Search

The world's first coronavirus disease 2019 human challenge trial using the D614G strain of severe acute respiratory syndrome 2 (SARS-CoV-2) is underway in the United Kingdom. The Wellcome Trust is funding challenge stock preparation of the Beta and Delta variant for a follow-up human challenge trial, and researchers at hVIVO are considering conducting these trials. However, little has been written thus far about the ethical justifiability of human challenge trials with SARS-CoV-2 variants of concern. We explore 2 specific characteristics of some variants that may initially be thought to make such trials unethical and conclude that SARS-CoV-2 variant challenge trials can remain ethical. [ABSTRACT FROM AUTHOR]

Controlled human challenge trials of SARS-CoV-2 vaccine candidates could accelerate the testing and potential rollout of efficacious vaccines. By replacing conventional phase 3 testing of vaccine candidates, such trials may subtract many months from the licensure process, making efficacious vaccines available more quickly. Obviously, challenging volunteers with this live virus risks inducing severe disease and possibly even death. However, we argue that such studies, by accelerating vaccine evaluation, could reduce the global burden of coronavirus-related mortality and morbidity. Volunteers in such studies could autonomously authorize the risks to themselves, and their net risk could be acceptable if participants comprise healthy young adults, who are at relatively low risk of serious disease following natural infection, if they have a high baseline risk of natural infection, and if during the trial they receive frequent monitoring and, following any infection, the best available care. [ABSTRACT FROM AUTHOR]

Ethical guidelines and recommendations for human subjects research typically focus on protecting the individuals who directly participate in that research. However, additional people, including sex partners of research participants, can also face harms and burdens from medical studies. In human immunodeficiency virus (HIV) cure-related research, a persistent ethical and practical challenge surrounds the use of analytical antiretroviral treatment interruptions. The challenge is usually discussed in relation to risks to study participants, but serious dangers accrue to nonparticipants, including sex partners of study participants. This multidisciplinary supplement relays the risks for nonparticipating sex partners in HIV cure-related studies and addresses the ethical dilemmas raised by these studies, with recommendations for researchers, advocates, sponsors, and oversight bodies. [ABSTRACT FROM AUTHOR]

Some HIV remission studies include a treatment interruption that seriously risks infecting participants' sex partners with HIV. What, ethically, is owed to these nonparticipants? Until greater certainty emerges on what protections should be afforded nonparticipants of research studies, what I call a "low-hanging fruit" approach may help researchers and review bodies determine how to address infection risks to nonparticipants in these studies. [ABSTRACT FROM AUTHOR]

This commentary considers an extreme idea for protecting against human immunodeficiency virus (HIV) transmission to sex partners of individuals participating in HIV remission studies with an analytical treatment interruption (ATI). Other human challenge studies, such as studies of influenza, commonly isolate participants during the trial, to protect their contacts and the community against infection. Why should HIV studies with a treatment interruption be any different, one might wonder? This article concludes that isolation should not be used in HIV remission studies with an ATI but also shows that the matter is complex. [ABSTRACT FROM AUTHOR]

Only a few of the recommendations made in this supplement are implemented in ongoing HIV remission studies that involve an analytical treatment interruption. The absence of these recommendations in protocols puts sexual partners of study participants at serious risk. This paper addresses one possible barrier to implementation: a certain misunderstanding among sponsors and research entities. [ABSTRACT FROM AUTHOR]