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萨城正在进行新冠儿童疫苗实验！
(KCRA)Pediatric COVID-19 vaccine trials underway in Sacramento. Here's what you should know
萨克拉门托正在进行COVID-19儿童疫苗试验。以下是你应该知道的
With millions of adults fully vaccinated, many families are wondering when their children will be able to receive the same protection.
随着数百万成年人完全接种疫苗，许多家庭想知道他们的孩子何时才能得到同样的保护。
Benchmark Research is currently looking for participants in the Sacramento area to join their trial for the Novavax pediatric vaccine.
Benchmark Research目前正在萨克拉门托地区寻找参与者加入他们的Novavax儿童疫苗试验。
The company says it's important to have a diverse pool of vaccine trial participants.
该公司表示，拥有多样化的疫苗试验参与者非常重要。
“We have to demonstrate to the authorities that it will induce a good immune response. That this younger group won’t have a more significant adverse experience such as sore arms and things like that," said Cynthia Dukes with Benchmark Research.
“我们必须向当局证明，它将引发良好的免疫反应。这组年轻人不会有更严重的不良经历，比如手臂酸痛之类的，”Benchmark Research公司的辛西娅·杜克说。
"We want to show that the safety is parallel to the adult groups as well. There’s always, based upon how much antibodies are around, how developed the immune system is, a potential for different sorts of reactions so the only way to do that is to test it in the populations in which we want to give it,” Dukes said.
“我们想证明这种安全性也与成人群体相同。基于抗体的数量，免疫系统的发展程度，总是有可能产生不同种类的反应，所以唯一的方法就是在我们想要注射的人群中进行测试。”杜克说道。
The Novavax vaccine comes in two doses. It could take up to another year before it's approved for public use.
Novavax疫苗有两种剂量。可能还需要一年的时间才能被批准用于公共用途。
Here are five things you need to know about pediatric vaccine trials:
以下是关于儿童疫苗试验你需要知道的5件事:
1. Who can participate in this trial with Benchmark Research?
1. 谁可以和Benchmark Research一起参与本次试验?
Anyone 12 to 17 years old, who is healthy and has no risk factors for COVID-19. They must live within driving distance from the Benchmark Research site in Sacramento.
任何12至17岁、健康且无COVID-19风险因素的人。他们必须住在萨克拉门托Benchmark Research的范围内。
2. How does this trial work?
2. 是如何运作的?
The parent or guardian calls the Benchmark Research recruitment center to have the child prescreened for inclusion into the study. If they meet the pre-screening over the phone, then they are invited to the clinic to enroll in the study.
家长或监护人致电Benchmark Research招募中心，对孩子进行筛选，以便纳入研究。如果他们通过电话与预先筛选者见面，那么他们就会被邀请到诊所参加这项研究。
After signing an informed consent, the child undergoes a physical exam. The physician will take a detailed history of the participant. A blood sample will be drawn for a measurement of the antibody in their blood. Then the participants would either get a placebo or the vaccine. They would be given an electronic diary for seven days, to answer questions about their symptoms. This process would continue for both doses of the vaccine.
在签署知情同意书后，孩子将接受体检。医生会记录受试者的详细病史。将抽取血液样本以测量他们血液中的抗体。然后参与者要么服用安慰剂，要么接种疫苗。研究人员会给他们一份为期七天的电子日记，以回答有关他们症状的问题。这一过程将继续用于两剂疫苗。
The participants would continue to be evaluated for one year.
参与者将继续接受一年的评估。
3. How long will this study last before the vaccine gets on the market?
3.在疫苗上市之前，这项研究将持续多久?
Enrollment into the trial could take two months. There would be another two months before the company would have the antibody results from the blood post the second dose that will tell us if it’s immunogenic or not.
参加试验可能需要两个月的时间。两个月后，该公司才会在第二次注射后获得血液抗体结果，这将告诉我们它是否具有免疫原性。
It could up to 12 months before the vaccine is available via emergency use for children 12 to 17 years of age
12个月后，12至17岁的儿童才能紧急使用这种疫苗
4. If the trial participants are following guidance to avoid getting the virus, what is the likelihood that they would contract the virus for you to determine if this vaccine actually works?
4. 如果试验参与者按照指导避免感染病毒，那么他们感染病毒的可能性有多大，您可以判断这种疫苗是否真的有效?
“In the adult studies we were looking for people who had a reasonable risk of exposure so we had a lot of healthcare workers, first responders, people who worked at grocery stores and such,” Dukes said. “…we know that teenagers aren’t real good with socially isolating. They are going back to school, they are participating in sports, so they are having risks of exposure through their everyday activities. So, it’s felt that they’ll just normally have enough exposure that we will get those cases in the placebo group. We are starting to see the number of cases in this age group go up compared to 6 to 8 months ago and so we think they will probably just have those normal exposures and we will see those cases regardless.”
杜克说:“在成人研究中，我们寻找的是有合理暴露风险的人，所以我们有很多医护人员、急救人员、在杂货店工作的人等等。”“……我们知道青少年不擅长社交孤立。他们回到学校，参加体育活动，所以他们在日常活动中面临着暴露的风险。与6到8个月前相比，我们开始看到这个年龄段的病例数量有所上升，所以我们认为他们可能只是正常接触。”
5. How can participants register?
5. 参加者如何登记?
Click here or call 1-888-902-9605.
点击这里或拨打1-888-902-9605。
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发表于 2021-4-29 13:52:52
发表于 2023-1-16 18:40:28