How COVID-19 human challenge trials work -- and why I volunteered | Sophie Rose

譯者: Venice Lau 審譯者: Man Chun Ma

[Recorded on October 26, 2020.

[ 此演講於 2020 年 10 月 26 日錄製 ]

COVID-19 vaccine development

[ 新冠肺炎疫苗的研發情況 ]

and ethical considerations around human challenge trials

[ 以及有關人體挑戰試驗的道德考慮 ]

are constantly evolving.]

[ 正在不斷地改變 ]

In April 2020,

2020 年 4 月，

I made what many perceive as a risky decision.

我做了一個大家都認為是冒險的決定。

I volunteered to be deliberately infected with COVID-19.

我自願成為新冠肺炎的感染者。

This infection would be part of what is called a human challenge trial,

這是人體挑戰試驗計劃的一部份。

where young, healthy people are given a vaccine

它們替健康的年輕人注射疫苗，

and are deliberately exposed to the virus that causes COVID-19.

然後故意讓他們暴露在新冠病毒中。

These trials help researchers figure out more quickly

這些實驗令研究人員更快速地

if a vaccine is working.

試驗疫苗是否有效。

I think this research is crucial,

我認為這是個重要的研究，

because today, I'm going to speak to you for six minutes.

因為今天，我將會用 六分鐘的時間進行演講。

In that time,

而這六分鐘裡，

roughly 1,250 people will be confirmed infected with COVID-19.

大約會有 1250 個人確診新冠肺炎，

Twenty-one people will die.

21 人將會死亡。

And then this pattern will repeat hour after hour and day by day,

這個模式會每天每小時地重覆，

until we're able to vaccinate most of the eight billion people

直到我們能夠為全球 80 億人裡

affected by this global crisis.

大部份受到疫情影響的人注射疫苗。

Scientists have been working around the clock

科學家日以繼夜地研究，

to make those vaccines a reality.

致力要研發出成功的疫苗。

But what should we do when the human cost of waiting for those vaccines

而在等待疫苗的期間， 每天都有愈來愈多的傷亡。

is rising by the day?

我們能夠做些什麼？

This is where human challenge trials come in.

這造就了人體挑戰試驗的出現。

They're different from the traditional phase three vaccine trials

這個計劃跟現有的

傳統第三階段臨床疫苗試驗不同，

taking place now,

where people are given a vaccine or placebo

當人們接種了疫苗或安慰劑後，

and asked to go about their everyday lives.

他們會被要求繼續進行日常生活。

Here, researchers have to wait to see how many people in each group

然後，研究人員將要等待，

看看每組裡有多少人受到感染。

become infected.

Until enough of them get sick,

除非有足夠的人數受到感染，

we don't have enough data to know whether a vaccine is working.

否則我們沒有足夠的數據， 去測試疫苗是否有效。

Finding an effective vaccine with this method

使用這個方法來尋找有效疫苗，

can take months or sometimes years,

可能要花上幾個月甚至幾年時間，

and it requires thousands of volunteers.

亦需要大量的志願者。

A challenge trial works faster

挑戰試驗計劃能更快速地測試疫苗。

because researchers control exposure,

因為研究人員控制了感染者的人數，

instead of waiting for people to get sick.

而並非等待他們受感染。

So instead of a year,

所以相比之下，不用一年，

we could know in as little as a month

我們最快只需要一個月

whether a vaccine seems effective.

便能夠知道疫苗是否有效。

Instead of thousands of volunteers,

傳統的方式需要數千位志願者，

a challenge trial relies on just 50 to 100.

挑戰試驗只需要 50 至 100 位。

Because we know for certain

因為我們能準確地知道，

when people are exposed and develop disease,

每個人何時會暴露於病毒中， 並成為病毒的感染者。

these trials also allow us to gather data

這些實驗協助我們收集不同數據，

about the early stages of infection and our immune response.

例如感染初期以及免疫系統的反應等。

This data is impossible to gather in any other way,

使用其他方式難以獲得這種數據，

especially for people who become infected but never show symptoms.

尤其是一些無徵狀患者。

This knowledge is important for designing policies

這些知識對於制定有關

that limit COVID-19 transmission.

控制新冠肺炎傳播的政策十分重要。

The time saved translates into precious months' head start

節省下來的時間能夠讓更多藥廠

on manufacturing,

開始研究如何生產疫苗，

getting us more working COVID-19 vaccines faster.

令我們更快得到更多有效的疫苗。

These trials are useful --

這些實驗很有用，

even though recent phase three results sound encouraging.

即使最近的臨床實驗結果亦有所起色。

The arrival of the first vaccine is going to be a monumental breakthrough.

第一支疫苗的誔生將會是個重大突破。

It just isn't quite the fairytale ending we're all hoping for.

不過，實際上事情並非如童話般順利。

We're going to need multiple vaccines,

我們需要多種不同的疫苗，

because we just don't have the infrastructure needed

因為我們沒有足夠的設施

to immunize all eight billion people on the planet with just one kind.

去為全球 80 億人接種同一種疫苗。

Each type of vaccine requires its own special process and equipment

每種疫苗都有需要有相應的設備和過程

to make, store and deliver it.

來製造、儲藏及運送。

If we had multiple working COVID-19 vaccines,

如果我們同時製造多種新冠肺炎疫苗，

we could make use of all of our equipment at the same time.

就能同時運用所有設備。

Some of the leading candidates need to be kept extremely cold

某些疫苗在運送到人們手中前，

before they are delivered to people.

