在于万隆临床试验的北京科兴新冠肺炎病毒疫苗的6项事实 –6 Facts of Covid-19 Sinovac Vaccine Clinical Trial in Bandung

Nafilah Sri Sagita K – detikHealth
2020年7月23日,星期四健康报道

雅加达— 好消息来自于万隆向新冠肺炎病毒科兴疫苗的临床试验的发展。
据估计,第三阶段的临床试验将很快实施了。

不过,对于志愿者或想注册为新冠肺炎病毒科兴疫苗研究试验对象的参与者必须有特殊要求。这些要求是什么?detikcom媒体总结了与万隆的新冠肺炎病毒科兴疫苗临床试验有关的6项事实,具体如下:

一、于2020年8月上旬执行
于2020年8月的早期,新冠肺炎病毒科兴疫苗的第3期临床试验将涉及到540个人。将对其受试者进行为三个月期间的监测,以评估或检测疫苗的进展。

作为UNPAD医学院的协调研究团队人员之一,dr. Eddy Fadliana表示, “在第一阶段,将有540名测试对象参加3个月的测试。这意味着将在头三个月内,对其540名测试对象的免疫和安全性都进行仔细检查。然后,在第三个月之后,将只向其对象进行安全性或其他功效性方面的监控。”

二、 谁有资格符合参于新冠肺炎病毒科兴疫苗临床试验项目?
参于新冠肺炎病毒科兴疫苗临床试验的志愿者或参与者是万隆市居民,他们都应处于生产年龄和健康的状况。

UNPAD医学院的研究人员之一,Kusnandi Rusmil 教授叙述说,“参于者在涉及临床研究试验时,将受到保健保护,并且由于自愿而未获得报酬。接下来的3天、5天或14天疫苗注射后,我们将会密切地检查与监督他们。如果他或她生病了,我们将检查他/她是否是因为其疫苗受损。然后,其他医生会检查他/她,我会继续追求进展,并向那位医生提出更多问题。”

三、新冠肺炎病毒科兴疫苗临床试验的自愿标准条件
对新冠肺炎病毒科兴疫苗的志愿者或临床试验参与者有一些要求,对象标准条件例如:
1)年龄在19至59岁之间;
2)目前是万隆市的居民及在万隆定居;
3)无新冠肺炎病毒病史或相关症状。

四、志愿者务必居在万隆
UNPAD医学院的研究人员之一,Kusnandi Rusmil教授继续解释,作为新冠肺炎病毒科兴疫苗临床研究对象的志愿者务必居住在大万隆市区。这样做的目的是为了便于监测疫苗六个月以上时期的疫苗临床试验。

“只有来自万隆的居民和住在万隆的居民才有资格参与并成为其疫苗临床试验的志愿者。假如想要成为志愿人员,他必须先移民到并住在万隆市,” Kusnadi 在位于万隆市,Eyckman 街第38号的UNPAD校医里,于7月22日强调表示。

五、万隆有6个地点用于新冠肺炎病毒科兴疫苗临床试验所
UNPAD医学院的新冠肺炎病毒科兴疫苗临床试验运营经理之一,dr. Eddy Fadliana指示,来自中国的新冠肺炎病毒科兴疫苗为第三期临床试验一共有6个地点,均所位于万隆市。其地名所在如下:
1)UNPAD 校医研究所;
2)位于Dipatiukur 之UNPAD 保健堂;
3)Ciumbuleuit 公共卫生中心;
4)Garuda 公共卫生中心;
5)Dago 公共卫生中心;
6)Sukaparkir 公共卫生中心

六、 疫苗每剂价格估计为 145,000印尼盾
Biofarma国营制药有限公司从印尼CNN媒体引述,将其每剂新冠肺炎病毒疫苗的价格范围定为5美元至10美元或等价于72,500印尼盾至145,000印尼盾。

Biofarma公司秘书Bambang Heriyanto表示价格范围可能仍会发生变化。
“疫苗价格仍在计算中,目前估计每剂在5至10美元之间药价,”他在7月22日周二晚间对CNNIndonesia.com说道。


6 Facts of Covid-19 Sinovac Vaccine Clinical Trial in Bandung 

Jakarta – Good news comes from the development of clinical trials of the Covid-19 Sinovac vaccine in Bandung. It’s estimated that the third phase of clinical trials will be carried out soon. 

