Loading clinical trials...

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

ACTIVE_NOT_RECRUITINGPHASE1

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

A Phase 1, Single Center, Open Label, Single Dose, Dose Escalation Study to Determine the Safety and Immunogenicity of a Novel Bivalent Norovirus G1.1 and G2.4 Vaccine Administered Orally to Healthy Volunteers Aged ≥ 18 Years and ≤ 80 Years Old

NCT06944717•Vaxart

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. ≥ 18 and ≤ 80 years old at the time of signing the Informed Consent Form (ICF).
•2. 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.
•3. Body mass index (BMI) \> 17.0 and \< 35.0 kg/m\^2 at Screening.
•4. 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).
•5. Male or female participants.
•1. Female participants must not be breastfeeding and must provide a negative pregnancy test at Screening and pre-dose on Day 0.
•2. 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.
•3. Male participants must fulfill one of the following criteria:
+3 more criteria

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 prior to Screening and reconfirmed at baseline.
•2. 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).
•3. Presence of immunosuppression or medical condition possibly associated with impaired immune responsiveness, including diabetes mellitus- type 1 and 2, asplenia, and functional asplenia.
•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. Such conditions may include but are not limited to:
•1. Any history of:
•* Gastrointestinal malignancy
•* Masabsorption
•* Pancreato-biliary disorders
•* Inflammatory bowel disease
•* Irritable bowel disease
+51 more criteria

Locations (1)

Johnson County Clin Trials - JCCT

Lenexa, Kansas, United States

Key Dates

Start Date

March 3, 2025

Primary Completion Date

May 1, 2026

Completion Date

May 1, 2026

Last Updated

April 29, 2025

Enrollment

ESTIMATED participants

Conditions

Norovirus Infections

Interventions

VXA-G1.1-NN

BIOLOGICAL

VXA-G2.4-NS

BIOLOGICAL

VXA G1.1 NN-T

BIOLOGICAL

VXA G2.4 NS-T

BIOLOGICAL

A Study to Evaluate Vaxart's Oral Bivalent GI.1/GII.4 Norovirus Vaccine in Healthy Lactating Females and Their Nursing Infants

NCT07254728

Norovirus Infections

View study

COMPLETEDPHASE1/PHASE2

Immunogenicity & Safety Study of Adenovirus Type 5 (AD5) Based Oral Norovirus Vaccines

NCT04875676

Norovirus Infections

View study

COMPLETED

Admission Pattern Among Children With Gastro-intestinal Infections Before and During the Covid-19 Pandemic

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate Vaxart's Oral Bivalent GI.1/GII.4 Norovirus Vaccine in Healthy Lactating Females and Their Nursing Infants

Immunogenicity & Safety Study of Adenovirus Type 5 (AD5) Based Oral Norovirus Vaccines

Admission Pattern Among Children With Gastro-intestinal Infections Before and During the Covid-19 Pandemic

Clinical Trial to Evaluate the Recombinant Norovirus Bivalent (GI. 1 / GII. 4) Vaccine (Hansenula Polymorpha)

A Clinical Trial to Evaluate the Safety and Immunogenicity of Norovirus Bivalent Vaccine