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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 change from baseline (day 1 pre-vaccination and day 28 pre-challenge) at day 36 post-challenge through end of active phase (day 57)
Awards & highlights
G1-1 Challenge Trial Summary
This trial is testing a vaccine for norovirus, a common virus that causes stomach flu. The trial will compare the vaccine to a placebo to see if it is effective.
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.Check my eligibility
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.See study design
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.
G1-1 Challenge Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can attend all required visits and respond to follow-ups for the study.
Select...
Is your blood type A or O?
G1-1 Challenge Trial Timeline
Screening ~ 1 day1 visit
Treatment ~ 12 months20 visits
Follow Up ~ change from baseline (day 1 pre-vaccination and day 28 pre-challenge) at day 36 post-challenge through end of active phase (day 57)
Screening ~ 1 day
Treatment ~ 12 months
Follow Up ~change from baseline (day 1 pre-vaccination and day 28 pre-challenge) at day 36 post-challenge through end of active phase (day 57)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreG1-1 Challenge 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
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
VaxartLead Sponsor
20 Previous Clinical Trials
1,263 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't donated or received blood products within the last 30 days.I can attend all required visits and respond to follow-ups for the study.You have had severe reactions to any vaccine in the past, which caused breathing difficulties, severe allergies, abdominal pain, or Guillain-Barre syndrome.Are you able to refrain from marijuana use during the course of the study participation?I have a bleeding disorder or experience significant bruising or bleeding that could complicate blood draws.I have had blood in my stool or black stools.If the doctor thinks that participating in the study may not be safe for you or may affect the study results, you will not be able to participate.I have been smoking at least a pack a day up until two months before the vaccination.In the last 6 months, I've had surgery, been immobile, had a head injury, taken blood thinners, or had a serious infection.My saliva test showed I am H type-1 antigen positive.I haven't used any experimental drugs or devices in the last 30 days.I haven't received any vaccines in the last 30 days and won't during the trial.I haven't had cancer or cancer treatment in the last 3 years, except for skin cancer.I do not have a spleen.Your body mass index (BMI) is between 17 and 35 kg/m2.Are you in good overall health?I am between 18 and 49 years old.I agree not to father a child or donate sperm and to use contraception or remain abstinent until Day 57.I have a condition like diabetes or angioedema that might weaken my immune system.You have a history of alcohol, drug or chemical abuse within the past year before getting vaccinated.I am not pregnant and follow one of the approved birth control methods or conditions.I understand the study's needs and agree to follow all its requirements.Is your blood type A or O?I have a history of bleeding, clotting issues, or autoimmune diseases.I have fewer than 3 or more than 3 bowel movements daily.
Research Study Groups:
This trial has the following groups:- Group 1: Active Vaccine Arm
- Group 2: Placebo Arm
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 1 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 12 Months
- Follow Ups: You may be asked to continue sharing information regarding the trial for 0 Months after you stop receiving the treatment.
Norovirus Patient Testimony for trial: Trial Name: NCT05212168 — Phase 1 & 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experiment still looking for more participants?
"The information available on clinicaltrials.gov verifies that this trial is still looking for candidates to enroll. The listing was first put up on 1/28/2022, with the latest update taking place 9/19/2022. So far, only 1 out of the desired 120 patients have been recruited from 1 location."
Answered by AI
Could I qualify to be a test subject for this experiment?
"This clinical trial is looking for 120 patients with norovirus infections between the ages of 18 and 49. Most importantly, candidates must meet the following criteria: Male or female between the ages of 18 - 49 years, inclusive, Able to give written informed consent, Healthy, as determined by the principal investigator (PI) or PI in consultation with the research monitor and Sponsor Healthy = No clinically significant health concerns or medical illness, as determined by medical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratories (complete blood count (CBC), chemistry and urinalysis), Confirmed blood type (A"
Answered by AI
How many study participants are included in this research?
"That is correct, the study detailed on clinicaltrials.gov is currently looking for patients to enroll. The trial was first announced on January 28th, 2020 and was last updated September 19th, 2020. So far, 1 site has been earmarked for this study but they need around 120 people total to participate."
Answered by AI
Are individuals outside of the target age range being included in this research?
"This particular trial is enrolling patients that are over 18 but younger than 49."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
AltaSciences LA
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+
0
Why did patients apply to this trial?
Interest in vaccines. To protect myself from the norovirus. Money compensation and to further medical advancement.
PatientReceived 1 prior treatment
I am just willing to volunteer to help create a cure or vaccine.
PatientReceived 2+ prior treatments
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- AltaSciences LA: < 24 hours
Average response time
- < 2 Days
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