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).
- Conditions
- Prophylaxis for H1N1 infectionInfection - Other infectious diseases
- Registration Number
- ACTRN12616000880448
- Lead Sponsor
- Vaxxas Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
1.Aged 18-45 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.Subject is fair-skinned (skin type I, II or III, according to the Fitzpatrick scale).
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.
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 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.
3.Has received an influenza vaccine or has been diagnosed by a doctor as having influenza in the last 12 months.
4.Known history of Guillain-Barre syndrome.
5.Recent vaccination (within 30 days prior to enrollment) with any vaccine.
6.Known Predisposition to keloid scar formation.
7.History of granulomatous diseases (especially sarcoidosis and granuloma annulare).
8.History of clinically significant gastrointestinal, hepatic, renal, cardiovascular, dermatological, immunological, respiratory, endocrine, oncological, neurological, metabolic, psychiatric disease or haematological disorders.
9.History of malignancy, other than non-melanoma skin cancer.
10.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.
11.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.
12.History of abnormal bleeding tendencies or thrombophlebitis unrelated to venepuncture or intravenous cannulation,
13.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.
14.History of any psychiatric illness or psychological disorder which may impair the ability to provide written informed consent or participate in the study.
15.Subject has donated blood or plasma or clinically significant blood loss 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 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.
19.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.
20.Previous exposure to the Nanopatch and its applicator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the safety and tolerability of delivering A/California/7/2009 (H1N1)-like vaccine coated Nanopatch at two distinct anatomical sites in comparison to a placebo-coated Nanopatch and intramuscular administration to the deltoid muscle of a trivalent seasonal influenza vaccine delivering approximately the same dose of A/California/7/2009 (H1N1) like vaccine. Assessed by:<br>Adverse event reporting, Draize scoring, and acceptability scoring form interview.[Day 3 Visit (3 days after application)]
- Secondary Outcome Measures
Name Time Method To evaluate the immune responses to Nanopatch application with A/California/7/2009 (H1N1) like vaccine at two distinct sites in comparison to placebo-coated Nanopatches and IM administration. Titres of anti -A/CAlifornia/07/2009 antibodies will be measured in serum by HIA and ELISA. [Day 7 and Day 14 post application]