Vaccine Trials

[aaronc879]

That’s tough, because you really don’t 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

 

[sengsational]

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!

 

[JoeWras]

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.

 

[gerntz]

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.

 

[gerntz]

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.

 

[gerntz]

Another speed bump in the Oxford AstraZeneca trial. Someone who volunteered for the trial in Brazil died.

https://www.cnbc.com/2020/10/21/ast...ys-volunteer-in-covid-vaccine-study-dies.html

I can't see that the person was infected with the virus such that the cause of death may have been something else.

 

[braumeister]

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.

That does seem to be the case. A good recent piece in New Scientist magazine discussed the risks. Might be behind a paywall, but the gist of it was that

getting COVID-19 doubles your normal annual risk of dying -- still very low if you are young, but higher the older you get.

According to MIT,

116 people in 1,000 in their mid-70s and older are likely to die if infected. That compares with less than 1 person in 1,000 for people under 50.

And even if personal risk is low, the risk that you may spread the infection to other more vulnerable people remains.

https://www.newscientist.com/article/mg24833050-700-your-covid-19-risk-how-to-navigate-this-new-world-of-uncertainty/?utm_source=nsnew&utm_medium=email&utm_campaign=NSNEW_221020

 

[Chuckanut]

Placebos will almost certainly be used.


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

I am curious. Is there any attempt to make the placebo duplicate some of the minor problems of getting the shot. For example, if the vaccine shot might cause swelling and itching at the injection site, do they put something into some of placebos to cause a bit of swelling and itching at the shot location?

 

[Alan]

I am curious. Is there any attempt to make the placebo duplicate some of the minor problems of getting the shot. For example, if the vaccine shot might cause swelling and itching at the injection site, do they put something into some of placebos to cause a bit of swelling and itching at the shot location?

Good question and the article doesn’t go into those sorts of details. With the phase 3 trials currently underway on 30,000 subjects I think this particular side effect will be investigated there.

They are only testing on 40 to 50 folks, giving small, then increasing doses of the vaccine to see what levels of vaccine produce the anti-viral responses they are looking for.

 

[JoeWras]

I am curious. Is there any attempt to make the placebo duplicate some of the minor problems of getting the shot. For example, if the vaccine shot might cause swelling and itching at the injection site, do they put something into some of placebos to cause a bit of swelling and itching at the shot location?

That is a good question. I'd like to know. I did my part to help the placebo effect in the following way...

A friend is in a trial. She announced to us that she is so glad she got the vaccine instead of the placebo. We asked, "How do you know?" She said, "My arm felt like it was going to fall off. I know I got it."

So, we asked her if maybe the placebo had something else in it to cause pain? It sewed some doubt in her mind.

 

[MichaelB]

This podcast includes a short discussion on clinical trials and if enrollees know or can figure out what they are getting. The interviewee is epidemiologist Saad Omer of Yale University and the podcast producer is Stat News, a magazine specialized in biotech. The magazine is subscription and very high news quality, their COVID articles are free, as is the podcast. https://www.statnews.com/2020/10/01...ls-risk-intermittent-fasting-data-disappoint/

 

[JoeWras]

This article goes into a bit more detail on placebos used in the trials.

https://theconversation.com/coronav...important-to-know-whats-in-the-placebo-146365

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 septicaemia vaccine 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. This prevents patients from knowing whether they are getting the placebo or the real treatment. The scientific term for hiding knowledge of who got what treatment is “blinding”.

 

[braumeister]

Just be sure you get the genuine placebo, not the generic knockoff version.

 

[JoeWras]

Just be sure you get the genuine placebo, not the generic knockoff version.

 

[sengsational]

This podcast includes a short discussion on clinical trials and if enrollees know or can figure out what they are getting.

That was a nice little discussion that helped me see the problem with this unblinding by participants guessing based on symptoms. If you follow along with the suggestions in the discussion, because the people who guess they got saline might be more careful in their distancing, and people who guess they got the real deal might be less careful in their distancing, then the study results will show both arms of the study closer to one and other (a more conservative result). If the vaccine is effective enough, I expect that this bit of 'noise' from guessing will be negligible.

 

[MuirWannabe]

Just be sure you get the genuine placebo, not the generic knockoff version.

I’ll only consider the same placebo Fauci gets.

 

[Montecfo]

Just be sure you get the genuine placebo, not the generic knockoff version.

