ACTRN12616000880448
Completed
Phase 1
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.
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Prophylaxis for H1N1 infection
- Sponsor
- Vaxxas Pty Ltd
- Enrollment
- 60
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
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 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.
Outcomes
Primary Outcomes
Not specified
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