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Status:

COMPLETED

Norovirus Challenge Study

Lead Sponsor:

Vaxart

Conditions:

Norovirus Infections

Eligibility:

All Genders

18-49 years

Phase:

PHASE1

PHASE2

Brief Summary

This is a Phase 2b randomized, double-blind, placebo-controlled vaccination and challenge study to assess the protective efficacy of the Vaxart Norovirus vaccine (VXA-G1.1-NN). Healthy adults will be ...

Detailed Description

Study Population Healthy male and female adult volunteers age 18 to 49 years inclusive with blood type O or A and who are confirmed H type-1 antigen secretory positive Investigational Product Active ...

Eligibility Criteria

Inclusion

  • 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)
  • Comprehension of the study requirements with ability and willingness to complete all assessments and comply with confinement period post viral challenge, and all scheduled visits and contacts
  • Confirmed blood type (A or O)
  • Demonstrated to be H type-1 antigen secretor positive (by saliva test)
  • Body mass index between 17 and 35 kg/m2, inclusive, at Screening
  • Female participants must have a negative pregnancy test at pre-vaccination and pre-challenge and fulfill one of the following Criteria:
  • At least one year post-menopausal;
  • Surgically sterile;
  • Use of oral, implantable, transdermal or injectable contraceptives for 30 days prior to immunization and until 60 days after challenge;
  • i. A reliable form of contraception must be approved by the Investigator (eg, double barrier method, Depo-Provera, intrauterine device, Norplant, oral contraceptives, contraceptive patches) d. Not be sexually active (abstinent) or in a same sex relationship (must be discussed with site staff and documented)
  • Male subjects must agree not to father a child or donate sperm, as well as to use contraception/barrier (a male condom) or be abstinent from heterosexual intercourse, from vaccination through the active period (Day 57)

