Ph 1b: Safety & Immunogenicity of Ad5 Based Oral Norovirus Vaccine

Completed · Phase 1 · Has a placebo group

Conditions studied: Norovirus Infections

In brief

A Phase 1b, multicenter, randomized, double-blind, placebo-controlled study to determine the safety and immunogenicity of an adenoviral-vector based oral norovirus vaccine expressing GI.1 VP1 administered orally to healthy older adult volunteers 55-80 years of age. The study is designed to assess the safety, tolerability, immunogenicity, and efficacy of 3 dose levels of vaccine with a 2-dose vaccination schedule (4 weeks apart) in healthy older adults (55 to 80 years old)

Key facts

Study ID

NCT04854746

Run by

Vaxart

People needed

66

Starts

2021-04-26

Expected to finish

2022-01-04

Last updated by the study team

2023-02-13

Who can join

Age: 55 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• To be eligible for this study, participants must meet all the following:
• Age
• 55 to 80 years old inclusive at the time of signing the Informed Consent Form (ICF).
• Type of Participants
• In stable and good general health, without significant medical illness, based on medical history, physical examination and vital signs at screening
• Safety laboratory values within the following range criteria at screening:
• Laboratory value of < grade 1 elevation from normal or decrease from normal with no clinical significance (NCS) for alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin,
• Laboratory value of < grade 1 from normal with no NCS for:
• decreased: albumin, magnesium, total protein and phosphorous
• elevated: amylase, BUN, CPK and creatine and;
• elevated or decreased: calcium, glucose, potassium and sodium;
• Body mass index (BMI) between 17 and 35 kg/m2 at screening
• 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).
• Gender and Reproductive Considerations
• Male or female participants Female participants must provide a negative pregnancy test at screening and baseline or be at least one year post-menopausal or surgically sterile. Female participants of childbearing potential must be willing to use a reliable oral, implantable, transdermal or injectable contraceptive for 30 days prior to and until 60 days post last study drug administration. The form of contraception must be approved by the Investigator Contraception use by men should be consistent with local regulations regarding the methods of contraception for participants in clinical studies.
• Informed Consent
• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.

You may not qualify if…

• The participants must be excluded from participating in the study if they meet any of the following:
• Medical Conditions
• 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 treatment for cancer treatment, 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
• 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.
• 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 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)
• Any significant hospitalization within the last year which in the opinion of the investigator or sponsor could interfere with study participation.
• Any of the following history or conditions that may lead to higher risk of clotting events and/or thrombocytopenia:

Where it is running

• WCCT — Cypress, California, United States
• Benchmark Research — New Orleans, Louisiana, United States
• Benchmark Research — Austin, Texas, United States

Full record on ClinicalTrials.gov

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