Influenza A (H7N9) Vaccine Delivered Intradermally by High-density Microarray Patch (HD-MAP)

Phase 1

Recruiting

• Conditions: H7N9 Influenza

• Registration Number: NCT06417853
• Lead Sponsor: Vaxxas Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-5-8
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 258

Inclusion Criteria

Inclusion Criteria:<br><br>Participants must meet all of the following inclusion criteria to be eligible for this<br>study:<br><br> - Aged 18 to 50 years (inclusive) at the time of consent;<br><br> - Body mass index (BMI) within the range 18.0 to 32.0 kg/m² (inclusive) at Screening;<br><br> - Being in good health, as determined by satisfactory physical examination, vital<br> signs, 12-lead ECG, laboratory evaluation, stable medical history and clinical<br> judgment of the Investigator. Participants with stable, chronic underlying illnesses<br> such as psychiatric/psychological disorders, hypertension, diabetes, ischemic heart<br> disease or hypothyroidism (or other conditions as per investigator's discretion) may<br> be enrolled at the discretion of the PI and provided their signs and symptoms are<br> controlled. If on regular prescription medication, the medication dose must have<br> been stable for at least three months prior to Screening;<br><br> - Adequate venous access in left or right arm to allow collection of small-volume<br> blood samples at different visits;<br><br> - Participants of childbearing potential must return a negative pregnancy test at<br> Screening (serum) and pre-dose on Day 1 (urine), and must agree to remain sexually<br> abstinent, use medically effective contraception or have a partner who is sterile or<br> same-sex, from Screening through to Day 78. The use of medically effective<br> contraception or IUD must be stable for at least three months prior to Screening.<br> Surgical sterilisation, e.g., tubal ligation, hysterectomy and bilateral<br> oophorectomy in women, or vasectomy in men, is required at least six months prior to<br> Screening. Post menopausal participants can be included, and are defined as those<br> with at least 12 months since their last menstrual period;<br><br> - Non-surgically sterilised, sexually active male participants with a female partner<br> of child-bearing potential must agree to use condoms, together with medically<br> effective contraception for their female partner through to Day 78;<br><br> - Participant is able to communicate effectively with study personnel and is<br> considered likely to be reliable, willing and cooperative in terms of compliance<br> with the protocol requirements;<br><br> - Participant is able and willing to provide written, personally signed, informed<br> consent to participate in the study<br><br>Exclusion Criteria:<br><br>Participants meeting any of the following exclusion criteria will not be eligible for<br>this study:<br><br> - Participants who have received any registered vaccine within 30 days prior to Day 1;<br><br> - Planned administration of any registered vaccine prior to the immunogenicity blood<br> draw on Day 43;<br><br> - Previous administration of any H7 vaccine, previous physician-confirmed H7 disease,<br> previous known or potential exposure to avian influenza virus H7N9 HA antigen or any<br> other avian influenza including H5N1, at any time in the past;<br><br> - Participants with birthmarks, tattoos, wounds, scars, moles, blemishes, heavy hair<br> or other skin conditions (such as eczema) at the planned vaccination sites (2<br> adjacent sites overlying the deltoid muscle which are at least 3 cm apart) that<br> could be expected to obscure the observation of treatment site reactions. If dosing<br> on Day 22 is performed on different arm than Day 1, the same exclusion criteria<br> shall apply;<br><br> - Participant with known chronic spontaneous urticaria or dermographism;<br><br> - Known predisposition to keloid-scar formation (participants who have developed a<br> scar caused by BCG vaccine can be included in the study);<br><br> - Known anaphylactic hypersensitivity to haemagglutinin or to any of the vaccine or<br> adjuvant excipients (squalene, polysorbate 80, sorbitan trioleate, sodium citrate<br> dihydrate, citric acid monohydrate, protein other than H7N9 including Madin Darby<br> Canine Kidney (MDCK) cell protein, (residual), MDCK cell DNA, (residual),<br> cetyltrimethylammonium bromide (residual), beta-propiolactone (residual), QS21<br> extract, or any other excipient contained in the study products;<br><br> - Allergy to a previous vaccination at any time in the past;<br><br> - Known history of demyelinating disease or Guillain-Barré syndrome;<br><br> - History of granulomatous diseases, including sarcoidosis and granuloma annulare;<br><br> - History of convulsions, epilepsy, other physician diagnosed central nervous system<br> diseases, excluding febrile convulsions experienced as a child that are considered<br> resolved;<br><br> - History of clinically significant haematological, gastrointestinal, hepatic, renal,<br> cardiovascular, dermatological, immunological, respiratory, endocrine, oncological,<br> neurological, metabolic, psychiatric disease, that, at the discretion of the<br> Investigator, precludes the participant from the study;<br><br> - Presence of active viral or bacterial infection, with or without fever (tympanic<br> temperature =38.0 °C), at Day 1 or within 72 hours prior to study vaccination, if<br> determined by the Investigator to be of clinical significance. Participants with a<br> minor illness such as mild diarrhoea or mild upper respiratory infection without<br> fever may be enrolled at the discretion of the Investigator. Enrolment may be<br> deferred for up to one week provided participant remains otherwise eligible and the<br> total Screening period does not exceed 14 days;<br><br> - History of any haematological malignancy or active neoplastic disease (Non-melanoma<br> skin cancer that was successfully treated within the 5 year period can be included<br> in the study). Active is defined as having received treatment within the five years<br> prior to Screening;<br><br> - Presence of an active medical condition, defined as a condition under current<br> evaluation or treatment, that is considered clinically significant by the<br> Investigator, or a recent illness that is considered clinically significant by the<br> Investigator;<br><br> - Any condition that, in the opinion of the Investigator, is considered clinically<br> significant or might interfere with the evaluation of the study objectives;<br><br> - Planned surgery requiring a general anaesthetic, or surgery requiring inpatient<br> hospitalisation for at least 24 hours from Screening through to Day 78;<br><br> - History of illness and/or infection with Hepatitis B, or Hepatitis C or Human<br> Immunodeficiency Virus (HIV), or a positive test for Hepatitis B surface antigen,<br> Hepatitis C or antibodies against HIV at Screening;<br><br> - History of abnormal bleeding, and/or thrombophlebitis unrelated to venepuncture or<br> intravenous cannulation;<br><br> - History of autoimmune or autoinflammatory immune-mediated medical conditions;<br><br> - Receiving chronic treatment with immunosuppressive therapy, including chronic use<br> (more than 14 continuous days) of corticosteroids within 30 days prior to Day 1.<br><br> - Participant who has received immunoglobulins and/or any blood or blood products<br> within three months prior to Day 1 or plans to receive any blood or blood products<br> at any time during the study;<br><br> - Participant who has donated blood or plasma, or has had clinically significant blood<br> loss, within 14 days prior to Day 1. Participants who plan to donate blood or plasma<br> within 12 weeks of dose 2 should also be excluded;<br><br> - Female participant who is pregnant or breast-feeding, or intends to

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified