Influenza A (H7N9) Vaccine Delivered Intradermally by High-density Microarray Patch (HD-MAP)
HD-MAP
Phase I Clinical Study to Evaluate the Safety and Tolerability of a Monovalent Influenza A (H7N9) Vaccine Delivered Intradermally by High-density Microarray Patch (HD-MAP) in Healthy Adults Aged 18 to 50 Years
1 other identifier
interventional
267
1 country
4
Brief Summary
Study SP-1219-007 is a multi-centre, randomised, study designed to access the safety and tolerability of two doses of monovalent Influenza A (H7N9) vaccine delivered intradermally by a microarray patch delivery system in healthy adults aged 18 to 50 years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2024
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 8, 2024
CompletedFirst Posted
Study publicly available on registry
May 16, 2024
CompletedStudy Start
First participant enrolled
July 31, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2026
CompletedMarch 27, 2026
March 1, 2026
1.5 years
May 8, 2024
March 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
Incidence, severity and duration of solicited systemic adverse reactions including fever, headache, malaise, myalgia, arthralgia, fatigue, sweating and shivering from Day 1 through Day 8 (Dose 1) and Day 22 through Day 29 (Dose 2);
387 days
Incidence, severity and duration of local adverse reactions including erythema, swelling, induration, ecchymosis, and vaccination site pain from Day 1 through Day 8 (Dose 1) and Day 22 through Day 29 (Dose 2);
387 days
Incidence and severity of unsolicited (spontaneously reported) treatment-emergent adverse events (TEAEs) from Day 1 through Day 78;
78 days
Incidence and severity of SAEs, MAAEs and PIMMCs from Day 1 through Day 387;
387 days
Incidence and severity of Application Site Reactogenicity Adverse Events with onset after Day 78 from Day 79 through Day 387;
387 days
Number of Participants with Clinically Significant Changes in Laboratory Tests from Day 1 to Day 387;
Clinical safety laboratory tests include Hematology, Biochemistry panel, Serology for Hepatitis B and C (HBsAg, HCV) and HIV (HIV-1 and HIV-2), Beta-human chorionic gonadotropin (HCG) serum pregnancy test for female participants of childbearing potential only. Females with natural amenorrhea for \<12 months and who ate not surgically sterile, and Urine pregnancy dipstick test will be performed onsite at pre-dose Day 1 and pre dose Day 22 for female participants of childbearing potential only.
387 days
Number of Participants with Clinically Significant Changes in Physical Examination from Day 1 to Day 387
A complete physical examination will include assessments of general appearance; skin and lymphatics; head; eyes; ears; nose; throat; cardiovascular system; respiratory system; abdomen/gastrointestinal system; musculoskeletal and neurological systems. Other body systems may also be examined as required, at the discretion of the Investigator.
387 days
Number of Participants with Clinically Significant Changes in Vital Signs from Day 1 through Day 387;
Vital sign measurements will include tympanic body temperature (in degrees Celsius \[°C\]), systolic and diastolic blood pressure (in millimeters of mercury \[mmHg\]), heart rate (in beats per minute) and respiratory rate (number of breaths per minute).
387 days
Local skin response, assessed by photo imaging and standardised scoring, measured at 10 minutes and 1 hour following application on Day 1 and Day 22, and at Days 4, 8, 29, and 78;
78 days
Concomitant medication usage.
387 days
Secondary Outcomes (4)
GMT of serum antibody response to H7N9 antigen, assessed by hemagglutination inhibition assay (HAI) at baseline and Days 8, 22, 29, 43, 78 and 387;
387 days
GMT of the serum virus neutralising antibody titres to H7N9 antigen, assessed by microneutralisation (MN) assay at baseline and Days 8, 22, 29, 43, 78 and 387.
387 days
GMT of serum antibody response to H7N9 antigen, seroconversion rate and % of subjects seropositive, assessed by hemagglutination inhibition assay (HAI) at baseline and Days 8, 22, 29, 43, 78 and 387.
387 days
Seroconversion based on serum HAI antibody titres, defined as either a pre-vaccination HAI titre < 1:10 and a post-vaccination HAI titre ≥ 1:40, or a pre-vaccination HAI titre ≥ 1:10 and a minimum 4-fold increase in post-vaccination HAI titre.
