Clinical trials: Norovirus
Norovirus Infection
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…
- Trial name
- VXA-NVV-103 (NCT03897309)
- Testing
- VXA-G1.1-NN, VXA-G2.4-NS
- Where
- United States
- Volunteers
- 86 people, healthy volunteers welcome
- Sponsor
- Vaxart
Prevention From Norovirus Infection
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.
- Trial name
- NCT01609257
- Testing
- Norovirus Bivalent Vaccine, Saline Comparator
- Where
- 5 sites in United States
- Volunteers
- 132 people, healthy volunteers welcome
- Sponsor
- Takeda
Gastroenteritis
Safety and Immunogenicity of HIL-214 in Healthy Japanese Infants
This is a phase 1, randomized, double-blind multi-center, placebo-controlled trial in Japan to evaluate the safety and immunogenicity of HIL-214 in healthy infants 5 months of age (-14/+14 days) at first trial vaccine…
- Trial name
- NCT06007781
- Testing
- HIL-214
- Where
- 4 sites in Japan
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- HilleVax
Norovirus Infections, Norovirus Gastroenteritis
A Study to Evaluate INT101 in Healthy Adults for the Prevention of Norovirus Gastroenteritis
This study is being conducted to evaluate the safety and immunogenicity of INT101, an investigational vaccine intended to prevent norovirus gastroenteritis, in healthy adults.
- Trial name
- INT-101 (NCT07818629)
- Testing
- INT101 Low Dose, INT101 High Dose
- Where
- South Korea
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- InThera Inc. Korea
Fibrostenotic Crohn's Disease
NOV-ERA - A Clinical Trial to Assess the Efficacy and Safety of Ontunisertib Compared to Placebo in Patients With Fibrostenosing Crohn's Disease
Many patients with Crohn's disease (CD) develop fibrotic narrowing (strictures) in their bowel, causing obstructive symptoms such as abdominal pain, cramping, or vomiting after meals.
- Trial name
- NCT07683325
- Testing
- Ontunisertib
- Where
- 11 sites in United States, Serbia and 1 more
- Volunteers
- 320 people
- Sponsor
- Agomab Spain S.L.U.
Gastrointestinal Infection
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.
- Trial name
- NCT03342547
- Testing
- Duodenal biopsy, Saliva
- Where
- China
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Chinese University of Hong Kong
Acute Gastroenteritis
A Multi-Site Clinical Evaluation of the ARIES Norovirus Assay
The ARIES Norovirus Assay is a real-time PCR based qualitative in vitro diagnostic test for the direct detection of Norovirus GI/GII RNA from stool specimens obtained from symptomatic patients.
- Trial name
- NCT02092259
- Where
- 5 sites in United States
- Volunteers
- 500 people
- Sponsor
- Luminex Corporation
Dengue, Chikungunya
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.
- Conditions
- Dengue, Chikungunya, Zika Virus Infection, Japanese Encephalitis
- Trial name
- RACSMEI (NCT07358910)
- Where
- Cambodia
- Volunteers
- 10,000 people, healthy volunteers welcome
- Sponsor
- Institut Pasteur du Cambodge
Gastroenteritis, Rota Virus Gastroenteritis
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.
- Conditions
- Gastroenteritis, Rota Virus Gastroenteritis, Dehydration in Children, Infectious Disease
- Trial name
- NCT06211621
- Where
- Denmark
- Volunteers
- 600 people
- Sponsor
- Region Zealand
Gastroenteritis Norovirus
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.
- Trial name
- VIROYSTER (NCT06568380)
- Testing
- Oyster consumption
- Where
- France
- Volunteers
- healthy volunteers welcome
- Sponsor
- Central Hospital, Nancy, France
Norovirus Gastroenteritis
Phase 1 Placebo-controlled, Randomized Trial of an Adenoviral-vector Based Norovirus Vaccine
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Determine the Safety and Immunogenicity of an Adenoviral-Vector Based Norovirus Vaccine (VXA-G1.1-NN) Expressing GI.1 VP1 and dsRNA Adjuvant…
- Trial name
- NCT02868073
- Testing
- VXA-G1.1-NN (high dose) Oral Vaccine Tablet, VXA-G1.1-NN (low dose) Oral Vaccine Tablet
- Where
- United States
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Vaxart
Healthy Adults
Susceptibility of Human Volunteers With Different Histo-Blood With Different Histo-Blood Group Antigens to Norovirus
Objectives: To evaluate the role of human histo-blood group antigens in susceptibility to Norovirus infections. Description of Study Design: Healthy volunteers with different blood types and low antibody titers to the challenge…
- Trial name
- NCT01322503
- Testing
- Norovirus
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Healthy
Infectivity of Norovirus in Shellfish Treated With High Hydrostatic Pressure Processing-Human Challenge Study
Norwalk virus and related "Norwalk-like viruses" are the most common cause of outbreaks of stomach sickness (nausea, vomiting, diarrhea) in older children and adults in the United States.
