H7N9 Influenza
Conditions
Keywords
Influenza A Monovalent Vaccine Microarray Delivery System
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.
Detailed description
258 participants will be randomized to receive two doses (Day 1 and 22) of either VXS-1219, VXS-1219 with QS21 adjuvant (VXS-1219A), an intramuscular comparator (H7N9 vaccine or H7N9 + MF59® vaccine) or an uncoated, vaccine-free HD-MAP Delivery system (VXS-1219U). VXS-1219A is identical to VXS-1219 with the only difference being this investigational product will be formulated with QS21. VXS-1219U, the vaccine-free microarray patch delivery system comparator, includes a terminally sterilized polymer patch and does not include any vaccine coating formulation on the micro-projections, but is otherwise identical to VXS-1219 and VXS-1219A. The primary objective of the study is to evaluate the safety and tolerability of two doses of H7N9 Influenza A vaccine (12 to 25 mcg HA) with and without QS21 adjuvant (3.3 to 8 mcg), administered by the microarray patch delivery system, compared to IM H7N9 vaccine (7.5 mcg HA) with and without MF59® and uncoated, vaccine-free microarray patch delivery system, administered 21 days apart. The secondary objectives of the study are to evaluate the immune response to two doses H7N9 Influenza A vaccine (12 to 25 mcg HA) with and without QS21 adjuvant (3.3 to 8 mcg), administered by the microarray patch delivery system, compared to IM H7N9 vaccine (7.5 mcg HA) with and without MF59® and uncoated, vaccine-free microarray patch delivery system, administered 21 days apart.
Interventions
BIOLOGICALUnadjuvanted Influenza A (H7N9) Monovalent Vaccine Injection
7.5 mcg Influenza A (H7N9) Injection
COMBINATION_PRODUCTUnadjuvanted Influenza A (H7N9) Monovalent Vaccine Microarray Patch Delivery System (low dose HA)
12 mcg Influenza A (H7N9) Microarray Patch Delivery System (VXS-1219)
COMBINATION_PRODUCTAdjuvanted Influenza A (H7N9) Monovalent Vaccine Microarray Patch Delivery System (high dose HA)
25 mcg Influenza A (H7N9) Microarray Patch Delivery System (VXS-1219)
BIOLOGICALAdjuvanted Influenza A (H7N9) Monovalent Vaccine Injection
7.5 mcg Influenza A (H7N9) with MF59® Injection
COMBINATION_PRODUCTAdjuvanted 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_PRODUCTAdjuvanted 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_PRODUCTAdjuvanted 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_PRODUCTAdjuvanted 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)
DEVICEMicroarray Patch Delivery System
Vaccine free Microarray Patch Delivery System (VXS-1219U)
Sponsors
Vaxxas Pty Ltd
Biomedical Advanced Research and Development Authority
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Exclusion criteria
Participants meeting any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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; | 387 days | 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. |
| Number of Participants with Clinically Significant Changes in Physical Examination from Day 1 to Day 387 | 387 days | 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. |
| Number of Participants with Clinically Significant Changes in Vital Signs from Day 1 through Day 387; | 387 days | 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). |
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Australia
Outcome results
None listed