387 days
Study Arms (8)
Arm 1: Influenza A (H7N9) Vaccine Intramuscular Injection
ACTIVE COMPARATOR7.5 mcg HA unadjuvanted IM injection (n=30)
Arm 2: Unadjuvanted Influenza A (H7N9) Vaccine Microarray Patch
EXPERIMENTALVXS-1219 12 mcg HA (n=30) and VXS-1219U (n =3)
Arm 3: Adjuvanted Influenza A (H7N9) Vaccine Microarray Patch
EXPERIMENTALVXS-1219 25 mcg HA (n=30) and VXS-1219U (n =3)
Arm 4: Adjuvanted Influenza A (H7N9) Vaccine Intramuscular Injection
ACTIVE COMPARATOR7.5 mcg HA with MF59® adjuvant 7.5 IM injection (n=30)
Arm 5: Adjuvanted Influenza A (H7N9) Vaccine Microarray Patch
EXPERIMENTALVXS-1219A 12 mcg HA + QS21 4 mcg (n=30) and VXS-1219U (n =3)
Arm 6: Adjuvanted Influenza A (H7N9) Vaccine Microarray Patch
EXPERIMENTALVXS-1219A 12 mcg HA + QS21 8 mcg (n=30) and VXS-1219 (n = 3)
Arm 7: Adjuvanted Influenza A (H7N9) Vaccine Microarray Patch
EXPERIMENTALVXS-1219A 20 mcg HA + QS21 3.3 mcg (n=30) and VXS-1219U (n=3)
Arm 8: Adjuvanted Influenza A (H7N9) Vaccine Microarray Patch
EXPERIMENTALVXS-1219A 20 mcg HA + QS21 6.7 mcg (n=30) and VXS 1219U (n=3)
Interventions
7.5 mcg Influenza A (H7N9) Injection
12 mcg Influenza A (H7N9) Microarray Patch Delivery System (VXS-1219)
25 mcg Influenza A (H7N9) Microarray Patch Delivery System (VXS-1219)
7.5 mcg Influenza A (H7N9) with MF59® Injection
12 mcg Influenza A (H7N9) with 8 mcg QS21 Microarray Patch Delivery System (VXS-1219A)
20 mcg Influenza A (H7N9) with 3.3 mcg QS21 Microarray Patch Delivery System (VXS-1219A)
Vaccine free Microarray Patch Delivery System (VXS-1219U)
12 mcg Influenza A (H7N9) with 4 mcg QS21 Microarray Patch Delivery System (VXS-1219A)
20 mcg Influenza A (H7N9) with 6.7 mcg QS21 Microarray Patch Delivery System (VXS-1219A)
Eligibility Criteria
You may qualify if:
- Aged 18 to 50 years (inclusive) at the time of consent;
- Body mass index (BMI) within the range 18.0 to 32.0 kg/m² (inclusive) at Screening;
- Being in good health, as determined by satisfactory physical examination, vital signs, 12-lead ECG, laboratory evaluation, stable medical history 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 at the discretion of the PI and 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;
- Adequate venous access in left or right arm to allow collection of small-volume blood samples at different visits;
- Participants 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 to Day 78. The use of medically effective contraception or IUD must be stable for at least three months prior to Screening. Surgical sterilisation, e.g., tubal ligation, hysterectomy and bilateral oophorectomy in women, or vasectomy in men, is required at least six months prior to Screening. Post menopausal participants can be included, and are defined as those with at least 12 months since their last menstrual period;
- 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 through to Day 78;
- 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;
- Participant is able and willing to provide written, personally signed, informed consent to participate in the study
You may not qualify if:
- Participants who have received any registered vaccine within 30 days prior to Day 1;
- Planned administration of any registered vaccine prior to the immunogenicity blood draw on Day 43;
- Previous administration of any H7 vaccine, previous physician-confirmed H7 disease, previous known or potential exposure to avian influenza virus H7N9 HA antigen or any other avian influenza including H5N1, at any time in the past;
- Participant with known chronic spontaneous urticaria or dermographism;
- Known predisposition to keloid-scar formation (participants who have developed a scar caused by BCG vaccine can be included in the study);
- Known anaphylactic hypersensitivity to haemagglutinin or to any of the vaccine or adjuvant excipients (squalene, polysorbate 80, sorbitan trioleate, sodium citrate dihydrate, citric acid monohydrate, protein other than H7N9 including Madin Darby Canine Kidney (MDCK) cell protein, (residual), MDCK cell DNA, (residual), cetyltrimethylammonium bromide (residual), beta-propiolactone (residual), QS21 extract, or any other excipient contained in the study products;
- Allergy to a previous vaccination at any time in the past;
- Known history of demyelinating disease or Guillain-Barré syndrome;
- History of granulomatous diseases, including sarcoidosis and granuloma annulare;
- History of convulsions, epilepsy, other physician diagnosed central nervous system diseases, excluding febrile convulsions experienced as a child that are considered resolved;
- 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;
- Presence of active viral or bacterial infection, with or without fever (tympanic temperature ≥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 one week provided participant remains otherwise eligible and the total Screening period does not exceed 14 days;
- History of any haematological malignancy or active neoplastic disease (Non-melanoma skin cancer that was successfully treated within the 5 year period can be included in the study). Active is defined as having received treatment within the five years prior to Screening;
- 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;
- Any condition that, in the opinion of the Investigator, is considered clinically significant or might interfere with the evaluation of the study objectives;
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
University of Sunshine Coast Clinical Trials
Morayfield, Queensland, 4506, Australia
University of Sunshine Coast Clinical Trials
Sippy Downs, Queensland, 4556, Australia
University of Sunshine Coast Clinical Trials
South Brisbane, Queensland, 4101, Australia
Doherty Clinical Trials Ltd
East Melbourne, Victoria, 3002, Australia
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- The study will be mixed and will contain open label and double-blinded groups; the active comparator groups (Group 1: H7N9 unadjuvanted IM and Group 4: H7N9 with MF59® IM) will be open-label whilst groups (Groups 2, 3 and 5 to 8: VXS-1219 and VXS-1219A) will be double-blinded.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2024
First Posted
May 16, 2024
Study Start
July 31, 2024
Primary Completion
January 30, 2026
Study Completion
January 30, 2026
Last Updated
March 27, 2026
Record last verified: 2026-03