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Immunogenicity & Safety Study of Adenovirus Type 5 (AD5) Based Oral Norovirus Vaccines | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

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

A Phase 1b, Open-label, Boost-optimization Study of an Adenoviral- Vector Based Oral Norovirus Vaccine (VXA-G1.1-NN) Expressing GI.1 VP1 Administered Orally to Healthy Adult Volunteers

NCT04875676•Vaxart

View on ClinicalTrials.gov

Summary

To evaluate the immunogenicity of VXA-G1.1-NN with repeat-dose administration at Day 1 and varying boost schedules (Week 4, 8 or 12 post initial dose) in healthy adults aged 18-55, inclusive, and to assess the safety and tolerability of VXA- G1.1-NN with repeat-dose administration at varying boost schedules (Week 4, 8 or 12) in healthy adults aged 18-55, inclusive

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•To be eligible for this study, participants must meet all the following:
•Age
•1. 18 to 55 years old inclusive at the time of signing the Informed Consent Form (ICF).
•Type of Participants
•2. 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
•3. Body mass index (BMI) between 17 and 35 kg/m2 at screening
•4. 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
•5. Male or female participants Contraception use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
•a. Female participants must provide a negative pregnancy test at each required visit and fulfill one of the following criteria:
+8 more criteria

Exclusion Criteria

•The participants must be excluded from participating in the study if they meet any of the following:
•Medical Conditions
•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 of screening and reconfirmed at baseline
•2. Cancer, or received treatment for cancer, within past 3 years (excluding basal cell carcinoma or squamous cell carcinoma)
•3. Presence of immunosuppression or medical condition possibly associated with impaired immune responsiveness, including diabetes mellitus 1 and 2
•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. Esophageal Motility Disorder
•2. Malignancy
•3. Malabsorption
+26 more criteria

Locations (1)

WCCT Global, Inc.

Cypress, California, United States

Key Dates

Start Date

April 30, 2021

Primary Completion Date

October 30, 2021

Completion Date

February 16, 2022

Last Updated

May 22, 2024

Enrollment

ACTUAL participants

Conditions

Norovirus Infections

Interventions

VXA-G1.1-NN

BIOLOGICAL

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

NCT06944717

Norovirus Infections

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COMPLETEDPHASE1

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

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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: May 22, 2024Data 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

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

Inclusion Criteria

Exclusion Criteria

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

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

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