- Trial name
- Shellfish (NCT00674336)
- Testing
- High Hydrostatic Pressure Processing
- Where
- United States
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Emory University
Gastroenteritis Norovirus
New Challenge Pool of Norwalk Virus Inoculum
The main objective of this study is to see the number of volunteers that get sick from a Norwalk virus (NV) inoculation with typical symptoms of nausea, vomiting, and diarrhea.
- Trial name
- NCT00138476
- Testing
- Norwalk Virus
- Where
- United States
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Gastroenteritis Norovirus
Optimal Human Dose for GII.2 Norovirus (Snow Mountain) Challenge Studies
This is a phase I, randomized, double blind, as well as partially blinded (for Cohort 4), placebo-controlled safety, illness, and infection study of a new experimental human challenge stock of the Norovirus genogroup II, genotype…
- Trial name
- NCT02473224
- Testing
- Norovirus GII.2 Challenge
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Acute Gastroenteritis, Norovirus Acute Gastroenteritis
A Study to Investigate the Safety and Efficacy of mRNA-1403 in Participants ≥18 Years of Age for the Prevention of Acute Gastroenteritis
The primary objectives of this study are to evaluate the safety and reactogenicity of mRNA-1403, and to demonstrate the efficacy of mRNA-1403 to prevent protocol-defined moderate or severe norovirus acute gastroenteritis (AGE)…
- Trial name
- Nova 301 (NCT06592794)
- Testing
- mRNA-1403
- Where
- 283 sites in United States, Australia and 5 more
- Volunteers
- 37,864 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Norovirus Infections
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.
- Trial name
- NCT05626803
- Testing
- Open label Bivalent GII.4/GI.1 high dose vaccine 2×10 to the power 11 IU/dose, Bivalent GII.4/GI.1 high dose vaccine 2×10 to the power 11 IU/dose, Bivalent GII.4/GI.1 medium dose vaccine 1×10 to the power 11 IU/dose
- Where
- 3 sites in United States
- Volunteers
- 135 people, healthy volunteers welcome
- Sponsor
- Vaxart
Norovirus Prevention
Safety and Immunogenicity of Norovirus Bivalent Virus-Like Particle Vaccine in Healthy Adults
The purpose of this study is to evaluate the safety of the norovirus bivalent virus-like particle (VLP) vaccine for further development by assessing the rates of serious adverse events (SAEs), unsolicited adverse events (AEs)…
- Trial name
- NCT02142504
- Testing
- Norovirus Bivalent VLP Vaccine
- Where
- 10 sites in United States
- Volunteers
- 454 people, healthy volunteers welcome
- Sponsor
- Takeda
Gastroenteritis
Bivalent Norovirus Vaccine Study
Randomized, multi-site, dose-escalation study of the safety and immunogenicity of four dosage levels of Intramuscular (IM) Norovirus Bivalent VLP Vaccine adjuvanted with MPL and Al(OH)3 compared to controls.
- Trial name
- NCT01168401
- Testing
- NoV GI.1/GII.4 Bivalent VLP Vaccine, Saline
- Where
- 3 sites in United States
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Takeda
Viral Infection, Hematopoietic Stem Cell Transplantation (HSCT)
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…
- Conditions
- Viral Infection, Hematopoietic Stem Cell Transplantation (HSCT), Primary Immunodeficiency Disorders (PID)
- Trial name
- ATLANTIC (NCT04691622)
- Testing
- Norovirus -specific T-cell (NST) therapy
- Where
- 3 sites in United States
- Volunteers
- 48 people
- Sponsor
- Children's National Research Institute