Back to resultsPhase 1 Placebo-controlled, Randomized Trial of an Adenoviral-vector Based Norovirus Vaccine
Primary Purpose
Norovirus Gastroenteritis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
VXA-G1.1-NN (high dose) Oral Vaccine Tablet
VXA Placebo Tablets
VXA-G1.1-NN (low dose) Oral Vaccine Tablet
Sponsored by
About this trial
This is an interventional prevention trial for Norovirus Gastroenteritis
Eligibility Criteria
Inclusion Criteria:
- Male or female volunteers aged 18 - 49 years, inclusive
- Able to give written informed consent
- Healthy (no clinically significant health concerns)
- Safety laboratory values within the following range criteria normal range
- Body mass index between 17 and 35 at screening
Exclusion Criteria:
- Receipt of any investigational norovirus vaccine within two years prior to study
- Receipt of any investigational vaccine, drug or device within 8 weeks preceding vaccination
- Administration of any licensed vaccine within 30 days prior to study
- Presence of significant uncontrolled medical or psychiatric illness (acute or chronic) including institution of new medical/surgical treatment or significant dose alteration for uncontrolled symptoms or drug toxicity within 3 months of screening and reconfirmed at baseline
- History of drug, alcohol or chemical abuse within 1 year prior to vaccination
- Presence of a fever ≥ 38oC measured orally at baseline
- Stool sample with occult blood at screening -
Sites / Locations
- Celerion, Inc.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
H1N1 (high dose) Oral Vaccine Tablet
H1N1 (low dose) Oral Vaccine Tablet
Placebo Tablets
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Incidence of Treatment Emergent Solicited and Unsolicited Adverse Events
Solicited Symptoms of Reactogenicity (thru Day 8); unsolicited Adverse Events thru Day 28 post vaccination
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02868073
Brief Title
Phase 1 Placebo-controlled, Randomized Trial of an Adenoviral-vector Based Norovirus Vaccine
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
July 29, 2016 (Actual)
Primary Completion Date
October 5, 2016 (Actual)
Study Completion Date
October 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vaxart
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
Detailed Description
The study will enroll 66 subjects in four cohorts. All subjects will receive a single administration of VXA-G1.1-NN at a low dose, a high dose or placebo.
Two sentinel groups will enroll 3 subjects each in an open-label manner (Cohorts 1 and 3) to receive VXA-G1.1-NN prior to enrolling either of the randomized, controlled cohorts (Cohorts 2 and 4). Within the double-blinded Cohorts (2 and 4), placebo subjects will receive the same number of tablets as the vaccine subjects in that Cohort. Subjects will be enrolled and dosed in the low dose groups prior to initiation of dosing in the high dose group.
Cohort 1: 3 subjects at low dose Cohort 2: 20 subjects at low dose and 10 placebo Cohort 3: 3 subjects at high dose Cohort 4: 20 subjects at low dose and 10 placebo
Subjects will be followed for 28 days post vaccination for preliminary immunogenicity. Subjects will continue to be followed for 1 year post-vaccination for long term safety.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Norovirus Gastroenteritis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
H1N1 (high dose) Oral Vaccine Tablet
Arm Type
Experimental
Arm Description
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.
Arm Title
H1N1 (low dose) Oral Vaccine Tablet
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Tablets
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
VXA-G1.1-NN (high dose) Oral Vaccine Tablet
Other Intervention Name(s)
H1N1 (high dose) Oral Vaccine Tablet
Intervention Description
The drug product will be provided as small white enteric-coated tablets. Multiple tablets will be administered to deliver the high dose.
Intervention Type
Other
Intervention Name(s)
VXA Placebo Tablets
Other Intervention Name(s)
Placebo Control
Intervention Description
The placebo will be provided as small white enteric-coated tablets that are similar in size and number to the active drug product tablets.
Intervention Type
Biological
Intervention Name(s)
VXA-G1.1-NN (low dose) Oral Vaccine Tablet
Other Intervention Name(s)
H1N1 (low dose) Oral Vaccine Tablet
Intervention Description
The drug product will be provided as small white enteric-coated tablets. Multiple tablets will be administered to deliver the low dose.
Primary Outcome Measure Information:
Title
Incidence of Treatment Emergent Solicited and Unsolicited Adverse Events
Description
Solicited Symptoms of Reactogenicity (thru Day 8); unsolicited Adverse Events thru Day 28 post vaccination
Time Frame
Day 1 thru Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or female volunteers aged 18 - 49 years, inclusive
Able to give written informed consent
Healthy (no clinically significant health concerns)
Safety laboratory values within the following range criteria normal range
Body mass index between 17 and 35 at screening
Exclusion Criteria:
Receipt of any investigational norovirus vaccine within two years prior to study
Receipt of any investigational vaccine, drug or device within 8 weeks preceding vaccination
Administration of any licensed vaccine within 30 days prior to study
Presence of significant uncontrolled medical or psychiatric illness (acute or chronic) including institution of new medical/surgical treatment or significant dose alteration for uncontrolled symptoms or drug toxicity within 3 months of screening and reconfirmed at baseline
History of drug, alcohol or chemical abuse within 1 year prior to vaccination
Presence of a fever ≥ 38oC measured orally at baseline
Stool sample with occult blood at screening -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Sterling, MD, PhD
Organizational Affiliation
Celerion
Official's Role
Principal Investigator
Facility Information:
Facility Name
Celerion, Inc.
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68502
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29997294
Citation
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.
Results Reference
derived
Learn more about this trial
Phase 1 Placebo-controlled, Randomized Trial of an Adenoviral-vector Based Norovirus Vaccine
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