Clinical trials: Norovirus Infections
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 Infections
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…
- Trial name
- CIN-002 (NCT01435811)
- Testing
- Norovirus challenge pool (GII.4, CIN-1)
- Where
- United States
- Volunteers
- 60 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
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
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 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
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
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
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 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
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
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
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
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
Anogenital Herpes, COVID-19
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.
- Conditions
- Anogenital Herpes, COVID-19, Herpes Labialis
- Trial name
- NCT01306084
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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 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
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
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