Clinical trials: Norovirus
Gastroenteritis
Serologic Assay Validation and Proficiency Testing of HIL-214 in Adults
The purpose of this trial is to obtain serum for proficiency testing to confirm assay validity is maintained following the dosing of adults with a pediatric dose of HIL-214.
- Trial name
- NCT05972733
- Testing
- HIL-214
- Where
- 2 sites in United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- HilleVax
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)
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, Healthy Participants
Serologic Assay Validation, Proficiency Testing, Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine
The purpose of this study is to collect serum samples to evaluate serologic assays and to establish proficiency panels for serologic assays used for assessment of post vaccination immune response after intramuscular (IM)…
- Trial name
- NCT02475278
- Testing
- NoV GI.1/GII.4 Bivalent VLP Vaccine
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Takeda
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
Healthy Volunteers, Norovirus, Prevention
Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent VLP Vaccine
The purpose of this study is to select the optimal formulation of the norovirus vaccine from different concentrations of virus-like particles (VLP), Aluminum Hydroxide and MPL adjuvant (3-O-desacyl-4'-monophosphoryl lipid A) for…
- Trial name
- NOR-107 (NCT02038907)
- Testing
- Hepatitis A Vaccine, Norovirus Bivalent VLP Vaccine
- Where
- 2 sites in Belgium
- Volunteers
- 420 people, healthy volunteers welcome
- Sponsor
- Takeda
Healthy Volunteers
Efficacy and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-like Particle Vaccine in Adults
The purpose of this study is to evaluate the efficacy of the Norovirus (NoV) GI.1/GII.4 bivalent virus-like particle vaccine against moderate or severe acute gastroenteritis (AGE) due to genotype-specific (GI.1 and GII.4) NoV…
- Trial name
- NCT02669121
- Testing
- NoV GI.1/GII.4 Bivalent VLP Vaccine
- Where
- United States
- Volunteers
- 4,748 people, healthy volunteers welcome
- Sponsor
- Takeda
Gastroenteritis Norovirus
NNITS-Nitazoxanide for Norovirus in Transplant Patients Study
This is a phase 2 multi-center, double-blind, placebo-controlled study of the efficacy and safety of nitazoxanide for the treatment of solid organ and hematopoietic stem cell transplant recipients with symptomatic diarrhea due to…
- Trial name
- NCT03395405
- Testing
- Nitazoxanide
- Where
- 12 sites in United States
- Volunteers
- 31 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
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 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
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
Relapsed or Refractory Mantle Cell Lymphoma (MCL)
Ph2 Gem/Nov/Rituxan Rel/Ref MantleCell
To determine the efficacy (response rate) produced by the combination of Gemzar, Novantrone, and Rituxan in relapsed or refractory MCL
- Trial name
- NCT00656084
- Testing
- gemcitabine, mitoxantrone, rituximab
- Volunteers
- 16 people
- Sponsor
- US Oncology Research
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
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
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
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