Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06417853




Registration number
NCT06417853
Ethics application status
Date submitted
8/05/2024
Date registered
16/05/2024
Date last updated
16/05/2024

Titles & IDs
Public title
Influenza A (H7N9) Vaccine Delivered Intradermally by High-density Microarray Patch (HD-MAP)
Scientific title
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
Secondary ID [1] 0 0
SP-1219-007
Universal Trial Number (UTN)
Trial acronym
HD-MAP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
H7N9 Influenza 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Unadjuvanted Influenza A (H7N9) Monovalent Vaccine Injection
Combination Product - Unadjuvanted Influenza A (H7N9) Monovalent Vaccine Microarray Patch Delivery System (low dose HA)
Combination Product - Adjuvanted Influenza A (H7N9) Monovalent Vaccine Microarray Patch Delivery System (high dose HA)
Other interventions - Adjuvanted Influenza A (H7N9) Monovalent Vaccine Injection
Combination Product - Adjuvanted Influenza A (H7N9) Monovalent Vaccine Microarray Patch Delivery System (low dose HA, low dose adjuvant)
Combination Product - Adjuvanted Influenza A (H7N9) Monovalent Vaccine Microarray Patch Delivery System (low dose HA, high dose adjuvant)
Combination Product - Adjuvanted Influenza A (H7N9) Monovalent Vaccine Microarray Patch Delivery System (high dose HA, low dose adjuvant)
Combination Product - Adjuvanted Influenza A (H7N9) Monovalent Vaccine Microarray Patch Delivery System (high dose HA, high dose adjuvant)
Treatment: Devices - Microarray Patch Delivery System

Active Comparator: Arm 1: Influenza A (H7N9) Vaccine Intramuscular Injection - 7.5 mcg HA unadjuvanted IM injection (n=30)

Experimental: Arm 2: Unadjuvanted Influenza A (H7N9) Vaccine Microarray Patch - VXS-1219 12 mcg HA (n=30) and VXS-1219U (n =3)

Experimental: Arm 3: Adjuvanted Influenza A (H7N9) Vaccine Microarray Patch - VXS-1219 25 mcg HA (n=30) and VXS-1219U (n =3)

Active Comparator: Arm 4: Adjuvanted Influenza A (H7N9) Vaccine Intramuscular Injection - 7.5 mcg HA with MF59® adjuvant 7.5 IM injection (n=30)

Experimental: Arm 5: Adjuvanted Influenza A (H7N9) Vaccine Microarray Patch - VXS-1219A 12 mcg HA + QS21 4 mcg (n=30) and VXS-1219U (n =3)

Experimental: Arm 6: Adjuvanted Influenza A (H7N9) Vaccine Microarray Patch - VXS-1219A 12 mcg HA + QS21 8 mcg (n=30) and VXS-1219 (n = 3)

Experimental: Arm 7: Adjuvanted Influenza A (H7N9) Vaccine Microarray Patch - VXS-1219A 20 mcg HA + QS21 3.3 mcg (n=30) and VXS-1219U (n=3)

Experimental: Arm 8: Adjuvanted Influenza A (H7N9) Vaccine Microarray Patch - VXS-1219A 20 mcg HA + QS21 6.7 mcg (n=30) and VXS 1219U (n=3)


Other interventions: Unadjuvanted Influenza A (H7N9) Monovalent Vaccine Injection
7.5 mcg Influenza A (H7N9) Injection

Combination Product: Unadjuvanted Influenza A (H7N9) Monovalent Vaccine Microarray Patch Delivery System (low dose HA)
12 mcg Influenza A (H7N9) Microarray Patch Delivery System (VXS-1219)

Combination Product: Adjuvanted Influenza A (H7N9) Monovalent Vaccine Microarray Patch Delivery System (high dose HA)
25 mcg Influenza A (H7N9) Microarray Patch Delivery System (VXS-1219)

Other interventions: Adjuvanted Influenza A (H7N9) Monovalent Vaccine Injection
7.5 mcg Influenza A (H7N9) with MF59® Injection

Combination Product: Adjuvanted Influenza A (H7N9) Monovalent Vaccine Microarray Patch Delivery System (low dose HA, low dose adjuvant)
12 mcg Influenza A (H7N9) with 4 mcg QS21 Microarray Patch Delivery System (VXS-1219A)

Combination Product: Adjuvanted Influenza A (H7N9) Monovalent Vaccine Microarray Patch Delivery System (low dose HA, high dose adjuvant)
12 mcg Influenza A (H7N9) with 8 mcg QS21 Microarray Patch Delivery System (VXS-1219A)

