/01/2015
Date registered
4/02/2015
Date last updated
24/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomized, double blind, placebo-controlled, parallel group, pilot study to assess the safety and efficacy of a therapeutic Herpes Simplex Virus-2 (HSV-2) Deoxyribonucleic Acid (DNA) vaccine in HSV-2 positive adults
Scientific title
A Phase l/IIa, randomized, double blind, placebo-controlled, parallel group, pilot study to assess the safety and efficacy of a therapeutic HSV-2 DNA vaccine in HSV-2 positive adults
Secondary ID [1] 285967 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Genital Herpes 293899 0
Condition category
Condition code
Infection 294207 294207 0 0
Sexually transmitted infections

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
HSV-2 DNA Vaccine
Two injection regimens of the HSV-2 DNA vaccine will be compared with placebo, administered by intradermal injection as three, 4-weekly doses followed by a 6-month booster. The first injection regime will consist of subjects receiving an injection to each forearm. Once this is fully allocated, the second injection regime will commence recruiting. The second injection regime consists of two injections into the one forearm. Each injection will contain a dose of 500 mcg
Intervention code [1] 290943 0
Treatment: Other
Comparator / control treatment
Placebo vaccine
Two injection regimens of the placebo vaccine will be compared with the active vaccine, administered by intradermal injection as three, 4-weekly doses followed by a 6-month booster. The first injection regime will consist of subjects receiving an injection to each forearm. Once this is fully allocated, the second injection regime will commence recruiting. The second injection regime consists of two injections into the one forearm.
Control group
Placebo

Outcomes
Primary outcome [1] 293992 0
Safety. Possible adverse events include erythema, induration and pain at the injection site
Timepoint [1] 293992 0
The incidence and severity of adverse events in each treatment group, including vaccine related adverse events will be measured from enrollment until approximately 6 months after the booster injection. Possible adverse events include injection site reactions. The Principal Investigator will closely monitor these. There will also be a Data Safety Monitoring Review Committee that will meet regularly
Secondary outcome [1] 312321 0
Immunogenicity. Immune responses to HSV gD2 antigens will be measured using ELISA and ELISPOT assays
Timepoint [1] 312321 0
Antibody responses will be measured prior to vaccination and 4 weeks after each vaccination. Cell mediated responses will be measured at baseline and 1 week after each vaccination and at end of study visit 6 months post final vaccination

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects will be randomised in a 3:1 ratio to receive either investigational vaccine or placebo. Central randomization by computer will be used to allocate the patient into either the vaccine or placebo group
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Given the pilot and exploratory nature of the study, the focus of the statistical analysis will be descriptive rather than hypotheses testing

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
Recruitment postcode(s) [1] 9111 0
4006 - Herston

Funding & Sponsors
Funding source category [1] 290558 0
Commercial sector/Industry
Name [1] 290558 0
Admedus Vaccines Pty Ltd
Address [1] 290558 0
PO Box 836
Stones Corner QLD 4120
Country [1] 290558 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Admedus Vaccines Pty Ltd
Address
PO Box 836
Stones Corner QLD 4120
Country
Australia
Secondary sponsor category [1] 289250 0
None
Name [1] 289250 0
Nil
Address [1] 289250 0
Nil
Country [1] 289250 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292202 0
QIMR Berghofer Medical Research Institute HREC
Ethics committee address [1] 292202 0
QIMR Locked Bag 2000
Royal Brisbane and Women's Hospital
Qld 4029
Ethics committee country [1] 292202 0
Australia
Date submitted for ethics approval [1] 292202 0
04/11/2014
Approval date [1] 292202 0
22/12/2014
Ethics approval number [1] 292202 0
P2079

Summary
Brief summary
The aim of this study is to assess the safety and tolerability of the HSV-2 DNA vaccine. We will also investigate whether the vaccine is immunogenic i.e. if it has any effect on the immune system and what type of response is induced. The study will also investigate the vaccine’s effectiveness in combating and/or treating HSV-2 infection
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54022 0
Dr Paul Griffin
Address 54022 0
Q-Pharm Pty Ltd
Level 5
QIMR-Clive Berghofer Cancer Research Centre
300C Herston Road Herston QLD 4006
Country 54022 0
Australia
Phone 54022 0
+61738453636
Fax 54022 0
+61738453630
Email 54022 0
p.griffin@qpharm.com.au
Contact person for public queries
Name 54023 0
Mr Neil Finlayson
Address 54023 0
Admedus Vaccines Pty Ltd
PO Box 836
Stones Corner QLD 4120
Country 54023 0
Australia
Phone 54023 0
+61734436996
Fax 54023 0
+61734437779
Email 54023 0
nfinlayson@admedusvaccines.com
Contact person for scientific queries
Name 54024 0
Mr Neil Finlayson
Address 54024 0
Admedus Vaccines Pty Ltd
PO Box 836
Stones Corner QLD 4120
Country 54024 0
Australia
Phone 54024 0
+61734436996
Fax 54024 0
+61734437779
Email 54024 0
nfinlayson@admedusvaccines.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