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Johnson & Johnson Covid-19 vaccine study paused due to unexplained illness in participant

由于參與者出現原因不明的疾病，強生暫停新冠疫苗研究

The study of Johnson & Johnson’s Covid-19 vaccine has been paused due to an unexplained illness in a study participant.

由于一位研究參與人員患上原因不明的疾病，強生決定暫停新冠疫苗研究。

A document sent to outside researchers running the 60,000-patient clinical trial states that a “pausing rule” has been met, that the online system used to enroll patients in the study has been closed, and that the data and safety monitoring board — an independent committee that watches over the safety of patients in the clinical trial — would be convened. The document was obtained by STAT.

一份發給外界研究人員（負責進行由6萬名患者參加的臨床試驗）的文件表明，研究目前已達到“暫停規定”，用于招募研究參與人員的在線系統已經關閉，數據和安全監督委員會-一家獨立的、密切關注臨床試驗中患者安全情況的委員會將會召開會議。目前該文件已由STAT獲取。

Contacted by STAT, J&J confirmed the study pause, saying it was due to “an unexplained illness in a study participant.” The company declined to provide further details.

STAT與強生取得聯絡后，強生證實研究已暫停并表明，暫停是由于“研究參與人員出現原因未明的疾病”。公司拒絕透露更多細節。

“We must respect this participant’s privacy. We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information,” the company said in a statement.

公司在一份聲明中表示：“我們必須尊重該參與者的隱私。我們也正在了解更多有關該參與者的患病情況。在我們分享更多的信息之前，我們需要了解所有事實。”

J&J emphasized that so-called adverse events — illnesses, accidents, and other bad medical outcomes — are an expected part of a clinical study, and also emphasized the difference between a study pause and a clinical hold, which is a formal regulatory action that can last much longer. The vaccine study is not currently under a clinical hold. J&J said that while it normally communicates clinical holds to the public, it does not usually inform the public of study pauses.

強生強調表示，所謂的不良事件，比如疾病、事故以及其他不良藥物結果都是臨床研究中預期的一部分。強生同時也強調了研究暫停和臨床限制之間的區別。臨床限制是正式的監管行動，其持續時間會更長。疫苗研究目前不處于臨床限制階段。強生表示，通常其會將臨床限制通報給大眾，但一般不會將研究暫停告知大眾。

The data and safety monitoring board, or DSMB, convened late Monday to review the case. J&J said that in cases like this “it is not always immediately apparent” whether the participant who experienced an adverse event received a study treatment or a placebo.

數據和安全監管委員會（DSMB）于上周一召開會議以對案例進行審查。強生表示，在類似的這種情況中，出現不良反應的參與者是接受研究治療還是安慰劑并非立刻知曉。

Though clinical trial pauses are not uncommon — and in some cases last only a few days — they are generating outsized attention in the race to test vaccines against SARS-CoV-2, the virus that causes Covid-19.

盡管臨床試驗暫停并不鮮見，并且在某些情況下僅僅持續數日，但是暫停會引起大量的關注，特別是在大家都在競相測試SARS-CoV-2，一種引起新冠病毒的疫苗。

Given the size of Johnson & Johnson’s trial, it’s not surprising that study pauses could occur, and another could happen if this one resolves, a source familiar with the study said.

考慮到強生試驗的規模，研究暫停完全在意料之內。如果該問題得到了解決，那么還可能出現其他的問題，一位熟悉研究的人員表示。

“If we do a study of 60,000 people, that is a small village,” the source said. “In a small village there are a lot of medical events that happen.”

“如果我們的研究對象是6萬人，那么相當于是一個小村莊。在這個小村莊內，會出現許多醫療事件”，該人員表示。

On Sept. 8, a large study of another Covid-19 vaccine being developed by AstraZeneca and Oxford University was put on hold because of a suspected adverse reaction in a patient in the United Kingdom. It’s believed that the patient had transverse myelitis, a spinal cord problem. Studies of the vaccine resumed roughly a week after it was paused in the United Kingdom, and have since been restarted in other countries as well. It remains on hold, however, in the United States. 

9月8日，另一個由AstraZeneca和牛津大學所研發的新冠疫苗大型研究項目也由于英國的一位患者出現疑似副作用而處于暫停狀態。據說，該患者有橫斷性脊髓炎，即一種脊髓疾病。疫苗研究大約在英國暫停一周后又繼續啟動并也開始在其他國家重新啟動。然而，該項目在美國仍處于暫停狀態。

Johnson and Johnson began enrolling volunteers in its Phase 3 study?on Sept. 23. Researchers planned to enroll 60,000 participants in the United States and other countries.

9月23日，強生開始為第3期研究招募志愿者。研究人員計劃在美國和其他國家招募6萬名參與者。

以上內容摘自CNBC，編輯：Susan