SARS-CoV-2 临床研究参与者标准与程序 – PARTICIPANTS CRITERION AND PROCEDURES OF SARS-CoV-2 CLINICAL RESEARCH

序言

SARS-COV-2灭活疫苗是一种由冷冻或被杀死的病毒制成的疫苗,因此可以安全地服用。该疫苗已超过第一和第二期临床试验,并显示出高水平的安全性和高防护性的成果。

目前,Bio Farma与中国科兴生物研发有限公司有所合作,将为大规模服用该第三期研究的灭活SARS-COV-2疫苗之前在进行临床研发。

于印度尼西亚,本项临床试验将由Padjadjaran大学医学院,于Hasan Sadikin友谊总医院的儿科医学部与PT Bio Farma国营制药公司和政府卫生部的研发机构(Litbangkes)合作中实践。

通过此传单,我们打算邀请您来参加我们将从事的临床试验研究。非常感谢您的参与,并且本项目是自愿的。此项临床研究旨在于注射2剂疫苗后,确定该SARS-COV-2疫苗的免疫反应与安全性。

谁符合资格参加本项临床研究?

一、 年龄在18至50岁之间的健康成年人(在COVID-19大流行期间)通过实施社区隔离与
按照政府的建议规定运用个人防护设备,使自己免受传染的风险。

二、目前不参加或即将参与其他临床试验。

三、没有被新冠肺炎病毒感染过的病历。

四、在临床研究开始前的14天内,参与者务必:
4.1. 没有接触过冠状病毒(正核酸)患者的接触病例。
4.2. 没有向以新冠肺炎病毒影响的地区或社区为住所地的任何发烧(过)或忍受呼吸道症状患者接触过。
4.3. 在家庭、工作单位、学校或教室里等小人群场所中,没有两件或两件以上发烧和/
或忍受呼吸道症状的病例。

五、仍未或没有体验过任何轻度、中度或重度疾病、失常或慢性疾病、血液异常,
尤其是传染病和/或身体发烧(体温超 37.5度)。

六、在临床研究期间,非是怀孕、哺乳期或妊娠打算的女性。

七、没有哮喘病史,或对疫苗过敏。

八、最近4周内,请勿接受或进行任何会干扰或影响着免疫反应的治疗 ,
例如:静脉注射免疫球蛋白,血液制品或长期皮质类固醇治疗(> 2周)。

九、过去或至少一个月内未进行任何免疫接种,或在下一个月将服用另一种疫苗。

十、住在万隆市,并不打算在临床试验完成之前,从疫苗研究区迁居。

SARS-CoV-2临床研究参与者之程序如下:

  • 当研究医师宣布您可以参加或符合条件临床研究之后,将会进行随机化程序,以确定您是否将以注射用水的形式服用SARS-CoV-2疫苗还是安慰剂。
  • 之后,您将根据指定的时间表服用两(2)剂SARS-CoV-2疫苗或安慰剂注射。
  • 您将大约7个月参与此研究项目。
  • 注射安慰剂后,那些接受安慰剂的人将接种已注册的SARS-CoV-2疫苗。
  • 在临床研究期间,您的血液样本将分四次来抽取,即分别在您的第0次实地访视、第3次访视、第5次访视和第6次访视,每次多达4 立方厘米(约1茶匙)从静脉血管抽。血液样本将由训练有素且经验丰富的人员抽血。

如果您有兴趣参与此SARS-CoV-2疫苗临床试验研究,请联系:
联系信息:
办公单位 : Clinical Research Unit 
儿科医学部门,第一楼
友谊总医院(RSUP) Hasan Sadikin 
注册电话:+6222-203 4471 
WA手机号码:+62811 2214 235 01 

志愿者注册开放至2020年8月31日

您的参与将为印度尼西亚SARS-CoV-2疫苗的研发做出贡献。谢谢!

If you are interested in being involved in this SARS-CoV-2 Vaccine clinical trial research, please: 
CONTACT US 
Office : Clinical Research Unit 
1st fl. of Pediatrics Department
RSUP Hasan Sadikin 
TLP. 022 203 4471 
WA. 0811 2214 235 01 

Registration Opened until August 31, 2020

Your participation will contribute to the development of the SARS-CoV-2 Vaccine in Indonesia. Thank You! 

FOREWORD 

SARS-COV-2 inactivated vaccine is a vaccine made from a frozen or killed virus so that it is safe to use. This vaccine has exceeded the phase 1 and 2’ tests showing the results of a high level of safety and high protection.

Currently, Bio Farma collaborates with Sinovac Research & Development Co., Ltd., China in the development of phase 3 inactivated SARS-COV-2 vaccines before they are mass applied.

In Indonesia, this clinical trial will be carried out by the Department of Pediatrics of Hasan Sadikin Hospital / Faculty of Medicine, Padjadjaran University in collaboration with PT Bio Farma and Research and Development Agency of Ministry of Health.

Through this leaflet, we intend to invite you to participate in clinical trial research that we will pursue. Your participation is greatly appreciated and is voluntary. This clinical research aims to determine the immune response and safety of the SARS-COV-2 vaccine after administering 2 doses of the vaccine.

WHO CAN PARTICIPATE IN THIS RESEARCH ? 

  1. Healthy adults aged between 18 to 50 years, those who during the COVID-19 pandemic, has kept themselves from the risk of transmission by implementing social distancing, and using personal protective equipment in accordance with government recommendations. 
  2. Currently not participating or will participate in other clinical trials.
  3. Has no history of being infected with Covid-19. 
  4. Within 14 days before the clinical research starts, the participants must:  A). Have no history of contact with patients infected with corona virus (positive nucleic acid).  B). Have no history of contact with patients whom show any fever or respiratory symptoms that are domiciled in areas or communities affected by Covid-19. C).Not having two or more cases of fever and/or respiratory symptoms in any area with small scope of people, such as home, work, school or classroom.
  5. Not having or experienced any mild, moderate or severe disease, abnormalities or chronic diseases, blood disorders, especially infectious diseases and / or fever (body temperature is > 37.5 ° C). 
  6. Not women who are pregnant, breastfeeding or planning to be in pregnancy during the clinical research period.
  7. Has no history of asthma, or who is allergic to vaccines. 
  8. In the last 4 weeks, do not receive or do any therapy that can interfere with the immune response (for example: intravenous immunoglobulin, products derived from blood, or long-term corticosteroid therapy (> 2 weeks). 
  9. Not getting any immunizations in the past or at least within a month or will receive another vaccine in the next one month.
  10. Reside in the city of Bandung and not planning to move from the research area before the clinical trial is completed. 

THE CLINICAL RESEARCH PARTICIPANTS’ PROCEDURES ARE AS FOLLOWS:

  1. After you are declared to be able to participate in clinical research by a research physician, randomization procedures will be carried out to determine whether you will get the SARS-CoV-2 vaccine or a placebo in the form of water for injection.
  2. After that, you will get two (2) doses of SARS-CoV-2 vaccine or placebo based on the specified schedule. 
  3. You will participate in this research for approximately 7 months. 
  4. Those of you who receive a placebo will get SARS-CoV-2 vaccination after the vaccine is registered. 
  5. During the clinical research, your blood samples will be taken on four occasions, which on your 0 visit, 3 visit, visit 5 and visit 6 as many as 4 cc (about 1 teaspoon) of blood to be drawn from the veins. Blood samples will be taken by trained and experienced personnel.

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