The Case for Human Challenge Trials in COVID-19

Ambuehl, S., A. Ockenfels, and A.E. Roth. 2020. Payment in challenge studies from an economics perspective. Journal of Medical Ethics 46(12): 831–832.

Article  PubMed  Google Scholar 

Anomaly, J., and J. Savulescu. 2019. Compensation for cures: Why we should pay a premium for participation in “challenge studies” Bioethics 33(7): 792–797.

Article  PubMed  PubMed Central  Google Scholar 

Blumenthal-Barby, J., and P. Ubel. 2021. Payment of COVID-19 challenge trials: Underpayment is a bigger worry than overpayment. Journal of Medical Ethics 47(8): 585–586.

Article  PubMed  Google Scholar 

Bull, S., E. Jamrozik, A. Binik, and M.J. Parker. 2020. SARS-CoV-2 challenge studies: Ethics and risk minimisation. Journal of Medical Ethics 47(12): e79.

Article  PubMed  Google Scholar 

Calina, D., T. Hartung, A.O. Docea, et al. 2020. COVID-19 vaccines: Ethical framework concerning human challenge studies. Daru 28(2): 807–812.

Article  PubMed  PubMed Central  Google Scholar 

Callow, K.A. 1985. Effect of specific humoral immunity and some non-specific factors on resistance of volunteers to respiratory coronavirus infection. Epidemiology and Infection 95(1): 173–189.

CAS  Google Scholar 

Chan, S. 2021. Vaccine policy, challenge trials, and the ethics of relative risk. New St Cross Ethics Seminars. The Oxford Uehiro Centre for Practical Ethics, University of Oxford. https://youtu.be/9ZKFqeJzvWM. Accessed 31 May 2022.

Clift, A.K., C.A.C. Coupland, R.H. Keogh, et al. 2020. Living risk prediction algorithm (QCOVID) for risk of hospital admission and mortality from coronavirus 19 in adults: National derivation and validation cohort study. BMJ 371: m3731.

Article  PubMed  Google Scholar 

Crameri, G.A.G., M. Bielecki, R. Zust, T. W. Buehrer, Z. Stanga, and J. W. Deuel. 2020. Reduced maximal aerobic capacity after COVID-19 in young adult recruits, Switzerland, May 2020. Eurosurveillance 25(36): 2001542.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Cutter, L. 2016. Walter Reed, yellow fever, and informed consent. Military Medicine 181(1): 90–91.

Article  PubMed  Google Scholar 

Davis, H.E., L. McCorkell, J. Moore Vogel, and E.J. Topol. 2023. Long COVID: Major findings, mechanisms and recommendations. Nature Reviews Microbiology 21(3): 133–146.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Dawson, L., J. Earl, and J. Livezey. 2020. Severe Acute Respiratory Syndrome Coronavirus 2 human challenge trials: Too risky, too soon. Journal of Infectious Diseases 222(3): 514–516.

Article  CAS  PubMed  Google Scholar 

Department for Business Energy & Industrial Strategy. 2021 VTF objectives and membership of the steering group. Department of Business Energy and Industrial Strategy, United Kingdom https://www.gov.uk/government/publications/the-vaccine-taskforce-objectives-and-membership-of-steering-group/vtf-objectives-and-membership-of-the-steering-group. Accessed 31 May 2022.

Department for Business, Energy & Industrial Strategy, and Kwasi Kwarteng. 2021. World’s first coronavirus Human Challenge study receives ethics approval in the UK. February 17. Department for Business Energy and Industrial Strategy, United Kingdom. https://www.gov.uk/government/news/worlds-first-coronavirus-human-challenge-study-receives-ethics-approval-in-the-uk. Accessed 31 May 2022.

Desai, A.D., M. Lavelle, B.C. Boursiquot, and E.Y. Wan. 2022. Long-term complications of COVID-19. American Journal of Physiology—–Cell Physiology 322(1): C1–C11.

Article  CAS  PubMed  Google Scholar 

Douaud, G., S. Lee, F. Alfaro-Almagro, et al. 2022. SARS-CoV-2 is associated with changes in brain structure in UK Biobank. Nature 604(7907): 697–707.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Eyal, N. 2020. Why challenge trials of SARS-CoV-2 vaccines could be ethical despite risk of severe adverse events. Ethics of Human Research 42(4): 24–34.

Article  Google Scholar 

Fernandez Lynch, H., and E.A. Largent. 2020. Compensating for research risk: Permissible but not obligatory. Journal of Medical Ethics 46(12): 827–828.

Article  PubMed  Google Scholar 

Freckelton, I. 2021. Human challenge trials: Ethical and legal issues for COVID-19 Research. Journal of Law and Medicine 28(2): 311–322.

PubMed  Google Scholar 

Gordijn, B., and H. Ten Have. 2021. COVID-19 and the ethics of human challenge trials. Medicine, Health Care and Philosophy 24(1): 1–2.

Article  PubMed  Google Scholar 

Grimwade, O., J. Savulescu, A. Giubilini, et al. 2020. Payment in challenge studies: Ethics, attitudes and a new payment for risk model. Journal of Medical Ethics 46(12): 815–826.

Article  PubMed  Google Scholar 

Halpern, S.D., J.H. Karlawish, D. Casarett, J.A. Berlin, and D.A. Asch. 2004. Empirical assessment of whether moderate payments are undue or unjust inducements for participation in clinical trials. Archives of Internal Medicine 164(7): 801–803.

