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A Phase I Trial of VAXART's COVID-19 Vaccine

Trial Profile

A Phase I Trial of VAXART's COVID-19 Vaccine

Status: Planning
Phase of Trial: Phase I

Latest Information Update: 10 Aug 2020

At a glance

  • Drugs COVID-19 vaccine VAXART (Primary)
  • Indications COVID 2019 infections
  • Focus Adverse reactions
  • Sponsors Vaxart
  • Most Recent Events

    • 10 Aug 2020 According to a Vaxart media release, the COVID-19 Investigational New Drug (IND) application has been filed with the USA Food and Drug Administration (FDA).
    • 20 May 2020 According to a Kindred Biosciences media release, the company has entered into an agreement with Vaxart,for the manufacture of Vaxarts oral vaccine candidate for COVID-19. KindredBio will produce the candidate vaccine bulk drug substance under Good Manufacturing Practices, and provide it to Vaxart to be formulated into a vaccine tablet to be taken by mouth instead of by needle injection. KindredBio will manufacture the vaccine for clinical trials beginning in the second half of 2020.
    • 21 Apr 2020 According to a Vaxart media release, the first stage of the collaboration between Vaxart and the Emergent BioSolutions for development services to prepare for cGMP production of an oral COVID-19 vaccine is underway and, provided Vaxart elects to proceed with cGMP manufacturing, Emergent is expected to produce bulk cGMP vaccine in time to allow the initiation of this trial.

Trial Overview

Purpose

This Phase I trial will assess VAXART's COVID-19 vaccine.

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections prevention -

Subjects

  • Subject Type patients
  • Sex male & female

Trial Details

Organisations

  • Sponsors Vaxart
  • Affiliations Vaxart

Trial Dates

  • Initiation Dates

    Planned : 01 Jul 2020

Other Details

  • Design prospective
  • Phase of Trial Phase I
  • Location Unknown
  • Focus Adverse reactions

Interventions

Drugs Route Formulation
COVID-19 vaccine VAXARTPrimary Drug Oral Tablet

Oral COVID-19 vaccine

description: The Vaxart's COVID-19 vaccine would be administered orally using a room temperature-stable tablet.

Trial Centres

Centres

Centre Name Location Trial Centre Country
Vaxart
-
-

Trial History

Event Date Event Type Comment
10 Aug 2020 Other trial event According to a Vaxart media release, the COVID-19 Investigational New Drug (IND) application has been filed with the USA Food and Drug Administration (FDA). Updated 14 Aug 2020
20 May 2020 Other trial event According to a Kindred Biosciences media release, the company has entered into an agreement with Vaxart,for the manufacture of Vaxarts oral vaccine candidate for COVID-19. KindredBio will produce the candidate vaccine bulk drug substance under Good Manufacturing Practices, and provide it to Vaxart to be formulated into a vaccine tablet to be taken by mouth instead of by needle injection. KindredBio will manufacture the vaccine for clinical trials beginning in the second half of 2020. Updated 24 May 2020
21 Apr 2020 Other trial event According to a Vaxart media release, the first stage of the collaboration between Vaxart and the Emergent BioSolutions for development services to prepare for cGMP production of an oral COVID-19 vaccine is underway and, provided Vaxart elects to proceed with cGMP manufacturing, Emergent is expected to produce bulk cGMP vaccine in time to allow the initiation of this trial. Updated 23 Apr 2020
23 Mar 2020 New trial record New trial record Updated 23 Mar 2020
18 Mar 2020 Other trial event According to a Vaxart media release, the company has entered into an agreement with Emergent BioSolutions Inc. whereby Emergent will deploy its contract development and manufacturing (CDMO) services to help develop and manufacture Vaxart's experimental oral vaccine candidate for coronavirus disease (COVID-19). Updated 23 Mar 2020
18 Mar 2020 Other trial event According to a Vaxart media release, the company expects to initiate this trial early in the second half of 2020. Updated 23 Mar 2020

References

  1. Vaxart. VAXART ANNOUNCES IT ENTERED INTO AN AGREEMENT WITH EMERGENT BIOSOLUTIONS FOR THE DEVELOPMENT AND MANUFACTURING OF ORAL CORONAVIRUS (COVID-19) VACCINE CANDIDATE. Media-Rel 2020;.

    Media Release
  2. Emergent BioSolutions. EMERGENT BIOSOLUTIONS SIGNS DEVELOPMENT AND MANUFACTURING AGREEMENT WITH VAXART FOR THEIR EXPERIMENTAL ORAL VACCINE CANDIDATE FOR CORONAVIRUS DISEASE. Media-Rel 2020;.

    Media Release
  3. Vaxart. Vaxart Announces IND Filed for COVID-19 Vaccine. Media-Rel 2020;.

    Media Release
  4. Kindred Biosciences Announces COVID-19 Vaccine Manufacturing Agreement with Vaxart. Media-Rel 2020;.

    Media Release
  5. Vaxart. Vaxart Announces Positive Pre-Clinical Data for its Oral COVID-19 Vaccine Program. Media-Rel 2020;.

    Media Release
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