Trials Sponsors Conditions Drugs Pricing

Conditions

Acute Gastroenteritis Norwalk Virus Infection

Keywords

Prevention of acute gastroenteritis due to infection with and experimental Norwalk Virus

Outcome Measures

Primary Outcomes (1)

Percentage of Participants with Viral Acute Gastroenteritis (AGE)
Viral AGE was a composite endpoint for the analysis of clinical illness and was defined as meeting one or more definitions of Norwalk Virus Infection and one or more of the definitions of AGE. Norwalk Virus Infection: * PAN-Immunoglobulin (Ig) Enzyme Linked Immunosorbent Assay (ELISA) for anti-Norwalk Virus Antibody IgM, IgG and IgA, ≥4-fold rise in titer in serum on Challenge Day 30 compared to Pre-Challenge. * Reverse Transcription Polymerase Chain Reaction (RT-PCR), a single positive post-challenge stool sample. * Norwalk Virus Antigen, a single positive post-challenge stool sample. Acute Gastroenteritis: -\>200 grams of watery feces in 24-hour collection that immediately takes the shape of the container. * Vomiting and watery feces ≤200 grams on the same or consecutive days. * One vomiting episode plus one of the following symptoms: abdominal cramps or pains, nausea, bloating, loose feces, fever ≥99.7° Fahrenheit, or myalgia on the same or consecutive days.
7 Days Post-Challenge

Secondary Outcomes (18)

Percentage of Participants with Norwalk Virus Infection Anytime Post Challenge
Up to 30 Days Post-Challenge
Severity of Viral AGE using the Modified Vesikari Scale
Up to 30 Days Post-Challenge
Duration of Viral AGE Among Challenged Participants
Up to 30 Days Post-Challenge
Percentage of Participants with Norwalk Virus Antigen Detected in the Stool
Days 1 thru 4, 7, 21 and 30 in the Challenge Stage
Percentage of Participants with Seroconversion in Serum Anti-Norwalk Virus
Pre-Challenge to 30 Days Post-Challenge
+13 more secondary outcomes

Study Arms (2)

Norwalk VLP Vaccine 100 µg

EXPERIMENTAL

Norwalk Virus-like Particle (VLP) Vaccine 100 µg, dry powder, intranasally using a delivery device with a puff of air, 50 µg in each nostril, on Days 0 and 21 in the Vaccination Stage. Norwalk Virus, 48 Reverse Transcription Polymerase Chain Reaction (RT-PCR) units, solution, orally, on Day 42 in the Challenge Stage.

Biological: Norwalk VLP vaccineBiological: Norwalk virus

Placebo

PLACEBO COMPARATOR

Norwalk VLP placebo-matching vaccine, dry powder, intranasally using a delivery device with a puff of air, 50 µg in each nostril, on Days 0 and 21 in the Vaccination Stage. Norwalk Virus, 48 RT-PCR units, solution, orally, on Day 42 in the Challenge Stage.

Biological: mannitol and sucroseBiological: Norwalk virus

Interventions

Norwalk VLP vaccineBiological

Norwalk VLP vaccine dry powder

Norwalk VLP Vaccine 100 µg

mannitol and sucroseBiological

Mannitol and sucrose as placebo-matching Norwalk VLP Vaccine dry powder

Placebo

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Grouped treatment entry
mannitol and sucrose
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record

Eligibility Criteria

Age18 Years - 50 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Signed informed consents.
Age 18 - 50 years, inclusive.

Sponsors & Collaborators

Takeda
Industrylead

Study Sites (3)

SNBL

Baltimore, Maryland, 21201, United States

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, 45206, United States

Baylor College of Medicine

Houston, Texas, 77030-3498, United States

Related Publications (1)

Atmar RL, Bernstein DI, Harro CD, Al-Ibrahim MS, Chen WH, Ferreira J, Estes MK, Graham DY, Opekun AR, Richardson C, Mendelman PM. Norovirus vaccine against experimental human Norwalk Virus illness. N Engl J Med. 2011 Dec 8;365(23):2178-87. doi: 10.1056/NEJMoa1101245.
PMID: 22150036DERIVED

MeSH Terms

Interventions

MannitolSucrose

Intervention Hierarchy (Ancestors)

Sugar AlcoholsAlcoholsOrganic ChemicalsCarbohydratesDisaccharidesOligosaccharidesPolysaccharidesSugars

Study Officials

Robert L Atmar, MD
Baylor College of Medicine
PRINCIPAL INVESTIGATOR
David I Bernstein, MD
Children's Hospital Medical Center, Cincinnati
PRINCIPAL INVESTIGATOR
Clayton D Harro, MD
Johns Hopkins University
PRINCIPAL INVESTIGATOR
Mohamed S Al-Ibrahim, MD
SNBL Clinical Pharmacology Center, Inc.
PRINCIPAL INVESTIGATOR

Enrollment

98 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 8, 2009

First Posted

September 9, 2009

Study Start

August 4, 2009

Actual (reported)

Norwalk Vaccine Study

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (18)

Study Arms (2)

Norwalk VLP Vaccine 100 µg

Placebo

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

Related Publications (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (18)

Study Arms (2)

Norwalk VLP Vaccine 100 µg

Placebo

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

Related Publications (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations