Vaccine Trial

12,575 Views | 95 Replies | Last: 5 yr ago by BiochemAg97
LeisureSuitLarry
How long do you want to ignore this user?
I have the opportunity to participate in a Covid vaccination study.
Yea or Nay?
amercer
How long do you want to ignore this user?
AG
I would.

But you should read the informed consent form, ask questions, and decide for yourself.
P.U.T.U
How long do you want to ignore this user?
AG
I would ask your doctor. If you are young and healthy it may be more dangerous than Covid.
doctorAg13
How long do you want to ignore this user?
AG
I would definitely consider it. I'm participating in a study now. I still remember Baylor College of Medicine soliciting volunteers for flu vaccine in the Commons my freshman year on campus - participated in those, too. Plus I think they gave a small stipend to us students at the time.
No material on this site is intended to be a substitute for professional medical advice, diagnosis or treatment. See full Medical Disclaimer.
PJYoung
How long do you want to ignore this user?
AG
LeisureSuitLarry said:

I have the opportunity to participate in a Covid vaccination study.
Yea or Nay?


I got my shot yesterday. Do it.

Moderna released info on it this morning. Its looking very very positive. They hope to have it out to the public in November.
PJYoung
How long do you want to ignore this user?
AG
https://www.cnbc.com/2020/08/26/moderna-says-its-coronavirus-vaccine-shows-promising-results-in-small-trial-of-elderly-patients.html

Quote:

Moderna's potential coronavirus vaccine generated a promising immune response in elderly patients in an early stage clinical trial, the biotech firm announced Wednesday.

The company tested its vaccine on 10 adults between the ages of 56 and 70 and 10 elderly adults aged 71 and older, Moderna said. Each participant received two 100 microgram doses of the vaccine 28 days apart.

The volunteers produced neutralizing antibodies, which researchers believe are necessary to build immunity to the virus, and killer T-cells, Moderna said in its results, which have not yet been published in a peer-reviewed journal. Additionally, the antibodies that were produced were higher than those seen in people who have recovered from Covid-19.
LeisureSuitLarry
How long do you want to ignore this user?
I believe this is a study for Moderna.
PJYoung
How long do you want to ignore this user?
AG
LeisureSuitLarry said:

I believe this is a study for Moderna.

Yes that's the one I'm in.

My wife and 80 year old father are also in it.

Do it.
PJYoung
How long do you want to ignore this user?
AG
dubberage
How long do you want to ignore this user?
The vaccine is scheduled to be released on Nov. 4 . . . .
Not a Bot
How long do you want to ignore this user?
AG
PJYoung said:

https://www.cnbc.com/2020/08/26/moderna-says-its-coronavirus-vaccine-shows-promising-results-in-small-trial-of-elderly-patients.html

Quote:

Moderna's potential coronavirus vaccine generated a promising immune response in elderly patients in an early stage clinical trial, the biotech firm announced Wednesday.

The company tested its vaccine on 10 adults between the ages of 56 and 70 and 10 elderly adults aged 71 and older, Moderna said. Each participant received two 100 microgram doses of the vaccine 28 days apart.

The volunteers produced neutralizing antibodies, which researchers believe are necessary to build immunity to the virus, and killer T-cells, Moderna said in its results, which have not yet been published in a peer-reviewed journal. Additionally, the antibodies that were produced were higher than those seen in people who have recovered from Covid-19.

This is the big part IMO.
Bluecat_Aggie94
How long do you want to ignore this user?
AG
I would after asking a few questions. As long as there were no personal issues with how the vaccine was developed, I'm all in.
Big Baccala
How long do you want to ignore this user?
AG
Why? Phase 2 results were good.
buffalo chip
How long do you want to ignore this user?
S
pbrancazio said:

Why? Phase 2 results were good.
The Swine Flu vaccine in 1976 was approved through similar studies. My wife and I were early patients of the fully approved vaccine. My wife became very ill for about 10 days. During that time, there was a reaction to the vaccine that caused partial paralysis. It was reported widely on television as an increased susceptibility to Guillain-Barre syndrome. Many years later further studies showed that the media exaggerated the issue (huh). We did not suffer from the syndrome, but it was a cause for much concern.

I applaud the early testers. I hope to taste the fruits of your courage when the vaccine is deemed safe.
Bucketrunner
How long do you want to ignore this user?
My spouse had Guillan Barre in 1973 and took the regular annual flu shots for years before he actually read the release he was signing. I am hoping this new vaccine will be one that is safe for him to take.
BiochemAg97
How long do you want to ignore this user?
AG
PJYoung said:

https://www.cnbc.com/2020/08/26/moderna-says-its-coronavirus-vaccine-shows-promising-results-in-small-trial-of-elderly-patients.html

Quote:

Moderna's potential coronavirus vaccine generated a promising immune response in elderly patients in an early stage clinical trial, the biotech firm announced Wednesday.

