Active — Not RecruitingPhase 1

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

United States60 participantsStarted 2025-03-03

Plain-language summary

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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. ≥ 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:
. Male participants must fulfill one of the following criteria:

Exclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants Experiencing Solicited Symptoms of Reactogenicity (Gastrointestinal and Systemic) for 1 Week Following Study Intervention Dose

Timeframe: 7 days

Duration of Solicited Symptoms of Reactogenicity (Gastrointestinal and Systemic) for 1 Week Following Study Intervention Dose

Timeframe: Approximately 1 year

Severity of Solicited Symptoms of Reactogenicity (Gastrointestinal and Systemic) for 1 Week Following Study Intervention Dose

Timeframe: 7 days

Number of Participants Experiencing Unsolicited Adverse Events (AE) for 28 Days Following the Study Intervention Dose

Timeframe: 28 days

Number of Participants Experiencing Unsolicited New Onset of Chronic Illness (NOCI) for 28 Days Following the Study Intervention Dose

Timeframe: 28 days

Duration of Unsolicited AEs for 28 Days Following the Study Intervention Dose

Timeframe: Approximately 1 year

Trial details

NCT IDNCT06944717

SponsorVaxart

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-05-01

View on ClinicalTrials.gov More Norovirus Infections trials

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. ≥ 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:
. Male participants must fulfill one of the following criteria:

Exclusion criteria

. 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.

What they're measuring

Number of Participants Experiencing Solicited Symptoms of Reactogenicity (Gastrointestinal and Systemic) for 1 Week Following Study Intervention Dose

Timeframe: 7 days

Duration of Solicited Symptoms of Reactogenicity (Gastrointestinal and Systemic) for 1 Week Following Study Intervention Dose

Timeframe: Approximately 1 year

Severity of Solicited Symptoms of Reactogenicity (Gastrointestinal and Systemic) for 1 Week Following Study Intervention Dose

Timeframe: 7 days

Number of Participants Experiencing Unsolicited Adverse Events (AE) for 28 Days Following the Study Intervention Dose

Timeframe: 28 days

Number of Participants Experiencing Unsolicited New Onset of Chronic Illness (NOCI) for 28 Days Following the Study Intervention Dose

Timeframe: 28 days

Duration of Unsolicited AEs for 28 Days Following the Study Intervention Dose

Timeframe: Approximately 1 year