What side effects are associated with this type of intervention?

The Vaxart Norovirus vaccine (VXA-G1.1-NN) is an oral vaccine designed to stimulate an immune response to Norovirus. Common side effects for vaccines that stimulate immune responses typically include mild reactions such as local site reactions (e.g., pain, redness, or swelling), mild fever, fatigue, and headache. Serious adverse effects are rare but can include allergic reactions. As with other vaccines, monitoring for any adverse effects post-vaccination is important to ensure safety.

What prior FDA approvals exist?

There are no FDA-approved treatments specifically for Norovirus that stimulate an immune response similar to the VXA-G1.1-NN vaccine. Current management of Norovirus primarily focuses on supportive care, such as rehydration and symptom management. The VXA-G1.1-NN vaccine is being studied for its potential to stimulate an immune response to Norovirus, but it has not yet received FDA approval.

What other types of research exist?

Currently, there are no specific alternatives to VXA-G1.1-NN mentioned in the provided context. However, promising approaches for Norovirus treatment and prevention include other vaccine candidates under development, antiviral drugs targeting Norovirus replication, and supportive care measures to manage symptoms. Patients should consult with their healthcare provider for the most up-to-date treatment options available in 2024.

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Virus Therapy

Norovirus Vaccine for Norovirus Infection (G1-1 Challenge Trial)

Phase 1 & 2

Waitlist Available

Research Sponsored by Vaxart

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Are you in good overall health?

Are you able to refrain from marijuana use during the course of the study participation?

Timeline

Screening 1 day

Treatment 12 months

Follow Up 0 days

Summary

This trial tests a pill vaccine for Norovirus in healthy adults with certain blood types. The vaccine helps the immune system recognize and fight the virus by using a harmless version of it.

Who is the study for?

Healthy adults aged 18-49 with blood type A or O, who can commit to the study schedule and are non-smokers. Women must not be pregnant and use approved contraception methods. Excluded if you have significant health issues, recent surgeries increasing thrombosis risk, immune system problems, drug/alcohol abuse history, contact with vulnerable populations post-challenge or work in food service/healthcare.

What is being tested?

The trial is testing Vaxart's Norovirus vaccine (VXA-G1.1-NN) against a placebo. Participants receive one dose of either the vaccine or placebo and later get exposed to Norovirus in an isolation ward to see if the vaccine prevents gastroenteritis symptoms.

What are the potential side effects?

Potential side effects may include typical reactions at the site where you took the tablet like discomfort or swelling, general feelings of being unwell such as headaches or fatigue, stomach-related issues including nausea or diarrhea after taking the oral vaccine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can attend all required visits and respond to follow-ups for the study.

Select...

Is your blood type A or O?

Timeline

Screening ~ 1 day1 visit

Treatment ~ 12 months20 visits

Follow Up ~ 0 days0 visits

Screening ~ 1 day

Treatment ~ 12 months

Follow Up ~0 days

This trial's timeline: 1 day for screening, 12 months for treatment, and 0 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of norovirus Norwalk virus infection post vaccine and post challenge

To assess VP1-specific serum Immunoglobin G (IgG) by Mesoscale Discovery (MSD) assay

To assess histo-blood group antigen (HBGA) blocking antibodies by blockade titer (BT50)

+3 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active Vaccine ArmActive Control2 Interventions

Subjects receiving Norovirus GI.1 Norwalk VP1 Vaccine, Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with dsRNA Adjuvant

Group II: Placebo ArmPlacebo Group2 Interventions

Subject receiving Placebo oral tablets similar in appearance and number to active vaccine tablets

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Norovirus, particularly those similar to the VXA-G1.1-NN vaccine, work by stimulating the body's immune response to the virus. These treatments introduce a form of the virus or viral components to the immune system, prompting it to recognize and combat the actual virus more effectively upon exposure. This is crucial for Norovirus patients as it can significantly reduce the severity and duration of symptoms, prevent the spread of the virus, and lower the risk of severe dehydration and other complications associated with acute gastroenteritis.

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