Clinical trials: Norovirus
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
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
Healthy
Infectivity of Norovirus in Groundwater-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
- NCT00313404
- Testing
- Safety tested norovirus inoculum
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Emory University
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 Infections
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…
- Trial name
- NCT07254728
- Testing
- VXA-G1.1-NN, VXA-G2.4-NS
- Where
- 5 sites in South Africa
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Vaxart
Gastroenteritis
Efficacy and Safety of Two Doses of HIL-214 in Children
This is a randomized, placebo-controlled study that is being done to evaluate the safety and effectiveness of two doses of the HIL-214 vaccine compared to a placebo.
- Trial name
- NCT05281094
- Testing
- HIL-214
- Where
- 17 sites in United States, Colombia and 5 more
- Volunteers
- 3,084 people, healthy volunteers welcome
- Sponsor
- HilleVax
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)
Norovirus
Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine in an Elderly Population
The purpose of this study is to further develop a formulation and dose regimen of the norovirus GI.1/GII.4 bivalent virus-like particle (VLP) vaccine that is immunogenic and safe in an elderly population aged 60 years and above.
- Trial name
- NCT02661490
- Testing
- Norovirus GI.1/GII.4 Bivalent VLP Vaccine, 0.9% sodium chloride (saline)
- Where
- 10 sites in United States
- Volunteers
- 320 people, healthy volunteers welcome
- Sponsor
- Takeda
Norovirus
Recombinant, Bivalent, Norovirus Vaccine Study
This clinical study will evaluate the vaccine candidate rNV-2v, which is under development to prevent disease triggered by noroviruses. Noroviruses are one of the leading causes of gastrointestinal diseases in the world.
- Trial name
- NCT05508178
- Testing
- Norovirus GI.4 / GII.4 Bivalent VLP Vaccine (100 µg), Norovirus GI.4 / GII.4 Bivalent VLP Vaccine (300 µg)
- Where
- Belgium
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Icon Genetics GmbH
Norovirus
Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle (VLP) Vaccine in Children
The purpose of this study is to select the optimal formulation of the norovirus vaccine from different concentrations of virus-like particles (VLP) combined with aluminum hydroxide for further development in children.
- Trial name
- NCT02153112
- Testing
- GI.1/GII.4 (15/15), GI.1/GII.4 (15/50), GI.1/GII.4 (50/50)
- Where
- 12 sites in Colombia, Finland and 1 more
- Volunteers
- 840 people, healthy volunteers welcome
- Sponsor
- Takeda
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
Norovirus Infection
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.
- Trial name
- NCT03721549
- Testing
- Norwalk GI.1 Virus
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- WCCT Global
Norovirus
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CDI-988 in Healthy Adults After Challenge With Snow Mountain Virus
Participants in this study will be given either CDI-988 or placebo orally before receiving a norovirus challenge virus and continuing for 5 days. Participants will not know whether they are getting placebo or CDI-988.
- Trial name
- NCT07198139
- Testing
- CDI-988, Snow Mountain Virus
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Cocrystal Pharma, Inc.
Norovirus Infections
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…
- Trial name
- VXA-NVV-105 (NCT04875676)
- Testing
- VXA-G1.1-NN
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Vaxart
Norovirus Infections, Norwalk Gastroenteritis
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
- Trial name
- NCT05916326
- Testing
- Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine，Recombinant (Hansenula polymorpha)
- Where
- 3 sites in China
- Volunteers
- 8,000 people, healthy volunteers welcome
- Sponsor
- National Vaccine and Serum Institute, China
Gastroenteritis
Evaluation of Recombinant Norovirus Hexavalent Vaccine in Healthy Subjects
To evaluate the safety and immunogenicity of different dose levels of the Recombinant Norovirus Hexavalent Vaccine in healthy subjects aged 18-59 years given three doses of the vaccine at 28-day intervals.
- Trial name
- NCT05805618
- Testing
- Recombinant Norovirus Hexavalent Vaccine
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Syneos Health
Norovirus
Phase 1 Norwalk Vaccine Study
Randomized, double blind, multi-site, study in healthy adults, comparing safety and immunogenicity of two dosage levels of Norwalk VLP Vaccine with adjuvant/excipients and with placebo controls Primary Objective: Safety as…
- Trial name
- NCT00806962
- Testing
- Adjuvant/Excipients, Norwalk VLP Vaccine
- Where
- 4 sites in United States
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- LigoCyte Pharmaceuticals, Inc.
Norovirus Acute Gastroenteritis
Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1403 and mRNA-1405 to Prevent Norovirus Acute Gastroenteritis in Healthy Adults 18 to 80 Years of Age
The purpose of the Part A Phase 1 of this study is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1403 and mRNA-1405 in healthy adult participants 18 to 49 years of age and 60 to 80 years of age.
- Trial name
- NCT05992935
- Testing
- mRNA-1403, mRNA-1405
- Where
- 16 sites in United States, Australia
- Volunteers
- 1,407 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
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)
Norwalk Gastroenteritis, Norovirus Infections
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.
- Trial name
- NCT04188691
- Testing
- Norovirus Bivalent (GI.1 / GII.4) Vaccine（low）, Norovirus Bivalent (GI.1 / GII.4) Vaccine（middle）, Norovirus Bivalent (GI.1 / GII.4) Vaccine（high）
- Where
- China
- Volunteers
- 510 people, healthy volunteers welcome
- Sponsor
- National Vaccine and Serum Institute, China