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 show how the device performs, whether patients could use it themselves to apply the patches, and how long the patch should be left on the skin. 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 two parts. The first part is the 1cm² patch that has a series of micro-projections that hold the vaccine coating (placebo in this study). The second part is an applicator device that holds the patch in place and applies it to the skin.
the study is in 2 parts: Part A will be completed before recruitment to part B starts. Subjects in part A cannot re enter into part B
Part A:
Group A: Twenty subjects receive six gas-jet coated High Density Micro Array patc
The vaccine delivery device consists of two parts. The first part is the 1cm² patch that has a series of micro-projections that hold the vaccine coating (placebo in this study). The second part is an applicator device that holds the patch in place and applies it to the skin. the study is in 2 parts: Part A will be completed before recruitment to part B starts. Subjects in part A cannot re enter into part B Part A: Group A: Twenty subjects receive six gas-jet coated High Density Micro Array patches (HD-MAPs): one on each of the volar forearm, upper arm (over the deltoid muscle), and posterior shoulder (over the upper trapezius muscle) on each side of the body. A trained user will apply a HD-MAP to each anatomical site on the side of the body of the subject’s dominant hand. The subject will self-administer a HD-MAP to each site on the opposite side of the body, at the same sites. All applications are for 30 seconds. Part B: Forty subjects receive six Micro jet (MJet) coated HD-MAPs: one on each of the volar forearm, upper arm (over the deltoid muscle), and posterior shoulder (over the upper trapezius muscle). On one side of the body MAP applications will be 30 seconds. For 20 of these subjects, MAP applications will be 10 seconds on the opposite side of the body. For 20 of these subjects MAP applications will be 2 seconds on the opposite side of the body. This will be determined sequentially. There is no active vaccination delivered in this study
Sponsors
Vaxxas Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
1. Aged 18-64 years (inclusive). 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 study completion; 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, upper arms, or posterior shoulder regions (both arms) which could reasonably obscure potential application sites 2. Subject with known chronic spontaneous urticaria / dermographism 3. Subject with known allergy/sensitivity to ingredients, including gold 4. Previous adverse reaction to fluorescein or synthetic dyes 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 basal cell skin cancer. 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 or thrombophlebitis unrelated to venepuncture or intravenous cannulation 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 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 60 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
Outcome results
None listed