Exclusion

  • Administration/use of any investigational drug or device 30 days prior to vaccination through the active period (Day 57)
  • Administration of any licensed vaccine within 30 days prior to vaccination or planned use of the above stated during the active period (through Day 57)
  • Presence of a significant medical condition, which, in the opinion of the investigator, precludes participation in the study. Significant medical condition = for example, psychiatric conditions, or gastrointestinal disease, such as peptic ulcer, symptoms or evidence of active gastritis or gastroesophageal reflux disease, inflammatory bowel disease, alcohol or illicit drug abuse/dependency, or other laboratory abnormalities
  • Laboratory values outside the range of normal for platelet counts and the following coagulation tests: prothromibin time test (PT/INR), activated partial thromboplastine time test (aPTT) and fibrinogen
  • Any of the following history or conditions that may lead to higher risk of clotting events and/or thrombocytopenia:
  • Family or personal history of bleeding or thrombosis
  • History of heparin-related thrombotic events, and/or receiving heparin treatments
  • History of autoimmune or inflammatory disease
  • Presence of any of the following conditions known to increase risk of thrombosis within 6 months prior to screening:
  • Recent surgery other than removal/biopsy of cutaneous lesions
  • Immobility (confined to bed or wheelchair for 3 or more successive days)
  • Head trauma with loss of consciousness or documented brain injury
  • Receipt of anticoagulants for prophylaxis of thrombosis
  • Recent clinically significant infection
  • Any one of the following ECG findings within 45 days prior to vaccination:
  • Exclusionary ECG findings:
  • QTc F (interval duration \> 450 msec (male) or \> 470 msec (female)
  • QRS interval greater than 120 msec
  • PR interval greater than 220 msec
  • Clinically significant ST-T wave changes or pathologic Q waves
  • History of cancer or cancer treatment within past 3 years (excluding basal cell or squamous cell carcinomas)
  • Presence of immunosuppression or medical condition possibly associated with impaired immune responsiveness, including diabetes mellitus or angioedema
  • Donation or use of blood or blood products within 30 days prior to vaccination through the active period (Day 57)
  • Diagnosed bleeding disorder or significant bruising or bleeding difficulties that could make blood draws problematic
  • Any condition that resulted in the absence or removal of the spleen
  • Evidence of confirmed infection with human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) with confirmatory assays
  • Abnormal stool pattern (fewer than 3 bowel movements per week or more than 3 per day)
  • History of irritable bowel disease or 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:
  • Esophageal Motility Disorder
  • Malignancy
  • Malabsorption (e.g. Celiac disease, gluten intolerance)
  • Pancreaticobiliary disorders
  • Irritable bowel syndrome
  • Inflammatory Bowel Disease
  • Surgical Resection with the exception of appendectomy or a minor resection that is deemed acceptable by investigator and sponsor
  • Gastroesophageal reflux disease (GERD)
  • Hiatal Hernia
  • Peptic Ulcer (History of cholecystectomy is not exclusionary)
  • Use of proton pump inhibitors, H2 blockers or antacids within 7 days prior to vaccination through the active period (Day 57)
  • Use of antibiotics within 30 days prior to vaccination through the active period (Day 57) Note: use of a brief (≤ 10 days) course of oral or topical antibiotic for minor upper respiratory infection (URI), urinary tract infection (UTI), dental work, or skin infection allowed within the screening period, but must be completed 7 days prior to first vaccination
  • Use of medication known to affect the immune function (e.g. systemic corticosteroids and others) within 14 days prior to vaccination through the active period (Day 57)
  • Regular use of nonsteroidal anti-inflammatory drugs within 7 days prior to vaccination through the active period (Day 57)
  • Use of over-the-counter probiotics or antidiarrheals within 7 days prior to vaccination through the active period (Day 57)
  • Evidence of recent (within 2 months of vaccination) or of current nonbacterial gastroenteritis suggestive of NV infection \[vomiting or unformed or watery stools (\> 2 during a 24-hour period)\]
  • Any gastroenteritis within the past 2 weeks prior to vaccination
  • Acute disease within 72 hours prior to vaccination, defined as the presence of a moderate or severe illness with or without fever (as determined by the Investigator through medical history and physical examination). (Assessment may be repeated during screening period)
  • Presence of a fever ≥ 38ºC measured orally at baseline
  • History if hematochezia (blood in stool) or melena (black stool)
  • Any significant hospitalization within the last year which in the opinion of the investigator or sponsor could interfere with study participation
  • History of serious reactions to any vaccination such as anaphylaxis, respiratory problems, Guillain-Barre syndrome, hives or abdominal pain
  • History of a hypersensitivity or allergic reaction to any component of the investigational vaccine or placebo, including but not limited to fish gelatin. Subjects with known fish allergies should be excluded.
  • History of drug, alcohol or chemical abuse within 1 year prior to vaccination
  • Positive test for drugs of abuse or alcohol at screening, vaccination baseline and pre-challenge (except for previous marijuana use; concurrent or ongoing use of marijuana during the active study period).
  • Consistent/habitual smoking within 2 months prior to vaccination (defined as smoking ≥ 1 pack of cigarettes a day). Smoking is not permitted during the inpatient stay
  • Other conditions, in the clinical judgment of the investigator, that would jeopardize the safety or rights of a subject or interfere with the evaluation of the study
  • Social/Occupational:
  • Living with or having daily contact with children \< 5 years old or women known to be pregnant or nursing; this includes significant contact at home, school, day-care, or equivalent facilities
  • Living with or having daily contact with elderly persons \> 70 years of age or infirmed, diapered individuals, persons with disabilities or incontinence; this includes at work or visits to nursing homes and day-care or equivalent facilities
  • Employment in the food service industry such as restaurant or cafeteria facilities; specifically, this includes persons whose employment requires food handling and processing in the 4 weeks following viral challenge
  • Health-care workers with patient contact expected in the 4 weeks following viral challenge
  • Expected contact, via employment or at home, with immunocompromised persons in the 4 weeks following viral challenge. Immunocompromised persons = HIV-positive, receiving immunosuppressive medications such as oral steroids, anti-neoplastic agents
  • Presence of household members who have received the Ad4 or Ad7 vaccines within 2 months prior to vaccination
  • Employment as an airline flight attendant or cruise ship crew, scheduled to work in the 4 weeks following challenge
  • Persons planning to live in a confined environment (eg, a cruise, camp, etc.) in the 4 weeks following viral challenge

Key Trial Info

Start Date :

December 27 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 27 2023

Estimated Enrollment :

165 Patients enrolled

Trial Details

Trial ID

NCT05212168

Start Date

December 27 2021

End Date

October 27 2023

Last Update

November 5 2025

Active Locations (1)

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AltaSciences LA

Cypress, California, United States, 90630