Assessment of an Oral Influenza B Vaccine Tablet (VXA-BYW.10) Following Single Dose Administration in Healthy Adults

Phase 1 , Placebo-Controlled, Dose-Ranging Trial to Determine Safety and Immunogenicity of an Oral Adenoviral-Vector Based Influenza B Vaccine

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.

Study Overview

• Status: Completed
• Conditions: Seasonal Influenza B
• Intervention / Treatment: Biological: VXA-BYW.10 (Low Dose) Oral Vaccine; Biological: VXA-BYW.10 (High Dose) Oral Vaccine; Other: Placebo Tablets

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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 1

Contacts and Locations

Study Locations

• New Zealand
  • Christchurch, New Zealand, 8011
    • CCST

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: VXA-BYW.10 (Low Dose) Oral Vaccine; Single administration of Influenza B (Low Dose) oral vaccine tablets	Biological: VXA-BYW.10 (Low Dose) Oral Vaccine; Enteric coated tablet for oral delivery; Other Names: Influenza B (Low Dose) Oral Vaccine Tablets
EXPERIMENTAL: VXA-BYW.10 (High Dose) Oral Vaccine; Single administration of Influenza B (High Dose) oral vaccine tablets	Biological: VXA-BYW.10 (High Dose) Oral Vaccine; Enteric coated tablet for oral delivery; Other Names: Influenza B (High Dose) Oral Vaccine Tablets
PLACEBO_COMPARATOR: Placebo Tablets; Matching placebo dose (size and number of tablets) to low dose vaccine (part 1) and high dose (part 2)	Other: Placebo Tablets; Enteric coated tablet for oral delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Tolerability of Single High Dose of an Oral Influenza B Tablet Vaccine	Safety determined by reported solicited (reactogenicity) and unsolicited AEs.	Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity of Single high Dose of an Oral Influenza B Tablet Vaccine	Efficacy determined by HAI titers at Day 28 post-vaccination	Day 28

Collaborators and Investigators

• Sponsor: Vaxart

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 20, 2015
• Primary Completion (ACTUAL): November 21, 2016
• Study Completion (ACTUAL): November 21, 2016

Study Registration Dates

• First Submitted: September 9, 2015
• First Submitted That Met QC Criteria: September 10, 2015
• First Posted (ESTIMATE): September 11, 2015

Study Record Updates

• Last Update Posted (ACTUAL): May 31, 2018
• Last Update Submitted That Met QC Criteria: May 29, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Influenza B
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: VXA03-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO