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Virus Therapy
Bivalent Norovirus Vaccine for Norovirus Infection
Phase 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Summary
This trial is testing two vaccine candidates to prevent norovirus-induced gastroenteritis. Bivalent delivery evaluates safety and immunogenicity against a matching placebo.
Who is the study for?
Healthy volunteers with a BMI of 17-35, not pregnant or breastfeeding, in stable health without significant illness. Women must use effective contraception or be post-menopausal/surgically sterile; men must also practice birth control. Participants should have no history of certain medical conditions like bleeding disorders, uncontrolled illnesses, cancer treatments within 3 years (except some skin cancers), immune system issues including diabetes, and gastrointestinal diseases that could affect the vaccine's distribution.
What is being tested?
The trial is testing two doses of an oral bivalent Norovirus vaccine against a placebo to see if it's safe and can create an immune response. The vaccines target GI.1 and GII.4 strains responsible for gastroenteritis. Some participants will receive high-dose vaccines while others get medium doses or a placebo for comparison.
What are the potential side effects?
Potential side effects are not detailed but may include typical reactions to vaccinations such as soreness at the site where the vaccine was given, mild fever, fatigue, headache, muscle pain, chills or nausea.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Open Label SentinelExperimental Treatment1 Intervention
Bivalent GII.4/GI.1 vaccine Bivalent GII.4/GI.1 high dose vaccine (VXA-GII.4-NS plus VXA-G1.1-NN) 1×10 to the power 11 tablets total dose is 2×10 to the power 11 IU/dose (sentinel n=10)
Group II: Medium Dose ArmExperimental Treatment1 Intervention
Bivalent GII.4/GI.1 vaccine Bivalent GII.4/GI.1 medium dose vaccine (VXA-GII.4-NS plus VXA-G1.1-NN) 5×10 to the power 10 tablets total dose is 1×10 to the power 11 IU/dose (N=50)
Group III: High Dose ArmExperimental Treatment1 Intervention
Bivalent GII.4/GI.1 vaccine Bivalent GII.4/GI.1 high dose vaccine (VXA-GII.4-NS plus VXA-G1.1-NN) 1×10 to the power 11 tablets total dose is 2×10 to the power 11 IU/dose (N=50)
Group IV: Placebo ArmPlacebo Group1 Intervention
Placebo tablets (N= 25)
Find a Location
Who is running the clinical trial?
VaxartLead Sponsor
21 Previous Clinical Trials
11,293 Total Patients Enrolled
James Cummings, MDStudy DirectorVaxart, Inc.
7 Previous Clinical Trials
10,796 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can attend all visits, do all tests, and swallow pills as required.I have a history of blood clots or conditions that increase my risk.I have a history of bleeding or clotting issues.I agree to either not have sex or use effective birth control.I understand the study and can sign the consent form.I have a condition that weakens my immune system.I haven't had cancer or cancer treatment in the last 3 years, except for certain skin cancers.I have a history of inflammatory bowel disease or similar conditions.I do not have a spleen.I haven't had a fever or serious illness in the last 72 hours and no major hospital stays in the past year.I am not breastfeeding, can provide a negative pregnancy test, and meet the contraception or menopause criteria.I have a bleeding disorder or often have unexplained bruises or bleeding.I have not had any severe illnesses or mental health issues in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Open Label Sentinel
- Group 2: High Dose Arm
- Group 3: Medium Dose Arm
- Group 4: Placebo Arm
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Norovirus Patient Testimony for trial: Trial Name: NCT05626803 — Phase 2
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