Combination Product: Adjuvanted Influenza A (H7N9) Monovalent Vaccine Microarray Patch Delivery System (high dose HA, low dose adjuvant)
20 mcg Influenza A (H7N9) with 3.3 mcg QS21 Microarray Patch Delivery System (VXS-1219A)

Combination Product: Adjuvanted Influenza A (H7N9) Monovalent Vaccine Microarray Patch Delivery System (high dose HA, high dose adjuvant)
20 mcg Influenza A (H7N9) with 6.7 mcg QS21 Microarray Patch Delivery System (VXS-1219A)

Treatment: Devices: Microarray Patch Delivery System
Vaccine free Microarray Patch Delivery System (VXS-1219U)
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Combination Product
Intervention code [3] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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);
Timepoint [1] 0 0
387 days
Primary outcome [2] 0 0
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);
Timepoint [2] 0 0
387 days
Primary outcome [3] 0 0
Incidence and severity of unsolicited (spontaneously reported) treatment-emergent adverse events (TEAEs) from Day 1 through Day 78;
Timepoint [3] 0 0
78 days
Primary outcome [4] 0 0
Incidence and severity of SAEs, MAAEs and PIMMCs from Day 1 through Day 387;
Timepoint [4] 0 0
387 days
Primary outcome [5] 0 0
Incidence and severity of Application Site Reactogenicity Adverse Events with onset after Day 78 from Day 79 through Day 387;
Timepoint [5] 0 0
387 days
Primary outcome [6] 0 0
Number of Participants with Clinically Significant Changes in Laboratory Tests from Day 1 to Day 387;
Timepoint [6] 0 0
387 days
Primary outcome [7] 0 0
Number of Participants with Clinically Significant Changes in Physical Examination from Day 1 to Day 387
Timepoint [7] 0 0
387 days
Primary outcome [8] 0 0
Number of Participants with Clinically Significant Changes in Vital Signs from Day 1 through Day 387;
Timepoint [8] 0 0
387 days
Primary outcome [9] 0 0
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;
Timepoint [9] 0 0
78 days
Primary outcome [10] 0 0
Concomitant medication usage.
Timepoint [10] 0 0
387 days
Secondary outcome [1] 0 0
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;
Timepoint [1] 0 0
387 days
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
387 days
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
387 days
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
387 days

Eligibility
Key inclusion criteria
Participants must meet all of the following inclusion criteria to be eligible for this
study:

- 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
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants meeting any of the following exclusion criteria will not be eligible for this
study:

- 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;

- Participants with birthmarks, tattoos, wounds, scars, moles, blemishes, heavy hair or
other skin conditions (such as eczema) at the planned vaccination sites (2 adjacent
sites overlying the deltoid muscle which are at least 3 cm apart) that could be
expected to obscure the observation of treatment site reactions. If dosing on Day 22
is performed on different arm than Day 1, the same exclusion criteria shall apply;

- 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;

- Planned surgery requiring a general anaesthetic, or surgery requiring inpatient
hospitalisation for at least 24 hours from Screening through to Day 78;

- 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;

- History of abnormal bleeding, and/or thrombophlebitis unrelated to venepuncture or
intravenous cannulation;

- History of autoimmune or autoinflammatory immune-mediated medical conditions;

- Receiving chronic treatment with immunosuppressive therapy, including chronic use
(more than 14 continuous days) of corticosteroids within 30 days prior to Day 1.

- Participant who has received immunoglobulins and/or any blood or blood products within
three months prior to Day 1 or plans to receive any blood or blood products at any
time during the study;

- Participant who has donated blood or plasma, or has had clinically significant blood
loss, within 14 days prior to Day 1. Participants who plan to donate blood or plasma
within 12 weeks of dose 2 should also be excluded;

- Female participant who is pregnant or breast-feeding, or intends to become pregnant,
from Screening through EoS;

- A history of alcohol or drug abuse in the past 12 months, or current declared alcohol
consumption >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);

- 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;

- Use of any investigational drug or device within 30 days, or five half-lives of the
drug (whichever is longer) before Day 1, or planned use of another investigational
drug or device at any time during the study;

- 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

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
5/07/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2026
Actual
Sample size
Target
258
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
University of Sunshine Coast Clinical Trials - Morayfield
Recruitment hospital [2] 0 0
University of Sunshine Coast Clinical Trials - Sippy Downs
Recruitment hospital [3] 0 0
University of Sunshine Coast Clinical Trials - South Brisbane
Recruitment hospital [4] 0 0
Doherty Clinical Trials Ltd - East Melbourne
Recruitment postcode(s) [1] 0 0
4506 - Morayfield
Recruitment postcode(s) [2] 0 0
4556 - Sippy Downs
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
3002 - East Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Vaxxas Pty Ltd
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Biomedical Advanced Research and Development Authority
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT06417853
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06417853