deltatrials
Completed PHASE1 INTERVENTIONAL 3-arm NCT02547792

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

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

Sponsor: Vaxart

Updated 8 times since 2017 Last updated: May 29, 2018 Started: Oct 20, 2015 Primary completion: Nov 21, 2016 Completion: Nov 21, 2016
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1 trial investigates Seasonal Influenza B and is currently completed. Vaxart leads this study, which shows 8 recorded versions since 2015 — indicating limited longitudinal coverage. Longitudinal tracking of infectious disease trials helps identify durability of treatment effects.

Study Description(click to expand)

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.

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.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotActive Not Recruiting~Feb 2017 – ~Jun 2017 · 4 months · monthly snapshotActive Not Recruiting~Jun 2017 – ~Jun 2018 · 12 months · monthly snapshotActive Not Recruiting~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

8 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed PHASE1

  2. Sep 2024 — Present [monthly]

    Completed PHASE1

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE1

  5. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE1

    Status: Active Not RecruitingCompleted

Show 3 earlier versions
  1. Jun 2017 — Jun 2018 [monthly]

    Active Not Recruiting PHASE1

  2. Feb 2017 — Jun 2017 [monthly]

    Active Not Recruiting PHASE1

  3. Jan 2017 — Feb 2017 [monthly]

    Active Not Recruiting PHASE1

    First recorded

Oct 2015

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Vaxart
Data source: Vaxart

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations