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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02547792




Registration number
NCT02547792
Ethics application status
Date submitted
9/09/2015
Date registered
11/09/2015
Date last updated
31/05/2018

Titles & IDs
Public title
Assessment of an Oral Influenza B Vaccine Tablet (VXA-BYW.10) Following Single Dose Administration in Healthy Adults
Scientific title
Phase 1 , Placebo-Controlled, Dose-Ranging Trial to Determine Safety and Immunogenicity of an Oral Adenoviral-Vector Based Influenza B Vaccine
Secondary ID [1] 0 0
VXA03-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Seasonal Influenza B 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - VXA-BYW.10 (Low Dose) Oral Vaccine
Other interventions - VXA-BYW.10 (High Dose) Oral Vaccine
Other interventions - Placebo Tablets

Experimental: VXA-BYW.10 (Low Dose) Oral Vaccine - Single administration of 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

Placebo Comparator: Placebo Tablets - Matching placebo dose (size and number of tablets) to low dose vaccine (part 1) and high dose (part 2)


Other interventions: VXA-BYW.10 (Low Dose) Oral Vaccine
Enteric coated tablet for oral delivery

Other interventions: VXA-BYW.10 (High Dose) Oral Vaccine
Enteric coated tablet for oral delivery

Other interventions: Placebo Tablets
Enteric coated tablet for oral delivery

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and Tolerability of Single High Dose of an Oral Influenza B Tablet Vaccine - Safety determined by reported solicited (reactogenicity) and unsolicited AEs.
Timepoint [1] 0 0
Day 28
Secondary outcome [1] 0 0
Immunogenicity of Single high Dose of an Oral Influenza B Tablet Vaccine - Efficacy determined by HAI titers at Day 28 post-vaccination
Timepoint [1] 0 0
Day 28

Eligibility
Key inclusion criteria
- In good health as established by medical history, physical examination, and laboratory
testing at the time of enrollment.
Minimum age
18 Years
Maximum age
49 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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 design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Vaxart
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT02547792
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Liebowitz, MD, PhD
Address 0 0
Vaxart, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications