Active clinical trials for "Caliciviridae Infections"

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.

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). Healthy adults will be randomized in a 1:1 ratio to receive one oral dose of vaccine or placebo. Arm 1: VXA-G1.1-NN oral vaccine tablets [1x1011 IU±0.5 log] Arm 2: Placebo tablets similar in appearance and number to active vaccine tablets Approximately 28 days post-vaccination, subjects will be admitted to an isolation ward and challenged with the NV GI.1 Norwalk challenge strain. After challenge, subjects will be monitored for signs and symptoms of acute gastroenteritis (AGE) from Day 29 to discharge. At 4 days post challenge (Day 33) asymptomatic subjects will be discharged from the isolation ward and will be followed in a series of outpatient visits and telephone calls. Symptomatic subjects may be kept in the isolation ward for up to an additional 3 days.

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. Bivalent GI.1 and GII.4 vaccines are being investigated for the prevention of noroviral gastroenteritis caused by norovirus GI.1 and GII.4.

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

The purpose of this study is to determine the effect of nitazoxanide suspension in treating diarrhea caused by enteric viruses in children less than 12 years of age.

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 Dosing in Healthy Adult Volunteers. The study consists of 2 parts: Part 1 is the double-blinded portion where subjects will be randomized to one of two monovalent vaccine groups, bivalent vaccine group or placebo. Subjects will be followed for ~4 weeks post vaccination for safety and immunogenicity. Part 2 will consist of an open label booster vaccination for the bivalent treatment group ~4 months post initial vaccination. All subjects will be followed for long term safety for 1 year post initial vaccination.

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 tolerability of VXA- G1.1-NN with repeat-dose administration at varying boost schedules (Week 4, 8 or 12) in healthy adults aged 18-55, inclusive

The objective of this study is to determine the prevalence of secondary lactose intolerance in renal transplant recipients (RTR) with chronic norovirus infection. In the investigators cohort of 1000 renal transplant recipients (RTRs) in the University Hospital of Zurich, the investigators are currently aware of 10 patients with chronic norovirus infection, which was proven by positive polymerase chain reaction (PCR) analysis of recent stool samples, whereas chronic virus shedding is defined as more than two PCR positive samples in an interval of at least one month. Concomitant viral (other than norovirus), bacterial or parasitic (particularly Gardia lamblia) intestinal infections are excluded by negative stool cultures and PCR analyses, respectively. Main exclusion criterion for the present case series is a concomitant intestinal infection (other than norovirus) and primary lactose intolerance, which is previously excluded by absence of the CC genotype of the DNA variant -13910 T/C upstream in the LCT gene. After obtaining written and oral informed consent, the investigators perform a lactose hydrogen breath (LH2BT) test and a lactose tolerance test (LTT) in all eligible RTRs with proven chronic norovirus infection irrespective of current abdominal symptoms. The study population (N=10) is divided into two groups according to the gastrointestinal symptoms (asymptomatic versus symptomatic, such as chronic diarrhoea or diffuse abdominal discomfort). The investigators chose the cut-off three or more stools per day as indicative of diarrhoea for the purpose of this study. RTRs with otherwise unexplainable chronic diarrhoea but absent norovirus infection serve as control group (N=10).

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. The purpose is also to evaluate the safety of the vaccine and the immunogenicity of the vaccine.

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. The active period consists of data collection at Day 1, Day 8, and Day 29. Safety follow-up continues by phone screen at Day 180 and Day 365.