None listed
Conditions
Brief summary
This study is designed to assess whether QIV antigen, administered by HD-MAPs applied to the human skin using an integrated applicator, is safe and well tolerated in healthy adult volunteers. This study represents the first time that HD-MAPs coated with QIV antigen will be applied to humans
Interventions
• QIV HD-MAP intradermal (ID) delivery system (VXS-1222) (active);
• Uncoated, vaccine-free HD-MAP ID delivery system (VXS 1222U) (inactive);
• Influvac® Tetra (Northern Hemisphere [NH] 2022/2023) intramuscular (IM) injection (active comparator).
VXS-1222 is an integrated, single-use, ID QIV delivery system containing a mechanical, dome-spring that applies an array of micro-projections to the skin at approximately 20 m/s. The spring is actuated by pressing down on the top of the applicator with
• QIV HD-MAP intradermal (ID) delivery system (VXS-1222) (active); • Uncoated, vaccine-free HD-MAP ID delivery system (VXS 1222U) (inactive); • Influvac® Tetra (Northern Hemisphere [NH] 2022/2023) intramuscular (IM) injection (active comparator). VXS-1222 is an integrated, single-use, ID QIV delivery system containing a mechanical, dome-spring that applies an array of micro-projections to the skin at approximately 20 m/s. The spring is actuated by pressing down on the top of the applicator with a finger and the whole delivery system (including the HD-MAP) is removed after two minutes of application time. VXS-1222 (active) includes an aseptically produced 0.64 cm² polymer array (or ‘patch’) with approximately 1,600 micro-projections. VXS-1222 (active) HD-MAP will be coated with 30 µg, 60 µg or 100 µg HA of QIV. Based on an estimated 70% transfer of QIV into study participants, approximately 21, 42 or 70 µg of QIV will be delivered ID per VXS 1222 HD-MAP application. The QIV to be used in VXS-1222 (active) is comprised of the following 2022/2023 Northern Hemisphere strains: • A/Victoria/2570/2019 (H1N1) pdm09-like strain; • A/Darwin/9/2021 (H3N2)-like strain; • B/Austria/1359417/2021-like strain (Victoria lineage); • B/Phuket/3073/2013-like strain (Yamagata lineage). The QIV virus strain composition is identical to Influvac Tetra (NH 2022/2023) (active comparator). These are also the same strains that were used in the TGA-approved Southern Hemisphere 2022 Influvac Tetra vaccine (AUST R 292237, Viatris Pty Ltd). Eligible participants (n=150) will be randomised into the one of the following five treatment groups and will receive a single treatment of ID VXS-1222 (active), ID VXS 1222U (inactive), or IM Influvac Tetra (NH 2022/2023) (active comparator) on Day 1, as per their assigned group: • Group 1: VXS-1222 (active), expected QIV delivered amount 21 µg (5 µg/strain) hemagglutinin (HA), n=35; • Group 2: VXS-1222 (active), expected QIV delivered amount 42 µg (11 µg/strain) HA, n=35; • Group 3: VXS-1222 (active), expected QIV delivered amount 70 µg (18 µg/strain) HA, n=35; • Group 4: VXS-1222U (inactive), n=10; Doses will be administered by a trained Study site team member. Training will be provided by the sponsor and documented in the study records.
Sponsors
Vaxxas Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1) Aged 18 to 50 years (inclusive) at the time of consent; 2) Body mass index (BMI) within the range 18.0 to 32.0 kg/m² (inclusive) at Screening; 3) Being in good health, as determined by satisfactory medical history, physical examination, vital signs, laboratory evaluation and clinical judgment of the Investigator. Participants with stable, chronic underlying illnesses such as psychiatric/psychological disorders, hypertension, diabetes, ischemic heart disease or hypothyroidism (or other conditions as per investigator’s discretion) may be enrolled provided their signs and symptoms are controlled. If on regular prescription medication, the medication dose must have been stable for at least three months prior to Screening; 4) Adequate venous access in left or right arm to allow collection of a number of small-volume blood samples at different time points; 5) Women of childbearing potential must return a negative pregnancy test at Screening (serum) and pre-dose on Day 1 (urine), and must agree to remain sexually abstinent, use medically effective contraception or have a partner who is sterile or same-sex, from Screening through EoS. Post menopausal women can be included, and are defined as those with at least 12 months since their last menstrual period; 6) Non-surgically sterilised, sexually active male participants with a female partner of child-bearing potential must agree to use condoms, together with medically effective contraception for their female partner; 7) Participant is able to communicate effectively with study personnel and is considered likely to be reliable, willing and cooperative in terms of compliance with the protocol requirements; 8) Participant is able and willing to provide written, personally signed, informed consent to participate in the study.