These placebos are getting rushed to market.

 

[kyzymurgist]

Kroger announced the rollout of $25 rapid antibody tests. This could adversely affect the vaccine trials by providing a cheap way for test subjects to unblind the trials.

DW and I will probably do this as soon as tests are available. The results will not change our behavior since we still don't know how effective any of the vaccines will be.

 

[aaronc879]

Kroger announced the rollout of $25 rapid antibody tests. This could adversely affect the vaccine trials by providing a cheap way for test subjects to unblind the trials.

DW and I will probably do this as soon as tests are available. The results will not change our behavior since we still don't know how effective any of the vaccines will be.

I have been getting rapid antibody tests as a requirement for work for months. No big deal. As far as the trial, you have the people sign paperwork agreeing not to have an antibody test done unless trial administrators ok it.

 

[kyzymurgist]

I have been getting rapid antibody tests as a requirement for work for months. No big deal. As far as the trial, you have the people sign paperwork agreeing not to have an antibody test done unless trial administrators ok it.

We were not asked to sign anything related to antibody tests. But we are in a phase 2 trial where blinding may not be as critical.

 

[JoeWras]

And now the scammers are targeting people interested in trials. With the excitement of being in a trial, people may lower their guard. Sites may ask for SS# or even bank info (your payment has to go some where, right?) during sign up. Yikes! From the FTC.

https://www.consumer.ftc.gov/blog/2...-trial-real-or-fake-learn-how-tell-difference

Preying on our natural desire to help others, scammers have created fake websites and promotional materials, posing as legitimate researchers. Their goal? To take your personal information and your money. They might promise you a doctor’s care and more than $1000 in payment...but as soon as they try to charge you for access, or ask for your Social Security, bank account, or credit card number, your Spidey sense should start tingling, because, unfortunately, some of these so-called “research studies” are fake.
...

• Legitimate clinical trials do gather information to identify ideal candidates. To screen for participants for COVID-19 trials, they might ask for your name, contact information, age, gender, race, ethnicity, or various pre-existing conditions associated with higher risk of a COVID-19-related mortality. But they should never ask you to give your Social Security number during recruitment or screening.

 

[Gumby]

From National Geographic, here is a clearly written summary of all the vaccine candidates, how they work, their current testing status and some projections as to when they could be available. https://www.nationalgeographic.com/...racker-how-they-work-latest-developments-cvd/

 

[cathy63]

From National Geographic, here is a clearly written summary of all the vaccine candidates, how they work, their current testing status and some projections as to when they could be available. https://www.nationalgeographic.com/...racker-how-they-work-latest-developments-cvd/

I also like the NYT's vaccine page (no login required): https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html

It allows you to filter by what's in phase 1, what's approved, etc.

 

[Amethyst]

I have a friend who is in one of the trials of a synthetic vaccine made to resemble the virus's protein spikes - there is no virus material in it at all.

After 2-3 months, he got tested to see if he had COVID antibodies, which he didn't. Then he remembered that the test is to see if you've been exposed to actual virus, not to see if you have antibodies for the virus spikes So he's still in the dark about whether he got vaccine or placebo. All he knows is that, either way, he hadn't been exposed to COVID-19.

Kroger announced the rollout of $25 rapid antibody tests. This could adversely affect the vaccine trials by providing a cheap way for test subjects to unblind the trials.

DW and I will probably do this as soon as tests are available. The results will not change our behavior since we still don't know how effective any of the vaccines will be.

 

[kyzymurgist]

I have a friend who is in one of the trials of a synthetic vaccine made to resemble the virus's protein spikes - there is no virus material in it at all.

After 2-3 months, he got tested to see if he had COVID antibodies, which he didn't. Then he remembered that the test is to see if you've been exposed to actual virus, not to see if you have antibodies for the virus spikes So he's still in the dark about whether he got vaccine or placebo. All he knows is that, either way, he hadn't been exposed to COVID-19.

Kroger is using the Assure COVID-19 IgG/IgM Rapid Test Device. According to Novavax, their vaccine elicits a strong IgG spike protein response in 100% of subjects after a single injection. Even more than found in convalescent plasma of Cocid-19 survivors.

So I think the Kroger test should give a positive for anyone receiving the Novavax vaccine. Their vaccine is based on the SARS-COV-2 spike protein.