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Trial registered on ANZCTR


Registration number
ACTRN12622001101774
Ethics application status
Approved
Date submitted
1/08/2022
Date registered
10/08/2022
Date last updated
25/01/2023
Date data sharing statement initially provided
10/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Safety, performance, and acceptability of intradermal application of an excipient-coated High Density Micro-Array Patch (HD-MAP) delivery system: Study in children and their parents/guardians
Scientific title
Safety, performance, and acceptability of intradermal application of an excipient-coated High Density Micro-Array Patch (HD-MAP) delivery system: Study in children and their parents/guardians
Secondary ID [1] 307675 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
vaccination 327211 0
Condition category
Condition code
Public Health 324350 324350 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Vaxxas Pty Ltd is developing a novel approach for the intradermal administration of vaccines via a High Density Microarray Patch (HD-MAP) housed in an applicator device. The HD-MAP consists of a 1.5 cm2 polymer patch with a dense array of micro-projections on the skin-facing surface. The intention is for a liquid vaccine coating to be applied to the micro-projections which dries and stabilises the vaccine for delivery to patients. However, in this study no vaccine will be used. The HD-MAP applicator is a hand-held dome spring-activated device designed to reliably and reproducibly apply the HD-MAP to the skin. The HD-MAP and applicator are used for one application only. This delivery system enables the micro-projections to breach the stratum corneum of the skin and penetrate into the epidermis and upper dermis to a maximum depth of around 80 to 120 microns.
The study population consists of healthy children, 6-24 months of age, and their parents/guardians as dyads in three groups (n = 10-20, per group). There will be three treatment groups in the study:
Trained users will apply one excipient-coated HD-MAP to the guardian’s upper arm for ten seconds. Then, the trained user will apply one excipient-coated HD-MAP to the child at either the:
1. Anterolateral thigh,
2. Upper arm, or
3. Ventrogluteal area.
The choice of application site for children will be dependent upon the way in which the parent/guardian is most comfortable holding the child.
All applications will have a wear time of 10 seconds before removal.
The patches will be applied only once to each of the areas described.
The applications will be done at the clinical site facility
The excipient-coated (placebo) HD-MAP is a terminally sterilised 1.5 cm² polymer patch with 2,900 micro-projections coated with an excipient solution. The excipient solution contains L-histidine, sorbitol, trehalose dihydrate, gelatine, and sodium phosphates.
Intervention code [1] 324152 0
Prevention
Intervention code [2] 324163 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 through out the study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332151 0
To assess the rate (number) of adverse events deemed possibly, probably, or definitely related to treatment administration in this population of subjects.
There is no comparator population in this study.
AEs will be assessed in accordance with CTCAE4
There are no known/possible adverse events associated with this placebo coated device.
Timepoint [1] 332151 0
30m mins post application then Day 7 and Day 28 post application. If required a further assessment will be done at Day 60.
Primary outcome [2] 332171 0
Local skin response (measured by erythema, oedema/induration, redness extent, skin flaking, application site visibility).
Measured by skin assessment and photographed.
Timepoint [2] 332171 0
30 mins post application then Day 7 and Day 28 post application
Secondary outcome [1] 412390 0
Post application analysis of HD-MAP engagement with the skin.
Measured by scanning electron microscope.
Timepoint [1] 412390 0
Once the HD-MAP is removed from the skin it will be returned to the lab and viewed under scanning electron microscope. There is no protocol defined timepoint associated with this assessment.
Secondary outcome [2] 412464 0
Skin assessment using non-invasive methods such as Dermatoscopy, Trans epidermal water loss (TEWL)
Timepoint [2] 412464 0
Measured pre-device administration and immediately following device administration
Secondary outcome [3] 412670 0
Parent/Guardian perception of HD-MAP delivery system via questionnaires and structured interviews with a member of the research team. The questionnaire and interview questions are designed specifically for this study.
Timepoint [3] 412670 0
On day 0 post dose and again at Day 28.

Eligibility
Key inclusion criteria
Children (subjects must meet all of the following criteria to be eligible for participation in the study):
Aged 6 months, and above
Subject has a Body Mass Index (BMI) between the 5th and 85th percentile.
Satisfactory medical assessment, with no clinically significant or relevant abnormalities (in the opinion of the Investigator) in medical history and physical examination.

