| Eligibility |
Inclusion Criteria:
To be confirmed at Screening
1. Healthy male and female participants 18 to 45 years of age, inclusive.
2. Female participant of childbearing potential willing to use 2 effective methods of
contraception, i.e., established method of contraception + condom, if applicable
(unless of non-childbearing potential or where abstaining from sexual intercourse is
in line with the preferred and usual lifestyle of the participant) from the first dose
until 2 months after the last dose of Investigational Medicinal Product (IMP).
3. Female participant of non-childbearing potential. For the purposes of this study, this
is defined as the participant being amenorrhoeic for at least 12 consecutive months or
at least 4 months post-surgical sterilisation (including bilateral fallopian tube
ligation or bilateral oophorectomy with or without hysterectomy).
4. Female participant of childbearing potential or non-childbearing potential with a
negative pregnancy test at Screening.
5. Female participant of post-menopausal status confirmed by demonstrating at Screening
that the serum level of the follicle stimulating hormone (FSH) falls within the
respective pathology reference range. In the event a participant's menopausal status
has been clearly established (for example, the participant indicates she has been
amenorrhoeic for 10 years, confirmed by medical history, etc), but serum FSH levels
are not consistent with a postmenopausal status, determination of the participant's
eligibility to be included in the study will be at the Investigator's discretion
following consultation with the Sponsor.
6. Male participant willing to use an effective method of contraception or 2 effective
methods of contraception, i.e., established method of contraception + condom, if
applicable (unless anatomically sterile or where abstaining from sexual intercourse is
in line with the preferred and usual lifestyle of the participant) from first dose
until a stool sample tested for presence of the vaccine strains is negative.
7. Participant with a body mass index (BMI) of = 19 or =34 kg/m^2 (BMI = body weight (kg)
/ [height (m)]^2).
8. No clinically significant history of liver or active gall bladder disease.
9. No clinically significant history of ongoing gastro-intestinal disease or abnormality.
10. No clinically significant history of previous allergy / sensitivity to ZH9/ZH9PA or
sodium bicarbonate.
11. No clinically significant history of anaphylactic shock following vaccination.
12. No clinically significant history of hypersensitivity (e.g., hives/rash/swollen
lips/difficulty with breathing) to azithromycin, ampicillin,
trimethoprim-sulfamethoxazole or ciprofloxacin.
13. No clinically significant abnormal laboratory test results (in the opinion of the
investigator) for serum biochemistry, haematology and/or urine analyses within 28 days
before receiving the first dose administration of the IMP.
14. Participant with a negative urinary drugs of abuse (DOA) screen (including alcohol and
cotinine) test results, determined within 28 days before the first dose administration
of the IMP unless there is a documented medical explanation for the positive result
other than drugs of abuse (e.g., the participant has been prescribed opioids for
pain). (N.B.: A positive test result may be repeated at the Investigator's
discretion).
15. Participant with negative human immunodeficiency virus (HIV), hepatitis B surface
antigen (HBsAg)) and hepatitis C virus antibody (HCV Ab) test results at Screening.
16. No clinically significant abnormalities in 12-lead electrocardiogram (ECG) or vital
signs determined within 28 days before first dose of IMP.
17. Participant must be available to complete the study (including all follow up visits).
18. Participant must be willing to consent to have data entered into The Over Volunteering
Prevention System (TOPS).
19. Participant must provide written informed consent to participate in the study.
To be re-confirmed on Day 0 / prior to each dosing visit
1. Participant continues to meet all screening inclusion criteria.
2. Participant with a negative urinary drugs of abuse screen (including alcohol and
cotinine) prior to dosing unless there is a documented medical explanation for the
positive result other than drugs of abuse (e.g., the participant has been prescribed
opioids for pain). (N.B.: A positive test result may be repeated at the Investigator's
discretion).
3. Female participant of childbearing potential or non-childbearing potential with a
negative pregnancy test on admission.
Exclusion Criteria:
To be confirmed at Screening:
1. Participant with any clinically significant medical (cardiovascular disease,
pulmonary, hepatic, gallbladder or biliary tract, renal, haematological,
gastrointestinal, endocrine, immunologic, dermatological, neurological, autoimmune
disease or current infection) or psychiatric condition (see also exclusion criterion
number 21) that, in the opinion of the Investigator, precludes participation in the
study. This will include any clinically significant abnormal serum biochemistry
results and/or haematological results and/or urine analytical results.
2. Participant with a history of heart disease or of rheumatic fever.
3. Participant with a significant acute febrile illness (including fever of 38.0^0C or
greater within 14 days) of each dose of IMP (Days 0, 21 and 42).
4. Participant who has chronic diseases: Chronic diseases will include all autoimmune and
immunocompromising conditions and any other chronic condition, which at the judgment
of the Investigator, may put the participant at higher risk of side effects from the
study vaccine. Conditions in the latter category might include unexplained anaemia,
hepato-biliary disease, uncontrolled hypertension, participant with prosthetic joints
or heart valves, etc.
5. Participant with sickle cell anaemia.
6. Participant who has undertaken a course of antibiotics/antibacterials within 28 days
prior to each dose of IMP (Days 0, 21 and 42).
7. Use of prescription or non-prescription drugs within 28 days or 5 half-lives
(whichever is longer) prior to receiving the first dose of IMP, unless in the opinion
of the Investigator and Sponsor's Responsible Physician the medication will not
interfere with the study procedures or compromise participant safety.
8. Participant who uses antacids, proton pump inhibitors or H2 blockers on a regular
basis or has consumed proton pump inhibitors or H2 blockers within 24 hours prior to
each dose of IMP.
9. Participant who has received investigational or licensed vaccines in the 28 days prior
to dosing or anticipates receiving a vaccine other than study medication up to Day 84
of the study.
10. Participant with symptoms consistent with Typhoid fever concurrent with travel to
countries where typhoid infection is endemic (most of the developing world) within 2
years prior to first dose of IMP.
11. Vaccination against Typhoid within 3 years prior to first dose of IMP.
12. Ingestion of Typhoid bacteria in a challenge study within 3 years prior to dosing.
13. Participant who works as a commercial food handler.
14. Participant who is a health care worker in direct contact with patients.
15. Participant who is a childcare worker.
16. Participant who has household contact with immuno-compromised individuals, pregnant
women, children < 2 years of age or individuals > 70 years of age.
17. Participant who has person(s) living with him/her who, in the opinion of the
Investigator, may be at risk of disease if exposed to the vaccine strain.
18. Participant with a known impairment of immune function or receiving (or has received
in the 6 months prior to study entry) cytotoxic drugs or immunosuppressive therapy
(including systemic corticosteroids).
19. Participant who is a current smoker (cigarettes, tobacco and/or e-cigarettes) or has
stopped smoking in the last 3 months prior to Screening.
20. A clinically significant history of drug or alcohol abuse [defined as the consumption
of more than 14 units of alcohol a week] within the past two years prior to Screening.
21. Inability to communicate well with the Investigators (i.e., language problem, poor
mental development or impaired cerebral function).
22. Participation in a New Chemical Entity (NCE) clinical study within the previous 3
months or a marketed drug clinical study within the 30 days before the first dose of
IMP. (Washout period between studies is defined as the period of time elapsed between
receiving the last dose of the previous study and receiving the first dose of the next
study).
23. Donation of 450 millilitres (mL) or more blood within the 3 months before the first
dose of IMP.
24. Participant who, in the opinion of the Investigator, is unsuitable for participation
in the study.
To be re-confirmed at Day 0 / prior to each dosing visit:
1. Development of any exclusion criteria since the Screening visit.
2. Use of prescription or non-prescription drugs since Screening, unless in the opinion
of the Investigator and Sponsor's Responsible Physician, the medication will not
interfere with the study procedures or compromise participant safety.
3. Participation in a clinical study since Screening.
4. Donation of 450 mL or more blood since Screening.
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