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UK, Baptist Health Lexington, Norton Healthcare partner in Phase 3 COVID-19 vaccine clinical trial

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By Mallory Powell
University of Kentucky

The University of Kentucky, in partnership with Baptist Health Lexington and Norton Healthcare in Louisville, has been selected as a testing site for the Janssen Pharmaceutical Companies of Johnson & Johnson’s Phase 3 clinical research study, called the ENSEMBLE trial, to evaluate Janssen’s investigational COVID-19 vaccine candidate, JNJ-78436735, also known as Ad26.COV2.S.

The Phase 3 randomized, double-blind, placebo-controlled clinical trial is designed to evaluate the safety and efficacy of a single vaccine dose of the Janssen investigational COVID-19 vaccine candidate versus placebo, in approximately 60,000 people, including significant representation from those 60 and older.

Janssen’s investigational COVID-19 vaccine leverages Janssen’s AdVac technology. The same technology was used to develop Janssen’s European Commission-approved Ebola vaccine regimen and is the basis for its HIV, RSV and Zika vaccine candidates. To date, more than 100,000 individuals have been vaccinated with a Janssen AdVac-based vaccine.

Principal Investigator Dr. Richard Greenberg (left) and CCTS Clinical Operations Director Linda Rice, BSN, RN, CCRC. (Photo by Mark Cornelison)

The UK, Baptist Health Lexington and Norton Healthcare research teams plan to enroll at least 2,000 local volunteers for the trial, which is open to people over 18 who meet inclusion criteria, including adults with and without health issues associated with an increased risk for progression to severe COVID-19.

UK’s Dr. Richard Greenberg, an infectious disease expert with four decades of experience in vaccine development, leads this local effort.

“Service to our Commonwealth is why UK was created,” said UK President Eli Capilouto. “We are doing everything we can to respond and intervene against this pandemic, now including leading a vaccine clinical trial. We are proud of this opportunity to work with our communities — especially those most impacted — in efforts to contribute to the fight against COVID-19.”

Janssen has joined other pharmaceutical companies in making a pledge to the world that it will continue to adhere to its high scientific, ethical and regulatory standards and will rely on robust clinical evidence to guide the development of its investigational COVID-19 vaccine candidate. Janssen is committed to transparency and sharing information related to the Phase 3 ENSEMBLE study – including publishing the complete study protocol.

Greenberg, the principal investigator for the study, brings extensive expertise to the trial. His history in vaccine development includes serving in Bihar, India for the successful effort by the World Health Organization to eradicate smallpox, leading a cooperative shingles prevention study with the VA here in Lexington, and working in a partnership with the military to develop vaccines for plague, botulism, and smallpox. He has led more than 28 vaccine trials and published more than 150 peer reviewed papers.

“The most important effort to end this pandemic requires the cooperation and participation of many scientists, doctors, public health leaders, politicians, and the people of the world,” Greenberg said. “To have a chance to be a small part of the solution is not only an opportunity for the university but an honor for me. I thank the many people working so hard at all levels of this project — from those behind the scenes to all of our volunteers — because they know how important this to the world.”

A member of the study team takes a nose swab of a young man. (Photo by Mark Cornelison)

Individuals interested in learning more about participating in the trial can visit StopCOVIDKy.com to find more information and answer a pre-screening questionnaire, after which the research team may contact them to determine if they are eligible. All information is confidential, and completing the questionnaire does not obligate you to join the study. Qualified participants will be compensated.

At UK, the trial is organized and implemented through the infrastructure of the UK Center for Clinical and Translational Science (CCTS), whose mission is to accelerate discoveries that improve health. The CCTS also serves as the coordinating center for all three sites.

“The Center for Clinical and Translational Science is devoted to the stimulation of innovation, through the support of high-quality translational research, with an emphasis on team science, workforce development, and community engagement. COVID-19 is an urgent and critical public health crisis, and UK’s participation in this trial would not be possible without the CCTS infrastructure. We are proud and eager partners with Dr. Greenberg,” said Dr. Philip Kern, CCTS director.

The Baptist Health Lexington arm of the study is led by Dr. David Dougherty, an infectious disease specialist, along with a clinical research team.

“We are proud to partner with other providers to bring the latest innovations in healthcare and wellness to our communities,” said William G. Sisson, president of Baptist Health Lexington.

In Louisville, the Norton Healthcare arm of the study is led by infectious disease specialist and system epidemiologist Dr. Paul Schulz.

“Norton Healthcare has one of the largest community healthcare system-based research portfolios in the country, and we know our employees and members of the community will step up to this opportunity to participate,” Schulz said.

To learn more about the trial and participating, go to StopCOVIDKy.com. Additional information is also available at Janssen’s ENSEMBLE website.

ENSEMBLE is being initiated in collaboration with the Assistant Secretary for Preparedness and Response (ASPR), Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

This project has been funded in whole or in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under Other Transaction Agreement HHSO100201700018C.

