Two-part, randomised, double-blind, placebo-controlled study in healthy participants to investigate the skin tolerability of micro-projection array patches coated with inactivated split influenza virus haemagglutinin (HA) from A/Singapore/GP1908/2015 (A/Michigan/45/2015(H1N1)-like) vaccine.

Phase 1

Completed

• Conditions: prevention of influenza infection; Infection - Other infectious diseases; Public Health - Other public health

• Registration Number: ACTRN12618000112268
• Lead Sponsor: Vaxxas Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-25
• Study Completion: 2018-12-31
• Last Update Posted: 26 August 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 210

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the safety and tolerability of A/Singapore/GP1908/2015 antigen delivered by the micro-projection array patch (MAP) in comparison to an uncoated MAP and intramuscular administration of both a quadrivalent seasonal influenza vaccine and a monovalent vaccine delivering approximately the same dose of A/Singapore/GP1908/2015 (A/Sing) HA protein.<br>Treatment site reaction, pain scores, and skin irritation index will be summarised at each assessment time by treatment group. Comparisons between sites of application and between MAP and intramuscular injection administration and active (A/Sing) versus placebo administrations will be analysed using appropriate statistical tests.<br>Pain scores will be assessed b a 100 mm visual analogue scale.. [Skin tolerability will be assessed daily to Day 7 then at Day 22 then fortnightly up to Day 60 or at resolution.<br>]