Adults (subjects must meet all of the following criteria to be eligible for participation in this study):
Aged 18 to 64 years old.
Satisfactory medical assessment, with no clinically significant or relevant abnormalities (in the opinion of the Investigator) in medical history and physical examination.
Subject can communicate effectively with study personnel and is considered reliable, willing, and cooperative in terms of compliance with the protocol requirements.
Subject is able and willing to provide written, personally signed and dated informed consent to participate in the study
Minimum age
6 Months
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
All subjects meeting any of the following criteria will not be eligible for participation in this study:
Subject with birthmarks, tattoos, wounds, scars, moles, blemishes, heavy hair or other skin conditions (such as eczema) on upper arms (or thighs, in case of children aged 6-24 months) that could be expected to obscure the observation of application site reactions.
Subject with known severe chronic spontaneous urticaria / dermographism.
Subject with a known, clinically significant history of asthma, eczema, hay fever, or allergy manifested as food- or drug-induced urticaria.
Subject with known allergy/sensitivity to ingredients of MAP (plastic) or coating (sugars, gelatine).
Previous adverse reaction to fluorescein or synthetic dyes, for example, after angiography or ophthalmic procedures.
Recent vaccination (within 28 days prior to Day 0) with any vaccine or a plan to be vaccinated in the 7 days after HD-MAP application.
Known predisposition to keloid scar formation.
History of granulomatous diseases (especially sarcoidosis and granuloma annulare).
History of convulsions, seizures (including childhood febrile), epilepsy, other central nervous system diseases
History of clinically significant gastrointestinal, hepatic, renal, cardiovascular, dermatological, immunological, respiratory, endocrine, oncological, neurological, metabolic, psychiatric disease, or haematological disorders.
A clinically significant history of cancer defined as lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years prior to screening.
An active medical condition or recent illness (within 3 months) that is considered clinically significant by the PI and is under evaluation or treatment.
History of Hepatitis B, Hepatitis C, or HIV infection.
History of abnormal bleeding, and/or thrombophlebitis unrelated to venepuncture or intravenous cannulation (e.g. haemophilia, thrombocytopenia).
A history of alcohol or drug abuse in the last 12 months or current alcohol consumption is >4 standard drinks (or equivalent) per day.
Use of any prescription medication (except for contraceptives or hormone replacement therapy for guardian) within 7 days of enrolment, unless approved by the PI. All medications will be documented and reviewed for acceptance by the PI or a medically qualified nominee.
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.
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)
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
Single group
Other design features
The study groups will consist of guardian and child dyads so that Vaxxas can engage guardian opinions on this novel method of vaccination.
There will be three treatment groups in the study:
Trained users will apply one excipient-coated HD-MAP to the guardian’s upper arm for ten seconds. Then, the trained user will apply one excipient-coated HD-MAP to the child at either the:
Anterolateral thigh,
Upper arm, or
Ventrogluteal area.

The HD-MAP remains on the skin of the subjects for ten seconds and is then removed (wear time).
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis
A total of 30-60 guardian/parent, child dyads are planned to be included in the study. The sample size was not based on any formal statistical calculations. It is proposed that 10-20 dyads per age group will provide sufficient data to fulfil the objectives of the study.

Safety data for each subject will include treatment site reaction and will be summarised after application. Subjects will be instructed to report adverse events to the PI, or designee. Descriptive statistics of demographics (age, height and weight at screening, and 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.
Local reactions will be listed in tables and summarised.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/09/2022
Actual
11/10/2022
Date of last participant enrolment
Anticipated
11/10/2023
Actual
Date of last data collection
Anticipated
1/11/2023
Actual
Sample size
Target
30
Accrual to date
10
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 22890 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 38195 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 311946 0
Commercial sector/Industry
Name [1] 311946 0
Vaxxas Pty Ltd
Country [1] 311946 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Vaxxas Pty Ltd
Address
Vaxxas Pty Limited
Suite 13.02, Level 13
179 Elizabeth Street
Sydney, NSW 2000, Australia
Country
Australia
Secondary sponsor category [1] 313431 0
None
Name [1] 313431 0
Address [1] 313431 0
Country [1] 313431 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311376 0
Metro South Research Ethics
Ethics committee address [1] 311376 0
Metro South Research
Level 7, Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102
Ethics committee country [1] 311376 0
Australia
Date submitted for ethics approval [1] 311376 0
17/11/2021
Approval date [1] 311376 0
05/07/2022
Ethics approval number [1] 311376 0
HREC/2021/QMS/81653

Summary
Brief summary
This clinical trial is a critical step in the development of the Vaxxas HD-MAP vaccine delivery system and will verify the safety and consistency of device performance in paediatric subjects at several potential anatomical application sites. The paediatric population represents a significant segment of the vaccination market; therefore, it is vital to know if the performance of the HD-MAP delivery system differs in this population and whether it presents any additional safety risks. Furthermore, the opinions of guardian/child dyads on the acceptability of the delivery system will be collected.
Trial website
none
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120882 0
Dr Sophie Wen
Address 120882 0
Paediatric Infection Specialist
Queensland Specialist Immunisation Service
Children’s Health Queensland Hospital and Health Service
501 Stanley St.
South Brisbane, QLD 4101
Country 120882 0
Australia
Phone 120882 0
+61 7 3068 1558
Fax 120882 0
Email 120882 0
[email protected]
Contact person for public queries
Name 120883 0
Ben Baker
Address 120883 0
Vaxxas Pty Limited
Translational Research Institute
37 Kent St.
Woolloongabba, QLD 4102, Australia
Country 120883 0
Australia
Phone 120883 0
+61 402 703 063
Fax 120883 0
Email 120883 0
[email protected]
Contact person for scientific queries
Name 120884 0
Ben Baker
Address 120884 0
Vaxxas Pty Limited
Translational Research Institute
37 Kent St.
Woolloongabba, QLD 4102, Australia
Country 120884 0
Australia
Phone 120884 0
+61 402 703 063
Fax 120884 0
Email 120884 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 aggregate results of the full study cohort 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.