None listed
Conditions
Brief summary
Vaxxas Pty Ltd is developing a novel needle-free high-density microarray patch (HD MAP) delivery system for the intradermal administration of vaccines. This technology may offer potential advantages over conventional needle and syringe delivery of vaccines. This Phase I clinical study is a critical step in the development of the HD-MAP delivery system to verify its safety and suitability for use in children. The study will help confirm the safety and consistency in performance of the HD-MAP delivery system in children at different anatomical administration sites and using different hold times. The paediatric population represents a significant segment of the population requiring vaccination; therefore, evaluating the safety and suitability of the HD-MAP delivery system in children is essential. The findings could support the future development of a needle-free approach to routine childhood vaccinations and facilitate vaccine delivery in low- and middle-income countries, including during outbreak scenarios.
Interventions
Vaxxas Pty Ltd is developing a novel needle-free high-density microarray patch (HD MAP) delivery system for the intradermal administration of vaccines to prevent infectious diseases. VXM-305-00-P is a sterile, placebo-coated HD-MAP delivery system consisting of a polymer HD-MAP integrated into an aluminium applicator. The HD-MAP consists of a square (~1 cm) array with approximately 2,300 micro-projections. The HD-MAP delivery system is placed on the skin and actuated by pressing down on the top
Vaxxas Pty Ltd is developing a novel needle-free high-density microarray patch (HD MAP) delivery system for the intradermal administration of vaccines to prevent infectious diseases. VXM-305-00-P is a sterile, placebo-coated HD-MAP delivery system consisting of a polymer HD-MAP integrated into an aluminium applicator. The HD-MAP consists of a square (~1 cm) array with approximately 2,300 micro-projections. The HD-MAP delivery system is placed on the skin and actuated by pressing down on the top of the applicator with a finger. This activates an internal mechanical dome-spring that then accelerates the HD-MAP toward the skin at high speed, enabling the dense array of micro-projections to breach the stratum corneum, and deliver a dried coating to the upper dermis and epidermis. After a defined hold time the entire delivery system, with the HD-MAP, is removed. In this study the HD-MAP includes a dried placebo coating consisting of inactive excipients, diluent buffers and a water-soluble fluorescein sodium dye (less than 2 micrograms per HD-MAP). The formulation has been developed to support the manufacture and stability of a future vaccine coating and is not intended to have any active or therapeutic effect. No vaccine is included in the current investigational product. Inclusion of a fluorescein dye will enable transfer of the coating to the skin to be measured after HD-MAP administration. In this study each child and adult participant will receive a single administration of VXM-305-00-P, to a single anatomical site, for a defined hold time, by a trained administrator at the clinical investigator site. The potential anatomical skin sites to be investigated which are of relevance to immunisations in children are the upper arm (overlying the deltoid muscle), the anterolateral thigh, or the dorsal forearm. An adaptive clinical study design will be used to include subsequent stages and groups. At Stage 1, eligible participants (n=10 children, n=10 adults, per group) will be randomised to receive a single administration of VXM-305-00-P only, to the skin of one arm (area overlying the deltoid muscle) for either a 3 second hold time (Group 1) or a 10 second hold time (Group 2). The treatment arms selected for Stage 2 will depend on the outcomes from Stage 1. These may include administration of VXM-305-00-P by a trained administrator to the skin of the upper arm, thigh or forearm, for a 3 or 10 second hold time. Stage 2 will not commence until all outcomes data for Stage 1 have been analysed, and is anticipated to commence 4-6 weeks after the last participant enrolment for Stage 1. At Stage 2, unique and eligible participants (n=10-20 children, and n=10-20 adults), will be randomised into one of the following treatment arms based on the results at Stage 1: Stage 1 Outcome 1 - Results from both Group 1 and Group 2 pass a predefined skin delivery bar. Study continuation to Group 3 = VXM-305-00-P to the thigh or upper arm, for 3 seconds and Group 4 = VXM-305-00-P to the forearm, for 3 seconds. Stage 1 Outcome 2 – Results from either Group 1 or Group 2 do not pass skin delivery bar. Study continuation to Group 3 = VXM-305-00-P to the thigh, for 3 seconds with no Group 4. Stage 1 Outcome 3 - Results from both Group 1 and Group 2 do not pass skin delivery bar. Study continuation to Group 3 = VXM-305-00-P to the thigh, for 3 seconds, and Group 4 = VXM-305-00-P to the thigh, for 10 seconds. An adaptive clinical study design will be used to include subsequent stages and groups, which may include a total of 4 stages consisting of 1-2 treatment groups, with a potential total of 7 groups. For each study stage it is intended that only newly screened unique participants will be enrolled and a single VXM-305-00-P only will be administered to a single site on the participant for a defined hold time. At the end of each study stage, analysis of the participant safety data will be performed by the Sponsor prior to progression to the next stage, to ensure participant safety. No significant safety concerns should be identified to enable the study to progress to the next stage. Depending on acceptable safety, tolerability and measured HD-MAP delivery system performance outcomes assessed after each stage, the study may progress to the next stage or be completed after that stage. The design for subsequent Stages 3 and 4 will be determined after analysis of the prior stage(s) and proposed via a clinical protocol amendment. No vaccine is included in the investigational product at any study stage. The anticipated overall duration of the study is approximately 14 months.
