1Day Sooner

1Day Sooner is a non-profit that advocates on behalf of COVID-19 challenge trial volunteers. After a vaccine candidate is created in a lab, it is developed through a combination of pre-clinical evaluation and three phases of clinical trials that test its safety and efficacy. In traditional Phase III trials, participants receive the vaccine candidate or a placebo/active comparator, and efficacy is judged by comparing the prevalence of infection in the vaccine group and the placebo/comparator group, to test the hypothesis that significantly fewer participants in the vaccine group get infected. In these traditional trials, after receiving the treatment, participants return to their homes and their normal daily lives so as to test the treatment under real world conditions. Since only a small proportion of these participants may encounter the disease, it may take a large number of participants and a good deal of time for these trials to reveal differences between the vaccine and placebo groups. In a human challenge trial (HCT), willing participants would receive the vaccine candidate or placebo and, after some time for the vaccine to take effect, be deliberately exposed to live coronavirus. Since exposure to the virus is guaranteed in HCTs, it may be possible to judge a vaccine candidate’s efficacy more quickly and with far fewer participants than a standard Phase III trial. While HCT efficacy results do not traditionally provide sufficient basis for licensure on their own, they could allow us to (1) more quickly weed out disappointing vaccine candidates or (2) promote the development of promising candidates in conjunction with traditional Phase III studies. In addition, by gathering detailed data on the process of infection and vaccine protection in a clinical setting, researchers could learn information that proves extremely useful for broader vaccine and therapeutic development efforts. Altogether, there are scenarios in which the speed of HCTs and the richness of the data they provide accelerate the development of an effective and broadly accessible COVID-19 vaccine, with thousands of lives spared (depending on the pandemic’s long-term trajectory).

1Day Sooner

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