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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 day 180
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 day 180
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 180
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The immunogenicity of a bivalent dosing regimen of GI.1 and GII.4. Parameter: Geometric mean concentration (GMC) of Serum -Anti-VP1 GI.1 IgG, Anti-VP1 GII.4 and BT50 for both vaccine
The immunogenicity of a bivalent dosing regimen of GI.1 and GII.4. Parameter: Geometric mean fold rise (GMFR) of Serum -Anti-VP1 GI.1 IgG, Anti-VP1 GII.4 and BT50 for both vaccine
The safety of a bivalent dosing regimen of GI.1 and GII.4, to select the dose level with which to safely proceed into Phase 3 development. Parameter: Frequency, duration and severity of Solicited Symptoms of Reactogenicity (GI and systemic)
+4 moreTrial 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
20 Previous Clinical Trials
1,293 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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Am I eligible to join this clinical experiment?
"Applicants who wish to be considered for inclusion in the study should possess norovirus infections and meet age requirements of 18-80. This particular research is expected to enroll a total of 623 participants."
Answered by AI
Does the age restriction for this trial extend past fifty years of age?
"This clinical trial necessitates that patients are aged 18 to 80. For those outside this age range, there is an alternative study available for minors and seniors respectively."
Answered by AI
At what quantity of locations is this experiment taking place?
"At the present moment, 9 sites are recruiting for this study. Locations such as Rochester, Saint Paul and Long Beach to name a few provide convenient access to potential participants. To avoid unnecessary travel expenses it is sensible to choose the nearest clinic when enrolling in this trial."
Answered by AI
Has the Open Label Sentinel been officially certified by the FDA?
"Given the Phase 2 status of Open Label Sentinel, there is evidence that it carries a level-2 safety rating as only preliminary data exists to support its efficacy."
Answered by AI
Is this medical experiment recruiting participants right now?
"This medical investigation is not presently enrolling patients, which was last verified on the 15th of November 2022. Although no current recruitment is occurring for this specific trial, other research projects are actively recruiting volunteers."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
Ark Clinical Research
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
Hopefully that you guys can help my condition.
PatientReceived 2+ prior treatments
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