Volunteers of the New Crown Vaccine Trial: Contribute to the power of ordinary people Phase I clinical trials are divided into low, medium, and high dose groups. Subjects can resume normal life after 14 days of isolation and undergo blood tests regularly.
Subject Chen Kai was vaccinated.
Photo courtesy
Volunteers vaccinated. Photo courtesy
The recombinant new crown vaccine developed by the scientific research team of the Military Medical Research Institute of the Academy of Military Sciences led by Academician Chen Wei is undergoing a phase Ⅰ clinical trial in Wuhan, Hubei. Volunteers recruited in the early stage have joined the group one after another and have been vaccinated recently.
On March 17, the research team pre-registered the Phase I clinical trial of the recombinant neocrown vaccine at the China Clinical Trial Registry. Subjects were required to be patients with non-neocoronavirus pneumonia, aged 18 to 60 years. One low-, medium-, and high-dose vaccine. Pre-registration information showed that the trial required at least 108 subjects and the study took 6 months.
Chen Kai and Ren Chao are both volunteers. When talking about their original intention to participate in the trial, both said that they are ordinary people and that they only want to contribute to the vaccine trial.
Process recording time accurate to minute
Volunteer No. 011, the owner of fishing gear shop owner Chen Kai, was injected with the new crown vaccine at 11:54 on March 19. After slight reactions such as elevated body temperature and lack of energy, Chen Kai's physical condition has returned to normal. In an interview, he was a jogger who was running in circles in a segregated hotel room.
Beijing News: Remember the timing of the vaccine?
Chen Kai: Because the entire process is physical examination, temperature detection, or signed informed consent, doctors and nurses need to make a record in the logbook at each step, they will write the specific time, accurate to the minute, remember to be clear .
Beijing News: How to notice the recruitment information?
Chen Kai: Late at night on March 16th and early morning on the 17th, swipe Weibo to see it, then apply, share the information with friends, and he also signed up. No hesitation before signing up. Because I have been paying attention to the epidemic information, after all, I am in Wuhan. I also saw the information about the academician Chen Wei of the Academy of Sciences's vaccine on Weibo before, so I think the technology is OK and there is no risk.
Beijing News: When was the research team notified?
Chen Kai: I received a phone call at noon on March 18th, and a physical examination was conducted in the afternoon. After the physical examination, we were notified to go to the next morning for a re-examination. Then I qualified to join the group. At 11:54 on the 19th, I was vaccinated.
Beijing News: Does your body have any reaction after injection?
Chen Kai: I personally have some reactions. After waking up in the morning, I felt some sore muscles on both sides of my buttocks. At first I thought it was caused by a hard sleep on the bed, but I turned on my phone and looked at the electronic thermometer, which was more than 37 ° C, and I felt that the body had responded to the vaccine. Volunteers each have a 24-hour electronic thermometer, which can monitor their body temperature in real time for 24 hours.
The body temperature has been around 37 ° C, and my spirit is not very good, so I lie in bed again. I got up to eat at noon and observed that my body temperature often exceeded 37.2 ℃. I called the front desk to report it. The front desk medical staff sent me a mercury thermometer to let me test and observe more. Communicating with the volunteers in the group, most of the batches of our injection on March 19 had some reactions. They were a slight increase in body temperature, a lack of energy, and dizziness. In the afternoon, experts from the scientific research team came to inquire about the situation with everyone, so we don't have to worry about it.
After dinner, his condition gradually improved. When I went to bed at 11pm, my temperature returned to normal. Talk to volunteers and friends in the group before bed, and most of them are back to normal.
Three meals a day during the isolation period
Beijing News: Which group are you in?
Chen Kai: I participated in the low-dose group trial, as well as the medium-dose and high-dose groups. If most of our volunteers produce antibodies normally, the vaccine is reliable and effective.
Beijing News: Does the research team suggest a trial risk?
Chen Kai: When applying online, the application platform has some explanations about adverse reactions. After passing the medical examination, he will sign an informed consent form before performing other testing items.
