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

Phase 1

Recruiting

• Conditions: vaccination; Public Health - Other public health

• Registration Number: ACTRN12622001101774
• Lead Sponsor: Vaxxas Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-08-10
• Last Update Posted: 30 January 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

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

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the rate (number) of adverse events deemed possibly, probably, or definitely related to treatment administration in this population of subjects.<br>There is no comparator population in this study.<br>AEs will be assessed in accordance with CTCAE4<br>There are no known/possible adverse events associated with this placebo coated device. [ 30m mins post application then Day 7 and Day 28 post application. If required a further assessment will be done at Day 60.];Local skin response (measured by erythema, oedema/induration, redness extent, skin flaking, application site visibility). <br>Measured by skin assessment and photographed. [30 mins post application then Day 7 and Day 28 post application<br>]

Secondary Outcome Measures

Name	Time	Method
Post application analysis of HD-MAP engagement with the skin.<br>Measured by scanning electron microscope.[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. ];Skin assessment using non-invasive methods such as Dermatoscopy, Trans epidermal water loss (TEWL) [Measured pre-device administration and immediately following device administration];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.[On day 0 post dose and again at Day 28. ]