VBI Vaccines has commenced enrolment in an adaptive Phase I/II clinical study of its enveloped virus-like particle (eVLP) Covid-19 vaccine candidate, VBI-2902.

VBI-2902 is a monovalent Covid-19-specific vaccine expressing the SARS-CoV-2 spike protein.

The randomised, observer-blind, placebo-controlled study will analyse the safety, tolerability, and immunogenicity of VBI-2902, adjuvanted with aluminum phosphate.

The Phase I part of the study will assess a one and two-dose regimen of a 5µg dose of VBI-2902 and will enrol up to 60 healthy adult subjects aged 18 to 54.

Initial data from Phase I part is anticipated by the end of the second quarter this year depending on the enrolment rate.

The Phase II part will be a dose-escalation extension study evaluating one- and two-dose regimens. Planned to be carried out at nine clinical sites in Canada, it will enrol an expanded adult population across three age groups of 18 to 54, 55 to 65, and 65 and above.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

VBI Vaccines president and CEO Jeff Baxter said: “We are excited to begin the clinical assessment of our eVLP approach to vaccination against coronaviruses with this first clinical study of VBI-2902.

“We are committed to bringing forward candidates that add meaningful clinical and medical benefit to those already approved, be it as a one-dose administration, more durable immune responses, and/or providing broader protection against known and emerging variants of Covid-19.”

The adaptive Phase I/II study is backed by funding of up to C$56m ($44.2m) from the Strategic Innovation Fund of the Government of Canada.

Canada Innovation, Science and Industry Minister François-Philippe Champagne said: “Our government is investing in a range of ‘Made-in-Canada’ solutions to support our fight against Covid-19.

“Today’s news is a welcome development, bringing VBI one step closer to delivering a safe and effective Covid-19 vaccine for Canadians.”