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SARS-CoV-2 human challenge study:

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus is a novel betacoronavirus that likely emerged late last year from an animal reservoir in China. There is little to no pre-existing immunity against it in the human population. The clinical picture for the disease it causes, coronavirus disease 2019 (COVID-19), ranges from very mild to fatal. The virus is highly transmissible and has spread globally.

As of 20 March 2020, the WHO (World Health Organization) is reporting that it is tracking the development of forty-four SARS-CoV-2 candidate vaccines. Two of these candidates have entered phase one and the other forty-two remain in the pre-clinical stage.

Recent estimates show that it will be 12-18 months until a vaccine is licensed and made widely available. A key bottleneck in the vaccine development timeline is the length of phase 3 clinical trials, which usually involve thousands of participants that have to be extensively followed in the field in order to assess differences in COVID-19 incidence between the vaccine and control groups. Some researchers have suggested that, in the midst of a global pandemic, controlled human challenge studies may be a way to accelerate vaccine development. Such a study would involve deliberately exposing healthy volunteers to live SARS-CoV-2 virus rather than to wait for them to be exposed to it in a natural setting. Conducting such a study would mean that phase 3 testing is bypassed entirely. More on a human challenge study design proposal here.

This question asks: When will a human challenge study in which a SARS-CoV-2 vaccine candidate is administered to at least 80 people be completed?

For our purposes, a vaccine is a product that stimulates a person’s immune system to produce immunity to a specific disease, protecting the person from that disease and a human challenge study is when participants are intentionally challenged with an infectious disease organism.

This question resolves as the date when the first article is published that presents the claim that at least 80 patients have received the candidate vaccine as part of a human challenge study. This article must be authored by at least one of those involved in the funding, organizing, or researching of the relevant clinical trial. The credibility of this article will be determined by Metaculus. Pre-prints will be considered and they need not be peer-reviewed.

If this does not resolve before 08 April 2023, it resolves as >08 April 2023.


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