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Old 10-20-2020, 01:58 AM   #61
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On the radio this morning they announced that the UK is going to proceed with challenge trials, beginning in January.

https://www.nature.com/articles/d41586-020-02821-4

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Young, healthy people will be intentionally exposed to the virus responsible for COVID-19 in a first-of-its kind Ďhuman challenge trialí, the UK government and a company that runs such studies announced on 20 October. The experiment, set to begin in January in a London hospital if it receives final regulatory and ethical approval, aims to accelerate the development of vaccines that could end the pandemic.

Human challenge trials have a history of providing insight into diseases such as malaria and influenza. The UK trial will try to identify a suitable dose of the SARS-CoV-2 virus that could be used in future vaccine trials. But the prospect of deliberately infecting people ó even those at low risk of severe disease ó with SARS-CoV-2, a deadly pathogen that has few proven treatments, is uncharted medical and bioethical territory.
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UK Researchers to Deliberately Infect Participants with Covid-19 For Vaccine Trial
Old 10-21-2020, 10:05 AM   #62
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UK Researchers to Deliberately Infect Participants with Covid-19 For Vaccine Trial

Some sucker hero volunteers will be human guinea pigs in January, taking a trial vaccine, then getting purposefully infected with Covid-19 to see what happens.

Desperate times calls for desperate measures, I guess .

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Researchers in the United Kingdom will deliberately infect 90 healthy volunteers with COVID-19 to study the virus and potentially speed up development of a vaccine, a type of trial that Harvard investigators have said could ease the global death burden.

Imperial College London and a group of researchers said Tuesday that they are preparing a human challenge study, a type of research used infrequently because some question the ethics of infecting otherwise healthy individuals.

...

The Imperial College partnership plans to begin work in January, with results expected by May. Before any research begins, the study must be approved by ethics committees and regulators.
In the first phase of the study, researchers will expose paid volunteers to the virus using nasal drops in an effort to determine the smallest level of exposure needed to cause COVID-19.


The studies don’t come without significant ethical considerations, as noted by Lipsitch and his colleagues in their article.
https://www.msn.com/en-us/health/med...al/ar-BB1aehMq
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Old 10-21-2020, 10:56 AM   #63
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From the article, I gathered that the volunteers are nearly all, if not all, young people, who hope and expect that the risk to them of contracting COVID-19 is not very high.

That said, there is risk (plus even a "bad cold" is nothing to mess with) and I am amazed by these young people's altruism.

For some reason, I am reminded of a casual conversation at work some 10 years ago. I was the boss. The subject arose of astronauts going to Mars, to try to survive, probably for decades, until technology advanced to be able to go and bring them back. Everyone but the youngest team members (an 18-year-old woman and 22-year-old man) opined that no astronaut would want to take such a chance and be away from Earth for such a large part of their lives, possibly dying on Mars.

The two young people enthusiastically said they would want to be on the first mission! It would be so cool in and of itself, they agreed, and it would be doing something for mankind.

They were serious! Both were intelligent, and I knew they each planned to get married and raise families. I wonder what they would say about it nowadays.
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Old 10-21-2020, 12:24 PM   #64
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Another speed bump in the Oxford AstraZeneca trial. Someone who volunteered for the trial in Brazil died.

https://www.cnbc.com/2020/10/21/astr...tudy-dies.html
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Old 10-22-2020, 11:58 AM   #65
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Another speed bump in the Oxford AstraZeneca trial. Someone who volunteered for the trial in Brazil died.

https://www.cnbc.com/2020/10/21/astr...tudy-dies.html
That someone died is tragic.

The good news is the volunteer received the placebo, not the vaccine.

https://www.scmp.com/news/world/amer...cine-test-dies
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Aztrazeneca resumes covid trial- good news
Old 10-23-2020, 05:53 PM   #66
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Aztrazeneca resumes covid trial- good news

JNJ also.

https://www.cnn.com/2020/10/23/healt...mes/index.html
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Old 10-24-2020, 04:54 PM   #67
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I tried to sign up for the JNJ trial but they said that they had no clinics in my area.

The JNJ vaccine is what I want when offered.
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Old 10-24-2020, 05:04 PM   #68
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Originally Posted by easysurfer View Post
Some sucker hero volunteers will be human guinea pigs in January, taking a trial vaccine, then getting purposefully infected with Covid-19 to see what happens.

Desperate times calls for desperate measures, I guess .
I was wondering how Covid trials would determine how effective the vaccine is. I do phase 1 clinical drug trials for a living so have taken dozens of developemental drugs and even I would likely not voluntarily be infected with the virus that causes Covid-19.
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Old 10-24-2020, 05:16 PM   #69
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I was wondering how Covid trials would determine how effective the vaccine is. I do phase 1 clinical drug trials for a living so have taken dozens of developemental drugs and even I would likely not voluntarily be infected with the virus that causes Covid-19.
I think there are at least two methods for determining effectiveness:

1. A larger sample size (say, N=30,000 to 60,000) where they randomly vaccinate half and placebo the other half, then just wait for three months and see how many people get infected in each half. I think this is the majority of vaccine trials for coronavirus.

2. A smaller sample size (N=1000?) where they randomly vaccinate half and placebo the other half, then deliberately expose a large portion (or all?) to the coronavirus and see who gets infected in each half. This is a challenge trial and is the kind described by the previous poster. I am only aware of one of these for coronavirus, and it is in England IIRC, not the US. I don't think the FDA would approve a challenge trial for coronavirus for the reason you allude to - it's probably too dangerous.
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Old 10-25-2020, 03:33 AM   #70
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Originally Posted by SecondCor521 View Post
I think there are at least two methods for determining effectiveness:

1. A larger sample size (say, N=30,000 to 60,000) where they randomly vaccinate half and placebo the other half, then just wait for three months and see how many people get infected in each half. I think this is the majority of vaccine trials for coronavirus.

2. A smaller sample size (N=1000?) where they randomly vaccinate half and placebo the other half, then deliberately expose a large portion (or all?) to the coronavirus and see who gets infected in each half. This is a challenge trial and is the kind described by the previous poster. I am only aware of one of these for coronavirus, and it is in England IIRC, not the US. I don't think the FDA would approve a challenge trial for coronavirus for the reason you allude to - it's probably too dangerous.

Exactly right I think. Step 1 above works best in areas of high infection. Step 2 is guaranteed that volunteers will be exposed but you canít use vulnerable folks as that could well be bad for them if the vaccine doesnít work Exposures are given I believe by spraying up the nostrils.
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Old 10-25-2020, 04:26 AM   #71
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Exactly right I think. Step 1 above works best in areas of high infection. Step 2 is guaranteed that volunteers will be exposed but you canít use vulnerable folks as that could well be bad for them if the vaccine doesnít work Exposures are given I believe by spraying up the nostrils.
Thatís tough, because you really donít know who is vulnerable until after the fact. You only have rough probabilities.
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Old 10-25-2020, 04:41 AM   #72
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Human challenge trials increase risk for the enrolled participants but reduce it for the population at large. If enrollees have an adequate awareness of their risk the trade off is positive.
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Old 10-25-2020, 05:49 AM   #73
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Thatís tough, because you really donít know who is vulnerable until after the fact. You only have rough probabilities.
Yes indeed, which is why they are not normally used.

Only having only young, fit, test subjects, the best you can hope to see is a good reaction to the vaccine in terms of the production of anti-bodies and T-cells and the subject not getting sick. The vaccine may have the same good reaction to vulnerable subjects who may still get sick.
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Old 10-25-2020, 06:06 AM   #74
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Human challenge trials increase risk for the enrolled participants but reduce it for the population at large. If enrollees have an adequate awareness of their risk the trade off is positive.
Spock says: "Logic clearly dictates that the needs of the many outweigh the needs of the few."

Thank you to these volunteers!

So are the challenge trials being done with placebo too? I mean, that's really the only good way, right? Man, that means a good portion of folks will be getting it. I think it will also be interesting to see who in placebo don't get it, despite the viral dose. A lot will be learned from such an aggressive study.
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Old 10-25-2020, 07:13 AM   #75
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Spock says: "Logic clearly dictates that the needs of the many outweigh the needs of the few."

Thank you to these volunteers!

So are the challenge trials being done with placebo too? I mean, that's really the only good way, right? Man, that means a good portion of folks will be getting it. I think it will also be interesting to see who in placebo don't get it, despite the viral dose. A lot will be learned from such an aggressive study.
Placebos will almost certainly be used.


https://www.nature.com/articles/d41586-020-02821-4

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The precise design of the study has not been finalized. But it is likely that a small number of participants will receive a very low dose of a SARS-CoV-2 ‘challenge strain’ derived from a currently circulating virus and grown under stringent conditions. If none or few of the participants become infected, the researchers will seek permission from an independent safety monitoring board to expose participants to higher doses. This process will be repeated until researchers identify a dose that infects most of those exposed, says Catchpole.

Once an appropriate dose is identified, Open Orphan could be asked to run a series of challenge trials testing several vaccines. Catchpole says that the design of these trials, including which vaccines will be included, has not been determined. He envisions that some trial participants will receive a placebo injection instead of a vaccine, but he also says that head-to-head trials comparing two or more vaccines could be run. Other vaccine studies that the company runs typically enrol 40–50 volunteers for each trial arm, he says.
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Old 10-25-2020, 07:30 AM   #76
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Thatís tough, because you really donít know who is vulnerable until after the fact. You only have rough probabilities.
This is very true. My Mom knows a family who had a Father and Son get infected. Both healthy, the Father had minimal symptoms but the Son had to go into ICU and barely survived. He was in his 20's and healthy so you don't know who is vulnerable. Very dangerous to intentionally get infected
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Old 10-25-2020, 07:31 AM   #77
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I can't imagine how any IRB would approve purposefully infecting non-vaccinated humans, no matter how low the chances of serious disease progression.


That being said, if I were on the board, and we thought we could get willing participants, I'd be leading the charge!
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Old 10-25-2020, 07:41 AM   #78
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Placebos will almost certainly be used.


https://www.nature.com/articles/d41586-020-02821-4
Wow! They are going to start the study by making sure people get it.
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Old 10-25-2020, 07:54 AM   #79
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From the article, I gathered that the volunteers are nearly all, if not all, young people, who hope and expect that the risk to them of contracting COVID-19 is not very high.
Maybe I have this wrong, but I didn't think the risk of contracting the virus is lower for young people, or maybe just slightly/somewhat less, but that the frequency of bad outcomes from contracting it is way way way lower than for old folks.
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Old 10-25-2020, 07:59 AM   #80
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Some sucker hero volunteers will be human guinea pigs in January, taking a trial vaccine, then getting purposefully infected with Covid-19 to see what happens.

Desperate times calls for desperate measures, I guess .
Great that there are people willing to take risk for the benefit of the rest of us. Heroes I say.
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