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Trial registered on ANZCTR


Registration number
ACTRN12622000597796
Ethics application status
Approved
Date submitted
14/04/2022
Date registered
21/04/2022
Date last updated
13/09/2023
Date data sharing statement initially provided
21/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Phase I clinical study to evaluate the safety and tolerability of SARS-CoV-2 spike protein (HexaPro) delivered intradermally by a high-density microarray patch (HD-MAP), in healthy adults aged 18 to 50 years.
Scientific title
Phase I clinical study to evaluate the safety and tolerability of SARS-CoV-2 spike protein (HexaPro) delivered intradermally by a high-density microarray patch (HD-MAP), in healthy adults aged 18 to 50 years.
Secondary ID [1] 306938 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
SARS-CoV-2 infection
 326051 0
Condition category
Condition code
Infection 323358 323358 0 0
Other infectious diseases
Respiratory 323404 323404 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
44 subjects will be selected for the study and randomised into one of three groups. At least 15 subjects will receive VXS-1223 30 mcg (treatment Arm 1- active) and 15 subjects will receive VXS-1223 90 mcg (treatment Arm 2 - active). 14 subjects will receive VXS-1223U (treatment Arm 3 - placebo).

To maintain the study blind, each subject will receive 3 patches:
The Treatment arm 2 will receive 3 patches of VXS-1223 30mg to achieve a dose of 90mg. Subjects in Treatment arm 1 will receive 1 patch of VXS-1223 30mg and 2 patches of uncoated (placebo) VXS1223U and subjects in Treatment arm 3 will receive 3 uncoated, placebo patches of VXS1223U.

The patches will be dispensed from the unblinded Pharmacist according to the Randomisation list. The receipt and administration of the patches will be recorded in the site source data files.

The VXS-1223 (or placebo) in each group is delivered intradermally by a high-density microarray patch (HD-MAP) via an integrated, single-use, intradermal (ID) vaccine-delivery system, containing a mechanical, dome-spring that applies the array of micro-projections to the skin at approximately 20 m/s. The spring is actuated by pressing down on the top of the applicator with a finger and the whole delivery system (including the HD-MAP) is removed after 2 minutes (± 10 seconds) of application time.
VXS-1223 (active) includes an aseptically produced 0.64 cm² polymer array (or ‘patch’) with approximately 1,700 micro-projections, coated with 30 mcg of a modified SARS-CoV-2 spike protein (HexaPro).

The HD-MAP is administered by a small number of trained individuals at the study site, to maintain consistency of application.
Intervention code [1] 323383 0
Prevention
Comparator / control treatment
VXS-1223U (treatment Arm 3 - placebo). This is an uncoated, vaccine free patch.
Control group
Placebo

Outcomes
Primary outcome [1] 331091 0
The primary outcome is a composite of Safety and tolerability of VXS-1223 (either 30 mcg or 90 mcg coated), compared with VXS-1223U. Assessed by:
• Number of subjects with SAEs deemed possibly, probably or definitely related to treatment administration from application to Day 90 (EoS) as reported by PI.
• Number of subjects with AEs deemed possibly, probably or definitely related to treatment administration from application to Day 28 as reported by PI or self reported.
• Changes in clinical laboratory samples (biochemistry, haematology) at screening and Day 0 (pre-treatment) through Day 7, Day 28 and Day 56 as determined by PI.
• Local skin response (including erythema and swelling) assessed by photo imaging, standardized scoring, measured at 1 hour, 2 hours following application on Day 0, and at Days 3, 7, 28, 56 and 90 as reported by PI
Timepoint [1] 331091 0
SAEs will be measured if reported from application to Day 90 post dose
AEs will be measured from application to Day 28 post dose by self reporting at clinic visits or noted on the diary card.
Clinical Laboratory findings will be assessed pre-dose then throughout the study to Day 90 post dose
Local skin response will be determined on Day 0 at pre-dose, 1 hr 2hr then at Days 3, 7, 28, 56 and 90 post dose
Secondary outcome [1] 408724 0
Immunogenicity as assessed by antibody titres in serum samples and saliva samples taken at Day 0 (pre-dose) and Days 7, 28, 56 and 90 post dose
Timepoint [1] 408724 0
Days 0 (pre-dose) and at Days 7, 28, 56 and 90 post dose.

