"People who participate in this trial will be advancing global vaccine science and will also have a chance to gain additional protection against COVID-19," said Dr. Michaeline McGuinty.Ottawa-area adults who are fully vaccinated with a COVID-19 mRNA vaccine are invited to participate in a clinical trial of a locally developed COVID-19 vaccine candidate, as a third dose or late booster vaccine. To be eligible, participants must have received their second mRNA vaccine dose at least four months ago, must be between the ages of 18 and 54, and must be in good health.
The trial is led at The Ottawa Hospital by Dr. Michaeline McGuinty and Dr. Bill Cameron. The vaccine candidate is developed by VBI Vaccines, a biotechnology company founded in Ottawa by Dr. Francisco Diaz-Mitoma, a former scientist at CHEO and VBI’s current Chief Medical Officer. The Ottawa Hospital’s Biotherapeutics Manufacturing Centre is supporting VBI in manufacturing its vaccine cell line.
“The technology behind this vaccine is promising,” said Dr. Michaeline McGuinty, an infectious disease specialist and clinician investigator at The Ottawa Hospital and lecturer at the University of Ottawa. “People who participate in this trial will be advancing global vaccine science and will also have a chance to gain additional protection against COVID-19.”
“It is important that we continue to develop and test vaccines, including Canadian-made vaccines, because COVID-19 isn’t going away and there is increasing evidence that boosters may be required, especially for people with higher risks,” said Dr. Bill Cameron, Medical Director of Clinical Research and infectious disease specialist at The Ottawa Hospital and professor at the University of Ottawa.
The vaccine candidate, called VBI-2905, contains the full spike protein from the Beta variant of SARS-CoV-2 (the virus that causes COVID-19), embedded in a synthetic lipid envelope. Using VBI’s enveloped virus-like particle (eVLP) technology, the vaccine particles are presented to the immune system as a close mimic of the natural presentation of viruses in order to elicit a potent immune response. In past clinical studies, the eVLP technology has demonstrated a clean safety profile. Additionally, eVLP vaccine particles do not contain infectious genetic material and therefore cannot replicate or revert to an infectious state.
An initial phase of this vaccine trial in 61 adults at four Canadian centres, including The Ottawa Hospital, showed that this type of vaccine is promising, with an excellent early safety profile and the ability to generate a strong immune response against the original/ancestral SARS-CoV-2 strain. Full results are being prepared for publication in a peer-reviewed journal.
“It is important that we continue to develop and test vaccines, including Canadian-made vaccines, because COVID-19 isn’t going away and there is increasing evidence that boosters may be required, especially for people with higher risks,” said Dr. Bill Cameron.
VBI is also working on another multivalent pan-coronavirus vaccine candidate that targets multiple human betacoronaviruses, such as severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS), with the aim of increasing the breadth of immune response to the vaccine.
“We are excited to initiate this next phase of clinical development and to be working once again with The Ottawa Hospital,” said Dr. Francisco Diaz-Mitoma, VBI’s Chief Medical Officer. “We look forward to sharing the results from this booster study of VBI-2905 and remain committed to our mission to contribute to the long-term solution against COVID-19 and its variants of concern.”
Individuals who volunteer to participate in the trial will receive the VBI-2905 vaccine candidate or a placebo. Neither the participants nor the study team will know which group a participant is in until the study ends. Safety, tolerability and immune responses will be evaluated. Participants are asked to refrain from receiving another COVID-19 vaccine for at least 56 days after receiving VBI-2905.
Ottawa-area residents who are interested in participating can call The Ottawa Hospital’s Clinical Investigation Unit at 613-737-8811 or email ciu@toh.ca to learn more. The trial is also recruiting participants at the Canadian Center for Vaccinology in Halifax, Nova Scotia, as well as in Mexico.
Photos for media: https://www.dropbox.com/sh/g9jv2sihiti1rcg/AAAjqPH5eHsTxIHd-TX1lVfma?dl=0
Media release from VBI Vaccines: https://www.vbivaccines.com/press-releases/initiation-of-vbi-2905-clinical-study/
About The Ottawa Hospital
The Ottawa Hospital is one of Canada’s top learning and research hospitals, where excellent care is inspired by research and driven by compassion. As the third-largest employer in Ottawa, our support staff, researchers, nurses, physicians, and volunteers never stop seeking solutions to the most complex health-care challenges. Our multi-campus hospital, affiliated with the University of Ottawa, attracts some of the most influential scientific minds from around the world. Backed by generous support from the community, we are committed to providing the world-class, compassionate care we would want for our loved ones. www.ohri.ca
Media Contact
Jenn Ganton
613-614-5253
jganton@ohri.ca