Sponsors
Vaxxas Pty Ltd
Study design
Allocation
Randomised controlled 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
Child participants must meet all of the following criteria to be eligible for inclusion in the study: 1) Aged 6-23 months of age. 2) Satisfactory medical assessment, with no clinically significant or relevant abnormalities (in the opinion of the Investigator) in medical history and physical examination. 3) A parent/guardian must be able and willing to provide written, personally signed and dated informed consent for their child to participate in the study. Adult participants must meet all of the following criteria to be eligible for inclusion in this study: 1) Aged 18 to 64 years old. 2) Satisfactory medical assessment, with no clinically significant or relevant abnormalities (in the opinion of the Investigator) in medical history and physical examination. 3) Participant can communicate effectively with study personnel and is considered reliable, willing, and cooperative in terms of compliance with the protocol requirements. 4) Participant is able and willing to provide written, personally signed and dated informed consent to participate in the study.
Exclusion criteria
Participants meeting any of the following criteria will not be eligible for inclusion in this study: 1) Participant with birthmarks, tattoos, wounds, scars, moles, blemishes, heavy hair or other skin conditions (such as eczema) on the administration site that could be expected to obscure the observation of administration site reactions. 2) Participant with known severe chronic spontaneous urticaria/dermographism. 3) Participant with a known, clinically significant history of asthma, eczema, hay fever, or allergy manifested as food- or drug-induced urticaria. 4) Participant with known allergy/sensitivity to ingredients of the HD-MAP (plastic) or coating (e.g., sucrose, sorbitol, salts, recombinant serum albumin). 5) Previous adverse reaction to fluorescein or synthetic dyes, for example, after angiography or ophthalmic procedures. 6) Recent vaccination (within 28 days prior to Day 1) with any vaccine or a plan to be vaccinated in the 7 days after investigational product administration. 7) Known predisposition to keloid scar formation (participants who have developed a scar caused by BCG vaccine can be included in the study). 8) History of granulomatous diseases (especially sarcoidosis and granuloma annulare). 9) History of convulsions, seizures (including childhood febrile), epilepsy, other central nervous system diseases. 10) History of clinically significant gastrointestinal, hepatic, renal, cardiovascular, dermatological, immunological, respiratory, endocrine, oncological, neurological, metabolic, psychiatric disease, or haematological disorders. 11) An active medical condition or recent illness (within 3 months) that is considered clinically significant by the Principal Investigator and is under evaluation or treatment. 12) History of Hepatitis B, Hepatitis C, or HIV infection. 13) History of abnormal bleeding, and/or thrombophlebitis unrelated to venepuncture or intravenous cannulation (e.g., haemophilia, thrombocytopenia). 14) Receiving chronic treatment with immune-suppressive therapy other than asthma inhalers and topical corticosteroids. All medications will be documented and reviewed for acceptance by the Principal Investigator or a medically qualified nominee. 15) History of any psychiatric illness or psychological disorder which may impair the ability to provide written informed consent or participate in the study. 16) Participant has donated blood or plasma or clinically significant blood loss within 14 days prior to screening visit. 17) Participant has received blood or plasma within 60 days prior to screening visit. 18) Participant is pregnant. 19) A history of alcohol or drug abuse in the last 12 months or current alcohol consumption is >4 standard drinks (or equivalent) per day. 20) Use of any prescription medication (except for contraceptives or hormone replacement therapy for parent/guardian) within 7 days of enrolment, which per discretion of the Investigator would impact safety of the study participant (in case the Investigator deems the pertinent prescription medication as acceptable, the participant can be considered for enrolment). All medications will be documented and reviewed for acceptance by the Principal Investigator or a medically qualified nominee. 21) Use of any investigational drug or device within 30 days prior to Day 1. Participants (adult/child) who have participated in any of the prior stages of this clinical study cannot participate in subsequent stages. 22) A Vaxxas employee, or relative of a Vaxxas employee.
Outcome results
None listed