None listed
Conditions
Brief summary
This is a first in human study to evaluate the safety, tolerability and performance of a new vaccine delivery device. The sponsor is developing a novel approach for the administration of vaccines that does not require the use of needles. Small nanopatches patches designed to carry the vaccine are applied to the skin and kept in place for 2 minutes. This study will assess how safe and acceptable these nanopatches are.
Interventions
Comparison of safety, tolerability and performance of uncoated and placebo coated Nanopatches and the Nanopatch applicator device (Vaccine Delivery Device).
The uncoated Nanopatch is a terminally sterilised 1cm2 monocrystalline silicon wafer with 8200 micro-projections.
The placebo-coated Nanopatch is a terminally sterilised 1 cm2 monocrystalline silicon wafer with 8200 micro-projections coated with hypromellose, trehalose dihydrate and phosphate buffered saline.
The Nanopatch delivery devic
Comparison of safety, tolerability and performance of uncoated and placebo coated Nanopatches and the Nanopatch applicator device (Vaccine Delivery Device). The uncoated Nanopatch is a terminally sterilised 1cm2 monocrystalline silicon wafer with 8200 micro-projections. The placebo-coated Nanopatch is a terminally sterilised 1 cm2 monocrystalline silicon wafer with 8200 micro-projections coated with hypromellose, trehalose dihydrate and phosphate buffered saline. The Nanopatch delivery device is a hand-held mechanical, spring loaded and reusable applicator (CAP02) calibrated at a specific speed of either 20 m/s (placebo coated patch) or 17.5 m/s (uncoated patch). There are 2 study cohorts; Patients in Cohort 1 on Day 0 will have one uncoated patch applied to the forearm and one uncoated patch applied to the deltoid. On Day 3 they will return to to the clinic and receive one placebo-coated patch to the forearm and one placebo-coated patch to the deltoid. Cohort 2 will only receive placebo-coated patches on one occasion (Day 0). Two patches will be applied to the forearm and 2 patches willbe applied to the deltoid region. Therefore each subject will have a total of 4 patches applied, 2 to the forearm and 2 to the deltoid region of the non-dominant arm. Each patch will be held on the arm for 2 minutes before manual removal. Observations (and photography) will be done at regular timepoints on the day of application for then daily for 6 days, then again at the end of study visit.
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 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Aged 18-45 years (inclusive). 2. Subject has a BMI within the range 18.0–30.0 kg/m2 3. Satisfactory medical assessment, with no clinically significant or relevant abnormalities in medical history, physical examination, vital signs and laboratory evaluation (haematology or biochemistry) 4. Adequate venous access in their left or right arms to allow collection of a number of blood samples. 5. Subject is fair-skinned. 6. Subject is able to communicate effectively with study personnel and is considered reliable, willing and cooperative in terms of compliance with the protocol requirements. 7. 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 on both forearms and deltoid regions which could reasonably obscure application site reactions. 2. Known Predisposition to keloid scar formation. 3. History of clinically significant gastrointestinal, hepatic, renal, cardiovascular, dermatological, immunological, respiratory, endocrine, oncological, neurological, metabolic, psychiatric disease or haematological disorders. 4. History of malignancy, other than non-melanoma skin cancer. 5. An active medical condition that is under evaluation or treatment, or a recent illness, a chronic illness, an autoimmune disease or had major surgery within the last year. 6. History of Hepatitis B, Hepatitis C or HIV infection or clinical laboratory serology is positive for Hepatitis B surface antigen, Hepatitis C or HIV antibodies. 7. History of abnormal bleeding tendencies or thrombophlebitis unrelated to venepuncture or intravenous cannulation, 8. 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. 9. History of any psychiatric illness or psychological disorder which may impair the ability to provide written informed consent or participate in the study. 10. Subject has donated blood or plasma or clinically significant blood loss within 60 days prior to screening visit 11. Subject is pregnant or breast-feeding. 12. A history of alcohol or drug abuse in the last 12 months or current alcohol consumption is >4 standard drinks (or equivalent) per day. 13. Use of any prescription medication within 7 days, unless approved by the PI. All medications will be documented and reviewed for acceptance by the Investigator or a medically qualified nominee. 14. Use of any investigational drug or device within 30 days or 10 half-lives of the drug, whichever is longer, prior to the Day 0.
Outcome results
None listed