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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Seasonal Influenza B

Intervention / Treatment
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* Biological: VXA-BYW.10 (Low Dose) Oral Vaccine
* Biological: VXA-BYW.10 (High Dose) Oral Vaccine
* Other: Placebo Tablets


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza B