COVINGTON, Ky. — Kentucky is one step closer to procuring a COVID-19 vaccine.


What You Need To Know

  • Northern Kentucky is giving patients COVID-19 vaccine

  • Large-scale Phase 3 trial

  • CTI Clinical Trial and Consulting Service is working with Johnson & Johnson

  • CTI dosed the first patient in the world

 

A Northern Kentucky-based research and clinical trial firm announced they have dosed the first patient in the large-scale Phase 3 trial of a coronavirus vaccine.

The U.S. Department of Health and Human Services’ Operation Warp Speed aims to produce and deliver 300 million doses of safe and effective vaccines with the initial doses available by January 2021.

At the moment there are only a handful of companies conducting COVID-19 vaccine trials including the Covington-based CTI Clinical Trial and Consulting Services.

“It is the largest study that has been conducted and the largest one that ever will be conducted for the COVID (-19) vaccine. It’s 60-thousand subjects,” said Tim Schroeder, CEO, and Founder of CTI.

His firm is tasked with studying Johnson & Johnson’s Janssen Pharmaceuticals global COVID-19 vaccine trial.

“We were fortunate here locally that we actually dosed the first subject in the world,” Schroeder said.

Schroeder said this trial is doubled in size compared to the vaccine trial studies happening across the country.

“The idea being the more people that you enroll, the more confident you can be about the safety data and the efficacy data,” Schroeder said.

It’s a randomized, placebo-controlled clinical trial designed to evaluate a single vaccine dose versus a placebo.

The trial will study people with and without co-morbidities associated with an increased risk for progression to severe COVID-19.

Schroeder is also taking part in the study himself along with one of the employees, Ryan Gifford.

Gifford lost his grandmother in the spring. Back in April, Gifford dropped off an iPad at the hospital she was in which became one of the last calls the family would make.

“And using that iPad, she talked to all three of her children, four grandchildren, and four great-grandchildren before she left, passed away,” Gifford said.

Now, Gifford has made it his mission and motivation to be a test subject.

“I would encourage people to join the fight for people’s grandparents, for people with autoimmune diseases that can’t do it. And the faster we enroll in these trials, faster that we get answers to whether or not this works, the faster we all get out of this,” Gifford said.

Similar studies are also taking place in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa, and right here at home.

Johnson & Johnson is also bumping up manufacturing capacity and remains on track to meet its goal of providing one billion doses of a vaccine if proven to be safe and effective.