A first-in-human study to evaluate the safety tolerability and performance of A/California/7/2009 (H1N1)- like vaccine coated Nanopatches in comparison to placebo coated Nanopatches and intramuscular injection of A/California/7/2009 (H1N1)-like vaccine.. Nanopatches will be delivered to skin using the Vaxxas Clinical Applicator Disposable Device (CAPD).
A first-in-human study to evaluate the safety tolerability and performance of A/California/7/2009 (H1N1)- like vaccine coated Nanopatches in comparison to placebo coated Nanopatches and intramuscular injection of A/California/7/2009 (H1N1)-like vaccine.. Nanopatches will be delivered to skin using an applicator device (CAPD). The study involves healthy adults.
Vaxxas Pty Ltd
60 participants
Jul 1, 2016
Interventional
Conditions
Summary
There will be three treatment groups: Group 1: 15 subjects receive 2 A/Cal Nanopatches delivering a total of 15 mcg of A/Cal Haemagglutinin (HA) protein and 5 subjects receive 2 placebo-coated Nanopatches to the volar forearm Group 2: 15 subjects receive 2 A/Cal Nanopatches delivering a total of 15 mcg of A/Cal HA protein and 5 subjects receive 2 placebo-coated Nanopatches to the deltoid. Group 3: 15 subjects receive intramuscular Fluvax containing 15 mcg of A/Cal HA protein and 5 subjects receive an intramuscular injection of sterile saline. Sentinel Group: The study will begin with sentinel dosing, with 2 subjects (1 active, 1 placebo) from each treatment group, with evaluation to day 7. After 7 days the subjects will be assessed for safety by adverse events, physical exam, vitals and local injection site reactions (halt criteria). In the absence of safety concerns the remainder of the subjects will be enrolled and randomised into the study. Safety assessments include: Blood pressure, aural temperature, heart rate, respiratory rate, biochemistry, haematology, pregnancy testing for females, serology (human immunodeficiency virus (HIV), Hepatitis B and C), adverse event monitoring and local tolerability and pain assessment of the Nanopatch application site and intramuscular injection site. The study is designed to test the hypothesis that Nanopatch application to the skin with a well characterised influenza vaccine antigen (A/California/7/2009 (H1N1)-like) results in comparable safety / local skin reaction to conventional intramuscular vaccination.
Eligibility
Inclusion Criteria8
- Aged 18-45 years (inclusive).
- Subject has a Body Mass Index (BMI) within the range 18.0–30.0 kg/m2
- Satisfactory medical assessment, with no clinically significant or relevant abnormalities in medical history,
- physical examination, vital signs and laboratory evaluation (haematology or biochemistry)
- Adequate venous access in their left or right arms to allow collection of a number of blood samples.
- Subject is fair-skinned (skin type I, II or III, according to the Fitzpatrick scale).
- Subject is able to communicate effectively with study personnel and is considered reliable, willing and cooperative in terms of compliance with the protocol requirements.
- Able and willing to provide written, personally signed and dated informed consent to participate in the study.
Exclusion Criteria20
- 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.
- 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.
- Has received an influenza vaccine or has been diagnosed by a doctor as having influenza in the last 12 months.
- Known history of Guillain-Barre syndrome.
- Recent vaccination (within 30 days prior to enrollment) with any vaccine.
- Known Predisposition to keloid scar formation.
- History of granulomatous diseases (especially sarcoidosis and granuloma annulare).
- History of clinically significant gastrointestinal, hepatic, renal, cardiovascular, dermatological, immunological, respiratory, endocrine, oncological, neurological, metabolic, psychiatric disease or haematological disorders.
- History of malignancy, other than non-melanoma skin cancer.
- 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.
- 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.
- History of abnormal bleeding tendencies or thrombophlebitis unrelated to venepuncture or intravenous cannulation,
- 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.
- History of any psychiatric illness or psychological disorder which may impair the ability to provide written informed consent or participate in the study.
- Subject has donated blood or plasma or clinically significant blood loss within 60 days prior to screening visit
- Subject is pregnant or breast-feeding.
- A history of alcohol or drug abuse in the last 12 months or current alcohol consumption is >4 standard drinks (or equivalent) per day.
- 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.
- 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.
- Previous exposure to the Nanopatch and its applicator
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Interventions
The A/Cal coated nanopatch is an aseptically produced 1cm square monocrystalline silicon wafer with approx 8200 micro-projections coated with 7.5mcg A/Cal, hypromellose, trehalose dihydrate and Phosphate buffered saline. Two patches to be applied on either the volar forearm or the deltoid. (total dose 15mcg). One patch is applied then left on the skin for 2 minutes before being removed then the second patch is applied adjacent to the first patch and administered in the same manner. The nanopatch delivery device is a hand held mechanical spring loaded, single use, disposable applicator calibrated at a specific speed of 20 m/s.
Locations(1)
View Full Details on ANZCTR
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ACTRN12616000880448