Back to resultsAssessment of an Oral Influenza B Vaccine Tablet (VXA-BYW.10) Following Single Dose Administration in Healthy Adults
Primary Purpose
Seasonal Influenza B
Status
Completed
Phase
Phase 1
Locations
New Zealand
Study Type
Interventional
Intervention
VXA-BYW.10 (Low Dose) Oral Vaccine
VXA-BYW.10 (High Dose) Oral Vaccine
Placebo Tablets
Sponsored by
About this trial
This is an interventional prevention trial for Seasonal Influenza B focused on measuring Influenza B
Eligibility Criteria
Inclusion Criteria:
- In good health as established by medical history, physical examination, and laboratory testing at the time of enrollment.
Exclusion Criteria:
- Positive for B influenza by HAI.
- Has had an influenza vaccine in the past 2 years.
- Current history of chronic alcohol use and/or illicit and/or recreational drug use.
- History of any confirmed or suspected immunodeficient or immunosuppressive condition
- Positive serology for HIV, HCV, or HBV
- Previous serious reactions to vaccination such as anaphylaxis, respiratory problems, hives, or abdominal pain.
- History of irritable bowel disease or other inflammatory digestive or gastrointestinal conditions that could affect the intended distribution of the vaccine targeting the mucosa of the small intestine
- Use of proton pump inhibitors(Nexium, Prilosec).
- Stool sample with occult blood at baseline exam
- Pregnancy
Sites / Locations
- CCST
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
VXA-BYW.10 (Low Dose) Oral Vaccine
VXA-BYW.10 (High Dose) Oral Vaccine
Placebo Tablets
Arm Description
Single administration of Influenza B (Low Dose) oral vaccine tablets
Single administration of Influenza B (High Dose) oral vaccine tablets
Matching placebo dose (size and number of tablets) to low dose vaccine (part 1) and high dose (part 2)
Outcomes
Primary Outcome Measures
Safety and Tolerability of Single High Dose of an Oral Influenza B Tablet Vaccine
Safety determined by reported solicited (reactogenicity) and unsolicited AEs.
Secondary Outcome Measures
Immunogenicity of Single high Dose of an Oral Influenza B Tablet Vaccine
Efficacy determined by HAI titers at Day 28 post-vaccination
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02547792
Brief Title
Assessment of an Oral Influenza B Vaccine Tablet (VXA-BYW.10) Following Single Dose Administration in Healthy Adults
Official Title
Phase 1 , Placebo-Controlled, Dose-Ranging Trial to Determine Safety and Immunogenicity of an Oral Adenoviral-Vector Based Influenza B Vaccine
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
October 20, 2015 (Actual)
Primary Completion Date
November 21, 2016 (Actual)
Study Completion Date
November 21, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vaxart
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a phase 1, single-center, placeb-controlled, double-blind study. The purpose of this study is to determine the safety and immunogenicity of an oral vaccine tablet to prevent seasonal influenza B tested at two dose levels (low and high dose). The study will enroll 27 subjects in the low dose cohorts (3 sentinel open label subjects followed by 24 subjects (randomized 2:1 to vaccine vs placebo, respectively). Subsequently, 27 subjects will be enrolled in the high dose cohort in a similar manner as to the low dose cohort. Safety and immunogenicity will be evaluated at Day 28. Long term safety follow-up will be evaluated through 1 year post vaccination.
Detailed Description
The study will enroll 54 subjects in four cohorts. All subjects will receive a single administration of VXA-BYW.10 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-BYW.10 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: 16 subjects at low dose and 8 placebo; Cohort 3: 3 subjects at high dose; Cohort 4: 16 subjects at low dose and 8 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
Seasonal Influenza B
Keywords
Influenza B
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VXA-BYW.10 (Low Dose) Oral Vaccine
Arm Type
Experimental
Arm Description
Single administration of Influenza B (Low Dose) oral vaccine tablets
Arm Title
VXA-BYW.10 (High Dose) Oral Vaccine
Arm Type
Experimental
Arm Description
Single administration of Influenza B (High Dose) oral vaccine tablets
Arm Title
Placebo Tablets
Arm Type
Placebo Comparator
Arm Description
Matching placebo dose (size and number of tablets) to low dose vaccine (part 1) and high dose (part 2)
Intervention Type
Biological
Intervention Name(s)
VXA-BYW.10 (Low Dose) Oral Vaccine
Other Intervention Name(s)
Influenza B (Low Dose) Oral Vaccine Tablets
Intervention Description
Enteric coated tablet for oral delivery
Intervention Type
Biological
Intervention Name(s)
VXA-BYW.10 (High Dose) Oral Vaccine
Other Intervention Name(s)
Influenza B (High Dose) Oral Vaccine Tablets
Intervention Description
Enteric coated tablet for oral delivery
Intervention Type
Other
Intervention Name(s)
Placebo Tablets
Intervention Description
Enteric coated tablet for oral delivery
Primary Outcome Measure Information:
Title
Safety and Tolerability of Single High Dose of an Oral Influenza B Tablet Vaccine
Description
Safety determined by reported solicited (reactogenicity) and unsolicited AEs.
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
Immunogenicity of Single high Dose of an Oral Influenza B Tablet Vaccine
Description
Efficacy determined by HAI titers at Day 28 post-vaccination
Time Frame
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:
In good health as established by medical history, physical examination, and laboratory testing at the time of enrollment.
Exclusion Criteria:
Positive for B influenza by HAI.
Has had an influenza vaccine in the past 2 years.
Current history of chronic alcohol use and/or illicit and/or recreational drug use.
History of any confirmed or suspected immunodeficient or immunosuppressive condition
Positive serology for HIV, HCV, or HBV
Previous serious reactions to vaccination such as anaphylaxis, respiratory problems, hives, or abdominal pain.
History of irritable bowel disease or other inflammatory digestive or gastrointestinal conditions that could affect the intended distribution of the vaccine targeting the mucosa of the small intestine
Use of proton pump inhibitors(Nexium, Prilosec).
Stool sample with occult blood at baseline exam
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Liebowitz, MD, PhD
Organizational Affiliation
Vaxart, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
CCST
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Assessment of an Oral Influenza B Vaccine Tablet (VXA-BYW.10) Following Single Dose Administration in Healthy Adults
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