A Trial of a Norovirus G1.1 and G2.4 Vaccine Administered Orally to Healthy Participants Aged ≥ 18 Years and ≤ 80 Years Old

Completed · Phase 1

Conditions studied: Norovirus Infections

In brief

The primary objective of this study is to determine the safety and immunogenicity of low and high dose regimens of a next generation norovirus bivalent G1.1 and G2.4 vaccine candidate in healthy participants.

Key facts

Study ID

NCT06944717

Run by

Vaxart

People needed

60

Starts

2025-03-03

Expected to finish

2026-04-14

Last updated by the study team

2026-07-27

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• ≥ 18 and ≤ 80 years old at the time of signing the Informed Consent Form (ICF).
• In stable and good general health and without significant medical illness (based on review of medical history, physical examination, current health status, and vital signs at Screening) as determined by the Investigator, with Screening lab values within normal limits or abnormalities assessed as not clinically significant.
• Body mass index (BMI) > 17.0 and < 35.0 kg/m\^2 at Screening.
• Available for all planned visits and tele-health appointments, and willing to complete all Protocol-defined procedures and assessments (including ability and willingness to swallow multiple small enteric-coated tablets per study dose).
• Male or female participants.
• Female participants must not be breastfeeding and must provide a negative pregnancy test at Screening and pre-dose on Day 0.
• Female participants must fulfill at least 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) or surgically sterile (hysterectomy, bilateral salpingectomy, bilateral oophorectomy, bilateral tubal occlusion/ligation).
• Female participants of childbearing potential must be willing to use a highly effective form of contraception for 30 days prior to study drug administration and until 60 days after study drug administration. Acceptable forms are oral, implantable, intrauterine, transdermal, intravaginal, injectable, double barrier or abstinence (participants using diaphragms must also use condoms). The Investigator must approve the form of contraception. Female participants must also refrain from egg donation for the 1 month prior to dosing through 60 days post-vaccination.
• Male participants must fulfill one of the following criteria:
• Male participants must agree to refrain from donating sperm and practice abstinence from all intercourse or use an effective method of birth control which includes condom use from study drug administration to 90 days post-dose.
• At least 1 year post-vasectomy and have confirmed that they have obtained documentation of the absence of sperm in the ejaculate.
• Capable of understanding and giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in the Protocol.

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 prior to Screening and reconfirmed at baseline.
• Cancer, or treatment for cancer or any procedure or preventive medication for cancer or to prevent recurrence, within past 3 years (excluding fully treated and resolved basal cell carcinoma or squamous cell carcinoma).
• Presence of immunosuppression or medical condition possibly associated with impaired immune responsiveness, including diabetes mellitus- type 1 and 2, asplenia, and functional asplenia.
• 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:
• Any history of:
• Gastrointestinal malignancy
• Masabsorption
• Pancreato-biliary disorders
• Inflammatory bowel disease
• Irritable bowel disease
• Hiatal hernia
• Surgical resection
• History of diagnosis or treatment in past 5 years of:
• Osophageal or gastric motility disorder
• Gastro esophageal reflux disorder if any of the following is met:
• History of severe or uncontrolled gastroesophageal reflux disease (GERD) at any point during this period.
• History of complicated GERD at any point during this period.
• Was on treatment for 12 continuous weeks at any point during this period.
• Has been with chronic or frequent GERD symptoms (e.g., more than twice per week) in the past year.
• Peptic ulcer if any of the following is met:
• History of severe or uncontrolled peptic ulcer at any point during this period.
• History of complicated peptic ulcer at any point during this period.
• Was on treatment for 12 continuous weeks at any point during this period.
• Has been with chronic or frequent peptic ulcer symptoms (e.g., more than twice per week) in the past year.
• Cholecystectomy if any of the following is met:

Where it is running

• Johnson County Clin Trials - JCCT — Lenexa, Kansas, United States

Full record on ClinicalTrials.gov

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