Eligibility
Key inclusion criteria
Subjects can be included in the study if they have received three doses of a COVID-19 vaccine. The first two COVID-19 vaccines can be any combination of Comirnaty® (Pfizer-BioNTech), Spikevax (Moderna Inc), and Vaxzevria (AstraZeneca) but participants must have received a third dose of either Comirnaty® (Pfizer-BioNTech) or Spikevax (Moderna Inc) (not Vaxzevria (AstraZeneca). The third dose must have be administered at least four months prior to the commencement of the study (Day 0).
Addition inclusion criteria are:
1. Participants must be healthy with no clinically significant underlying chronic conditions/illness
2. Aged 18–50 years (inclusive) at Day 0 (pre-dose);
3. With a body mass index (BMI) within the range 18.0–32.0 kg/m² (inclusive);
4. Satisfactory medical assessment: no clinically significant or relevant abnormalities (in the opinion of the Investigator) in medical history, physical examination, vital signs (blood pressure, tympanic temperature, heart rate, respiratory rate, ECG) and laboratory evaluation (haematology or biochemistry);
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Subject has tested positive for COVID-19 (PCR or RAT confirmed) since receiving their last COVID-19 vaccination or considers themselves highly likely to have had symptomatic COVID-19 disease in the four months prior to Day 0 of the study period.
2. Subject with birthmarks, tattoos, wounds, scars, moles, blemishes, heavy hair or other skin conditions (such as eczema) on upper arm region (where IP would be applied) that could be expected to obscure the observation of application-site reactions;
3. Subject with known chronic spontaneous urticaria / dermographism;
4. Known anaphylactic hypersensitivity or clinically significant allergy to a previous vaccination or to any of the vaccine components (recombinant human serum albumin, sodium chloride, sodium phosphate, potassium chloride);
5. Known anaphylactic hypersensitivity or clinically significant allergy as determined by the investigator
6. Recent vaccination (within 14 days prior to enrolment) with any vaccine, or a plan to be vaccinated during the study period with a COVID-19 vaccine or with an investigational COVID-19 vaccine (other than the study vaccine);
7. Known predisposition to keloid-scar formation;
8. History of granulomatous diseases (especially sarcoidosis and granuloma annulare);
9. History of convulsions, seizures (including childhood febrile), or epilepsy;
10. History of clinically significant haematological, gastrointestinal, hepatic, renal, cardiovascular, dermatological, immunological, respiratory, endocrine, oncological, neurological, metabolic, psychiatric disease, that, at the discretion of the Investigator, precludes the volunteer from the study;
11. An acute febrile illness at the time of enrolment;
12. 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
13. An active medical condition or recent illness (within 3 months) that is considered clinically significant by the PI and is under evaluation or treatment;
14. A history of major surgery within the past 3 months or planned major surgery during the course of the study that is considered clinically significant, for example within the past year;
15. History of illness and/or infection with Hepatitis B, or Hepatitis C or HIV, or, during screening, a positive test for Hepatitis B surface antigen, Hepatitis C or antibodies against HIV.

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 involved providing randomisation number to Pharmacist who dispensed as per Randomisation schedule which was not available to any other study site members except in an emergency.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
Demographic and clinical measurements will be summarised by frequencies for categorical variables and by mean, standard deviation and range for continuous variables.
No statistical testing between groups for safety endpoints is planned to be performed. Safety endpoints have been identified as being of main interest in this study. Study investigations will be exploratory, and conclusions based on the complete set of subject evidence.
Immune responses before and after a single treatment will be compared within and between groups. Confidence intervals and p-values will be presented for two-tailed tests, where significance is assumed for p<0.05. Analyses will be performed using Prism version 8.4.1 or higher.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/10/2022
Actual
20/10/2022
Date of last participant enrolment
Anticipated
16/01/2023
Actual
27/02/2023
Date of last data collection
Anticipated
30/04/2023
Actual
30/05/2023
Sample size
Target
44
Accrual to date
Final
44
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 23265 0
University of the Sunshine Coast Clinical Trials Centre - Sippy Downs - Sippy Downs
Recruitment postcode(s) [1] 38634 0
4556 - Sippy Downs

Funding & Sponsors
Funding source category [1] 311255 0
Commercial sector/Industry
Name [1] 311255 0
Vaxxas Pty Ltd
Country [1] 311255 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Vaxxas Pty Ltd
Address
Vaxxas Pty Ltd
37 Kent Street
Brisbane,
Queensland 4102
Country
Australia
Secondary sponsor category [1] 312615 0
None
Name [1] 312615 0
Address [1] 312615 0
Country [1] 312615 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310770 0
Bellberry HREC
Ethics committee address [1] 310770 0
Ethics committee country [1] 310770 0
Australia
Date submitted for ethics approval [1] 310770 0
30/09/2022
Approval date [1] 310770 0
17/10/2022
Ethics approval number [1] 310770 0

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

Contacts
Principal investigator
Name 118798 0
Dr Stephanie Wallace
Address 118798 0
University of Sunshine Coast, Level 1, 9 Ochre Way, Sippy Downs, QLD, 4556,
Country 118798 0
Australia
Phone 118798 0
+61 07 54563797
Fax 118798 0
Email 118798 0
swallac1@usc.edu.au
Contact person for public queries
Name 118799 0
Stephanie Wallace
Address 118799 0
University of Sunshine Coast
Level 1, 9 Ochre Way, Sippy Downs, QLD 4556
Country 118799 0
Australia
Phone 118799 0
+61 07 54563797
Fax 118799 0
Email 118799 0
swallac1@usc.edu.au
Contact person for scientific queries
Name 118800 0
Angus Forster
Address 118800 0
Vaxxas Pty Limited
37 Kent Street
Woolloongabba, QLD 4102
Country 118800 0
Australia
Phone 118800 0
+61 0734437838
Fax 118800 0
Email 118800 0
aforster@vaxxas.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Commercial in confidence


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
SourceTitleYear of PublicationDOI
Dimensions AIMicroarray patches: scratching the surface of vaccine delivery2023https://doi.org/10.1080/14760584.2023.2270598
N.B. These documents automatically identified may not have been verified by the study sponsor.