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Trial registered on ANZCTR


Registration number
ACTRN12616000880448
Ethics application status
Approved
Date submitted
21/06/2016
Date registered
5/07/2016
Date last updated
9/12/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
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).
Scientific title
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.
Secondary ID [1] 289513 0
None
Universal Trial Number (UTN)
U1111-1184-5260
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prophylaxis for H1N1 infection
 299263 0
Condition category
Condition code
Infection 299224 299224 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 295103 0
Prevention
Comparator / control treatment
Comparator 1, Placebo coated nanopatch is an aseptically produced 1cm square monocrystalline silicon wafer with approx 8200 micro-projections coated with hypromellose, trehalose dihydrate and Phosphate buffered saline. Two patches to be applied on either volar forearm or deltoid for 2 minutes.
The nanopatch delivery device is a hand held mechanical spring loaded, single use, disposable applicator calibrated at a specific speed of 20 m/s.
Comparator 2. Fluvax injection containing A/California/7/2009 (NYMC X-181) A/California/7/2009 (H1N1) – like):15 mcg haemagglutinin per dose
A/New Caledonia/71/2014 (NYMC X-257A) (A/Hong Kong/4801/2014 (H3N2) – like):
15 mcg haemagglutinin per dose
B/Brisbane/60/2008 (B/Brisbane/60/2008 - like): 15 mcg haemagglutinin per dose
Comparator 3: Placebo to Fluvax as sterile saline (0.9%)
Control group
Active

Outcomes
Primary outcome [1] 298705 0
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:
Adverse event reporting, Draize scoring, and acceptability scoring form interview.
Timepoint [1] 298705 0
Day 3 Visit (3 days after application)
Secondary outcome [1] 325017 0
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.
Timepoint [1] 325017 0
Day 7 and Day 14 post application

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.
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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The sample size was not based on any formal statistical calculations but is within the normal range for first time in humans clinical trials.No statistical testing between groups for safety endpoints is planned

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/07/2016
Date of last participant enrolment
Anticipated
10/07/2016
Actual
12/08/2016
Date of last data collection
Anticipated
Actual
9/09/2016
Sample size
Target
60
Accrual to date
Final
61
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 6007 0
Q-Pharm Pty - Clive Berghofer Research Centre (CBCRC) - Herston
Recruitment postcode(s) [1] 13429 0
4006 - Herston

Funding & Sponsors
Funding source category [1] 293886 0
Commercial sector/Industry
Name [1] 293886 0
Vaxxas Pty Ltd
Country [1] 293886 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Vaxxas Pty Ltd
Address
Vaxxas Pty Ltd
Suite 304, Level 3
1 Alfred Street
Sydney
NSW 2000
Australia
Country
Australia
Secondary sponsor category [1] 292712 0
None
Name [1] 292712 0
Address [1] 292712 0
Country [1] 292712 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295303 0
QIMR-Berghofer HREC
Ethics committee address [1] 295303 0
Locked bag 2000
Royal Brisbane and Womens Hospital
Herston
QLD 4029
Ethics committee country [1] 295303 0
Australia
Date submitted for ethics approval [1] 295303 0
19/05/2016
Approval date [1] 295303 0
03/06/2016
Ethics approval number [1] 295303 0
P2213

Summary
Brief 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.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57574 0
Dr Paul Griffin
Address 57574 0
Q-Pharm Pty Ltd
Level 5 300C Herston Road
HERSTON
Qld 4006
Country 57574 0
Australia
Phone 57574 0
+61 (0) 738453636
Fax 57574 0
+61 (0) 738453630
Email 57574 0
[email protected]
Contact person for public queries
Name 57575 0
Angus Forster
Address 57575 0
Vaxxas Pty Ltd
TRI
37 Kent Street
Woolloongabba
QLD 4102
Country 57575 0
Australia
Phone 57575 0
+61 (0) 734437838
Fax 57575 0
Email 57575 0
[email protected]
Contact person for scientific queries
Name 57576 0
Angus Forster
Address 57576 0
Vaxxas Pty Ltd
TRI
37 Kent Street
Woolloongabba
QLD 4102
Country 57576 0
Australia
Phone 57576 0
+61 (0) 734437838
Fax 57576 0
Email 57576 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseSafety, tolerability, acceptability and immunogenicity of an influenza vaccine delivered to human skin by a novel high-density microprojection array patch (NanopatchTM).2018https://dx.doi.org/10.1016/j.vaccine.2018.05.053
EmbaseMicroarray patches: scratching the surface of vaccine delivery.2023https://dx.doi.org/10.1080/14760584.2023.2270598
N.B. These documents automatically identified may not have been verified by the study sponsor.