The company tested its vaccine on 10 adults between the ages of 56 and 70 and 10 elderly adults aged 71 and older, Moderna said. Each participant received two 100 microgram doses of the vaccine 28 days apart.

The volunteers produced neutralizing antibodies, which researchers believe are necessary to build immunity to the virus, and killer T-cells, Moderna said in its results, which have not yet been published in a peer-reviewed journal. Additionally, the antibodies that were produced were higher than those seen in people who have recovered from Covid-19.

Promising that if the vaccine works in the phase 3, it will work for elderly at 100 microgram doses. I seem to recall they were running the phase 3 at 50 or 75 micrograms. Isn't uncommon for elderly to need a higher dose to get an equivalent immune response,

All that said, immune response does not prove the vaccine is effective. We still need the phase 3 results to show people who got the vaccine are less likely to get covid that people who got the placebo. I would be surprised if it didn't work given the immune response produced.
Marcus Aurelius
How long do you want to ignore this user?
AG
I have the opportunity to be a subject in the Moderna vaccine trial. Contemplating it. My partner doing it.
PJYoung
How long do you want to ignore this user?
AG
I would be shocked if I got the vaccine and not the placebo. I haven't had gland soreness or any other symptoms since receiving the first injection last week.

Moderna was at almost 18,000 enrollees last week out of 30,000 expected so they should be filled up this month sometime. We have had several employees sign up so we're doing our part.
BiochemAg97
How long do you want to ignore this user?
AG
PJYoung said:

I would be shocked if I got the vaccine and not the placebo. I haven't had gland soreness or any other symptoms since receiving the first injection last week.

Moderna was at almost 18,000 enrollees last week out of 30,000 expected so they should be filled up this month sometime. We have had several employees sign up so we're doing our part.


If I recall correctly, the side effects didn't really show up until the second injection in the phase 1 trial.
PJYoung
How long do you want to ignore this user?
AG
BiochemAg97 said:

PJYoung said:

I would be shocked if I got the vaccine and not the placebo. I haven't had gland soreness or any other symptoms since receiving the first injection last week.

Moderna was at almost 18,000 enrollees last week out of 30,000 expected so they should be filled up this month sometime. We have had several employees sign up so we're doing our part.


If I recall correctly, the side effects didn't really show up until the second injection in the phase 1 trial.

My father and wife both have had gland soreness under their arm and an area of redness around their injection site a few days after their first injection. I had none of that until today lol. Just noticed a circular area of red around my injection site 9 days after the shot! Crazy. No other symptoms so far. I guess it could still be the placebo. The mind does crazy things.
PJYoung
How long do you want to ignore this user?
AG
BiochemAg97 said:

PJYoung said:

I would be shocked if I got the vaccine and not the placebo. I haven't had gland soreness or any other symptoms since receiving the first injection last week.

Moderna was at almost 18,000 enrollees last week out of 30,000 expected so they should be filled up this month sometime. We have had several employees sign up so we're doing our part.


If I recall correctly, the side effects didn't really show up until the second injection in the phase 1 trial.


Right on schedule. My wife got her 2nd shot yesterday morning and had a rough night of sleeping last night with fever and chills.
plain_o_llama
How long do you want to ignore this user?
For anyone that is in one of these trials....
Do they do any blood work before the trial? It seems like it would be useful to have at least an antibody check beforehand.
PJYoung
How long do you want to ignore this user?
AG
I'm not sure what they do with it but they take around 8 vials of blood when you go in for your first shot. They do the same before the 2nd shot.
BiochemAg97
How long do you want to ignore this user?
AG
PJYoung said:

I'm not sure what they do with it but they take around 8 vials of blood when you go in for your first shot. They do the same before the 2nd shot.
I assume there will be another batch taken some time after the 2nd shot.
plain_o_llama
How long do you want to ignore this user?
This just moved on the wire so to speak
https://www.statnews.com/2020/09/08/astrazeneca-covid-19-vaccine-study-put-on-hold-due-to-suspected-adverse-reaction-in-participant-in-the-u-k
Duncan Idaho
How long do you want to ignore this user?
Well mother effer.
amercer
How long do you want to ignore this user?
AG
That's one of the reasons that the do the trails in 30,000 people.

If it's only 1/30,000 you are probably fine, but rolling it out to 7 billion people might not be a good idea.

Hopefully they find that the SAE was not drug related.
74Ag1
How long do you want to ignore this user?
AG
Hopefully not serious
Even flu vaccine causes fevers
buffalo chip
How long do you want to ignore this user?
S
The article paints this as business as usual for phase 3 trials. The only difference now is that all of us mouth breathers are actually watching so it seems much more material than it is. There are also 8 other phase 3 trials that have not been delayed like the Astra Jeneca trial.
plain_o_llama
How long do you want to ignore this user?
A little more out today....

There is a NY Times article (behind a paywall) that says the trial participant is suffering from
Transverse Myelitis

https://www.fiercebiotech.com/biotech/astrazeneca-s-covid-19-vaccine-hold-sparks-reassessment-race

The voluntary hold, details of which were first reported by Stat, follows a suspected adverse event in a U.K. participant in one of AstraZeneca's clinical trials of COVID-19 vaccine AZD1222. Accordingto a New York Times source, the participant suffered from transverse myelitis, inflammation of the spinal cord that can be triggered by infections.

.....

"Clinical holds are not necessarily unique and this is a large trial but given the importance of getting a vaccine to market and (i) perceived safety questions around expeditious pathway and (ii) AZN timing which we have pegged as not far behind PFE and MRNA, there will be a lot of focus here," analysts at RBC Capital Markets wrote in a note to investors.

......

"The expert noted that for adenovirus vaccines, there was a substantial and 'enviable' safety dataset amassed from immunizing US troops over the past 60 years. This, of course, does not mean new adverse events could not emerge with a novel vaccine, perhaps as an autoimmune response to the chimpanzee adenovirus vector used," the Jefferies analysts wrote in a note to investors.
amercer
How long do you want to ignore this user?
AG
buffalo chip said:

The article paints this as business as usual for phase 3 trials. The only difference now is that all of us mouth breathers are actually watching so it seems much more material than it is. There are also 8 other phase 3 trials that have not been delayed like the Astra Jeneca trial.


There are a bunch of potential outcomes that range from "no big deal we're restarting the trial immediately" to "this vaccine is toast, run for you lives"

Step 1 is determining if the adverse event is even related to the drug. You have to report all adverse events that happen to patients in trials, even if they obviously have nothing to do with the drug (because proof is way better than "obviously" )

IF it's related to the drug then a whole bunch of things will happen. I'm glad I'm not on that team right now because the pressure has to be absolutely crushing.
buffalo chip
How long do you want to ignore this user?
S
Thank you, amercer!

This medical mouth breather truly appreciates all of the knowledge and experience that is freely imparted by MDs, PhD researchers and others who are directly involved in the fight against COVID19. Thanks to all of you.
plain_o_llama
How long do you want to ignore this user?
It is interesting that Transverse Myelitis is a condition not a cause. As you suggest determining the cause then is important. So in describing a type of spinal inflammation the question is what is causing it. Is it a virus causing the inflammation, an auto-immune response, or something else?

There was a suggestion early on based on a case in Wuhan that SARS-CoV2 the virus might be a factor in causing myelitis.


https://www.medrxiv.org/content/10.1101/2020.03.16.20035105v2.full.pdf


Cause and effect get a little convoluted.
KidDoc
How long do you want to ignore this user?
AG
plain_o_llama said:

A little more out today....

There is a NY Times article (behind a paywall) that says the trial participant is suffering from
Transverse Myelitis

https://www.fiercebiotech.com/biotech/astrazeneca-s-covid-19-vaccine-hold-sparks-reassessment-race

The voluntary hold, details of which were first reported by Stat, follows a suspected adverse event in a U.K. participant in one of AstraZeneca's clinical trials of COVID-19 vaccine AZD1222. Accordingto a New York Times source, the participant suffered from transverse myelitis, inflammation of the spinal cord that can be triggered by infections.

.....

"Clinical holds are not necessarily unique and this is a large trial but given the importance of getting a vaccine to market and (i) perceived safety questions around expeditious pathway and (ii) AZN timing which we have pegged as not far behind PFE and MRNA, there will be a lot of focus here," analysts at RBC Capital Markets wrote in a note to investors.

......

"The expert noted that for adenovirus vaccines, there was a substantial and 'enviable' safety dataset amassed from immunizing US troops over the past 60 years. This, of course, does not mean new adverse events could not emerge with a novel vaccine, perhaps as an autoimmune response to the chimpanzee adenovirus vector used," the Jefferies analysts wrote in a note to investors.

Transverse myelitis is no joke but it happens after viral infections. The question here is if the vaccine caused it vs just a random post viral complication. Very hard to tell. I imagine they getting Ig levels to various other viruses to try and prove this patient had a recent infection with Coxsackie or Adeno or something.

BTW this is not the Moderna trial, different vaccine not mRNA based.
No material on this site is intended to be a substitute for professional medical advice, diagnosis or treatment. See full Medical Disclaimer.
plain_o_llama
How long do you want to ignore this user?
KidDoc said:



BTW this is not the Moderna trial, different vaccine not mRNA based.
Thanks for reminding people of that. Perhaps a new thread would have been a better place to avoid confusion.
Last Page
Page 1 of 3
 
×
subscribe Verify your student status
See Subscription Benefits
Trial only available to users who have never subscribed or participated in a previous trial.