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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02547792
Recruitment Status : Completed
First Posted : September 11, 2015
Last Update Posted : May 31, 2018
Sponsor:
Information provided by (Responsible Party):
Vaxart

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.

Condition or disease Intervention/treatment Phase
Seasonal Influenza B Biological: VXA-BYW.10 (Low Dose) Oral Vaccine Biological: VXA-BYW.10 (High Dose) Oral Vaccine Other: Placebo Tablets Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Phase 1 , Placebo-Controlled, Dose-Ranging Trial to Determine Safety and Immunogenicity of an Oral Adenoviral-Vector Based Influenza B Vaccine
Actual Study Start Date : October 20, 2015
Actual Primary Completion Date : November 21, 2016
Actual Study Completion Date : November 21, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

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 Name: 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 Name: 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




Primary Outcome Measures :
  1. Safety and Tolerability of Single High Dose of an Oral Influenza B Tablet Vaccine [ Time Frame: Day 28 ]
    Safety determined by reported solicited (reactogenicity) and unsolicited AEs.


Secondary Outcome Measures :
  1. Immunogenicity of Single high Dose of an Oral Influenza B Tablet Vaccine [ Time Frame: Day 28 ]
    Efficacy determined by HAI titers at Day 28 post-vaccination



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02547792


Locations
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New Zealand
CCST
Christchurch, New Zealand, 8011
Sponsors and Collaborators
Vaxart
Investigators
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Study Director: David Liebowitz, MD, PhD Vaxart, Inc.
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Responsible Party: Vaxart
ClinicalTrials.gov Identifier: NCT02547792    
Other Study ID Numbers: VXA03-001
First Posted: September 11, 2015    Key Record Dates
Last Update Posted: May 31, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Vaxart:
Influenza B
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs