New challenges emerge for planned human challenge trials. Warren Cornwall Science04 Dec 2020: Vol. 370, Issue 6521, pp. 1150 DOI: 10.1126/science.370.6521.1150 ”because there are no reliable treatments for severe COVID-19, people who volunteer to test a vaccine could die if they get sick. “
Dozens to be deliberately infected with coronavirus in UK ‘human challenge’ trials Ewen Callaway Nature . 2020 Oct;586(7831):651-652. doi: 10.1038/d41586-020-02821-4.
Human Challengeとは
Exploring human challenge studies with coronavirus to speed up COVID-19 vaccines
The Human Challenge Model is a study during which healthy volunteers are deliberately exposed to a virus, known as the “challenge virus”. This is different to standard vaccine clinical trials where volunteers are exposed to viruses naturally. The Human Challenge Model can provide a more efficient and faster way to develop vaccines as fewer volunteers are required. (About our COVID-19 volunteer trials UK COVID CHALLENGE)
Scientists will expose a small group of unvaccinated volunteers (somewhere between 50 and 90 people) to a very low dose of the virus, gradually increasing it until they find “the Goldilocks dose” — enough to infect most participants, but not enough to make them very ill. (The UK is about to start deliberately infecting volunteers with Covid-19 to test vaccines A “human challenge trial” just received ethics approval. Here’s what data it might provide — and why it’s very controversial. By Sigal Samuel Updated Feb 19, 2021, 1:55pm EST VOX)
Only after this initial phase concludes in the spring would the company actually inject volunteers with candidate vaccines to study their effectiveness. At that point, there would be a control group. “Half the volunteers will get a vaccine, half will get a placebo vaccine, and all of them will be exposed to the virus,” explained Andrew Catchpole, the chief scientific officer at Open Orphan, who’s conducting the study. (The UK is about to start deliberately infecting volunteers with Covid-19 to test vaccines A “human challenge trial” just received ethics approval. Here’s what data it might provide — and why it’s very controversial. By Sigal Samuel Updated Feb 19, 2021, 1:55pm EST VOX)
Covid-19: Human challenge studies will see people purposefully infected with virus BMJ 2020; 371 doi: https://doi.org/10.1136/bmj.m4101 (Published 22 October 2020) Cite this as: BMJ 2020;371:m4101
University of Oxford researchers have begun testing a COVID-19 vaccine in human volunteers in Oxford today. Around 1,110 people will take part in the trial, half receiving the vaccine and the other half (the control group) receiving a widely available meningitis vaccine. (Oxford COVID-19 vaccine begins human trial stage 23 APR 2020 University of Oxford)
In some COVID-19 vaccine trials, participants in the control group (the group receiving a placebo) are injected with a saline solution. In other trials, they receive an actual treatment. For example, in the COVID-19 vaccine developed by the University of Oxford, the control group receives a meningitis and septicaemiavaccine as a placebo. The benefit of using an actual vaccine as the placebo control is that it will cause a similar reaction at the site of the injection as the COVID-19 vaccine, such as muscle pain and soreness. (Coronavirus vaccine: why it’s important to know what’s in the placebo September 22, 2020 4.14am AEST The Conversation)
Human Challengeという手法自体は、古い歴史があるようですが、新型コロナウイルスのワクチンでやっていいことなのかどうかに関しては、賛否両論ありかなり白熱した議論があるようです。昨年来、賛成派、反対派両者から多数の論文が出版されていました。
Debate arises over human challenge trials in race to develop Covid-19 vaccine 2020/05/22 CNBC Television
Scientists Split Over Safety Of Coronavirus Human Challenge Trials For Vaccine | NBC News NOW 2020/08/19 NBC News
COVID-19 and the ethics of human challenge trials. Gordijn B, Ten Have H. Med Health Care Philos. 2021 Mar;24(1):1-2. doi: 10.1007/s11019-021-10001-y.
Human Challenge Studies With Wild-Type Severe Acute Respiratory Sydrome Coronavirus 2 Violate Longstanding Codes of Human Subjects Research Stanley M Spinola, Camilla Broderick, Gregory D Zimet, Mary A Ott Open Forum Infectious Diseases, Volume 8, Issue 1, January 2021 https://doi.org/10.1093/ofid/ofaa615 Published: 28 December 2020 Open Forum Infectious Diseases
Immunological considerations for SARS-CoV-2 human challenge studies Alexander D Douglas, Adrian V S Hill Nat Rev Immunol . 2020 Dec;20(12):715-716. doi: 10.1038/s41577-020-00472-0.
