| Eligibility |
Inclusion Criteria:
1. 18 to 55 years old, inclusive, at day of signing Informed Consent Form (ICF)
2. General good health, without significant uncontrolled medical illness, based on
medical history, physical examination, vital signs, and clinical laboratories (CBC,
chemistry, and urinalysis) as determined by the investigator in consultation with the
Research Monitor and Sponsor
3. Body mass index (BMI) between 17 and 35 kg/m2 at screening
4. Capable of giving signed informed consent which includes compliance with the
requirements and restrictions listed in the ICF and in this protocol
5. Available for all planned visits and phone calls, and willing to complete all
protocol-defined procedures and assessments (including ability and willingness to
swallow multiple small enteric-coated tablets per study dose)
6. Female participants must provide a negative pregnancy test at each required visit and
fulfill one of the following criteria:
1. At least 1 year post-menopausal (defined as amenorrhea for =12 consecutive months
prior to Screening without alternative medical cause)
2. Surgically sterile
3. Use of oral, implantable, transdermal or injectable contraceptives for 30 days
prior to initial vaccination and until 60 days after the last vaccination. The
form of contraception must be approved by the Investigator
4. A reliable form of contraception must be approved by the Investigator (e.g.,
double barrier method, Depo-Provera, intrauterine device, Norplant, oral
contraceptives, contraceptive patches)
5. Not be sexually active (abstinent) or be in a relationship with partner who is
sterile (must be discussed with site staff and documented)
7. Male participants must agree not to father a child or donate sperm, as well as to use
contraception/barrier (a male condom) or be abstinent from heterosexual intercourse
during the study active period (Day 29)
Exclusion Criteria:
1. Presence of significant uncontrolled medical or psychiatric illness (acute or chronic)
including institution of new medical/surgical treatment or significant dose alteration
for uncontrolled symptoms or drug toxicity within 3 months of screening and
reconfirmed at baseline
2. Cancer, or received treatment for cancer, within past 3 years (excluding basal cell
carcinoma or squamous cell carcinoma)
3. Presence of immunosuppression or medical condition possibly associated with impaired
immune responsiveness, including diabetes mellitus 1 and 2
4. History of irritable bowel disease or other inflammatory digestive or gastrointestinal
condition that could affect the distribution/safety evaluation of an orally
administered vaccine targeting the mucosa of the small intestine Norwalk GI.1
(VXA-G1.1-NN) Protocol No. VXA-NVV-106
________________________________________________________________________________
_________________________________________________________________________________
Version 1.2 Confidential Page 11 of 42 Date: 04 Jan 2022
Such conditions may include but are not limited to:
1. Esophageal Motility Disorder
2. Malignancy
3. Malabsorption
4. Pancreaticobiliary disorders
5. Irritable bowel syndrome
6. Inflammatory Bowel Disease
7. Surgical Resection
8. GERD
9. Hiatal Hernia
10. Peptic Ulcer (History of cholecystectomy is not exclusionary)
5. History of any form of angioedema
6. History of serious reactions to any vaccination such as anaphylaxis, respiratory
problems, hives or abdominal pain
7. Diagnosed bleeding disorder or significant bruising or bleeding difficulties that
could make blood draws problematic
8. Any condition that resulted in the absence or removal of the spleen
9. Acute disease within 72 hours prior to vaccination defined as the presence of a
moderate or severe illness (as determined by the Investigator through medical history
and physical exam); assessment may be repeated during screening period
10. Presence of a fever = 38oC measured orally at baseline; assessment may be repeated
during screening period
11. Laboratory values outside the range of normal for platelet counts and the following
coagulation tests: PT/INR, aPTT and fibrinogen
12. Any of the following history or conditions that may lead to higher risk of clotting
events and/or thrombocytopenia:
1. Family or personal history of bleeding or thrombosis
2. History of heparin-related thrombotic events, and/or receiving heparin treatments
3. History of autoimmune or inflammatory disease
4. Presence of any of the following conditions known to increase risk of thrombosis
within 6 months prior to screening:
- Recent surgery other than removal/biopsy of cutaneous lesions
- Immobility (confined to bed or wheelchair for 3 or more successive days)
- Head trauma with loss of consciousness or documented brain injury
- Receipt of anticoagulants for prophylaxis of thrombosis
- Recent clinically significant infection
13. Any significant hospitalization within the last year which in the opinion of Norwalk
GI.1 (VXA-G1.1-NN) Protocol No. VXA-NVV-106
14. Any other condition that in the clinical judgment of the investigator would jeopardize
the safety or rights of a participant taking in the study, would render the
participant unable to comply with the protocol or would interfere with the evaluation
of the study endpoints
15. Positive human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg) or
hepatitis C virus (HCV) tests at screening visit
16. Positive urine drug screen for drugs of abuse at screening
17. Positive breath or urine alcohol test at screening and baseline
18. Receipt of a licensed vaccine within 14 days prior to baseline vaccination or planned
administration during the study active period
19. Use of antibiotics, proton pump inhibitors, H2 blockers or antacids within 7 days
prior to study drug administration or planned use during the active study period
20. Use of medications known to affect the immune function (e.g., systemic corticosteroids
and others) within 2 weeks before study vaccination or planned use during the active
period
21. Daily use of nonsteroidal anti-inflammatory drugs within 7 days prior to study
vaccination or planned use during the active study period
22. Administration of any investigational vaccine, drug or device within 8 weeks preceding
study vaccination (Day 1), or planned use within the duration of the study
23. Donation or use of blood or blood products within 30 days prior to study vaccination
or planned donation during the active study period
24. History of drug, alcohol or chemical abuse within 1 year of screening
25. History of hypersensitivity or allergic reaction to any component of the
investigational vaccine, including but not limited to fish gelatin
|