The UK Center for Clinical and Translational Science is supported by a Clinical and Translational Science Award.

 

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The reason why liquor and cannabis stores are considered essential services in Manitoba – CTV News Winnipeg

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WINNIPEG —
With high COVID-19 case counts, many in Manitoba are asking why certain businesses are still open – including liquor and cannabis stores.

On Monday, Dr. Brent Roussin, Manitoba’s chief provincial public health official, said taking liquor stores and cannabis stores off the list of the essential services and shutting them down could cause more harm than good.

“Unintended consequences of not allowing access to theses types of products,” Roussin said.

For more than 40 years, Mitch Bourbonniere, a community outreach worker, has been working with those who are impacted by mental health and addiction. He says those untended consequences can be physical, emotional, and psychological withdrawals, and it could be life-threatening.

“Addiction has no demographic. Anyone and everyone can be afflicted by addiction in the wrong circumstance,” he said.

Addiction is an illness, he said, that causes intense suffering usually brought on by trauma. If the stores are closed, people are most likely to turn to more dangerous substances.

“Whether it is home brew, whether it is crack, whether it is meth, prescription drugs, anything they can get their hands on, if they can’t get a safe, viable, government-run product,” Bourbonniere said.

Bourbonniere also says closing stores opens the door for organized crime to take over the sales.

“People are absolutely going to get desperate and go to organized crime, they are going to go to the street, they are going to go to gangs,” said Bourbonniere.

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Manitoba reports record spike of more than 540 new COVID-19 cases on Monday – CTV News Winnipeg

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WINNIPEG —
Manitoba has once again set a record of COVID-19 cases, with more than 540 people testing positive for COVID-19 as of Monday morning.

Dr. Brent Roussin, the chief provincial public health officer, reported 546 new cases of COVID-19 on Monday, though three cases were removed from the total due to an error. This is the highest single-day spike of cases the province has seen yet.

The majority of the cases were reported in the Winnipeg region, which had 368 new cases as of Monday morning. The five-day test positivity rate in Winnipeg is now at 13.8 per cent.

The Southern Health region also reported a significant spike in cases, with 118 more cases.

The other cases include:

  • 21 cases in the Interlake-Eastern health region;
  • 27 cases in the Northern health region; and
  • 12 cases in the Prairie Mountain Health region.

The new cases bring Manitoba’s total since March to 14,087 and raises the five-day test positivity rate to 14 per cent.

DEATHS SURGE IN PAST 23 DAYS IN MANITOBA

Along with the cases, Roussin reported seven more people had died of COVID-19.

These people include:

  • A woman in her 90s from the Winnipeg health region, linked to the Maples Long-Term Care Home outbreak;
  • A woman in her 70s from the Winnipeg health region, linked to the Holy Family Personal Care Home outbreak;
  • A man in his 80s from the Southern Health–Santé Sud health region, linked to the Menno Home outbreak;
  • Two women in their 80s, and a man in his 60s from the Winnipeg health region; and
  • A man in his 70s from the Southern Health–Santé Sud health region.

Since March, 236 Manitobans have died of COVID-19. Deaths caused by COVID-19 have been surging in recent weeks. Roussin said the past 23 days, 161 people have died due to the virus.

“It might be easy just to think of these as numbers, but we all know these are Manitobans. These are people who were loved, who are missed right now,” Roussin said.

Hospitalizations also saw a jump as 296 people are now in hospital with COVID-19, 52 of whom are in the intensive care unit.

On Monday, 160 more Manitobans had recovered from COVID-19, bringing the total number of recoveries to 5,353. The number of active cases in Manitoba is reported to be 8,498.

TOP DOCTOR SEES SOME RESULTS OF RESTRICTIONS

This Thursday it will be two weeks – one full incubation cycle of the virus – since the entire province was placed under code red restrictions, which included closures of non-essential business and further restrictions on gathering sizes.

Roussin said health officials are starting to see some positive results from these restrictions.

“We have a fewer number of contacts per case right now, which can certainly be an early indicator that our restrictions are having their intended benefit,” he said. “It is expected that that is going to translate into fewer cases in the next week or 10 days.”

Roussin said three weeks ago, there was an average of seven contacts per case, which has gradually dropped to between four and two contacts in some cases.

“Certainly the trend is in the right direction.”

He said the province is still at a critical point, once again urging Manitobans to stay home.

“We have these critical restrictions in place for a reason – we are seeing these numbers that we cannot sustain in our health care system,” he said. “We need to bring these numbers down, and we need to act now to do so.” 

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Coronavirus: Manitoba reports record-breaking 543 new cases, 7 additional deaths | Watch News Videos Online – Globalnews.ca

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Manitoba’s chief medical officer of health Dr. Brent Roussin on Monday reported a record-breaking 543 new cases of COVID-19 in the province and seven additional deaths. It is the highest single-day increase the province has seen since the pandemic began, breaking the previous record of 494 cases announced Nov. 15.

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