None listed
Conditions
Brief summary
In this study we are trying to figure out if a vaccine against COVID-19 can be administered by an intradermal delivery system (a patch that is placed onto the skin by spring delivery) and if the vaccine is effective against COVID-19. Today most vaccines are delivered by injection using a needle (typically in the upper arm or thigh), this can be cause for anxiety for some people. Vaxxas have developed an intradermal delivery system (HD-MAP) to administer vaccines by pressing a patch to the skin of the upper arm. Vaxxas has developed a potential COVID-19 vaccine (HexaPro- modified SARS-CoV-2 spike protein) to be delivered with their intradermal delivery system. HD-MAP has been used in prior clinical trials of influenza vaccines as well as the uncoated patch, while HexaPro has not yet been given to humans.
Interventions
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
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.
Sponsors
Vaxxas Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
Yes
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);
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.
Outcome results
None listed