None listed
Conditions
Brief summary
The aim of this study is to assess the safety and performance of a new vaccine delivery device that uses a patch to deliver vaccines. This study will explore how how the device performs in older people, No vaccine is used in this study. A placebo coating on the patch is used to represent the vaccine.
Interventions
The vaccine delivery device consists of a 1cm² patch that has a series of micro-projections that hold the vaccine coating (placebo in this study) embedded in an applicator device that holds the patch in place and applies it to the skin.
Forty-eight subjects receive four patches: one on each of the volar forearm and upper arm (over the deltoid muscle). First, trained users will apply HD-MAPs on the subject’s dominant arm for 10 seconds. Next, the subject will apply the MAPs to their non-dominant
The vaccine delivery device consists of a 1cm² patch that has a series of micro-projections that hold the vaccine coating (placebo in this study) embedded in an applicator device that holds the patch in place and applies it to the skin. Forty-eight subjects receive four patches: one on each of the volar forearm and upper arm (over the deltoid muscle). First, trained users will apply HD-MAPs on the subject’s dominant arm for 10 seconds. Next, the subject will apply the MAPs to their non-dominant arm. There is no active vaccination delivered in this study All patches to be removed after 10 seconds. The patches will be applied once only to each of the areas described. As stated above, trained users will apply the patches to the subject's dominant arm then the subject will apply the patches to their non-dominant arm. The placebo excipient coating contains hypromellose, trehalose dihydrate, fluorescein sodium, and phosphate buffered saline The patch application will be supervised by trained staff.
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
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Aged 50 years (inclusive), or older. 2. Subject has a Body Mass Index (BMI) within the range 18.0–34.9 kg/m². 3. Satisfactory medical assessment, with no clinically significant or relevant abnormalities in medical history, physical examination, and vital signs. 4. Females of childbearing potential and males should either be sexually inactive (abstinent) for 14 days prior to Day 0 and throughout the study or be using one of the following acceptable birth control methods: i. Surgically sterile (hysterectomy and/or bilateral oophorectomy); ii. Surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to study initiation); iii. IUD in place for at least 3 months; iv. Stable hormonal contraceptive for at least 3 months prior to study through completion of study; v. Surgical sterilization (vasectomy) for male participants or for female participant’s partner at least 6 months prior to study vi. Condom for male participant together with effective contraception for their female partner. 5. Postmenopausal women must have had at least 12 months since their last menstrual period 6. Subject can communicate effectively with study personnel and is considered reliable, willing, and cooperative in terms of compliance with the protocol requirements. 7. Subject is able and willing to provide written, personally signed and dated informed consent to participate in the study.
Exclusion criteria
1. Subject with birthmarks, tattoos, wounds, scars, moles, blemishes, heavy hair or other skin conditions (such as eczema or sunburn) on forearms or upper arms (both arms) which could reasonably obscure potential application sites 2. Subject with known severe chronic spontaneous urticaria / dermographism 3. Subject with known allergy/sensitivity to ingredients of MAP (plastic) or coating (sugars), including gold 4. Previous adverse reaction to fluorescein or synthetic dyes, for example, after angiography or ophthalmic procedures. 5. Known predisposition to keloid scar formation 6. History of granulomatous diseases (especially sarcoidosis and granuloma annulare) 7. History of clinically significant gastrointestinal, hepatic, renal, cardiovascular, dermatological, immunological, respiratory, endocrine, oncological, neurological, metabolic, psychiatric disease, or haematological disorders 8. History of malignancy, other than in situ malignancy, basal cell carcinoma, or non-invasive squamous cell carcinoma of the skin. 9. An active medical condition (which is deemed as clinically significant) that is under evaluation or treatment, or a recent illness, a chronic illness, or an autoimmune disease 10. History of Hepatitis B, Hepatitis C, or HIV infection 11. History of abnormal bleeding tendencies unrelated to venepuncture or intravenous cannulation (e.g. haemophilia, thrombocytopenia). 12. Receiving chronic treatment with immune-suppressive therapy (asthma inhalers and topical corticosteroids are permitted). All medications will be documented and reviewed for acceptance by the Principal Investigator or a medically qualified nominee 13. History of any psychiatric illness or psychological disorder which may impair the ability to provide written informed consent or participate in the study 14. Subject has donated blood or plasma or clinically significant blood loss within 14 days prior to screening visit 15. Subject has received blood or plasma within 60 days prior to screening visit 16. Subject is pregnant or breast-feeding 17. A history of alcohol or drug abuse in the last 12 months or current alcohol consumption is >4 standard drinks (or equivalent) per day 18. Use of any prescription medication (except for contraceptives) within 7 days, unless approved by the PI. All medications will be documented and reviewed for acceptance by the PI or a medically qualified nominee 19. 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 20. A Vaxxas employee, or relative of a Vaxxas employee.
Outcome results
None listed