| Eligibility |
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 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
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