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When will several SARS-CoV-2 vaccine candidates be simultaneously tested in an adaptive trial design using a shared control group?

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.

In order to be considered effective enough to be licensed by regulatory authorities, vaccine candidates must usually be shown to be effective in randomized controlled trials (RCTs) with placebo groups. But there is concern that in this case, such RCTs may be ethically infeasible and may take too long. Given the high-mortality situations in which potential participants may find themselves in, there may not be acceptance of randomized controlled trials with control groups by a population. Moreover, the traditional phase I–III categories for RCTs are likely to prolong the timeline for development of a successful candidate.

One proposed solution is to test several vaccines at the same time in an adaptive trial design using a shared placebo group. This way, more participants would receive an active vaccine and multiple vaccine candidates can be tested at once. However, such an approach is likely to be especially logistically and statistically complex given that it has not been attempted at this scale before.

This question asks: When will several SARS-CoV-2 vaccine candidates be simultaneously tested in an adaptive trial design using a shared control group?

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.

This question resolves as the date when the first article is published that presents the claim that at least two vaccine candidates were simultaneously tested in an adaptive trial design using a shared control group. 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 need not be peer-reviewed.

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


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