Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2026-02-25 @ 3:02 AM
Study NCT ID:
NCT02547792
Status:
COMPLETED
Last Update Posted:
2018-05-31
First Post:
2015-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of an Oral Influenza B Vaccine Tablet (VXA-BYW.10) Following Single Dose Administration in Healthy Adults
Sponsor:
Vaxart
Organization:
Study Overview
Official Title:
Phase 1 , Placebo-Controlled, Dose-Ranging Trial to Determine Safety and Immunogenicity of an Oral Adenoviral-Vector Based Influenza B Vaccine
Status:
COMPLETED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: