First patient dosed in COVID-19 vaccine tablet clinical trial

A Phase I clinical trial to test VXA-CoV2-1, an oral tablet COVID-19 vaccine candidate, has been initiated with the first patient dosed.

COVID-19 vaccine tablets

Vaxart has announced that the first subject has been dosed in the company’s Phase I study of VXA-CoV2-1, an oral tablet COVID-19 vaccine candidate.

The Phase I, open-label, dose-ranging trial (NCT04563702) is designed to examine the safety and immunogenicity of two doses of VXA-CoV2-1 in up to 48 healthy adult volunteers aged 18 to 54 years old. Enrolment is expected to be completed by early November 2020, with participants receiving the low or high dose of the VXA-CoV2-1 oral tablet at days one and 29. Safety, reactogenicity and immunogenicity assessments will be performed at set times during the active phase.

“We are advancing VXA-CoV2-1 into clinical development based on the strength of pre-clinical data that showed that the vaccine is capable of inducing both a robust systemic immune response and a strong mucosal immune response, specifically in the lungs,” said Dr Sean Tucker, Chief Scientific Officer and founder of Vaxart. “We are eager to explore the clinical profile of VXA-CoV2-1 for effective protection against SARS-CoV-2 infection and transmission in healthy adults.”

The study is expected to be completed in December and will have a 12-month safety follow-up period post last vaccination.

“We are very excited about our oral tablet vaccine entering the clinic because we believe that the COVID-19 pandemic needs an oral alternative to injectable vaccines,” said Andrei Floroiu, Chief Executive Officer of Vaxart. “Our room temperature stable oral tablet vaccine has the potential to ease many of the problems associated with distribution and administration of cold chain dependent injectable vaccines and may make herd immunity more achievable by making it much easier to vaccinate more people faster. We are looking forward to receiving the first clinical data in the next few weeks.”

According to the company, pre-clinical studies showed this oral vaccine candidate induces systemic and mucosal immunity which are crucial to preventing SARS-CoV-2 infection and transmission. The vaccine is completely stable at room temperature and does not require refrigeration for long term storage or distribution, making it less expensive and easier for governments to dispense and stockpile compared to traditional injectable vaccines. 

Related organisations

Related drugs

Related diseases & conditions

7 responses to “First patient dosed in COVID-19 vaccine tablet clinical trial”

  1. Lydie says:

    Have a phobia of needles when will the tablet form vaccine for Covid be available

  2. Anne says:

    How will we know when this is available in the UK?

  3. Tracey says:

    When would you let me know, when would it be possible to let me know when I will be told if I going to be able to have the tablet instead of the vaccine

  4. Tracey Starkey says:

    How do you go about having a tablet instead of the vaccine

  5. Anthony Round says:

    How do I get the tablet and can I still have it as I have had my first jab

  6. Tracey says:

    How do you go about getting the tablet instead of the injection.Tracey

  7. geoffrey kay says:

    tablet form vaccine for covid is a must for those with phobias to needles

Leave a Reply

Your email address will not be published. Required fields are marked *

This site uses Akismet to reduce spam. Learn how your comment data is processed.