I thought this might be an interesting topic for discussion. What prompted the thought was a local news article I read this past week that indicated Moderna, a leading company in the race for a COVID vaccine, was looking for volunteers in my area to participate in a phase III clinical trial for their vaccine candidate. After a cursory review of the qualifications to participate, it appeared as though I might qualify. After much discussion with my wife I elected NOT to apply. For me the risks outweighed the potential benefit, however I think that others on this forum due to their own personal circumstances might have different views and it could prompt a lively discussion.

The upside would be that if the vaccine worked as they hope, life could return to normal for participants much sooner than for the general public, possibly as much as a year sooner. This could be a huge advantage for shoppers who are out in public everyday interacting with people and fearful of contracting the disease.

The downside, on the other hand, is that you only have a 50% chance of actually receiving the vaccine. The other 50% of participants receive a placebo and you have no way of knowing which group you are in. Also the vaccine may not be as effective as they hope which means you could be putting yourself at risk

My own view is that this might be beneficial for shoppers who are continuing to go out on shops anyway, so why not have the potential added protection. However for those, myself included, who are not currently out shopping, it could give a false since of security and put us at risk. Any thoughts?

Twenty-five years ago, with my kids grown and my health good, I likely would have considered volunteering and worked on the assumption I still should mask up when I go out until such a time as they found antibodies in my blood adequate to provide protection.

As we age, the thymus slows down on the T-cells it produces that can code the antibodies. This is why, for example, there are two varieties of the annual flu vaccine. The regular one just has enough inactive virus to cause the thymus T-cells to produce antibodies and the one for seniors that stimulates the thymus to produce T-cells that then can be taught to produce antibodies by the inactive virus.

Clinical trials generally test one variable at a time, so I suspect the vaccine they are trying will not have the materials to stimulate the thymus.

Nope, I would not do it because I have a bad heart and two different cancers. I would not qualify for the trial anyway.

No. For 2018, 197 fatal injuries from the flu shot (and over 4,000 serious injury claims filed). That's for something that's been around a long time. The number is small in comparison to those who get it -- just as the number of fatalities from the CCP Virus is small in comparison to the population. (sources: CDC VAERS page, infection2020.com).

I'll let other, more paranoid people be the guinea pigs. If it works and there is a significant reduction in fatalities vs. getting the virus, I would devote more consideration (but still probably wouldn't bother as the chance of dying from the CCP virus is very low.)

@2stepps, sorry to hear about your health issues. I hope you have good doctors working on the problems.

I dunno. But there is always the so-called placebo effect... in which you win, either way?

I am certainly no anti-vaxxer. Each year a large number of individuals die from the annual flu and what they have in common for the most part is that they did NOT get their annual flu shot. Without data at my fingertips I will just state my opinion that my risk of dying from flu without the annual vaccination is much higher than my risk of dying from a flu shot. My suspicion is that the folks who had side effects from the flu shot were related to the chicken egg standardly used to create the vaccinations. If you have an egg allergy you cannot take the regular flu shots. We are asked each year about any known allergies and specifically an allergy to eggs just prior to being administered the shot.

I personally am more than happy to get a shot rather than an illness. I keep my tetanus, pneumonia, and flu shots up to date. My doc has indicated that unless I am traveling to certain areas there is no need to do boosters on polio, smallpox, yellow fever and typhoid. When they came out with an improved shingles shot, we were quickly on the waiting list to get it even though we already had the less effective once-in-a-lifetime shingles shots. I had the childhood diseases--measles, mumps and chicken pox, and my doc indicates I don't also need the shot they give for that. Far better to spend a few bucks (or even a lot of bucks) getting a vaccination than being sick for a few or a whole lot of days. If my getting shots helps maintain 'herd immunity', that is just fine as well.

With COVID the issues appear to go well beyond mere survival. Because of the way it impacts body systems there have been reports of kidney damage requiring on-going dialysis, heart problems, blood clots throughout the body (that can cause death if they lodge in the heart), mental impacts, lung, kidney and liver problems, etc. The disease is still new enough that no one can say whether the degeneration will get worse over time or whether the body will repair itself over time. When they are needing to do full lung transplants to what was a healthy 23 year old because she is alive and has cleared the virus, but her lungs were demolished by the disease, that is a problem beyond mere survival. She will be on anti-rejection drugs for the rest of her life at a cost of about $15,000 the first year and around $10,000 per year thereafter. The strain on the organ donor pool is going to be catastrophic as well so please make sure you have registered yourself as an organ donor. Once you no longer need your organs, perhaps they can save someone else's life.

Twenty years (or more) ago, I would have done the trial. However, I have since then developed some health issues that put me at very high risk. Also,, remember that studies have shown that the pneumonia, shingles and seasonal flu vaccines need to be of a somewhat different formulation in order to have reasonable efficacy on us older adults. This has meant re-vaccination for the first two, for long term effect, plus a separate variety each year of the seasonal flu vaccine.

I suspect that Flash's description of the changes in thymus activity that come with aging may be the reasons for this phenomenon. If so, it may well be that, regardless of existing health conditions, persons over, say 65 or so, may not be the best trail subjects. Just having a vaccine that works well in younger people, and a high compliance rate among them, would be a huge leap when it comes to benefits for us older folks. Then trials in health older participants will tell the tale of what we can expect as we age.

All of this reminds me that I need to get the new shingles vaccine for folks over 60! Earlier, it was in short supply. Now it is available, and covered by my insurance. No excuses to delay.

Wales, the Shingrex is 2 shots given a couple of months apart. We were glad when we finally got called that it was our turn for the vaccine as my significant other had a wretched case of shingles that was considered 'mild' and having gotten it once, he was at higher probability of getting it again, and again, and again.

[www.nationalgeographic.com] is the article I was reading about our age dwindling thymus.

