Phase 1-2, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Safety, Immunogenicity, and Efficacy Study in Healthy Adults of Intramuscular Norovirus Bivalent Virus-like Particle Vaccine in Experimental Human Norovirus GII.4 Disease
Sponsor study identifier
Secondary identifiers
REGISTRY · WHO
interventional
132
1 country
5
Study Start
July 16, 2012
Actual (reported)Primary Completion
March 1, 2014
Actual (reported)Study Completion
March 18, 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 18, 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 25, 2012
Actual (reported)May 31, 2012
Actual (reported)July 16, 2012
Actual (reported)March 1, 2014
Actual (reported)March 18, 2014
Actual (reported)August 15, 2016
Actual (reported)Percentage of Participants With Viral AGE Clinical Illness and Fecal Virus Excretion Detected by RT-PCR OR 4-Fold Rise In Anti-GII.4 Norovirus P Particle Antibody Titer
Viral AGE due to Norovirus GII.4 strain during the inpatient stay that meets clinical illness definition 1,2 or 3 and positive for infection as measured by fecal virus excretion detected by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) OR a 4-fold rise in Immunoglobulin G Enzyme-Linked Immunosorbent Assay (IgG ELISA) anti-GII.4 norovirus P particle antibody titer from pre-challenge (Within 2 weeks of Challenge Day 0) to post-challenge (Challenge Day 30). The clinical illness definitions are 1: diarrhea (defined as ≥ 3 loose or liquid stools OR \>400-600 grams of loose or liquid stools produced in any 24-hour period), 2: vomiting (defined as ≥ 2 vomiting episodes in any 24-hour period) or 3. One Vomiting episode plus any loose or liquid stool in any 24-hour period OR one vomiting episode plus at least 2 of the following 5 events: nausea, fever ≥99.7°F orally, abdominal cramps or pains, abdominal gurgling or bloating, or myalgia in any 24-hour period.
Symptoms collected from Challenge dose (at least 28 days after dose 2) to discharge (at least 96 hours after challenge dose)
Percentage of Participants Experiencing Solicited Local Adverse Events Within 7 Days Post-Dose 1
Local Adverse Events included local injection site reactions/symptoms: pain, tenderness, redness, and swelling.
Within 7 days post-dose 1
Percentage of Participants Experiencing Solicited Local Adverse Events Within 7 Days Post-Dose 2
Local Adverse Events included local injection site reactions/symptoms: pain, tenderness, redness, and swelling.
Within 7 days post-dose 2
Percentage of Participants Experiencing Solicited Systemic Adverse Events Within 7 Days Post-Dose 1
Systemic signs or symptoms included: elevated daily oral temperature (fever), headache, fatigue, muscle aches, chills, joint aches and gastrointestinal symptoms of nausea, vomiting, diarrhea, abdominal cramps/pain.
Within 7 days post-dose 1
Percentage of Participants Experiencing Solicited Systemic Adverse Events Within 7 Days Post-Dose 2
Systemic signs or symptoms included: elevated fever, headache, fatigue, muscle aches, chills, joint aches and gastrointestinal symptoms of nausea, vomiting, diarrhea, abdominal cramps/pain.
Within 7 days post-dose 2
Percentage of Participants With Serious Adverse Events (SAEs) 365 Days Following the Last Study Vaccination
A SAE was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
365 Days Following Dose 2 (Up to 393 days)
Percentage of Participants With 4-Fold Rise In Serum P-Particle Antibody Titer by ELISA or Detection of Norovirus GII.4 by RT-PCR in the Stool
Pre Challenge to 30 Days Post Challenge
Severity of Viral AGE Due to GII.4 Strain Assessed by Modified Vesikari Scoring System During the Inpatient Phase
Symptoms collected from Challenge dose (at least 28 days after dose 2) to discharge (at least 96 hours after challenge dose)
Severity of Viral AGE Due to GII.4 Strain Assessed by Post-Challenge Symptom Collection During the Inpatient Phase
Symptoms collected from Challenge dose (at least 28 days after dose 2) to discharge (at least 96 hours after challenge dose)
Duration of Viral AGE Due to GII.4 Strain During the Inpatient Phase
Symptoms collected from Challenge dose (at least 28 days after dose 2) to discharge (at least 96 hours after challenge dose)
Percentage of Participants With GII.4 Norovirus Positive RT-PCR in the Stool During the Inpatient and /or Outpatient Phase
Pre Challenge to 30 Days Post Challenge
Correlation of GII.4 Serum HBGA Antibodies Prior to Challenge Associated With Protection From GII.4 Illness
Pre Challenge to Day 30 Post Challenge
Correlation of GII.4 Serum HGBA Antibodies Prior to Challenge Associated With Protection From GII.4 Infection
Pre Challenge to Day 30 Post Challenge
Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
Saline Placebo (0.9% sodium chloride (NaCl) and preservative-free), intramuscular (IM), Days 0 and 28.
2 doses IM 28 days apart
2 doses IM 28 days apart
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Emory University
Atlanta, Georgia, 30322, United States
SNBL
Baltimore, Maryland, 21201, United States
University of Rochester
Rochester, New York, 14642, United States
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, 45206, United States
Baylor College of Medicine
Houston, Texas, 77030-3498, United States
Bernstein DI, Atmar RL, Lyon GM, Treanor JJ, Chen WH, Jiang X, Vinje J, Gregoricus N, Frenck RW Jr, Moe CL, Al-Ibrahim MS, Barrett J, Ferreira J, Estes MK, Graham DY, Goodwin R, Borkowski A, Clemens R, Mendelman PM. Norovirus vaccine against experimental human GII.4 virus illness: a challenge study in healthy adults. J Infect Dis. 2015 Mar 15;211(6):870-8. doi: 10.1093/infdis/jiu497. Epub 2014 Sep 9.
Atmar RL, Bernstein DI, Lyon GM, Treanor JJ, Al-Ibrahim MS, Graham DY, Vinje J, Jiang X, Gregoricus N, Frenck RW, Moe CL, Chen WH, Ferreira J, Barrett J, Opekun AR, Estes MK, Borkowski A, Baehner F, Goodwin R, Edmonds A, Mendelman PM. Serological Correlates of Protection against a GII.4 Norovirus. Clin Vaccine Immunol. 2015 Aug;22(8):923-9. doi: 10.1128/CVI.00196-15. Epub 2015 Jun 3.
David Bernstein, MD
Cincinatti Children's Hospital
Mohamed S Al-Ibrahim, MB, ChB
SNBL Clinical Pharmacology Center
David Y Graham, MD
Baylor College of Medicine
Robert L Atmar, MD
Children's Hospital Medical Center, Cincinnati
132 participants (actual enrollment reported by the registry).
First Submitted
May 25, 2012
First Posted
May 31, 2012
Study Start
July 16, 2012
Actual (reported)Contact the study team to confirm eligibility.
Sundararajan A, Sangster MY, Frey S, Atmar RL, Chen WH, Ferreira J, Bargatze R, Mendelman PM, Treanor JJ, Topham DJ. Robust mucosal-homing antibody-secreting B cell responses induced by intramuscular administration of adjuvanted bivalent human norovirus-like particle vaccine. Vaccine. 2015 Jan 15;33(4):568-76. doi: 10.1016/j.vaccine.2014.09.073. Epub 2014 Nov 22.
G. Marshall Lyon, MD
Emory University
John J Treanor, MD
University of Rochester
Primary Completion
March 1, 2014
Actual (reported)Study Completion
March 18, 2014
Actual (reported)Last Updated
January 9, 2019
Results First Posted
August 15, 2016
Record last verified: 2019-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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