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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device, Combination product, Biological
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: t
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⁃ 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

Locations
Other Locations
Australia
Doherty Clinical Trials Ltd
RECRUITING
East Melbourne
University of Sunshine Coast Clinical Trials
RECRUITING
Morayfield
University of Sunshine Coast Clinical Trials
RECRUITING
Sippy Downs
University of Sunshine Coast Clinical Trials
RECRUITING
South Brisbane
Time Frame
Start Date: 2024-07-31
Estimated Completion Date: 2026-05
Participants
Target number of participants: 258
Treatments
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)
Related Therapeutic Areas
Sponsors
Collaborators: Biomedical Advanced Research and Development Authority
Leads: Vaxxas Pty Ltd

This content was sourced from clinicaltrials.gov