Experts from the research team will explain to us the entire project, including procedures, risk prompts, disposal measures, and safeguard measures. Experts also said that during the trial, no matter who, at any time feel unwilling to participate, they can quit at any time. After the explanation, volunteers signed the informed consent form voluntarily.
Beijing News: How is life in isolation?
Chen Kai: The isolation hotel is in a health center, not far from home. There is one room per person, and you cannot go out or go downstairs at will. Three meals a day during the quarantine period, and regularly delivered to the stool at the door of the room every day. All three meals were okay. Volunteers in the group also reported that they could not finish eating. We asked the hotel and said that it does n’t matter if we do n’t finish, we are afraid that we will not be full without it.
Beijing News: What else needs to be done after isolation?
Chen Kai: You can go back after the isolation and resume normal life. On the 28th day, the 3rd month, and the 6th month, the scientific research team will contact us for follow-up and blood tests will be performed.
Beijing News: What about other volunteers?
Chen Kai: Most of the volunteers in the group are over 30 years old. There are more male volunteers and slightly less female volunteers, only about 1/4 to 1/3.
Beijing News: There are many discussions on volunteers online. Have you considered the risks?
Chen Kai: Netizens are basically supportive. Signing up to become a volunteer has no lofty goal in itself, and I want to contribute as an ordinary Wuhan person. Many netizens feel that the vaccine is not yet on the market and may be risky, so they admire the volunteers. In fact, when we sign up for volunteers, we all understand the risks and have considered them. I don't think you need to worry too much. I personally feel that this is a very ordinary volunteer activity.
Good health 24 hours after injection
No. 038, Ren Chao, a staff member of the Department of Security of Wuhan University, participated in the middle-dose group trial as a volunteer and was vaccinated on March 20.
Beijing News: How to think of volunteering?
Ren Chao: On March 17, a friend sent me a link saying that the new crown vaccine has begun human trials. I was recruiting volunteers and I clicked in to sign up. On March 18th, Academician Chen Wei's team contacted me and said that the preliminary review was passed and a medical examination could be conducted. I went to the place they designated for medical examination.
On the morning of March 19, they told me that the medical examination was qualified. Because I need to be quarantined for 14 days after the injection, I have to ask for leave from the unit leader, and the leader is also very supportive.
Beijing News: Has there been any reaction since the injection?
Ren Chao: I have been injecting for more than 24 hours without any adverse reactions and everything is fine. I'm fine, I usually like sports.
Beijing News: Do you have any communication with other volunteers?
Ren Chao: We all live in single rooms and live in isolation. I only know that our oldest group is 57 years old and the youngest is 19 years old.
Beijing News: Have other friends around you participated in the experiment?
Ren Chao: The friend who sent me the registration link at the time also participated. He was in the low-dose group.
Just do one thing I can do
Beijing News: Have you and your family considered the risks of the trial?
Ren Chao: I am still a "bachelor" myself. I told my mother that I had signed up for a New Crown vaccine volunteer. She said, why go? I said, the whole country is helping us in Hubei and Wuhan. I do n’t want to go, so let the tugs take their mouths? Although my mother was worried, she was also a very reasonable person. After a few words, she agreed.
Beijing News: Because of volunteering, a lot of people have followed you recently?
Ren Chao: I have a vibrato, maybe because of that vibrato, somehow got angry. After all, it was something I decided to do, but I didn't expect such a result (fire).
Beijing News: Many netizens leave messages to praise the volunteers as "great."
Ren Chao: I personally think there is nothing great, just to do one thing I can do. The really great ones are scientists and medical staff who support Hubei and work in Hubei. They are great.
I'm a "bachelor". The whole country is helping us in Hubei and Wuhan. I don't want to go. Is it possible to let the family drag their mouths? ——Ren Chao, subject of the new crown vaccine number "038"
Becoming a volunteer does not have any lofty goals in itself. It is to be an ordinary Wuhan person and contribute your own strength. ——Chen Kai, New Crown vaccine number "011"
Beijing News reporter Xu Wen