Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001115325p
Ethics application status
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Submitted, not yet approved
Date submitted
Help: Date submitted
3/08/2026
Date registered
Help: Date registered
8/09/2026
Date last updated
Help: Date last updated
8/09/2026
Date data sharing statement initially provided
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8/09/2026
Type of registration
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Prospectively registered

Titles & IDs
Public title
Adaptive Phase I clinical study to evaluate the safety, tolerability and performance of VXM-305-00-P, an intradermal high-density microarray patch (HD-MAP) delivery system, in healthy children and adult parent/guardians
Scientific title
Adaptive Phase I clinical study to evaluate the safety, tolerability and performance of VXM-305-00-P, an intradermal high-density microarray patch (HD-MAP) delivery system, in healthy children and adult parent/guardians
Additional trial identifiers [1] 318053 0
VXM-305-001
Universal Trial Number (UTN)
Trial acronym
Related trial records
Not applicable.

Health condition
Health condition(s) studied:
Vaccination 343068 0
Condition category
Condition code
Public Health 339165 339165 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
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.   
Intervention code [1] 334955 0
Prevention
Intervention code [2] 334956 0
Treatment: Devices
Description of the comparator or control
There is no control group. The HD-MAP delivery system (VXM-305-00-P) to be studied is a placebo-coated device (i.e., no active ingredient). All participants will receive the same treatment. VXM-305-00-P is the only investigational product to be used for all study stages/groups.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 346431 0
To assess the safety and tolerability of the high-density microarray patch (HD-MAP) delivery system administered to children at different anatomical administration sites and of ages relevant to routine immunisation programs and administered to their adult parent/guardian. Safety and tolerability measures for both participant groups will be assessed together as a composite primary outcome.
Timepoint [1] 346431 0
Local skin response observed in clinic post-administration at Day 1 (at 30 minutes +/- 15 minutes post administration) and at Day 8. At Day 3 and Day 15 post administration, participants will be contacted remotely to collect information on administration site visibility. Unsolicited adverse events (spontaneously reported) will be collected for the study period through to Day 15 post-administration (End of Study).
Primary outcome [2] 346432 0
To measure HD-MAP delivery system performance (skin delivery efficiency by water soluble fluorescein dye) when administered by trained administrators to children, at different anatomical administration sites.
Timepoint [2] 346432 0
Applied HD-MAP will be retained following administration on Day 1 for analysis of fluorescein. There is no protocol defined timeline for completion of this assessment. Fluorescent dematoscopy photographs of the administration site should be performed as soon as possible following administration on Day 1.
Primary outcome [3] 346722 0
To measure HD-MAP delivery system performance (skin delivery efficiency by water soluble fluorescein dye) when administered by trained administrators to children, for different administration hold times
Timepoint [3] 346722 0
Applied HD-MAP will be retained following administration on Day 1 for analysis of fluorescein. There is no protocol defined timeline for completion of this assessment. Fluorescent dematoscopy photographs of the administration site should be performed as soon as possible following administration on Day 1.
Secondary outcome [1] 465811 0
To collect information about parent/guardian perceptions of the HD-MAP delivery system.
Timepoint [1] 465811 0
Adult participants self-reported in clinic reaction at Day 1 following HD-MAP delivery system administration. Adult parent/guardian perceptions at Day 8 post-administration of the HD-MAP delivery system.

Eligibility
Key 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.
Minimum age
6 Months
Maximum age
64 Years
Sex
Both males and females
Healthy volunteers
Yes
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation of study participants shall be performed via central randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Once a screened participant is deemed eligible by the Investigator/delegate, the process of randomisation will be performed using electronic case report form (eCRF) and the participant shall be stratified into adult/child in line with the clinical study protocol. The process of stratification shall be system driven and shall have no manual intervention.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis
Proposed study sample size:
Stage 1: n=40, to include n=20 children (minimum) and n=20 adults (approximate).
Stage 2: n=40, to include n=10-20 children (approximate) and n=10-20 adults (approximate)
Stage 3: n= 40, to include n=20 children (approximate) and n=20 adults (approximate).
Stage 4: n= 20, to include n=10 children (approximate) and n=10 adults (approximate).
An adaptive clinical study design will be used to include subsequent stages and groups, which may include a total of 4 stages and 7 treatment groups. Each study stage consists of 1 or 2 treatment groups. Each treatment group will include n=10 children, and n=10 adults (approximate). 
The total number of stages and study groups will be determined after analysis of Stage 1 and Stage 2 results. Subsequent stages will be proposed via clinical protocol amendment. The sample size is based on empirical considerations, and no formal sample size calculation has been performed.
Participant disposition, protocol deviations, demographics, medical history, prior medications, concomitant medications, and treatment will be summarised using descriptive statistics using the appropriate analysis populations as detailed in a separate Statistical Analysis Plan (SAP). For safety endpoints, the safety set will be used for all summaries and listings. All adverse events will be listed by participant and will include details of the onset date and time, duration, severity, causality, and treatment/medications administered. Local reactions will be summarised and/or listed as appropriate. No statistical analysis between groups for the safety endpoints (local and systemic adverse reactions) is planned. Such study investigations are exploratory, and conclusions are based on the complete set of participant evidence. Descriptive statistics of demographics (age, sex, race, ethnicity and skin tone) will be presented. Medical history information collected at screening will be listed.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/10/2026
Actual
Date of last participant enrolment
Anticipated
12/08/2027
Actual
Date of last data collection
Anticipated
31/08/2027
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 29938 0
The Royal Childrens Hospital - Parkville
Recruitment postcode(s) [1] 46301 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 322618 0
Commercial sector/Industry
Name [1] 322618 0
Vaxxas Pty Ltd
Country [1] 322618 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Vaxxas Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 325533 0
None
Name [1] 325533 0
Address [1] 325533 0
Country [1] 325533 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 321079 0
The Royal Children’s Hospital Human Research Ethics Committee
Ethics committee address [1] 321079 0
Ethics committee country [1] 321079 0
Australia
Date submitted for ethics approval [1] 321079 0
30/07/2026
Approval date [1] 321079 0
Ethics approval number [1] 321079 0

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

Contacts
Principal investigator
Name 152582 0
Prof Margaret Danchin
Address 152582 0
Murdoch Children's Research Institute, The Royal Children's Hospital. 50 Flemington Road, Parkville, Victoria 3052.
Country 152582 0
Australia
Phone 152582 0
+61 393455522
Fax 152582 0
Email 152582 0
[email protected]
Contact person for public queries
Name 152583 0
Angus Forster
Address 152583 0
Vaxxas Pty Ltd, 240 MacArthur Avenue, Hamilton 4007, Queensland.
Country 152583 0
Australia
Phone 152583 0
+61 721395400
Fax 152583 0
Email 152583 0
[email protected]
Contact person for scientific queries
Name 152584 0
Angus Forster
Address 152584 0
Vaxxas Pty Ltd, 240 MacArthur Avenue, Hamilton 4007, Queensland.
Country 152584 0
Australia
Phone 152584 0
+61721395400
Fax 152584 0
Email 152584 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.