None listed
Conditions
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.
Interventions
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 appl
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.
Sponsors
Vaxxas Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
6 Months to 64 Years
Healthy volunteers
Yes
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
Outcome results
None listed