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
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.
⁃ 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