Here’s how to apply for the Covid-19 vaccine trial

If you want to get the Covid-19 vaccine early, now is your chance.

Wednesday new website- coronaviruspreventionnetwork.org -Operated, allowing people in the US to register to participate in clinical trials of vaccines and monoclonal antibody therapies.

The website will process registrations for four large vaccine studies expected to begin this summer and fall, as well as subsequent studies.

The U.S. Department of Health and Human Services released its website on Wednesday to make the Fred Hutchinson Cancer Research Center in Seattle a coordinating center for vaccine clinical trials conducted by the National Institutes-funded Covid-19 Prevention Network. Appointed. Of health.

Challenges of performing very large and very complex tests very quickly

The vaccine, developed by Massachusetts biotechnology company Moderna, is expected to be first tested in large-scale trials. The trial was expected to begin this week, Start date moved Until late July or early August, according to Dr Carlos Del Rio, Principal Investigator at Modelna Sites at Emory University in Atlanta,

“It’s a goal, but these target dates move up and down. I won’t let the site start until I’m fully prepared. Some can start on July 27, others are August You can start on the 8th.

Despite the delays, the Covid-19 vaccine trial is progressing at an unprecedented rate as researchers try to achieve what would normally take years in months.

Delrio said it will try to enroll 6 to 7 subjects per week in a typical clinical trial, but the Covid vaccine trial will try to enroll that number in one day. Ultimately, we are aiming for a total of 750 study subjects across three sites in the Atlanta area.

He says he has not yet received approval from Emory’s Institutional Review Board to begin the exam, a requirement before moving forward.

“This is the most complex research study I have ever done and I need to do it in record time,” Del Rio said, he still hired staff and set up a facility for testing. I have secured.

Another clinical trial veteran, Dr. Richard Novak, agrees.

“I’ve had 25 years of vaccine testing, and this is the largest I have ever committed, and I don’t have enough staff or space,” said Lead Novak, University of Illinois at Chicago. Moderna trial in.

What researchers are looking for

The new website allows anyone interested in participating in a vaccine study to complete a short survey.

There are more than 100 sites in Japan and overseas, and if you register on the website, information will be sent to the nearest learning site.

Some questions are aimed at assessing the chances of becoming infected with Covid-19, such as race, what kind of work you do, and how many people you interact with each day. ..

May be rejected based on these answers. Those who go out and wear a mask when they leave home are not the best candidates for learning.

This is because the purpose of this study is to determine whether the vaccine protects people from Covid-19 illness. If most people at home are vaccinated and don’t get sick with Covid-19, it’s difficult to know if the vaccine protected them or their lifestyle protected them from the virus in the first place. is.

That’s why researchers are looking for people in the communities most affected by coronaviruses.

Dr. Karl Fichtenbaum, Dean of Medicine at the Moderna Trial at the University of Cincinnati Health, said:

Doctors say they will hire in churches and other organizations in these communities, as well as in workplaces where workers are at increased risk of getting Covid-19, such as factories and meat packing factories.

Researchers also aim for 40% of subjects because they are 65 years or older or 40% of subjects with underlying illnesses such as hypertension, lung disease, diabetes, and morbid obesity are more likely to develop Covid-19. I will.

Tens of thousands of volunteers needed

Moderna has completed a safety study with more than 100 subjects, but no results have been published yet. These late phase trials will monitor safety and focus on whether the vaccine protects against coronavirus transmission.

Novak said volunteers in the Moderna trial will receive two injections at monthly intervals. About half of the research volunteers will receive two doses of vaccine and the other half will receive placebo. This is a shot that has no therapeutic value. Neither doctors nor volunteers know who is taking which shot.

Volunteers will make seven appointments throughout the two-year course of study where blood will be taken and the nose wiped to check for Covid-19 infection.

Volunteers record symptoms weekly and discuss with the research staff over the phone.

“It needs to be done with great care, as it is an important part of clinical research,” said Novak. “The data must be perfect.”

The exact number of volunteers required for the exam is unknown. In a June interview, NIH director Dr. Francisco Linds told CNN About 30,000 Although a volunteer, Wednesday’s press release from Coordination Center Fred Hutchinson said there were 10,000 to 30,000 volunteers per trial.

In any case, tens of thousands of volunteers need to participate in the study.

“Even if you get the answer that it doesn’t work, I want to emphasize to people that you become part of something special,” Fichtenbaum said. “This is a very important scientific answer because we need to know what works. [and] Things that don’t work”