Clinical Trials for Norovirus Infections

Source: ClinicalTrials.gov — U.S. National Library of Medicine — A database of privately and publicly funded clinical studies conducted around the world (U.S. National Library of Medicine, public domain).

This page lists clinical trials related to Norovirus Infections from the ClinicalTrials.gov database.

Trial Summary

• Total studies: 23
• Recruiting: 3
• Active, not recruiting: 1
• Completed: 15
• Other: 4

Results are refreshed periodically and may not reflect the most current information available from ClinicalTrials.gov.

Recruiting Trials

NCT01306084 — Viral Infections in Healthy and Immunocompromised Hosts

Background:

- Viral infections are an important cause of illness and death in hospitalized patients as well as outpatients. New strains of viruses may appear and infect both healthy people and those with weak immune systems. A better understanding of these new virus strains (such as SARS-CoV-2, the virus that causes COVID-19) may help to control and prevent these infections. In particular, so…

NCT04691622 — Adoptive T Lymphocyte Administration for Chronic Norovirus Treatment in Immunocompromised Hosts

This is a Phase I dose-escalation study to evaluate the safety of norovirus -specific T-cell (NST) therapy for chronic norovirus infection in participants following hematopoietic stem cell transplantation (HSCT) or who are immunocompromised due to PID and have not undergone HSCT, or Solid Organ Transplant (SOT) recipients.

NCT07358910 — Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective

RACSMEI addresses the high burden of infectious diseases in low- and middle-income countries, including Cambodia, where limited surveillance and laboratory capacity often obscure etiologies and transmission dynamics. This knowledge gap hinders the design of effective prevention and control strategies.

RACSMEI will improve understanding across multiple pathogens using a multidisciplinary One He…

Active, Not Recruiting

NCT06944717 — A Trial of a Norovirus G1.1 and G2.4 Vaccine Administered Orally to Healthy Participants Aged ≥ 18 Years and ≤ 80 Years Old

The primary objective of this study is to determine the safety and immunogenicity of low and high dose regimens of a next generation norovirus bivalent G1.1 and G2.4 vaccine candidate in healthy participants.

Completed Trials

NCT00302640 — Study of Nitazoxanide Suspension in the Treatment of Diarrhea Caused by Enteric Viruses in Children

The purpose of this study is to determine the effect of nitazoxanide suspension in treating diarrhea caused by enteric viruses in children less than 12 years of age.

NCT01435811 — Dose Range Evaluation of Norovirus Challenge Pool (GII.4, CIN-1)

The purpose of this study is to determine a suitable dose of the human norovirus GII.4 challenge pool(CIN-1;031693) that induces illness in approximately 50% of susceptible subjects that would be useful for evaluation of vaccines and antivirals.

NCT01609257 — Norovirus Bivalent-Vaccine Efficacy Study

The purpose of this study is to determine whether the norovirus vaccine is effective in preventing acute gastroenteritis due to the experimental human Norovirus GII.4 challenge dose. The purpose is also to evaluate the safety of the vaccine and the immunogenicity of the vaccine.

NCT01840891 — Secondary Lactose Intolerance Due to Chronic Norovirus Infection

The objective of this study is to determine the prevalence of secondary lactose intolerance in renal transplant recipients (RTR) with chronic norovirus infection.

In the investigators cohort of 1000 renal transplant recipients (RTRs) in the University Hospital of Zurich, the investigators are currently aware of 10 patients with chronic norovirus infection, which was proven by positive polymera…

NCT06211621 — Admission Pattern Among Children With Gastro-intestinal Infections Before and During the Covid-19 Pandemic

During the Covid-19 pandemic, admission patterns for infections other than Covid-19 have changed dramatically among children worldwide.

Particularly admissions due to respiratory infections and later invasive streptococcal infections have been well documented.

However, few studies have compared rates af gastro-intestinal infections during the pandemic with the previous years.

This study aims…

NCT03721549 — Evaluation of Infectivity and Illness of Norwalk GI.1 Virus Lot 001-09NV in the Human Challenge Model

There is a need for safe, highly infectious Norovirus inocula for use in Norovirus vaccine-challenge studies to assess the efficacy of Norovirus vaccines and examine the immune response among vaccinated and unvaccinated subjects. The purpose of this study is to generate the infection and illness rate and immune response data necessary for the conduct of future investigation of Norovirus vaccine…

NCT03897309 — Safety & Immunogenicity Study of Ad5 Based Oral Norovirus Vaccines

VXA-NVV-103 is a phase 1B Randomized, Double-Blind, Placebo-Controlled, Multi-Center Safety and Immunogenicity Study of Adenoviral-vector Based Oral Norovirus Vaccines Expressing GI.1 or GII.4 VP1 with Monovalent or Bivalent Dosing in Healthy Adult Volunteers. The study consists of 2 parts: Part 1 is the double-blinded portion where subjects will be randomized to one of two monovalent vaccine g…

NCT04188691 — A Clinical Trial to Evaluate the Safety and Immunogenicity of Norovirus Bivalent Vaccine

A total of 450 subjects were enrolled, divided into four age groups, including 18-59 years, 6-17 years, 3-5 years, and 6-35 months. There are three types of the test vaccine component in each age group. A total of 30 people in each dose group were vaccinated with the test vaccine or placebo 1 or placebo 2, respectively, in a ratio of 3: 1: 1.

