Health
Here’s how to apply for the COVID-19 vaccine trial
Video above: If Fauci wants to get the vaccine of COVID-19 first “more cautiously optimistic” than viral vaccine, now is the time. On Wednesday, a new website (coronaviruspreventionnetwork.org) will be published and the US will need to register to participate in clinical trials of the vaccine. This website handles four large vaccine studies expected to launch this summer and fall, as well as all other enrollments that follow. The U.S. Department of Health and Human Services announced Wednesday that the Fred Hutchinson Cancer Research Center in Seattle was appointed as the coordination center for vaccine clinical trials operated by the National Institutes of Health-funded COVID-19 Prevention Network. website. Very Complex Trials A very fast vaccine developed by Moderna, a Massachusetts biotechnology company, is expected to be the first to be tested in a large trial. The trial was expected to begin this week, according to Dr Carlos del Rio, a senior researcher at Modelna Sites at Emory University in Atlanta, but the start date was changed in late July or early August. “It’s a goal, but these goals go up and down in dates. You can’t start your site until you’re completely ready. Some start on July 27, some start on August 8. “Del Rio said. Despite the delays, the COVID-19 vaccine trial moves at an unprecedented rate when researchers try to achieve what would normally take years, in months. Del Rio said he would enroll 6 or 7 study subjects per week in a typical clinical trial, but in the COVID vaccine trial he said he would try to enroll that number in the day. Ultimately, we aim to reach a total of 750 subjects across three sites in the Atlanta area. He pointed out that Emory’s Institutional Review Board has not yet received approval to start the trial. This is a requirement before moving forward. “It’s a complex research study I’ve done so far and I need to do it in record time.” I agree with Richard Novak, another clinical trial veteran. “I’ve been in the vaccine trial for 25 years and it’s the largest I have ever committed to doing, not having enough staff and enough space.” Moderna’s trial at the University of Illinois at Chicago Novak, who heads the company, said that the new website is what researchers are looking for, and anyone who is interested in participating in a vaccine study can answer a simple questionnaire. There will be over 100 sites. In the US and abroad, and after registering on the website, your information will be sent to the research site that is closest to you, some questions to assess the chances of becoming infected with COVID-19. Created in. You may be denied based on your answers about your race, what kind of work you are doing, how many people you are in contact with every day, and when you leave home and leave home too often. People who wear masks are not the best study target, the point of the study is to see if the vaccine protects people from illness with COVID-19. If you are vaccinated and do not get sick with COVID-19, it is difficult to know if the vaccine protected them or if their lifestyle protected them from the virus in the first place. “For the people in the communities most affected by the coronavirus, doctors are deciding that churches and other organizations in these communities, as well as factories and meatpacking factories,” said Dr. Carl Fichtenbaum, the Dean of Medicine for the exam. Workers will be hired in workplaces where there is a high risk of getting sick with COVID-19. According to Novak, people who are 65 years old or older or have high blood pressure or lungs because they are more likely to get sick with COVID-19. There are dozens of subjects with underlying illnesses such as illness, diabetes, morbid obesity, etc. requiredModerna has completed a safety study in over 100 subjects, but the results are still publicly available. These late trials will monitor safety and focus on whether the vaccine protects against the coronavirus, which Novak said twice a month for volunteers in the Moderna trial. Approximately half of the study volunteers receive the vaccine twice and the other half placebo (therapeutic value). No shot). Neither doctors nor volunteers know who took which shot. Volunteers will make 7 appointments, collect blood, wipe their nose and check for COVID-19 infection during the 2-year study period. Volunteers will record symptoms weekly, talk to research staff over the phone, and discuss mood. “Being an important part of clinical research, it must be done with extreme caution.” “Data must be impeccable.” The exact number of volunteers needed for the trial is unknown. .. In a June interview, NIH Director Dr. Francisco Linds told CNN that each trial had about 30,000 volunteers, but in a press release on Wednesday by Coordination Center Fred Hutchinson, There are 10,000 to 30,000 volunteers each. Fitch Tenbaum said thousands of volunteers need to step up for research. “I want to emphasize to people to participate in something special, even if they say it doesn’t work.” “This is a very important science because we need to know what works and what doesn’t. It’s an intelligent answer.”
Video above: Forchi, “carefully optimistic” about viral vaccines
If you want to get the vaccine for COVID-19 quickly, now is your chance.
Wednesday new website — coronaviruspreventionnetwork.org —Public and now allows people in the United States to register to participate in vaccine clinical trials.
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 announced its website on Wednesday to make the Fred Hutchinson Cancer Research Center in Seattle the center of coordination for vaccine clinical trials conducted by the National Institutes-funded COVID-19 Prevention Network. Appointed. 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 scheduled to start this week, but the start date was changed in late July or early August, according to Dr Carlos del Rio, a principal researcher at Modelna Sites at Emory University in Atlanta.
“That’s the goal, but these goal dates go up and down. I can’t start the site until I’m fully prepared. Some start on July 27, some start on August 8 ..
Despite the delays, the COVID-19 vaccine trial is progressing at an unprecedented speed, with researchers trying to achieve what would normally take years in months.
Delrio said it will 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 been testing vaccines for 25 years, and this is the largest I have ever committed to, I don’t have enough staff, not enough space,” leads Novak. Said the Moderna trial at the University of Illinois at Chicago.
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 possibility of getting 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.
That’s because the point of the study is to see if the vaccine will prevent people from getting sick with COVID-19. If people at home mostly are vaccinated and don’t get sick with COVID-19, it’s difficult to know if the vaccine protected them or if their lifestyle kept them away from the virus in the first place. ..
That’s why researchers are looking for people in the communities most affected by coronaviruses.
Dr. Carl 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 sick with COVID-19, such as factories and meatpacking plants.
Researchers have also set goals because 40% of subjects over the age of 65 or with underlying illnesses such as high blood pressure, lung disease, diabetes, or morbid obesity are more likely to develop COVID-19, Novak He said.
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 study volunteers receive the vaccine twice, and the other half receive the placebo (a shot of 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, at which 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 has to be done with great care because it is an important part of clinical research,” Novak said. “Data must be satisfactory.”
The exact number of volunteers required for the exam is unknown. In a June interview, NIH director Dr. Francisco Linds told CNN that each trial had about 30,000 volunteers, but Fred Hutchinson of the Coordination Center’s Wednesday press release said It states that there are 10,000 to 30,000 volunteers.
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 as we need to know what works. [and] What goes wrong?”
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