Article  PubMed  Google Scholar 

Hammond, J., H. Leister-Tebbe, A. Gardner, … et al. 2022. Oral Nirmatrelvir for high-risk, nonhospitalized adults with COVID-19. New England Journal of Medicine 386(15): 1397–1408.

Article  CAS  PubMed  Google Scholar 

Heriot, G.S., and E. Jamrozik. 2021. Not in my backyard: COVID-19 vaccine development requires someone to be infected somewhere. Medical Journal of Australia 214(4): 150–152.e1.

Article  PubMed  Google Scholar 

Higgins, P.G., R.J. Phillpotts, G.M. Scott, J. Wallace, L.L. Bernhardt, and D.A. Tyrrell. 1983. Intranasal interferon as protection against experimental respiratory coronavirus infection in volunteers. Antimicrobial Agents and Chemotherapy 24(5): 713–715.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Ioannidis, J.P.A., M. Salholz-Hillel, K.W. Boyack, and J. Baas. 2021. The rapid, massive growth of COVID-19 authors in the scientific literature. Royal Society Open Science 8(9): 210389.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Jamrozik, E., K. Littler, S. Bull, et al. 2021. Key criteria for the ethical acceptability of COVID-19 human challenge studies: Report of a WHO Working Group. Vaccine 39(4): 633–640.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Jamrozik, E., and M.J. Selgelid. 2020a. COVID-19 human challenge studies: Ethical issues. Lancet Infectious Diseases 20(8): e198–e203.

Article  CAS  PubMed  Google Scholar 

____ and ____ 2020b. Ethical issues surrounding controlled human infection challenge studies in endemic low-and middle-income countries. Bioethics 34(8): 797–808.

Article  PubMed  PubMed Central  Google Scholar 

____ and ____ 2020c. Human infection challenge studies in endemic settings and/or low-income and middle-income countries: Key points of ethical consensus and controversy. Journal of Medical Ethics 46(9): 601–609.

Article  PubMed  Google Scholar 

Jin, C., M.M. Gibani, M. Moore, et al. 2017. Efficacy and immunogenicity of a Vi-tetanus toxoid conjugate vaccine in the prevention of typhoid fever using a controlled human infection model of Salmonella Typhi: A randomised controlled, phase 2b trial. Lancet 390(10111): 2472–2480.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Jones, J.H. 2011. The Tuskegee syphilis experiment. In The Oxford textbook of clinical research ethics, edited by E.J. Emanuel, C. Grady, R.A. Crouch, K. Lie Reidar, G. Miller Franklin, and D. Wendler, 86–96. Oxford: Oxford University Press.

Google Scholar 

Kahn, J.P., L.M. Henry, A.C. Mastroianni, W.H. Chen, and R. Macklin. 2020. Opinion: For now, it’s unethical to use human challenge studies for SARS-CoV-2 vaccine development. Proceedings of the National Academy of Sciences USA 117(46): 28538-28542.

Article  CAS  Google Scholar 

Kester, K.E., D.A. McKinney, N. Tornieporth, et al. 2001. Efficacy of recombinant circumsporozoite protein vaccine regimens against experimental Plasmodium falciparum malaria. Journal of Infectious Diseases 183(4): 640–647.

Article  CAS  PubMed  Google Scholar 

Khan, W.H., Z. Hashmi, A. Goel, et al. 2021. COVID-19 pandemic and vaccines update on challenges and resolutions. Frontiers in Cell and Infection Microbiology 11: 690621.

Article  CAS  Google Scholar 

Killingley, B., A.J. Mann, M. Kalinova, et al. 2022. Safety, tolerability and viral kinetics during SARS-CoV-2 human challenge in young adults. Nature Medicine 28(5): 1031–1041.

Article  CAS  PubMed  Google Scholar 

Kolber, A.J. 2020. Why we (probably) must deliberately infect. Journal of Law and the Biosciences 7(1). https://doi.org/10.1093/jlb/lsaa024.

Levine, M.M., S. Abdullah, Y. M. Arabi, et al. 2021. Viewpoint of a WHO Advisory Group Tasked to Consider Establishing a Closely-monitored Challenge Model of Coronavirus Disease 2019 (COVID-19) in Healthy Volunteers. Clinical Infectious Diseases 72(11): 2035–2041.

Article  CAS  PubMed  Google Scholar 

MacLennan, C.A., and A. Saul. 2014. Vaccines against poverty. Proceedings of the National Academy of Sciences USA 111(34): 12307–12312.

Article  CAS  Google Scholar 

Macnaughton, M.R., H.J. Hasony, M.H. Madge, and S.E. Reed. 1981. Antibody to virus components in volunteers experimentally infected with human coronavirus 229E group viruses. Infection and Immunity 31(3): 845–849.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Manheim, D., and Team Day Sooner Research. 2021. Evolving ethics of COVID-19 challenge trials. Lancet Infectious Diseases 21(4): e79.

Article  CAS  PubMed  Google Scholar 

Manheim, D., W. Wiecek, V. Schmit, J. Morrison, and Team Day Sooner Research. 2021. Exploring risks of human challenge trials for COVID-19. Risk Analysis 41(5):

留言 (0)

沒有登入
gif