When could human challenge trials be deployed to combat emerging infectious diseases? Lessons from the case of a Zika virus human challenge trial

R Palacios, SK Shah - Trials, 2019 - Springer
… In light of the need to consider ethical issues proactively as a part of epidemic preparedness,
we use the case of a Zika virus HCT to explore whether and when HCTs might be ethically

[HTML][HTML] Ethical challenges posed by human infection challenge studies in endemic settings

MJ Selgelid, E Jamrozik - Indian journal of medical ethics, 2018 - ncbi.nlm.nih.gov
… are both scientific and ethical reasons to consider conducting … , the results of separate human
challenge studies helped (i) … in discussion of potential HCS with Zika virus(10); whether or …

Clinical trials of therapeutics for the prevention of congenital Zika virus disease: challenges and potential solutions

AP Salam, A Rojek, J Dunning… - Annals of internal …, 2017 - acpjournals.org
… for the Virus Zika virus has been isolated from brain tissues of human fetuses with … The
virus may be transferred via placental infection or by passage across the placenta (15), followed …

[图书][B] Human challenge studies in endemic settings: ethical and regulatory issues

E Jamrozik, MJ Selgelid - 2021 - library.oapen.org
… (i) areas of consensus regarding ethical issues and regulation in the context of LMIC HCS,
as well as (ii) unresolved … Zika virus infection experimentally induced in a human volunteer. …

Ethical issues surrounding controlled human infection challenge studies in endemic low‐and middle‐income countries

E Jamrozik, MJ Selgelid - Bioethics, 2020 - Wiley Online Library
Ethical Considerations for Zika Virus Challenge Trials does mention possible benefits of this
kind for challenge … workshop: An ethical framework for human challenge studies, organized …

COVID-19 human challenge studies: ethical issues

E Jamrozik, MJ Selgelid - The Lancet Infectious Diseases, 2020 - thelancet.com
Zika virus epidemic, the proposed human challenge studies … of an ethics consultation that
highlighted concerns regarding … Lessons from the case of a Zika virus human challenge trial. …

[HTML][HTML] Ethical approval for controlled human infectious model clinical trial protocols–A workshop report

E Jamrozik, K Littler, I Meln, W Van Molle, S Morel… - Biologicals, 2024 - Elsevier
… , and human challenge trials) are clinical studies that provide a … For the Zika virus (ZIKV), an
initial ethical review panel … a challenge model can be used to solve certain ethical issues in …

Response—Evaluating human trials: FDA's role

SK Shah, J Kimmelman, AD Lyerly, HF Lynch, FG Miller… - Science, 2018 - science.org
… review of specific protocols for Zika human challenge trials (HCTs), … knowledge about Zika
virus. However, comprehensive … ethical considerations related to a potential program of Zika

Current status of Zika virus vaccines: successes and challenges

A Pattnaik, BR Sahoo, AK Pattnaik - Vaccines, 2020 - mdpi.com
… The development of such models needs the participation of volunteers that require approval
by appropriate regulatory bodies, which should take into consideration the ethical issues as …

Human challenge trials in vaccine development

A Sekhar, G Kang - Seminars in Immunology, 2020 - Elsevier
… on ethical guidance for human challenge studies which is likely … for ethical considerations
for those planning human infection … discussions around human challenge studies for Zika virus […