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壹萬多人參與國藥集團阿布紮比三期試驗,參與人員42天禁出國旅行
半島華人雙語 2020-07-26 20:33:06



More than 10,000 people have volunteered to be part of Abu Dhabi's Phase 3 clinic trials for a vaccine to fight Covid-19.

阿布紮比衛生部門表示,誌願者們來自20個不同的國家,參加了為期42天的試驗。

The volunteers represent 20 different nationalities taking part in the 42-day trial, Abu Dhabi's health department said.

衛生部代理副部長Jamal Al Kaabi博士說,大量的參與者“將有助於證明試驗具有很高的有效性,並在大幅度人口統計範圍內顯示疫苗的作用”。

Dr Jamal Al Kaabi, the acting undersecretary of the department said that the large number of participants "will help demonstrate that the trials have a high chance of efficacy and show the vaccine’s effects across a wide range of demographics".

阿布紮比和艾因市是世界上第壹家獲得世界衛生組織(World Health Organisation)批準的第三階段試驗的所在地,這是批準疫苗用於大眾防疫使用的最後壹步。

Abu Dhabi and Al Ain are home to the world’s first World Health Organisation-enlisted Phase-III trial, which is the final step before a vaccine is approved for use among the public.

在阿布紮比試驗的疫苗是“滅活疫苗”。它是壹種設計用來保護人們抵抗這種疾病的疫苗,該疫苗使用了導致這種疾病的病毒的“死亡”版本。

The vaccine being trialled in Abu Dhabi is 'inactivated'. It is one type of vaccine designed to protect people against the disease and uses a “killed” version of the virus that causes the illness.

第三階段試驗通常評估壹種藥物在大量人口樣本中的有效性,科學家希望這將有助於識別提供免疫的特定抗體。全球已有20多種疫苗在臨床試驗中,另有140種疫苗在全球處於早期開發階段。只有3個處於三期試驗階段。

Phase 3 trials typically evaluate the effectiveness of a drug on a large population sample and scientists hope it will help identify specific antibodies that provide immunity. More than 20 vaccines are in clinical trials globally, while another 140 are in early development globally against the disease. Only three are in phase 3 trials.

阿聯酋審判仍在接受誌願者,在首都和艾因的五個地點舉行。衛生部表示,最初將有約5000名誌願者參與這項研究。

Volunteers are still being accepted for the UAE trial, which takes place at five sites in the capital and Al Ain. About 5,000 volunteers will be involved in the study at first, the health department said.

新冠肺炎國家臨床委員會主席、謝赫哈利法醫學城執行醫務主任Nawal Al Kaabi博士說:“這項運動不僅有助於抗擊新冠肺炎,而且將提供壹種衡量疫苗效果的高效方法。”

"The campaign not only helps in combating Covid-19 but will provide a highly effective approach to measuring the vaccine’s effects," said Dr Nawal Al Kaabi, the chair of the National Clinical Committee for Covid-19 and the executive medical director at Sheikh Khalifa Medical City.

阿聯酋的試驗是由中國疫苗制造商國藥控股、總部位於阿布紮比的人工智能公司Group 42和阿布紮比衛生服務公司Seha合作進行的。

The UAE trial is a partnership between Chinese vaccine manufacturer Sinopharm, Abu Dhabi-based artificial intelligence company Group 42 and Abu Dhabi Health Services Company, Seha.

阿布紮比衛生部門根據世界衛生組織以及美國食品藥品監督局的指導方針對該實驗進行監督。

It is being supervised by Abu Dhabi's health department in accordance with guidelines outlined by the World Health Organisation and the Food and Drug Administration of the United States.

“壹組來自Seha的專業醫師…將管理並參與臨床試驗的實施。所有的試驗將在專門的中心進行,這些中心配備了接納誌願者的設備,這些誌願者包括公民、所有國籍的居民和男女。”Al Kaabi博士說。

“A team of specialist medical practitioners from Seha ... will be managing and involved in conducting the clinical trials. All trials will be administered at dedicated centres equipped to accommodate the volunteers, which include citizens, residents of all nationalities and both sexes,” Dr Al Kaabi said.

在中國進行了第壹階段和第二階段的試驗。

Trials for Phase-1 and 2 took place in China.

需要1.5萬名誌願者,並且誌願者必須身體健康,年齡在18歲到60歲之間。阿布紮比衛生部主席謝赫·阿蔔杜拉·本·穆罕默德·阿勒·哈默德(Sheikh Abdullah bin Mohammed Al Hamed)是首位接受疫苗註射的誌願者。

Up to 15,000 volunteers are wanted and they must be in good health and between the ages of 18 to 60. Sheikh Abdullah bin Mohammed Al Hamed, chairman of the Department of Health Abu Dhabi, was the first volunteer to receive the jab.

衛生部周五的壹份聲明說道,參與試驗的阿聯酋人Hamad Al Balushi是首批接種疫苗的人之壹,他希望這項研究將對“阿聯酋和全球社區”都有好處。

Hamad Al Balushi, an Emirati taking part in the trial and one of the first to be given the vaccine hopes that the study will be of benefit "to both the UAE and global communities", a statement from the health department on Friday said.

另壹名來自阿曼的誌願者談到他為“在這壹歷史性試驗中成為首批誌願者之壹而感到自豪,並邀請我所有的兄弟姐妹加入我的行列”。

Another volunteer from Oman spoke of his pride to be one of the first volunteers "in this historic trial and invite all my brothers and sisters to join me".

誌願者必須在42天內至少訪問測試中心17次。

Volunteers must visit testing centres a minimum of 17 times over about 42 days.

這段時間他們不能出國旅行。試驗結束後,他們將有長達6個月的定期電話咨詢。

They cannot travel abroad during this time. After the trial, they will have regular phone consultations for up to six months.

人們可以在政府網站4humanity上註冊。ae或致電02 819 1111。

People can register on the government website 4humanity.ae or call 02 819 1111.

在接種疫苗前,妳將接受接種前的RT-PCR(反轉錄酶-聚合酶鏈鎖反應)檢測,之後才按照下面的程序:

You would need to undergo a pre- vaccine RT-PCR test, after which the trial will start with the first

vaccine dose:

第0天-接種疫苗(面對面)

Day 0-first dose(face-to-face)

第1-3天-醫學檢查

Day 1-3-Medical examination (face-to-face)

第4-7天-跟蹤(電話)

Day 4-7-follow-up(Telephone)

第8天-日誌跟蹤卡(面對面)

Day 8-Diary contact card (Face-to-face)

第14天-跟蹤(電話)

Day 14-Follow-up(Telephone)

第21天-第二針(在6點和24點之間打電話)

Day 21- Second dose( call between six to 24 hours)

第22-24天醫學檢查(面對面)

Day 22-24-Medical examination( Face-to-face)

第25-28天-跟蹤(電話)

Day 25-28-Follow-up (Telephone)

第29天-醫學檢查(面對面)

Day 29-medical examination (face-to-face)

第35天-(醫學檢查) (面對面)

Day 35-Medical examination (Face-to-face)

第42天-最終醫學檢查

Day 42-Final medica examination

https://www.toutiao.com/a6853766159502672388/



附件

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2020-7-29 18:28

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點解唔分成兩組人做雙盲測試???


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