The 18-59-year-old, 6-17-year-old, and 3-5-year-old…

NCT04854746 — Ph 1b: Safety & Immunogenicity of Ad5 Based Oral Norovirus Vaccine

A Phase 1b, multicenter, randomized, double-blind, placebo-controlled study to determine the safety and immunogenicity of an adenoviral-vector based oral norovirus vaccine expressing GI.1 VP1 administered orally to healthy older adult volunteers 55-80 years of age. The study is designed to assess the safety, tolerability, immunogenicity, and efficacy of 3 dose levels of vaccine with a 2-dose va…

NCT04875676 — Immunogenicity & Safety Study of Adenovirus Type 5 (AD5) Based Oral Norovirus Vaccines

To evaluate the immunogenicity of VXA-G1.1-NN with repeat-dose administration at Day 1 and varying boost schedules (Week 4, 8 or 12 post initial dose) in healthy adults aged 18-55, inclusive, and to assess the safety and tolerability of VXA- G1.1-NN with repeat-dose administration at varying boost schedules (Week 4, 8 or 12) in healthy adults aged 18-55, inclusive

NCT05212168 — Norovirus Challenge Study

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 randomized in a 1:1 ratio to receive one oral dose of vaccine or placebo.

• Arm 1: VXA-G1.1-NN oral vaccine tablets [1x1011 IU±0.5 log]
• Arm 2: Placebo tablets similar in appearance and number …

NCT05213728 — A Phase 1, Open-label, Safety and Immunogenicity Study of an Oral Multi-dose Administration Regimen With an Adenoviral-vector Based Tablet Norovirus Vaccine (VXA-G1.1-NN) Administered to Healthy Adult Volunteers

Subjects will receive multiple sub-doses over a 4-hour period to deliver a total overall dose of 1E11. Evaluations of immunogenicity, safety, and tolerability will be evaluated. The active period consists of data collection at Day 1, Day 8, and Day 29. Safety follow-up continues by phone screen at Day 180 and Day 365.

NCT05626803 — A Study to Determine the Safety and Immunogenicity of Bivalent GI.1 and GII.4 Vaccines in Healthy Volunteers

This study is designed to evaluate the safety and immunogenicity of two monovalent Norovirus (NoV) oral tableted vaccine candidates, VXA-G1.1-NN and VXA-GII.4-NS co-administered (bivalent delivery) against a matching placebo arm. Bivalent GI.1 and GII.4 vaccines are being investigated for the prevention of noroviral gastroenteritis caused by norovirus GI.1 and GII.4.

NCT05916326 — Phase III Clinical Trial to Evaluate the Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine，Recombinant (Hansenula Polymorpha)

The purpose of this study is to evaluate the Efficacy, Safety and Immunogenicity of the Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine，Recombinant (Hansenula polymorpha) in Healthy People Aged 6 Months to 13 Years After Vaccination

NCT07254728 — A Study to Evaluate Vaxart’s Oral Bivalent GI.1/GII.4 Norovirus Vaccine in Healthy Lactating Females and Their Nursing Infants

The primary objective of this study is to evaluate the safety and tolerability of an oral bivalent GI.1/GII.4 norovirus vaccine administration in healthy lactating female participants and to assess the short-term immunogenicity of oral bivalent GI.1/GII.4 norovirus vaccine administration in healthy lactating female participants and its association with the immunogenicity response in breastmilk.

Other (Terminated)

NCT02371538 — Human Breastmilk in Young Children With Norovirus Infection of the Gut

Human Breast milk in young children with Norovirus Infection

Other (Unknown)

NCT03342547 — Identification of Host Factors of Norovirus Infections in Mini-Gut Model

The primary objective in this study is to establish a list of host cellular proteins that mediate norovirus infection.

Norovirus is one of the most common pathogens attributed to diarrheal diseases from unsafe food. It is also the primary cause of mortality among young children and adults in foodborne infections. Norovirus is not just a foodborne burden. In a recent meta-analysis, norovirus ac…

Other (Withdrawn)

NCT06568380 — Validation of a Boindicator as Monitoring Tool for Oyster Norovirus Outbreak

Noroviruses are responsible for 700M of annual cases of gastroenteritis, of which 15M are directly related to the consumption of contaminated food, including oysters. Current regulations do not require control of human noroviruses in shellfish. However, an ISO standard recommended to detect their genome in high-risk foodstuffs. However, presence of viral genome doesn’t testify to the presence o…

NCT04941261 — Clinical Trial to Evaluate the Recombinant Norovirus Bivalent (GI. 1 / GII. 4) Vaccine (Hansenula Polymorpha)

Phase II clinical study will explore dose and safety, immunogenicity in 4 age groups, including 18-59 years old group, 6-17 years old group, 3-5 years old group, 6-35 months old group, with a total of 1716 subjects.