NCT02547792

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 11, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

October 20, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2016

Completed
Last Updated

May 31, 2018

Status Verified

May 1, 2018

Enrollment Period

1.1 years

First QC Date

September 9, 2015

Last Update Submit

May 29, 2018

Conditions

Seasonal Influenza B

Keywords

Influenza B

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Immunogenicity of Single high Dose of an Oral Influenza B Tablet Vaccine

    Day 28

Study Arms (3)

VXA-BYW.10 (Low Dose) Oral Vaccine

EXPERIMENTAL

Single administration of Influenza B (Low Dose) oral vaccine tablets

Biological: VXA-BYW.10 (Low Dose) Oral Vaccine

VXA-BYW.10 (High Dose) Oral Vaccine

EXPERIMENTAL

Single administration of Influenza B (High Dose) oral vaccine tablets

Biological: VXA-BYW.10 (High Dose) Oral Vaccine

Placebo Tablets

PLACEBO COMPARATOR

Matching placebo dose (size and number of tablets) to low dose vaccine (part 1) and high dose (part 2)

Other: Placebo Tablets

Interventions

VXA-BYW.10 (Low Dose) Oral VaccineBIOLOGICAL

Enteric coated tablet for oral delivery

Also known as: Influenza B (Low Dose) Oral Vaccine Tablets
VXA-BYW.10 (Low Dose) Oral Vaccine
VXA-BYW.10 (High Dose) Oral VaccineBIOLOGICAL

Enteric coated tablet for oral delivery

Also known as: Influenza B (High Dose) Oral Vaccine Tablets
VXA-BYW.10 (High Dose) Oral Vaccine
Placebo TabletsOTHER

Enteric coated tablet for oral delivery

Placebo Tablets

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • In good health as established by medical history, physical examination, and laboratory testing at the time of enrollment.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CCST

Christchurch, 8011, New Zealand

Location

MeSH Terms

Interventions

Vaccines

Intervention Hierarchy (Ancestors)

Biological ProductsComplex Mixtures

Study Officials

  • David Liebowitz, MD, PhD

    Vaxart, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2015

First Posted

September 11, 2015

Study Start

October 20, 2015

Primary Completion

November 21, 2016

Study Completion

November 21, 2016

Last Updated

May 31, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

NZ(1)