A Phase 1, Open-label, Safety and Immunogenicity Study of an Oral Multi-dose Administration Regimen With an Adenoviral-vector Based Tablet Norovirus Vaccine (VXA-G1.1-NN) Administered to Healthy Adult Volunteers
Completed · Phase 1
Conditions studied: Norovirus Infections
In brief
Subjects will receive multiple sub-doses over a 4-hour period to deliver a total overall dose of 1E11. Evaluations of immunogenicity, safety, and tolerability will be evaluated. The active period consists of data collection at Day 1, Day 8, and Day 29. Safety follow-up continues by phone screen at Day 180 and Day 365.
Key facts
- Study ID
- NCT05213728
- Run by
- Vaxart
- People needed
- 8
- Starts
- 2022-01-24
- Expected to finish
- 2022-02-24
- Last updated by the study team
- 2024-06-21
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 18 to 55 years old, inclusive, at day of signing Informed Consent Form (ICF)
- 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
- Body mass index (BMI) between 17 and 35 kg/m2 at screening
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
- 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)
- Female participants must provide a negative pregnancy test at each required visit and fulfill one of the following criteria:
- At least 1 year post-menopausal (defined as amenorrhea for ≥12 consecutive months prior to Screening without alternative medical cause)
- Surgically sterile
- 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
- 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)
- Not be sexually active (abstinent) or be in a relationship with partner who is sterile (must be discussed with site staff and documented)
- 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)
You may not qualify if…
- 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
- Cancer, or received treatment for cancer, within past 3 years (excluding basal cell carcinoma or squamous cell carcinoma)
- Presence of immunosuppression or medical condition possibly associated with impaired immune responsiveness, including diabetes mellitus 1 and 2
- 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
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- _________________________________________________________________________________ Version 1.2 Confidential Page 11 of 42 Date: 04 Jan 2022
- Such conditions may include but are not limited to:
- Esophageal Motility Disorder
- Malignancy
- Malabsorption
- Pancreaticobiliary disorders
- Irritable bowel syndrome
- Inflammatory Bowel Disease
- Surgical Resection
- GERD
- Hiatal Hernia
- Peptic Ulcer (History of cholecystectomy is not exclusionary)
- History of any form of angioedema
- History of serious reactions to any vaccination such as anaphylaxis, respiratory problems, hives or abdominal pain
- Diagnosed bleeding disorder or significant bruising or bleeding difficulties that could make blood draws problematic
- Any condition that resulted in the absence or removal of the spleen
- 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
- Presence of a fever ≥ 38oC measured orally at baseline; assessment may be repeated during screening period
- Laboratory values outside the range of normal for platelet counts and the following coagulation tests: PT/INR, aPTT and fibrinogen
- Any of the following history or conditions that may lead to higher risk of clotting events and/or thrombocytopenia:
Where it is running
- AltaSciences LA — Cypress, California, United States
Full record on ClinicalTrials.gov
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