Flash, thank you. I can take care of that at the pharmacy area of my local Giant Grocery store. Will put it on the list and put a note in the calendar about when the second one is due.

Absolutely not.

I would need to see several cycles of the vaccine to see what the long term side effects are. Sometimes, the side effects are worse than the disease.

I've been in a few clinical studies in the past and I can tell you I have never had more thorough exam, testing and close evaluation. I respect my current doc and what he does for me, but you just can't compare that to being a subject in a clinical study!

Vaccines have been around long enough that the base is not going to be something new and untested. The dead virus in the vaccine is unlikely to be a problem. The question to be answered is whether it stimulates the recipient's system to produce antibodies. No point in making batches of it if it doesn't.

I would not expect to see long term side effects. I frequently have short term side effects from vaccinations--a red and tender hot spot at the injection site, a little groggy for a day or two, perhaps a low grade fever in late afternoon for a day or so.

I would, depending on the pay (gotta be a lot) and whether I would endanger those in my household, which is why I backed out of the ebola study. For my own self I would take the chance. Not even trying to live forever. Just hoping for a quick and painless exit but the odds of that happening aren't good anyway.

I read the article this morning about the Moderna shot showing promise. They just discontinued giving the highest dose version since the side effects were worse in the volunteers than they cared to continue with. They also stressed in the article I read that they have no idea if the shot being tested right now in the form they are testing will produce lasting antibodies and if so for how long. They have no idea and do not know when they will have an idea.
So basically I would say if you are now or plan to shop while the virus is still around and are willing to join a trial I applaud you for offering to help find a vaccine for your fellow humans. But if you are doing it solely because you feel it MIGHT protect you it may be that it might very well lull you into a false sense of security out there you may or may not have. So be careful out there. The mind can trick you into misinterpreting what you read to rationalize doing what you want to do.

Flash, I get that. Your doctor knows your history and has been there for your peaks and valleys. Being with you for for a clinical trial, he can give his input when a small spike that would not phase a nurse, happens.

That small spike could be detrimental for a random person participating in a clinical trial for a new vaccine.

@Flash wrote:

I've been in a few clinical studies in the past and I can tell you I have never had more thorough exam, testing and close evaluation. I respect my current doc and what he does for me, but you just can't compare that to being a subject in a clinical study!

Vaccines have been around long enough that the base is not going to be something new and untested. The dead virus in the vaccine is unlikely to be a problem. The question to be answered is whether it stimulates the recipient's system to produce antibodies. No point in making batches of it if it doesn't.

I would not expect to see long term side effects. I frequently have short term side effects from vaccinations--a red and tender hot spot at the injection site, a little groggy for a day or two, perhaps a low grade fever in late afternoon for a day or so.

You misread me or I misled you. My doc does not do clinical trials. I like him and he is reasonably thorough. On the other hand the folks in a Clinical Study are not seeing 25-30 patients a day. When I have done clinical studies the visits always include bloodwork but there may have been tests and scans run by other providers. The visits have always included questionnaires, a simple to complex physical, a review of data obtained, an invitation to ask questions and where appropriate, issuance of study meds to last until the next visit. Contact time with study personnel close to an hour per visit.

I have been on the research end of many clinical trials done on the inpatient population,. In those types of trials the patients are being monitored 24/7 with nurses and docs just a few seconds away if anything should even slightly look like it is going wrong. Many other trials are done where the first line"volunteers" being tested are those who have nothing to lose as they are out of any other options that can save their lives. In the case of these trials very little is known about the expected outcome and you will be among the first tested. There are many heroes among us who join these trials and other heroes who also show up to work in health care facilities even though they know their risk of contracting a possibly deadly virus is there with them at work every day.

Last year when I got the Shingrix vaccine it was in very short supply and I had to really hunt it down. I hope things have changed.

@walesmaven wrote:

Flash, thank you. I can take care of that at the pharmacy area of my local Giant Grocery store. Will put it on the list and put a note in the calendar about when the second one is due.

Yes, I would participate in a clinical trial.

In exchange for a lifetime supply of nitrile gloves, I would consider it.

I might participate if I believed that the vaccine had a good chance of being successful, AND if I were guaranteed that I would be in the group that received the vaccine. The risk of being exposed to the virus as part of the control group would be too great unless I already had a terminal illness.

I think you can be comfortable that no medical ethics review of test protocols would allow deliberate exposure of subjects to live virus, whether they were test or placebo subjects.

An ethical protocol would test all subjects at inception to ascertain they had no antibodies to the virus already. Then you inject all subjects, half with the product with the dead virus and half with the product without the dead virus. Monitor all subjects closely over 3-4 weeks for adverse effects from the vaccine product and try to keep them isolated from sources of viral infection, systematically testing all of them for the appearance of antibodies. Of course these would be 'blind' studies where the folks interacting with the patients had no idea whether they were getting the test product or the placebo.

Generally in a study such as this each test subject is assigned a number prior to any baseline testing and behind the scenes they are matched up by demographics with one of each 'pair' assigned to test or placebo. In the studies in which I have participated, all product looked identical and mine simply came with my subject number on the label. In a test such as this, I suspect that up to half of the volunteer subjects would be thanked for their time and sent on their way because either they had antibodies already or there was something in their medical or social history that made them not fit the parameters of the study. I have been turned down for several studies that initially I was suitable enough for to do the original intake surveys, blood and other testing. It may have been that they did not have a 'pair' for me or it may have been that they had too many like me, even the folks with whom I interacted could not say. With each study I have had a 'daily diary' check list of yes/no for a number of symptoms that day, time of day I took the meds and a space for anything I had observed that might be health related. I also had a list of symptoms that any hour of the day I should call their emergency number immediately and symptoms that I should call the next day during business hours.