Pitt seeks volunteers for COVID-19 vaccine trial | Pennsylvania News

July 15–UPMC and University of Pittsburgh open recruitment of 750 volunteers for the coronavirus vaccine trial on Wednesday and 87 locations across the country where Pittsburgh is participating in a global effort to stop infections. Announced to be one of.

Recruitment activities are part of the national COVID-19 prevention network and operational warp speed, aiming to accelerate the creation of safe and effective vaccines to prevent people from getting the deadly COVID-19 disease. is.

The first trial to recruit volunteers is a Phase 3 trial testing an RNA-based vaccine developed by Moderna Inc. On Tuesday, Moderna published the results of a phase 1 trial by a small group of volunteers who showed mild side effects and the development of antibodies capable of fighting the virus that causes COVID-19.

The Cambridge, Massachusetts company is the first American company to start clinical trials for the COVID-19 vaccine, but at least 162 companies in the country and around the world have included three vaccine efforts in Pit. There are others. At least 23 of the global efforts, including Moderna, are already in clinical evaluation.

Following a successful Phase 1 and Phase 2 trial, Moderna announced that it will proceed to Phase 3 with 30,000 volunteers from 87 locations across the country, selected from 87 locations, including Pittsburgh.

“Pittsburgh was chosen as one of these sites, thanks to the expertise of our community and the infrastructure here at the University of Pittsburgh,” said UPMC Children’s Pittsburgh Vaccine Clinical Trials Unit. Dr. Judy Martin, who was on Tuesday afternoon, told the Pittsburgh Hospital and the Director of the Moderna vaccine trial locally at an online press conference. “So it’s a real honor for us to participate in this, Operation Warp Speed.”

Pitt and UPMC are already preparing for a second clinical trial. This will also require volunteers to work on an as yet unidentified vaccine.

“We hope to be chosen to participate in the third trial. Probably more,” directs the second vaccine effort and is the Director of Clinical Research for the University’s Infectious Diseases Division. Dr. Sharon Riddler said at a press conference.

The 750 people Pitt and UPMC seek cover only the first two exams, the exams directed by Moderna and the unnamed Dr. Riddler. Dr Martin said more volunteers would be recruited if Pittsburgh was selected for further trials.

Although Pitt and UPMC are regularly involved in vaccine trials, Dr. Martin goes back to March and finds that efforts to create a vaccine for the coronavirus that causes COVID-19 are better than those in other regions. Realizing that it may need far more volunteers, in the past she and her colleagues began setting up a vaccine applicant registration website.

The directory “is set up for many different types of vaccines,” Dr. Martin said. “But of course [COVID-19] The most important one at the moment. “

The registry was opened two months ago and already has about 700 volunteers, not all of whom are eligible to take part in the coronavirus test. Dr. Martin and Dr. Riddler encouraged more people to register.

To be eligible for the exam, people must be 18 or older and have no weakened immune system. Pitt and UPMC are people working in high-risk jobs and living situations that are likely to be exposed to COVID-19, such as dense housing, restaurants, grocery workers, public transport drivers, and healthcare workers. Wants to win. , Or a nursery or school teacher.

Other high-risk groups such as blacks, Latinos, the elderly, and people with underlying illnesses are also popular volunteers.

Volunteers are randomly assigned either vaccines or placebo-consisting of saline-injection. After the first injection, you can do a booster shot 4 weeks later. Volunteers, their clinicians, and researchers have no knowledge of whether they received the vaccine or placebo. Volunteers undergo regular blood tests for 1-2 years to see if their immune system is producing antibodies to fight the virus.

Email the trial director, or [email protected], Or call 412-692-7382 or visit their website https://www.chp.edu/research/clinical-studies/general-academic-pediatrics/pittsburgh-vaccine-unit-registry

The current global goal is to provide an effective vaccine to the world sooner than two years later, but Dr. Riddler said that tests such as Moderna were effective and that it moved to full production earlier than that. Even volunteers say researchers will continue to follow for at least two years.

Volunteers will be tracked for two years, so they will see or observe any safety concerns that have arisen over a longer time frame, she said. “In addition, the antibody reaction [of the body’s ability to fight the coronavirus off] It decreases with time. “

There were reasons for the particular infrastructure Pittsburgh was selected as one of the locations for the National Vaccine Trial Network, but Dr Martin said the history was also on the side of the region.

“Pittsburgh has a long tradition of vaccine research with Jonas Salk and the polio vaccine in the 1950s,” said Dr. Martin, a pediatric professor at Pitt. In Moderna’s trial, “Western Pennsylvania has another opportunity to participate in these research studies. These research studies make a real difference not only in the community, but both nationally and globally. Will bring. It enables us to help.”

Shawn D. Hamil: [email protected] Or 412-263-2579 or Twitter: @SeanDHamill

First Edition: July 15, 2020, 1:31 pm

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