Clinical trials: Norovirus
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.
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, 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 Infections
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.
- Trial name
- NCT06944717
- Testing
- VXA-G1.1-NN, VXA-G2.4-NS, VXA G1.1 NN-T
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Vaxart
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 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
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
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
Norovirus Infections
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).
- Trial name
- G1-1 Challenge (NCT05212168)
- Testing
- VXA-G1.1-NN, Norovirus GI.1 Norwalk Virus Inoculum
- Where
- United States
- Volunteers
- 165 people, healthy volunteers welcome
- Sponsor
- Vaxart
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
Gastroenteritis Norovirus
Phase I Norovirus Challenge Model
This is a safety and infectivity study of experimental human Norovirus genogroup GII.4 administered to 48 healthy non-pregnant adults, 18-49 years of age, negative for COVID-19 by antigen testing at the time of norovirus…
- Trial name
- NCT04174560
- Testing
- Norovirus GII.4 Challenge Pool
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Acute Gastroenteropathy Due to Norovirus
Clinical Trial of Protective Efficacy of Quadrivalent Recombinant Norovirus Vaccine (Pichia Pastoris)
The purpose of the research is to evaluate the protective efficacy, immunogenicity, and safety of quadrivalent recombinant norovirus vaccine (Pichia Pastoris) in people aged 6 weeks to 13 years.A total of 6600 infants and…
- Trial name
- NCT06524947
- Testing
- quadrivalent recombinant norovirus vaccine (Pichia pastoris)
- Where
- 3 sites in China
- Volunteers
- 6,600 people, healthy volunteers welcome
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
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 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.
- Trial name
- (VXA-G1-1-NN) (NCT05213728)
- Testing
- VXA-G1.1-NN
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Vaxart
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
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…
- Trial name
- VXA-NVV-104 (NCT04854746)
- Testing
- VXA-GI.1.NN
- Where
- 3 sites in United States
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Vaxart
Healthy Volunteers, Norovirus
Long-Term Immunogenicity of the Norovirus GI.1/GII.4 Bivalent Virus-like Particle (VLP) Vaccine (NoV Vaccine) in Adults
The purpose of this study is to evaluate descriptively the long-term immunogenicity of at least 1 NoV vaccine administration.
- Trial name
- NCT03039790
- Testing
- NoV Vaccine
- Where
- 11 sites in United States, Belgium
- Volunteers
- 528 people, healthy volunteers welcome
- Sponsor
- Takeda
Norovirus Infections, Norwalk Gastroenteritis
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.
- Trial name
- NCT04941261
- Testing
- middle-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine, high-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine
- Where
- China
- Volunteers
- 1,716 people, healthy volunteers welcome
- Sponsor
- National Vaccine and Serum Institute, China
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
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