Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000504819
Ethics application status
Approved
Date submitted
4/03/2021
Date registered
29/04/2021
Date last updated
2/03/2022
Date data sharing statement initially provided
29/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Older adult study to evaluate the safety, performance, usability, and acceptability of skin application of a placebo excipient coated High Density- Micro Array Patch (HD-MAP) technology intended for use in vaccinations.
Scientific title
Older adult study to evaluate the safety, performance, usability, and acceptability of skin application of a placebo excipient coated HD-MAP technology intended for use in vaccinations.
Secondary ID [1] 303603 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
Follow up study to ACTRN12620000179932

Health condition
Health condition(s) or problem(s) studied:
Vaccinations 320973 0
Condition category
Condition code
Public Health 318780 318780 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The vaccine delivery device consists of a 1cm² patch that has a series of micro-projections that hold the vaccine coating (placebo in this study) embedded in an applicator device that holds the patch in place and applies it to the skin.
Forty-eight subjects receive four patches: one on each of the volar forearm and upper arm (over the deltoid muscle). First, trained users will apply HD-MAPs on the subject’s dominant arm for 10 seconds. Next, the subject will apply the MAPs to their non-dominant arm.
There is no active vaccination delivered in this study
All patches to be removed after 10 seconds.
The patches will be applied once only to each of the areas described.
As stated above, trained users will apply the patches to the subject's dominant arm then the subject will apply the patches to their non-dominant arm.
The placebo excipient coating contains hypromellose, trehalose dihydrate, fluorescein sodium, and phosphate buffered saline
The patch application will be supervised by trained staff.
Intervention code [1] 319887 0
Prevention
Intervention code [2] 320167 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] 326724 0
To assess the rate (number) of adverse events deemed possibly probably or deficiently related to treatment administration in this population of subjects.
No comparator population in this study.
AEs will be assessed in accordance with CTCAE4.
Timepoint [1] 326724 0
30 mins post application, Day 7 post application and Day 28 post application
Primary outcome [2] 327061 0
local skin response (measured by erythema oedema/induration, redness extent, skin flaking, application site visibility)
Measured by skin assessment and photographed
Timepoint [2] 327061 0
Day 7 and Day 28 post application
Secondary outcome [1] 392476 0
Post application analysis of HD-MAP engagement with the skin.
Measured by scanning electron microscopy
Timepoint [1] 392476 0
Following device administration
Secondary outcome [2] 392478 0
Skin assessment using non invasive methods such as Dermatoscope, Transepidermal water loss (TEWL)
Timepoint [2] 392478 0
following device administration

Eligibility
Key inclusion criteria
1. Aged 50 years (inclusive), or older.
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 completion of study;
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
50 Years
Maximum age
No limit
Sex
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 or upper arms (both arms) which could reasonably obscure potential application sites
2. Subject with known severe chronic spontaneous urticaria / dermographism
3. Subject with known allergy/sensitivity to ingredients of MAP (plastic) or coating (sugars), including gold
4. Previous adverse reaction to fluorescein or synthetic dyes, for example, after angiography or ophthalmic procedures.
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 in situ malignancy, basal cell carcinoma, or non-invasive squamous cell carcinoma of the skin.
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 unrelated to venepuncture or intravenous cannulation (e.g. haemophilia, thrombocytopenia).
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 Principal 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 14 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, or relative of 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)
Not applicable
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Demographic and clinical measurements will be summarised by frequencies for categorical variables and by mean, standard deviation and range for continuous variables.
No statistical testing between groups for safety endpoints is planned to be performed. Study investigations will be exploratory, and conclusions based on the complete set of subject evidence.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2021
Actual
1/09/2021
Date of last participant enrolment
Anticipated
1/09/2021
Actual
31/12/2021
Date of last data collection
Anticipated
1/10/2021
Actual
28/02/2022
Sample size
Target
48
Accrual to date
Final
48
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 18851 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 33350 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 308023 0
Commercial sector/Industry
Name [1] 308023 0
Vaxxas Pty Ltd
Country [1] 308023 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Vaxxas Pty Ltd
Address
Suite 13.02, Level 13, 179 Elizabeth Street, Sydney, NSW 2000
Country
Australia
Secondary sponsor category [1] 308745 0
None
Name [1] 308745 0
Address [1] 308745 0
Country [1] 308745 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308014 0
Metro South Health HREC
Ethics committee address [1] 308014 0
Ethics committee country [1] 308014 0
Australia
Date submitted for ethics approval [1] 308014 0
Approval date [1] 308014 0
26/02/2021
Ethics approval number [1] 308014 0
HREC/2021/QMS/70621

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109234 0
Dr Gregory Siller
Address 109234 0
Central Brisbane Dermatology
Silverton Place,
Level 9/101 Wickham Terrace
Brisbane
QLD 4000
Country 109234 0
Australia
Phone 109234 0
+61 07 38314382
Fax 109234 0
none
Email 109234 0
[email protected]
Contact person for public queries
Name 109235 0
Ben Baker
Address 109235 0
Vaxxas Pty Limited
Translational Research Institute
37 Kent St.
Woolloongabba, QLD 4102, Australia
Country 109235 0
Australia
Phone 109235 0
+61 0402 703 063
Fax 109235 0
none
Email 109235 0
[email protected]
Contact person for scientific queries
Name 109236 0
Ben Baker
Address 109236 0
Vaxxas Pty Limited
Translational Research Institute
37 Kent St.
Woolloongabba, QLD 4102, Australia
Country 109236 0
Australia
Phone 109236 0
+61 0402 703 063
Fax 109236 0
none
Email 109236 0
[email protected]

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 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.