Halifax Trial for Canadian COVID-19 Vaccine Struggling to Find Participants-Halifax

Made in canada COVID-19 (New Coronavirus Infection) Vaccines in clinical trials at Halifax are struggling to recruit enough participants due to rising vaccination rates in Nova Scotia.

The Center for Canadian Vaccines at Dalhousie University is trying to complete the second phase of a phase I trial of a vaccine developed by Edmonton-based Entos Pharmaceuticals, but will find volunteers as more people will be shot. Says it is difficult.

The center’s director, Dr. Scott Harperin, said he was searching for about 12 people between the ages of 18 and 55 who had not yet been vaccinated and were not exposed to the virus. Required to complete the initial stages of the trial, requiring a total of 36 participants.

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In an interview Wednesday, Harperin said recruitment remains a challenge, especially given the state’s announcement of accelerated vaccine deployment this week and plans to give a second dose two to four weeks earlier than originally planned. Said that.

He also said that vaccination rates would only increase with vaccines available to people over the age of 20 in Nova Scotia.

“The vaccine deployment program is ahead of schedule, which means fewer people are in clinical trials,” says Harperin. “The number of people who have not been vaccinated yet is decreasing.”

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In an interview, Edmonton-based Entos CEO John Lewis said completing Phase 1 was the “gateway” to further clinical development of the vaccine.

“Obviously, if we can’t hire these patients, we could move the trial to another country,” Lewis said. “It can significantly delay the development of this vaccine.”

Currently, it requires about 600 participants, so Phase 2 of the study needs to be conducted outside Canada, he said.

The Covigenix VAX-001 vaccine is DNA-based and similar to the mRNA vaccine developed by Pfizer-BioNTech and Moderna.

However, Lewis said his company’s products are one-off and do not need to be stored at the low temperatures required by other vaccines, making them easier to deploy in rural areas, especially in developing countries.

The first stage of the completed Halifax trial is to administer a low dose of vaccine to assess safety, and the second phase is to administer an intermediate dose for a similar assessment. Both stages also include a placebo control group.

Ethical considerations

Lewis said there are ethical considerations given the availability of vaccines and the potential risk of getting the virus. An annual study requires at least 42 days of involvement to collect reliable data, but people can withdraw at any time and ask whether they were given a placebo or a vaccine, he said. It was. In either case, they can look for an approved vaccine.

And while people can’t pay to participate in clinical trials, they can be reimbursed, and Lewis gives a $ 50 gift to Halifax trial participants as an incentive for his company. He said he was offering a ticket.

“We want to acquire young healthy adults who have a very low overall risk of COVID-19 and want to contribute to the delivery of Canadian-made solutions,” says Lewis. ..

Harperin, who has nothing to do with Entos, added that the role of the vaccine center is to present the pros and cons of participation to interested parties and, at this time, to seek cooperation in the development of additional vaccines. ..

He said the development of Canadian vaccines is important because it provides the country with options, especially if it is determined at some point that further vaccination is needed.

“I think it’s very important for this vaccine maker, not just for others, to continue the process of getting more vaccines to market,” he said. “We are not there globally, and Canada continues to be at risk until we are there globally.”

For large-scale clinical trials, Canada’s elderly vaccination rates are high, so companies need to look abroad, Halperin said.

“You can’t do a large clinical trial, especially if you want to do it for all ages,” he said. “Now I couldn’t do that in Canada.”