The website will manage registration for the four major vaccine studies that are expected to start this summer and fall and all the others that follow.
The U.S. Department of Health and Human Services announced the website on Wednesday, together with the appointment of the Fred Hutchinson Cancer Research Center in Seattle as the coordination center for clinical trials of vaccines managed by the Covid-19 Prevention Network, funded. by the National Institutes of Health.
“This is the goal, but those target dates move up and down. They won̵
Despite the delay, studies on the Covid-19 vaccine are moving at an unprecedented rate, as researchers try to achieve what usually takes years in months.
Del Rio said he enrolled six or seven study subjects per week in a typical clinical trial, but for the Covid vaccine study he will try to enroll that number in one day. In the end, it aims to have a total of 750 study subjects at three sites in the Atlanta area.
He noted that he has not yet received approval from Emory’s Institutional Review Board to begin the process, a requirement before proceeding.
“This is the most complicated research study I have ever done, and we have to do it in record time,” said Del Rio, noting that he is still hiring staff and securing structures for the process.
Dr. Richard Novak, another veteran of the clinical trial agrees.
“I have been doing vaccine studies for 25 years, but this is the largest I have ever worked on and I don’t have enough staff and I don’t have enough space,” said Novak, who will lead the Modern Process at the University of Illinois. in Chicago.
What the researchers are looking for
On the new website, anyone interested in participating in a vaccine study can fill out a quick questionnaire.
There will be more than 100 sites in the U.S. and overseas, and after registering on the website, your information will be sent to the study site closest to you.
Many of the questions are designed to assess the likelihood that you are infected and ill with Covid-19, including your race, what type of work you do and how many people you come into contact with on a daily basis.
Based on these answers, you may be rejected. People who don’t go out much and wear a mask when they leave the house would not do the best subjects.
This is because the purpose of the study is to see if the vaccine protects people from getting Covid-19. If people who mostly stay at home are vaccinated and don’t get 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 the coronavirus.
“We need people in black and white and representative of communities hit hardest by the pandemic,” said Dr. Carl Fichtenbaum, medical director of the Modern Process at the University of Cincinnati Health.
Doctors say they will enroll in churches and other organizations in those communities, as well as in workplaces such as factories and meat packaging plants where workers are at high risk of falling ill with Covid-19.
The researchers also aim to have 40% of the study subjects over the age of 65 or with underlying conditions, such as hypertension, lung disease, diabetes and pathological obesity, as they are more likely to get sick than Covid-19, Novak said.
Tens of thousands of volunteers are needed
Moderna has completed a safety trial with over 100 study subjects, but has not yet published the results. These subsequent phase studies monitor safety and focus on the fact that the vaccine protects against coronavirus disease.
Novak said volunteers for the Moderna trial will receive two one-month spaced injections. About half of the study volunteers will receive two doses of the vaccine and the other half will receive placebo, a shot that has no therapeutic value. Neither the doctors nor the volunteers will know who gets the hit.
Volunteers will have appointments seven times during the two-year course of the study, where they will have blood drawn and their nose swabbed to check for Covid-19 infection.
Volunteers will keep a weekly diary of their symptoms and talk to the study staff on the phone to discuss how they feel.
“It has to be done meticulously because this is a fundamental part of clinical research,” said Novak. “The data must be flawless.”
However, tens of thousands of volunteers will have to step up their studies.
“I want to point out to people that you will be part of something special, even if the answer is that it doesn’t work,” said Fichtenbaum. “This is a very important scientific answer because we need to know what works [and] what won’t work. “
CNN’s John Bonifield and Dana Vigue contributed to this story.