CovidResearchTrials by Shray Alag


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Report for D017250: Caliciviridae Infections NIH

(Synonyms: Caliciviridae Infections)

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (10)


Name (Synonyms) Correlation
drug1925 Norovirus Bivalent (GI.1 / GII.4) Vaccine(high) Wiki 0.71
drug1926 Norovirus Bivalent (GI.1 / GII.4) Vaccine(low) Wiki 0.71
drug2550 Saliva Wiki 0.71
drug184 Aluminum adjuvant Wiki 0.71
drug1927 Norovirus Bivalent (GI.1 / GII.4) Vaccine(middle) Wiki 0.71
drug934 Duodenal biopsy Wiki 0.71
drug1922 Normal saline Wiki 0.32
drug752 Convalescent Plasma Wiki 0.29
drug2707 Standard of care Wiki 0.16
drug2698 Standard of Care Wiki 0.13

Correlated MeSH Terms (3)


Name (Synonyms) Correlation
D005759 Gastroenteritis NIH 0.50
D003141 Communicable Diseases NIH 0.06
D007239 Infection NIH 0.04

Correlated HPO Terms (0)


Name (Synonyms) Correlation

There are 2 clinical trials

Clinical Trials


1 Genome-wide CRISPR Screen for Host Factors Associated With Norovirus Infections in Stem Cell-derived Human Intestinal Enteroid 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. It is also the primary cause of mortality among young children and adults in foodborne infections. Norovirus is not just a foodborne burden. In a recent meta-analysis, norovirus accounts for nearly one-fifth of all causes of (including person-to-person transmission) acute gastroenteritis in both sporadic and outbreak settings and affects all age groups. Undoubtedly, norovirus is of paramount public health concern in both developed and developing countries. Research efforts to better understand norovirus pathobiology will be necessary for targeted intervention. From Middle East respiratory syndrome coronavirus to Zika virus, efforts to identify host factors important for mediating virus infection has always been a research priority. Such information will shed light on potential therapeutic targets in antiviral intervention. Norovirus virus-host interaction studies have been hampered by the lack of a robust cell culture model in the past 20 years. In 2016, norovirus has finally been successfully cultivated in a stem cell-derived three-dimensional human gut-like structure called enteroid or mini-gut. In this study, intestinal stem cells will be isolated from duodenal biopsies collected from participants, followed by differentiation into mini-guts. Genome-wide genetic screening for host essential and restrictive factors will be performed on infected mini-guts by knockout CRISPR and gain-of-function CRISPR SAM, respectively. Shortlisted candidates will undergo preliminary functional validation in cell lines. These data will provide insights into potential therapeutic targets against norovirus infection.

NCT03342547 Gastrointestinal Infection Procedure: Duodenal biopsy Procedure: Saliva
MeSH:Infection Communicable Diseases Caliciviridae Infections

Primary Outcomes

Description: Viability of enteroids as determined by microscopy

Measure: Establishment of human intestinal stem cell-derived enteroids

Time: An average of three months

2 A Randomized, Blind, Placebo-controlled Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Norovirus Bivalent (GI. 1 / GII. 4) Vaccine (Hansenulapolymorpha) in Healthy People Aged 6 Months to 59 Years

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. A total of 30 people in each dose group were vaccinated with the test vaccine or placebo 1 or placebo 2, respectively, in a ratio of 3: 1: 1. The 18-59-year-old, 6-17-year-old, and 3-5-year-old age groups were vaccinated 2 times at a time interval of 28 days. The 6-35 month age group is divided into two groups, Group 1 is inoculated with 2 doses interval of 28 days each, and Group 2 is inoculated with 3 doses interval of 28 days.

NCT04188691 Norwalk Gastroenteritis Norovirus Infections Biological: Norovirus Bivalent (GI.1 / GII.4) Vaccine(low) Biological: Norovirus Bivalent (GI.1 / GII.4) Vaccine(middle) Biological: Norovirus Bivalent (GI.1 / GII.4) Vaccine(high) Biological: Normal saline Biological: Aluminum adjuvant
MeSH:Caliciviridae Infections Gastroenteritis

Primary Outcomes

Measure: AE of local and systemic reactions within 30 minutes after each dose

Time: 30 minutes

Description: Active AE: Local and systemic adverse reactions occurring within 0-7 days after each dose of vaccination

Measure: All active AEs within 0-7 days after each dose

Time: 7 days

Description: Adverse events other than active AE include solicitation adverse events reported in addition to the specified solicitation time window

Measure: All non-active collection AEs within 0-28(30) days after each dose

Time: 28(30) days

Measure: All SAEs within 6 months after the last dose is vaccinated

Time: 6 months

Secondary Outcomes

Measure: Calculate geometric mean titer (GMT) of NoV GI.1 and GII.4 IgG antibodies

Time: 28 days after the full vaccination

Measure: Calculate positive rate of NoV GI.1 and GII.4 IgG antibodies

Time: 28 days after the full vaccination

Measure: Calculate NoV GI.1 and GII.4 HBGA-blocking antibody titers

Time: 28 days after the full vaccination

Measure: Calculate NoV GI.1 and GII.4 HBGA-blocking antibody positive rates

Time: 28 days after the full vaccination


HPO Nodes