Human challenge study: Difference between revisions

Revision as of 05:18, 21 June 2025

Latest revision as of 05:21, 21 June 2025

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The intent of a challenge study is to fast-track the timeline for providing evidence of safety and efficacy of a [[prescription drug|therapeutic drug]] or vaccine, especially by compressing (to a few months) the usually lengthy duration of [[Phases of clinical research|Phase{{nbsp}}II–III trials]] (typically, many years).<ref name=eyal/><ref name=callaway/><ref name="boodman">{{Cite web|url=https://www.statnews.com/2020/03/11/researchers-rush-to-start-moderna-coronavirus-vaccine-trial-without-usual-animal-testing/|title=Coronavirus vaccine clinical trial starting without usual animal data|publisher=STAT|author=Eric Boodman|date=13 March 2020|access-date=19 April 2020}}</ref> Following preliminary proof of safety and efficacy of a candidate drug or vaccine in laboratory animals and healthy humans, controlled "challenge" studies may be implemented to bypass typical Phase{{nbsp}}III research, providing an accelerated path to regulatory approval of the test compound for widespread prevention against an [[infectious disease]], such as COVID-19.<ref name=eyal/><ref name=cohen20/>

The design of a challenge study involves first, simultaneouslydeveloping and testing a well-tolerated dose of the infection. A vaccine candidate would be tested for [[immunogenicity]] and safety in laboratory animals and healthy adult volunteers (100 or fewer){{snd}}which is usually a sequential process using animals first{{snd}}and second, rapidly advancing its effective dose into a large-scale Phase{{nbsp}}II–III trial in low-risk, healthy volunteers (such as young adults), who would then be deliberately infected with the disease being tested against for comparison with a [[placebo]] control group.<ref name=eyal/><ref name=callaway/><ref name=cohen20/> In a challenge study for a vaccine to prevent an infectious disease, participants would be closely monitored for signs of [[toxicity]] and adequate [[immune response]], such as by producing substantial levels of [[antibody|antibodies]] against the virus causing the disease.<ref name=eyal/><ref name=callaway/><ref name=who-chall/>

==Ethics==