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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
267
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)
University of Sunshine Coast Clinical Trials
Morayfield, Queensland, Australia
University of Sunshine Coast Clinical Trials
Sippy Downs, Queensland, Australia
University of Sunshine Coast Clinical Trials
South Brisbane, Queensland, Australia
Doherty Clinical Trials Ltd
East Melbourne, Victoria, Australia
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);
Time frame: 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);
Time frame: 387 days
Incidence and severity of unsolicited (spontaneously reported) treatment-emergent adverse events (TEAEs) from Day 1 through Day 78;
Time frame: 78 days
Incidence and severity of SAEs, MAAEs and PIMMCs from Day 1 through Day 387;
Time frame: 387 days
Incidence and severity of Application Site Reactogenicity Adverse Events with onset after Day 78 from Day 79 through Day 387;
Time frame: 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.
Time frame: 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.
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7.5 mcg Influenza A (H7N9) with MF59® Injection
12 mcg Influenza A (H7N9) with 4 mcg QS21 Microarray Patch Delivery System (VXS-1219A)
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)
20 mcg Influenza A (H7N9) with 6.7 mcg QS21 Microarray Patch Delivery System (VXS-1219A)
Vaccine free Microarray Patch Delivery System (VXS-1219U)
Time frame: 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).
Time frame: 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;
Time frame: 78 days
Concomitant medication usage.
Time frame: 387 days
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;
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 387 days