Exclusion criteria
1) Participants who have received a registered or investigational (confirmed active) influenza vaccination within the six months prior to Day 1; 2) Participants who have had laboratory-confirmed influenza infection within the six months prior to Day 1; 3) Participants with birthmarks, tattoos, wounds, scars, moles, blemishes, heavy hair or other skin conditions (such as eczema) at the planned vaccination site that could be expected to obscure the observation of application-site reactions; 4) Participant with known chronic spontaneous urticaria or dermographism; 5) Known predisposition to keloid-scar formation; 6) Known anaphylactic hypersensitivity to haemagglutinin or to any of the vaccine excipients (potassium chloride, potassium phosphate, sodium phosphate, sodium chloride, calcium chloride, magnesium chloride, sulfobutyl-ß-cyclodextrin) and to residues of eggs (ovalbumin, chicken proteins), formaldehyde, cetrimonium bromide, polysorbate 80, gentamicin, sodium citrate, sucrose, tylosine tartrate, or hydrocortisone; 7) Allergy to a previous vaccination at any time in the past; 8) Recent vaccination (within 30 days prior to Day 1) or any planned vaccination up to Day 22 with any non-influenza vaccine. In addition, any planned vaccination with influenza vaccine other than the study vaccines for the duration of the study; 9) Known history of demyelinating disease or Guillain-Barré syndrome; 10) History of granulomatous diseases, including sarcoidosis and granuloma annulare; 11) History of convulsions, epilepsy, other central nervous system diseases, excluding febrile convulsions experienced as a child that are considered resolved; 12) History of clinically significant haematological, gastrointestinal, hepatic, renal, cardiovascular, dermatological, immunological, respiratory, endocrine, oncological, neurological, metabolic, psychiatric disease, that, at the discretion of the Investigator, precludes the participant from the study; 13) Presence of active viral of bacterial infection, with or without fever (tympanic temperature greater than or equal to 38.0 °C), at Day 1 or within 72 hours prior to study vaccination, if determined by the Investigator to be of clinical significance. Participants with a minor illness such as mild diarrhoea or mild upper respiratory infection without fever may be enrolled at the discretion of the Investigator. Enrolment may be deferred for up to two weeks provided participant remains otherwise eligible and the total Screening period does not exceed 28 days; 14) History of any haematological malignancy or active neoplastic disease (excluding non-melanoma skin cancer that was successfully treated). Active is defined as having received treatment within the 5 years prior to Screening; 15) Presence of an active medical condition, defined as a condition under current evaluation or treatment, that is considered clinically significant by the Investigator, or a recent illness that is considered clinically significant by the Investigator; 16) Any condition that, in the opinion of the Investigator, is considered clinically significant or might interfere with the evaluation of the study objectives; 17) Planned surgery requiring a general anaesthetic, or surgery requiring inpatient hospitalisation for at least 24 hours during the entire study period. 18) History of illness and/or infection with Hepatitis B, or Hepatitis C or Human Immunodeficiency Virus (HIV), or a positive test for Hepatitis B surface antigen, Hepatitis C or antibodies against HIV at Screening; 19) History of abnormal bleeding, and/or thrombophlebitis unrelated to venepuncture or intravenous cannulation; 20) Receiving chronic treatment with immunosuppressive therapy, including chronic use (more than 14 continuous days) of systemic corticosteroids within 30 days prior to Day 1. Intraarticular, intrabursal, intraocular, intranasal, inhaled, or topical corticosteroids, within the dosage of the package insert and without any sign of systemic exposure, are permitted. 21) Participant who has received immunoglobulins and/or any blood or blood products within 3 months prior to Day 1 or plans to receive any blood or blood products at any time during the study. 22) Participant who has donated blood or plasma, or has had clinically significant blood loss, within 14 days prior to Day 1; 23) Female participant who is pregnant or breast-feeding, or intends to become pregnant, from Screening through EoS; 24) A history of alcohol or drug abuse in the past 12 months, or current declared alcohol consumption less than 4 standard drinks per day for 7 days per week (one standard drink is equivalent to 285 mL of full-strength beer, 100 mL of wine or 30 mL of spirits); 25) Use of any prescription medication (with the exception of contraceptives, hormone replacement therapy, or stable doses of medication required for the management of stable, chronic underlying illnesses) within seven days prior to Day 1; 26) Use of any investigational drug or device within 30 days, or five half-lives of the drug (whichever is longer) before Day 1; 27) Was a participant in a placebo-controlled influenza vaccine clinical trial within six months prior to Screening for this study, if the treatment arm is not known. 28) An employee, or a first-degree family member of an employee, of the Sponsor, Contract Research Organization conducting this study, or study site involved in this study.
Outcome results
None listed