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NCT02547792

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

Completed Phase 1 Last updated 31 May 2018
What this trial tests

Phase 1 trial testing VXA-BYW.10 (Low Dose) Oral Vaccine in Seasonal Influenza B in 54 participants. Completed in 21 November 2016.

Timeline
20 October 2015
Primary endpoint
21 November 2016
21 November 2016

Quick facts

Lead sponsorVaxart
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposeprevention
Enrollment54
Start date20 October 2015
Primary completion21 November 2016
Estimated completion21 November 2016
Sites1 location across New Zealand

Drugs / interventions tested

Conditions studied

Sponsor

Vaxart — full company profile →

Who can join

Adults 18 to 49, any sex, with Seasonal Influenza B. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Noninvasive vaccination against infectious diseases.
    Zheng Z, Diaz-Arévalo D, Guan H, Zeng M. · · 2018 · cited 46× · PMID 29624470 · DOI 10.1080/21645515.2018.1461296
  2. Ebola virus disease candidate vaccines under evaluation in clinical trials.
    Martins KA, Jahrling PB, Bavari S, Kuhn JH. · · 2016 · cited 37× · PMID 27160784 · DOI 10.1080/14760584.2016.1187566
  3. Blades and barriers: Oral vaccines for conquering cancers and warding off infectious diseases.
    Yang K, Liu J, Zhao Y, Xu H, et al · · 2025 · PMID 40893667 · DOI 10.1016/j.apsb.2025.05.038

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Trials by the same sponsor.

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