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Trial registered on ANZCTR


Registration number
ACTRN12620000179932
Ethics application status
Approved
Date submitted
5/12/2019
Date registered
17/02/2020
Date last updated
17/02/2020
Date data sharing statement initially provided
17/02/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
A first-in-human study to evaluate the safety and performance of placebo excipient-coated high-density microarray patches applied by an integrated application device.
Scientific title
A first-in-human study to evaluate the safety and performance of placebo excipient-coated high-density microarray patches applied by an integrated application device.
Secondary ID [1] 299967 0
none
Universal Trial Number (UTN)
U1111-1244-7606
Trial acronym
none
Linked study record
none

Health condition
Health condition(s) or problem(s) studied:
Vaccinations 315425 0
Condition category
Condition code
Public Health 313724 313724 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The vaccine delivery device consists of two parts. The first part is the 1cm² patch that has a series of micro-projections that hold the vaccine coating (placebo in this study). The second part is an applicator device that holds the patch in place and applies it to the skin.
the study is in 2 parts: Part A will be completed before recruitment to part B starts. Subjects in part A cannot re enter into part B
Part A:
Group A: Twenty subjects receive six gas-jet coated High Density Micro Array patches (HD-MAPs): one on each of the volar forearm, upper arm (over the deltoid muscle), and posterior shoulder (over the upper trapezius muscle) on each side of the body. A trained user will apply a HD-MAP to each anatomical site on the side of the body of the subject’s dominant hand. The subject will self-administer a HD-MAP to each site on the opposite side of the body, at the same sites. All applications are for 30 seconds.
Part B:
Forty subjects receive six Micro jet (MJet) coated HD-MAPs: one on each of the volar forearm, upper arm (over the deltoid muscle), and posterior shoulder (over the upper trapezius muscle). On one side of the body MAP applications will be 30 seconds. For 20 of these subjects, MAP applications will be 10 seconds on the opposite side of the body. For 20 of these subjects MAP applications will be 2 seconds on the opposite side of the body. This will be determined sequentially.

There is no active vaccination delivered in this study
Intervention code [1] 316231 0
Treatment: Devices
Comparator / control treatment
There is no control group, the Device under study is a placebo device (ie no active ingredient). comparisons between the observed effects at different skin sites will be noted but the device is the same throughout the study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322193 0
Primary study endpoint (outcome)
• Number of subjects with SAEs deemed possibly, probably, or definitely related to treatment administration.
• Number of subjects with AEs deemed possibly, probably, or definitely related to treatment administration.
• Local skin response (erythema, oedema, redness extent, induration, skin flaking, application site visibility) and photo imaging thirty minutes post-application. Local skin response and other recorded adverse events will be assessed at Day 7 (±1 day). Any local skin responses still present at Day 28 (±2 days) will be followed up to resolution, or until the subject is lost to follow-up.
the outcome for Part A is the same as for Part B but with an increased number of subjects in part B
Timepoint [1] 322193 0
30 mins post application, Day 7 post application and Day 28 post application
Secondary outcome [1] 377654 0
Post-application analysis of HD-MAP engagement with skin using Scanning Electron Microscopy (SEM).

the outcome for Part A is the same as for Part B but with an increased number of subjects in part B
Timepoint [1] 377654 0
30 mins post application, Day 7 post application and Day 28 post application
Secondary outcome [2] 379860 0
Post-application analysis of delivered dose from HD-MAP to skin using residual fluorescein sodium dye on the HD-MAP.
Timepoint [2] 379860 0
30 mins post application, Day 7 post application and Day 28 post application
Secondary outcome [3] 379861 0
Skin assessment using non-invasive methods, such as dermatoscope, Trans epidermal water loss and Epsilon.
Timepoint [3] 379861 0
30 mins post application, Day 7 post application and Day 28 post application

Eligibility
Key inclusion criteria
1. Aged 18-64 years (inclusive).
2. Subject has a Body Mass Index (BMI) within the range 18.0–34.9 kg/m².
3. Satisfactory medical assessment, with no clinically significant or relevant abnormalities in medical history, physical examination, and vital signs.
4. Females of childbearing potential and males should either be sexually inactive (abstinent) for 14 days prior to Day 0 and throughout the study or be using one of the following acceptable birth control methods:
i. Surgically sterile (hysterectomy and/or bilateral oophorectomy);
ii. Surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to study initiation);
iii. IUD in place for at least 3 months;
iv. Stable hormonal contraceptive for at least 3 months prior to study through study completion;
v. Surgical sterilization (vasectomy) for male participants or for female participant’s partner at least 6 months prior to study
vi. Condom for male participant together with effective contraception for their female partner.
5. Postmenopausal women must have had at least 12 months since their last menstrual period
6. Subject can communicate effectively with study personnel and is considered reliable, willing, and cooperative in terms of compliance with the protocol requirements.
7. Subject is able and willing to provide written, personally signed and dated informed consent to participate in the study.
Minimum age
18 Years
Maximum age
64 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Subject with birthmarks, tattoos, wounds, scars, moles, blemishes, heavy hair or other skin conditions (such as eczema or sunburn) on forearms, upper arms, or posterior shoulder regions (both arms) which could reasonably obscure potential application sites
2. Subject with known chronic spontaneous urticaria / dermographism
3. Subject with known allergy/sensitivity to ingredients, including gold
4. Previous adverse reaction to fluorescein or synthetic dyes
5. Known predisposition to keloid scar formation
6. History of granulomatous diseases (especially sarcoidosis and granuloma annulare)
7. History of clinically significant gastrointestinal, hepatic, renal, cardiovascular, dermatological, immunological, respiratory, endocrine, oncological, neurological, metabolic, psychiatric disease, or haematological disorders
8. History of malignancy, other than basal cell skin cancer.
9. An active medical condition (which is deemed as clinically significant) that is under evaluation or treatment, or a recent illness, a chronic illness, or an autoimmune disease
10. History of Hepatitis B, Hepatitis C, or HIV infection
11. History of abnormal bleeding tendencies or thrombophlebitis unrelated to venepuncture or intravenous cannulation
12. Receiving chronic treatment with immune-suppressive therapy (asthma inhalers and topical corticosteroids are permitted). All medications will be documented and reviewed for acceptance by the Investigator or a medically qualified nominee
13. History of any psychiatric illness or psychological disorder which may impair the ability to provide written informed consent or participate in the study
14. Subject has donated blood or plasma or clinically significant blood loss within 60 days prior to screening visit
15. Subject has received blood or plasma within 60 days prior to screening visit
16. Subject is pregnant or breast-feeding
17. A history of alcohol or drug abuse in the last 12 months or current alcohol consumption is >4 standard drinks (or equivalent) per day
18. Use of any prescription medication (except for contraceptives) within 7 days, unless approved by the PI. All medications will be documented and reviewed for acceptance by the PI or a medically qualified nominee
19. Use of any investigational drug or device within 30 days or 5 half-lives of the drug, whichever is longer, prior to the Day 0
20. A Vaxxas employee

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 not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Allocation into study groups will be done sequentially.
Phase
Not Applicable
Type of endpoint(s)
Safety
Statistical methods / analysis
All collected subject information will be included within subject listings and summarized in tables with treatment received (forearm, upper arm, and trapezius applications).
Treatment site reaction and skin irritation index will be summarised at each assessment time. Comparisons between degree of engagement and estimated delivery efficiency at sites of application will be analysed using appropriate statistical tests.
Descriptive statistics of demographics (age, height and weight at screening, race/ethnic origin) will be presented. Medical history information collected at screening will be listed. All adverse events will be listed by subject and will include details of the onset date and time, duration, severity, causality and treatment/medications administered.
Vital signs (blood pressure, heart rate, and oral temperature) will be listed by subject and summarised in tables by treatment group.
Physical examination data will be listed by subject.
Local reactions will be listed by subject and summarised in tables by treatment group.
Concomitant medications will be entered as Trade names and coded using the WHO DD according to the ATC codes. All medications will be listed by subject, start and stop date and time, end date and time, dose, route of administration and reason for administration.

Recruitment
Recruitment status
Recruiting
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 hospital [1] 15410 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 28731 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 304427 0
Commercial sector/Industry
Name [1] 304427 0
Vaxxas Pty Ltd
Address [1] 304427 0
Vaxxas Pty Ltd
Suite 13.02, Level 13, 179 Elizabeth Street, Sydney, NSW 2000
Country [1] 304427 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Vaxxas Pty Ltd
Address
Vaxxas Pty Ltd
Suite 13.02, Level 13, 179 Elizabeth Street, Sydney, NSW 2000
Country
Australia
Secondary sponsor category [1] 304685 0
None
Name [1] 304685 0
Address [1] 304685 0
Country [1] 304685 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304863 0
Metro South HREC
Ethics committee address [1] 304863 0
Metro South Health HREC
Metro South Research
Level 7, Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102
Ethics committee country [1] 304863 0
Australia
Date submitted for ethics approval [1] 304863 0
25/10/2019
Approval date [1] 304863 0
11/11/2019
Ethics approval number [1] 304863 0
HREC/2019/QMS/56578

Summary
Brief summary
The aim of this study is to assess the safety and performance of a new vaccine delivery device that uses a patch to deliver vaccines. This study will show how the device performs, whether patients could use it themselves to apply the patches, and how long the patch should be left on the skin. No vaccine is used in this study. A placebo coating on the patch is used to represent the vaccine.
Trial website
none
Trial related presentations / publications
none
Public notes
none

Contacts
Principal investigator
Name 98446 0
A/Prof Greg Siller
Address 98446 0
Prof. Greg Siller, MBBS, Adj. Assoc. Prof.
Central Brisbane Dermatology
Suite 95, Level 9, Silverton Place,
101 Wickham Terrace,
Brisbane, QLD 4000, Australia
Country 98446 0
Australia
Phone 98446 0
+61 07 38314382
Fax 98446 0
none
Email 98446 0
sillermedical@bigpond.com
Contact person for public queries
Name 98447 0
Mr Ben Baker
Address 98447 0
Vaxxas Pty Limited
Translational Research Institute
37 Kent St.
Woolloongabba, QLD 4102, Australia
Country 98447 0
Australia
Phone 98447 0
+61 0402 703 063
Fax 98447 0
none
Email 98447 0
bbaker@vaxxas.com
Contact person for scientific queries
Name 98448 0
Mr Ben Baker
Address 98448 0
Vaxxas Pty Limited
Translational Research Institute
37 Kent St.
Woolloongabba, QLD 4102, Australia
Country 98448 0
Australia
Phone 98448 0
+61 0402 703 063
Fax 98448 0
none
Email 98448 0
bbaker@vaxxas.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Only the results of the full cohorts will be available as per the protocol
What supporting documents are/will be available?
No other documents available
Summary results
No Results