However, volunteers or someone who wants to register as a participant in the Corona vaccine research subject must have special requirements. What are those requirements? The 6 facts summarized by detikcom media related to clinical trials of Covid-19 Sinovac vaccine in Bandung are noted as follows:

1. Executed in early August 2020 
Phase 3 clinical trials of Sinovac’s Covid-19 vaccine will involve 540 people in the early stage of August 2020. Three-month monitoring will be carried out on the subjects to see the progress of the vaccine.

“At first stage, there will be 540 test subjects for 3 months. It means that the first 3 months, 540 test subjects’ immunities and safeties will be examined closely. Then after the third month, they just will be monitored for the safety or in other terms of efficacy,” said dr. Eddy Fadliana as a Coordinator research team of UNPAD Medical Faculty.

2. Who are eligible for taking part in the Covid-19 Sinovac vaccine clinical trial tests? 
Volunteers or participants who will take part in the Covid-19 Sinovac vaccine clinical trial are the Bandung residents, whom in the productive ages and in a healthy conditions.

“The participants will be under insurance protection while undertaking the clinical research, and not being paid due to their voluntary. And we’ll monitor and supervise them closely, for the next 3 days, 5 days, or after 14 days, and on. If he or she gets sick, we’ll examine him/her whether it’s because of the vaccine or not. Then other doctor will check on him and I will pursue the further progress and question much more,” said one of UNPAD Medical Faculty research personnel, Prof. Kusnandi Rusmil.

3. Voluntary criterion on clinical trials of the Covid-19 Sinovac vaccine 
There are several requirements regarding volunteers or clinical trial participants of the Covid-19 Sinovac vaccine, such as follow: 
1) Aged from 19 to 59 years old; 
2) Currently residents in Bandung city; 
3) Has no history of COVID-19 disease or symptoms. 

4. The volunteers must reside in Bandung 
UNPAD Medical Faculty research personnel, Prof. Kusnandi Rusmil explained, the volunteers who are the subjects of Covid-19 Sinovac vaccine clinical research must reside in Greater Bandung area. It’s intended as so in order to facilitate monitoring of clinical trials of the vaccine for over six months.

“Only residents from Bandung and live in Bandung are eligible for the clinical trial participants or volunteers. If someone who wants become volunteers, he must migrate and live in Bandung first,” said Kusnadi in UNPAD Educational Hospital at Jalan Eyckman No. 38, Bandung on Wednesday (22/7/2020).

5. There are 6 locations for Covid-19 Sinovac vaccine clinical trials in Bandung 
UNPAD Medical Faculty Operational Manager of Covid-19 vaccine clinical trials, Eddy Fadlyana showed that there are 6 spots for phase three clinical trials of Covid-19 Sinovac vaccine from China, where are all located in Bandung city. The locations are namely as below:
1) UNPAD Educational Hospital;
2) UNPAD Health Center at Dipatiukur; 
3) Ciumbuleuit Public Health Center;
4) Garuda Public Health Center;
5) Dago Public Health Center;
6) Sukaparkir Public Health Center.

6. The price of the vaccine is estimated at IDR 145,000 per dose 
Quoted from CNN Indonesia, Biofarma Pharmaceuticals State-owned Company sets the price of the corona vaccine in the range of US $ 5 to US $ 10 or equivalent to IDR 72,500 to IDR 145,000 per dose.   

Biofarma Corporate Secretary, Bambang Heriyanto stated the price range could still change. “The vaccine price is still being calculated, and for current estimation is ranged between US$ 5 to 10 per dose,” said Bambang to CNNIndonesia.com on Tuesday night (22/7).

源自:https://health.detik.com/berita-detikhealth/d-5104464/6-fakta-uji-klinis-vaksin-corona-sinovac-di-bandung?tag_from=news_beritaTerkait&_ga=2.114085959.1376508774.1595470233-284526300.1595470233


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