Journal of Clinical Trials

Journal of Clinical Trials
Open Access

ISSN: 2167-0870

+44 7868 792050

Editorial - (2020)

Human Challenge Trial and Expedite Vaccine Development: Ethical Issues

Hendri S*
*Correspondence: Hendri S, Department of Clinical Center, Medical University, Moscow, Russia, Email:

Author info »


In light of the present COVID-19 crisis, we are seeing an intense specialise in the question of how soon we will make a vaccine available to guard the general public from the novel SARS-CoV-
2 coronavirus. Typically, developing a vaccine against any illness can take years and many dollars, and in some cases we still might not have complete success [1] for instance , we've a vaccine for influenza, but it's not a universal vaccine; there's no vaccine for HIV, even after decades of research.

Human Challenge Trial

According to the WHO, HCTs are “trials during which participants are intentionally challenged (whether or not they need been vaccinated) with an communicable disease organism. This challenge organism could also be on the brink of wild-type and pathogenic, adapted and/or attenuated from wild-type with less or no pathogenicity, or genetically modified in some manner.”

Person's Challenge Trial

The purpose of an HCT is that the same as that of animal challenge studies and models, with the added advantage of studying the potential drug vaccine candidates directly in humans during a controlled environment. This enables the research community to screen potential drug vaccine candidates and move the foremost promising candidates to larger trials [2].

Ethical Considerations

Public engagement can help to assess the local acceptability of human challenge studies, maximise transparency by responding to any community concerns, and elucidate the potential effect of research on the community [3].

The ethical acceptability of COVID-19 human challenge studies would be in part contingent on there being potential benefits (for public health or for participants) that outweigh the expected risks. Important potential benefits to public health include those arising from the acceleration of vaccine development, the development of more effective vaccines, and the improvement of relevant scientific knowledge that can inform public health practice results regarding correlates of protection or the risks of transmission from asymptomatic individuals [4].


All of this could be done supported what challenge agent the Challenge Unit plans to figure with, so it's important to possess agile facilities which will adapt to the various requirements of various organisms being studied. It is additionally important for the operational team to understand the bounds of its facilities and resources, and to never comply with study an organism that's incompatible with the grade of the facilities. Know your expertise, but also know your limitations [5].


  1. Knezevic I, Moorthy V, Sheets RL. WHO consultation on clinical evaluation of vaccines. JAMA.2015;33(17):1999-2003.
  2. Catchpole A, Fullen D, Noulin N, Mann A, Gilbert A, Lanbkin- Williams R. The Manufacturing of Human Viral Challenge Agents for Use in Clinical Studies to Accelerate the Drug Development Process. BMC.2009;22:620.
  3. Jamrozik E, Selgelid MJ. COVID-19 human challenge studies: ethical issues. Lancet Infect Dis. 2020;20(8):e198
  4. Lakdawala SS, Menachery VD. The search for a COVID-19 animal model. Science. 2020;368:942
  5. Docea AO, Tsatsakis A, Albulescu D, Cristea O, Zlatian O, Vinceti M, et al. A new threat from an old enemy: re-emergence of coronavirus (review). Int J Mol Med. 2020;45:1631

Author Info

Hendri S*
Department of Clinical Center, Medical University, Moscow, Russia

Citation: Hendri S (2020) Human Challenge Trial and Expedite Vaccine Development. J Clin Trials. S4:e002

Received: 27-Oct-2020 Accepted: 12-Nov-2020 Published: 20-Nov-2020 , DOI: 10.35248/2167-0870.20.S4.e002

Copyright: © 2020 Hendri S. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.