None listed
Conditions
Brief summary
This study is designed to test the hypothesis that MAP application to the skin using a small number of healthy adult subjects with a well characterised influenza vaccine antigen (A/Singapore/GP1908/2015) results in comparable safety / local skin reaction to conventional intramuscular vaccination. This study represents the first time that polymer MAPs with an active vaccine will be applied to humans. Therefore, this study will assess both systemic and the local reaction to application of the A/Sing MAP delivering a 15 mcg HA intramuscular-equivalent dose with the application of three MAPs, in comparison to uncoated MAPs, intramuscular injection with Afluria Quadrivalent (delivering 15 mcg A/Sing HA) and intramuscular injection with 15 mcg A/Sing HA (as a monovalent antigen). The local skin response will be monitored for up to 60 days. On-site clinic assessments will be performed up to 2 hours post application and at 1, 3, 7, 21 and 60 days (if required) post application. Phone calls will be made at Day 36 and Day 50
Interventions
The study is in 2 parts,with 4 parallel treatment groups in Part A and 9 parallel treatment groups in Part B. In both study parts the interventional exposure group being studied is the Micro array projections (MAPs) coated with A/Singapore/GP1908/2015 antigen (A/Sing) in various doses. The comparator products are listed in the section below.
The A/Sing MAP comes in 2 doses; 5mcg Haemagglutinin protein (HA) or 2.5 mcg HA. They are single use. For each subject, a MAP is applied for 2 mins then
The study is in 2 parts,with 4 parallel treatment groups in Part A and 9 parallel treatment groups in Part B. In both study parts the interventional exposure group being studied is the Micro array projections (MAPs) coated with A/Singapore/GP1908/2015 antigen (A/Sing) in various doses. The comparator products are listed in the section below. The A/Sing MAP comes in 2 doses; 5mcg Haemagglutinin protein (HA) or 2.5 mcg HA. They are single use. For each subject, a MAP is applied for 2 mins then removed then the next patch is applied for 2 mins then removed etc. The MAP is applied by a trained medical professional. Study Part A: Group 1 subjects will receive 3 x 5mcg A/Sing coated MAPs to the forearm, total dose 15mcg HA. Groups 2, 3 and 4 will receive comparator products (described in section below) Study Part B: Group 1 subjects receive 3 x 5mcg A/Sing coated MAPs to the forearm, total dose 15mcg HA Group 2 subjects receive 3 x 5mcg A/Sing coated MAPs to the forearm, total dose 15mcg HA and they will undergo additional testing of punch biopsy of application site. Group 3 subjects receive 2 x 5mcg A/Sing coated MAPs to the forearm plus 1 uncoated (placebo MAP, total dose 10mcg HA Group 4 subjects receive 1 x 5mcg A/Sing coated MAP to the forearm plus 2 uncoated (placebo MAPs, total dose 5mcg HA Group 5 subjects receive 1 x 2.5mcg A/Sing coated MAP (2.5mcg HA) plus 2 uncoated (placebo) MAPs to the forearm, total dose 2.5 mcg HA Group 8 subjects receive 3 x 5mcg A/Sing coated MAPs to the deltoid muscle, total dose 15 mcg HA The MAP delivery device is a hand-held mechanical, spring loaded, disposable applicator (Vaxxas Clinical Applicator, disposable, CAP) calibrated at a specific speed of 20 m/s. Each MAP will be delivered to the skin and left in situ for 2 minutes. It will then be removed by a gloved finger by gently tensioning the skin around the patch with one hand, whilst pulling the MAP directly up and away from the skin with the other hand.
Sponsors
Vaxxas Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Aged 18-50 years (inclusive). 2. Subject has a Body Mass Index (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. Females of childbearing potential and males should either be sexually inactive (abstinent) for 14 days prior to screening and throughout the study or be using one of the following acceptable birth control methods: a. Surgically sterile (hysterectomy and/or bilateral oophorectomy); b. Surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to study initiation); c. IUD in place for at least 3 months; d. Stable hormonal contraceptive for at least 3 months prior to study through completion of study; e. Surgical sterilization (vasectomy) for male participants or for female participant’s partner at least 6 months prior to study f. Condom for male participant together with effective contraception for their female partner. 6. Postmenopausal women must have had at least 12 months since their last menstrual period 7. Subject is able to communicate effectively with study personnel and is considered reliable, willing and cooperative in terms of compliance with the protocol requirements. 8. 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) on forearms and upper arm regions (both arms) which could reasonably obscure application site reactions. 2. Subject with known chronic spontaneous urticaria / dermographism 3. Known anaphylactic hypersensitivity to a previous influenza vaccination or to eggs, neomycin, polymyxin B sulphate or any of the constituents or trace residues of the study vaccine. 4. Has received an influenza vaccine or has been diagnosed by a doctor as having influenza in the last 12 months. 5. Known history of Guillain-Barré syndrome. 6. Recent vaccination (within 30 days prior to enrolment) with any vaccine. 7. Known predisposition to keloid scar formation. 8. History of granulomatous diseases (especially sarcoidosis and granuloma annulare). 9. History of clinically significant gastrointestinal, hepatic, renal, cardiovascular, dermatological, immunological, respiratory, endocrine, oncological, neurological, metabolic, psychiatric disease or haematological disorders. 10. History of malignancy, other than non-melanoma skin cancer. 11. An active medical condition (which is deemed as clinically significant) that is under evaluation or treatment, or a recent illness, a chronic illness, an autoimmune disease or had major surgery within the last year. 12. 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. 13. History of abnormal bleeding tendencies or thrombophlebitis unrelated to venepuncture or intravenous cannulation. 14. 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. 15. History of any psychiatric illness or psychological disorder which may impair the ability to provide written informed consent or participate in the study. 16. Subject has donated blood or plasma or clinically significant blood loss within 60 days prior to screening visit. 17. Subject is pregnant or breast-feeding. 18. A history of alcohol or drug abuse in the last 12 months or current alcohol consumption is >4 standard drinks (or equivalent) per day. 19. 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 Investigator or a medically qualified nominee. 20. Use of any investigational drug or device within 30 days or 5 half-lives of the drug, whichever is longer, prior to the Day 1. 21. Previous exposure to the Nanopatch and its applicator as a participant in previous clinical studies.
Outcome results
None listed