A Phase 1, Randomized, Double-Blind, Placebo-controlled, Dose-ranging Trial to Determine the Safety and Immunogenicity of an Adenoviral-vector Based Norovirus Vaccine (VXA-G1.1-NN) Expressing GI.1 VP1 and dsRNA Adjuvant Administered Orally to Healthy Volunteers
Sponsor study identifier
interventional
66
1 country
1
Study Start
July 29, 2016
Actual (reported)Primary Completion
October 5, 2016
Actual (reported)Study Completion
October 1, 2017
Actual (reported)A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Determine the Safety and Immunogenicity of an Adenoviral-Vector Based Norovirus Vaccine (VXA-G1.1-NN) Expressing GI.1 VP1 and dsRNA Adjuvant Administered Orally to Healthy Volunteers
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 1, 2017
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.
July 29, 2016
Actual (reported)August 11, 2016
Actual (reported)August 16, 2016
Actual (reported)October 5, 2016
Actual (reported)October 1, 2017
Actual (reported)Incidence of Treatment Emergent Solicited and Unsolicited Adverse Events
Solicited Symptoms of Reactogenicity (thru Day 8); unsolicited Adverse Events thru Day 28 post vaccination
Day 1 thru Day 28
Singe dose of orally administered VXA-G1.1-NN (high dose) Oral Vaccine Tablet. VXA-G1.1-NN is an E1/E3-deleted replication-defective Adenovirus serotype 5 vaccine vector for prevention of noroviral gastroenteritis caused by Norovirus GI.1. The vaccine vector encodes for a full length VP1 (major capsid protein) gene from Norvirus GI.1 Norwalk.
Singe dose of orally administered VXA-G1.1-NN (low dose) Oral Vaccine Tablet. VXA-G1.1-NN is an E1/E3-deleted replication-defective Adenovirus serotype 5 vaccine vector for prevention of noroviral gastroenteritis caused by Norovirus GI.1. The vaccine vector encodes for a full length VP1 (major capsid protein) gene from Norvirus GI.1 Norwalk.
The drug product will be provided as small white enteric-coated tablets. Multiple tablets will be administered to deliver the high dose.
The placebo will be provided as small white enteric-coated tablets that are similar in size and number to the active drug product tablets.
Celerion, Inc.
Lincoln, Nebraska, 68502, United States
Kim L, Liebowitz D, Lin K, Kasparek K, Pasetti MF, Garg SJ, Gottlieb K, Trager G, Tucker SN. Safety and immunogenicity of an oral tablet norovirus vaccine, a phase I randomized, placebo-controlled trial. JCI Insight. 2018 Jul 12;3(13):e121077. doi: 10.1172/jci.insight.121077.
Laura Sterling, MD, PhD
Celerion
66 participants (actual enrollment reported by the registry).
First Submitted
August 11, 2016
First Posted
August 16, 2016
Study Start
July 29, 2016
Actual (reported)Singe dose of VXA Placebo tablets. The placebo tablets are small off-white tablets that are similar in size and number to the active vaccine dose being delivered.
The drug product will be provided as small white enteric-coated tablets. Multiple tablets will be administered to deliver the low dose.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
October 5, 2016
Actual (reported)Study Completion
October 1, 2017
Actual (reported)Last Updated
May 31, 2018
Record last verified: 2018-05
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Source: ClinicalTrials.gov.
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