需要被儲存於極低溫的環境。

This can be really hard,

這可能是個難題，

especially in countries where there isn't reliable electricity

特別是某些國家可能 沒有可靠的電力供應，

or a secure method to store them.

或是沒有安全的方法儲存疫苗。

Scientists have been using human challenge trials

數百年來，科學家一直 使用人類挑戰試驗的方式。

for hundreds of years.

They've sped up the development of vaccines against typhoid and cholera,

這加快了傷寒和霍亂疫苗的研發速度，

and they've helped us better understand how immunity develops

加強了我們對免疫力的認識，

to things like the flu, malaria and dengue.

以及如何對付流感、瘧疾 和登革熱等疾病。

We've even used them for other types of coronavirus before.

我們亦曾將這些試驗， 用於其他類型的冠狀病毒上。

There's been a lot of debate

有很多爭議，

about whether challenge trials are too risky.

認為挑戰試驗太過冒險。

I happen to think that those risks are worth taking.

但我認為冒這些險很值得。

A challenge trial would only recruit young and healthy participants --

挑戰試驗只會招募年輕健康的參加者，

think between the ages of 20 and 29.

他們年齡大約在 20 至 29 歲之間。

Fewer than one percent of people in that age-group

在這個年齡層，

need to be taken to hospital after becoming infected with COVID-19.

只有少於 1% 的人在確診新冠肺炎後， 需要進院接受治療。

So it would likely be even lower in a challenge trial,

在挑戰試驗中的人數將會更少，

because researchers check to make sure

因為研究人員會確保每一位參與者

that participants have no preexisting conditions.

沒有任何先天疾病或長期疾病。

The risk of a young healthy person dying of COVID-19

一個健康的年輕人 死於新冠肺炎的風險，

is around five thousandths of a percent.

大約是 0.005%。

That means for every 100,000 20-year-olds who become infected with COVID-19,

換句話說，每十萬位 20 歲的確診者，

about five die.

當中只有 5 位會死於新冠肺炎。

If I were to give birth in the United States,

如果我生於美國，

my risk of dying would be higher than that.

我死亡的風險將會更高。

Or you could choose to think about it this way.

你可以從另一個角度試想，

If my little sister needed a kidney,

如果我的妹妹需要換腎，

I wouldn't hesitate for a moment before I offered her mine.

我亦會毫不猶豫地捐出我的腎。

And if I can take on that risk to benefit a loved one,

如果我能夠冒這個風險 來幫助我的親人，

it makes sense to allow people to take on a similar risk

人們為了加快疫苗研發進度而冒險，

to speed up the development of a vaccine

亦是十分值得的舉動，

that would benefit not just their loved ones,

這不但幫助了他們的親人，

but everyone around them as well.

亦幫助了他們身邊的每一位。

There's a lot we still don't know,

現在我們還有很多未知數，

especially about the long-term effects of COVID-19 infection.

特別是關於長期感染新冠肺炎的影響。

I volunteered despite that uncertainty

儘管有很高的不確定性， 我依然願意成為志願者。

because like many of you, I feel frustrated

因為我跟你們一樣沮喪，

knowing that hundreds of thousands of people are dying.

為成千上萬的人去世而感到悲痛。

And that's without mentioning the millions more who are struggling

更不用提，有數百萬位 仍在苦苦掙扎的人。

as measures to stop the spread take a toll on their physical,

疫情不但危害了他們的生理健康，

emotional and mental well-being.

防疫措施亦影響了他們的情緒和心理。

It turns out I'm not alone in feeling this way.

幸好有很多和我抱著相同想法的人。

Since May, over 39,000 people from across the world

自五月起，有超過 39000 位 來自世界各地的人。

have volunteered to participate in potential COVID-19 challenge trials

透過一個我幫助創立的非牟利組織， 名為 1DaySooner，

through a nonprofit I helped found called 1Day Sooner.

志願性地參與新冠肺炎的挑戰實驗。

We advocate for challenge trial participants

我們為挑戰試驗的參與者提供援助，

and have been encouraging stakeholders to begin preparing for these trials.

以及鼓勵不同持份者準備各種實驗。

As early as May,

早在五月，

when challenge trials were still being considered

當我們仍在考慮

是否應該進行挑戰實驗的時候，

for their role in the fight against COVID-19,

the World Health Organization cited 1Day Sooner

世界衛生組織列舉了 1Day Sooner

as an example of the kind of public engagement needed

作為其中一個需要公眾協助，

to run a challenge trial.

進行挑戰試驗的組織。

In mid-October,

在十月中，

the UK government formally announced their intention

英國政府正式宣佈，

to conduct a challenge trial at the beginning of 2021.

他們打算在 2021 年初， 進行挑戰實驗。

It is clear that the COVID-19 pandemic is a global crisis.

新冠肺炎的爆發是一個全球危機，

It has inspired record-shattering innovation,

同時啟發了不少破紀錄的創新技術，

and it has highlighted the heroic acts of many frontline workers,

更突顯出許多前線醫護的英勇行為，

but is has also taken a catastrophic toll.

但同時亦帶來了災難性的損失。

The arrival of each new vaccine brings us one step closer to rebuilding.

每一種新疫苗的誔生， 都讓我們往重建的道路更進一步。

But the true global solution

但真正的解決這個全球問題的方法，

lies in those vaccines being in the hands of people all over the world.

取決於世界各地持有疫苗的人。

Challenge trials could be a part of that solution.

挑戰試驗只是其中一個解決辦法。

Thank you.

謝謝。