Coronavirus Human Infection Challenge Studies: Assessing Potential Benefits and Risks Euzebiusz Jamrozik, George S Heriot, Michael J Selgelid J Bioeth Inq . 2020 Dec;17(4):709-715. doi: 10.1007/s11673-020-10030-x. Epub 2020 Aug 25.
Key criteria for the ethical acceptability of COVID-19 human challenge studies: Report of a WHO Working Group. Jamrozik E, Littler K, Bull S, Emerson C, Kang G, Kapulu M, Rey E, Saenz C, Shah S, Smith PG, Upshur R, Weijer C, Selgelid MJ; WHO Working Group for Guidance on Human Challenge Studies in COVID-19. Vaccine. 2021 Jan 22;39(4):633-640. doi: 10.1016/j.vaccine.2020.10.075. Epub 2020 Oct 28.
Human Challenge Studies Are Unlikely to Accelerate Coronavirus Vaccine Licensure Due to Ethical and Practical IssuesJ Infect Dis . 2020 Oct 1;222(9):1572-1574. doi: 10.1093/infdis/jiaa457.
COVID-19 human challenge studies: ethical issues Euzebiusz Jamrozik, Michael J Selgelid Lancet Infect Dis . 2020 Aug;20(8):e198-e203. doi: 10.1016/S1473-3099(20)30438-2. Epub 2020 May 29.
Ethical guidelines for deliberately infecting volunteers with COVID-19 Adair D Richards J Med Ethics . 2020 Aug;46(8):502-504. doi: 10.1136/medethics-2020-106322. Epub 2020 May 27.
COVID-19 vaccine development: Time to consider SARS-CoV-2 challenge studies? G Owen Schaefer, Clarence C Tam, Julian Savulescu, Teck Chuan Voo Vaccine . 2020 Jul 14;38(33):5085-5088. doi: 10.1016/j.vaccine.2020.06.007. Epub 2020 Jun 4.
Severe Acute Respiratory Syndrome Coronavirus 2 Human Challenge Trials: Too Risky, Too Soon Liza Dawson, Jake Earl, Jeffrey Livezey J Infect Dis . 2020 Jul 6;222(3):514-516. doi: 10.1093/infdis/jiaa314.
Why Challenge Trials of SARS-CoV-2 Vaccines Could Be Ethical Despite Risk of Severe Adverse Events Nir Eyal Ethics Hum Res . 2020 Jul;42(4):24-34. doi: 10.1002/eahr.500056. Epub 2020 May 22.
Why we (probably) must deliberately infect Adam J Kolber J Law Biosci. 2020 May 11;7(1):lsaa024. doi: 10.1093/jlb/lsaa024. eCollection Jan-Jun 2020.
Good news for tens of thousands of volunteers in the COVID-19 vaccine trials: Many of those who received a placebo are now being offered a vaccine — in some cases, earlier than they would otherwise have been eligible. (Vaccine trial participants who received placebo now hop the line for the real thing from Pfizer, Moderna By JUDY PERES CHICAGO TRIBUNE | JAN 14, 2021 AT 5:16 PM)
Diabetics and health care professionals use bolus to refer to a dosage of fast-acting insulin with a meal (as opposed to basal rate, which is a dose of slow-acting insulin or the continuous pumping of a small quantity of fast-acting insulin to cover the glucose output of the liver). (Bolus Wikipedia)
Orchiectomy is the name given to the surgical procedure to remove the testicles. The procedure is considered a type of hormone therapy, since its main purpose is to reduce the production of testosterone by the body. There are two types of orchiectomy. During a simple orchiectomy, the surgeon removes both testicles by making an incision in the front of the scrotum, while a subcapsular orchiectomy consists of the removal of the tissue from the lining of the testicles, which is where testosterone is produced. In either of the cases, both the penis and the scrotum remain intact.
男性ホルモンの産生場所と前立腺癌のホルモン治療
Hormone therapy can be conducted with drugs or surgery.
Testosterone and dihydrotestosterone (DHT) are the two main male sex hormones and are called androgens.
Androgens are produced by the testicles, adrenal gland and prostate cancer tumor itself