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Follow My Journey as a Moderna Phase 3 COVID-19 Vaccine Participant

dioxide45

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interesting, I would want to know if I received the vaccine or placebo
That negates the purpose of a double blind study. If someone knew they got the placebo, it may change how they go about their daily lives and skew the results.
 

x3 skier

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I received the second questionnaire yesterday. Typical new patient form, medications, conditions, surgeries, etc. They also scheduled an in person interview for two weeks from now to review what I just sent them. For each visit to the test center at a Hospital, they pay a stipend (Debit Card) that will cover gas money and maybe a lunch.

Cheers
 

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Hope all is well with everyone participating. Unfortunately there are still no facilities within reasonable distance to us.

On another note, 4 members of my immediate family are all positive for COVID.

2 of my nephews (20’s) were seriously ill for about 3 days. This turned into mainly “head cold” symptoms with severe headaches.

My father who has mobility issues and an auto immune disease, experienced only sinus/head cold symptoms.

My mother, who is his caretaker, has had all of the same symptoms/severe headache, along with extreme dizziness and fainting.

It seems everyone is getting better slowly.

Just thought I’d share their experience with COVID so far.

Take care.
 

amy241

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Hope all is well with everyone participating. Unfortunately there are still no facilities within reasonable distance to us.

On another note, 4 members of my immediate family are all positive for COVID.

2 of my nephews (20’s) were seriously ill for about 3 days. This turned into mainly “head cold” symptoms with severe headaches.

My father who has mobility issues and an auto immune disease, experienced only sinus/head cold symptoms.

My mother, who is his caretaker, has had all of the same symptoms/severe headache, along with extreme dizziness and fainting.

It seems everyone is getting better slowly.

Just thought I’d share their experience with COVID so far.

Take care.
I am so happy to hear your family members are all recovering!

I return for my second dose of the experimental vaccine on 8/31. I will have a 7 day eDiary to complete on an app about any side effects experienced. That will be followed by weekly safety calls for the next 3 weeks. I am sure my visit on 8/31 will involve another blood draw (not fun).
 
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amy241

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I received the second questionnaire yesterday. Typical new patient form, medications, conditions, surgeries, etc. They also scheduled an in person interview for two weeks from now to review what I just sent them. For each visit to the test center at a Hospital, they pay a stipend (Debit Card) that will cover gas money and maybe a lunch.

Cheers
Which program are you enrolled in - Moderna, Pfizer, AstraZeneca?
 

x3 skier

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Which program are you enrolled in - Moderna, Pfizer, AstraZeneca?
Moderna. Run by the University of Cincinnati Medical School.

Cheers
 

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Moderna. Run by the University of Cincinnati Medical School.

Cheers
That’s great! Keep us posted and let us know how it goes.
 

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I received the second dose of the experimental vaccine on 8/31, 28 days after my first dose. I had an eDiary I had to keep for 7 days following the vaccine. So far, so good. I had a dull headache and fatigue the day after the injection - exactly the same as after my first dose. They were gone the next day and no further side effects. I’ll take these to Covid-19 any day! It was another long nasal swab (not fun) and blood draw on this second visit.

I return on 10/2 for another blood draw and monitoring.
 

dioxide45

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I received the second dose of the experimental vaccine on 8/31, 28 days after my first dose. I had an eDiary I had to keep for 7 days following the vaccine. So far, so good. I had a dull headache and fatigue the day after the injection - exactly the same as after my first dose. They were gone the next day and no further side effects. I’ll take these to Covid-19 any day! It was another long nasal swab (not fun) and blood draw on this second visit.

I return on 10/2 for another blood draw and monitoring.
It is possible you received a second dose of a placebo?
 

amy241

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It is possible you received a second dose of a placebo?
Anything is possible - since I really do not know what I received. I will say that I had a headache and fatigue the day after each vaccine which leads me to think I might have received the real vaccine but who knows? They took vials of blood and someone told me you can get a headache from a blood draw so that could have been it as well.
 

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It is possible you received a second dose of a placebo?
Since the effectiveness of the vaccine is being tested based on 2 doses, and the trial is 2 doses of either the placebo or vaccine candidate, this is unlikely. Vaccine trials are closely monitored to ensure this doesn’t happen.

Since there were symptoms post vaccination that align with the expected timeline of a potential response, two things are possible. 1. The recipient received the vaccine candidate, or 2. The recipient is experiencing the placebo effect.

The vials that are used for a blood draw hold only a few ml’s of blood. The chances of suffering side effects from this are minimal. Unless, of course, they drew pint(s) of blood.
 

x3 skier

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Had my first visit for the Moderna Trial yesterday. The plan was to spend a couple hours on paperwork, discussions about the process and return next week for the first dose of the placebo or vaccine. I asked if we could do both on the first visit and this was ok (after some consultations with all the staff).

We spent two hours going over the paperwork and the process of the trial. I also got an app for my phone to report my temperature and symptoms, if any, daily for 7 days after the first injections and then weekly. After the second injection, this sequence is repeated. After that, there was the blood draw, a total of 8 vials. Then, I got the injection and sat around for 30 minutes waiting to see if I grew a third eye or some other immediate reaction. So far, all I have experienced is a pretty sore shoulder, similar to what I experienced with my latest flu shot. Wether that means I got the placebo or vaccine, is unknown.

One thing that may not have been noted before is that as the trial lasts two years, in the event the Moderna vaccine (or any other vaccine(s)) are approved for general release, I can obtain the approved vaccine. If I got a placebo in this trial, and Moderna has been approved, I can get the actual vaccine. If one of the other potentials is approved, I can take that one if I choose. How this will work out is hazy to both the Folks conducting the trial and me but I don’t have to wait two years for the Moderna trial to complete if one is approved before.

This first visit was one of a total of some seven over the two years. Each has a stipend attached. Yesterday I recieved a reloadable debit card with $125 for the first combo visit. There’s varying stipends for wellness phone calls, the two injections, regular visits and other contacts. Nice but not the reason to participate :cool:

More to post as the time passes.

Cheers
 

BarbmC

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Had my first visit for the Moderna Trial yesterday. The plan was to spend a couple hours on paperwork, discussions about the process and return next week for the first dose of the placebo or vaccine. I asked if we could do both on the first visit and this was ok (after some consultations with all the staff).

We spent two hours going over the paperwork and the process of the trial. I also got an app for my phone to report my temperature and symptoms, if any, daily for 7 days after the first injections and then weekly. After the second injection, this sequence is repeated. After that, there was the blood draw, a total of 8 vials. Then, I got the injection and sat around for 30 minutes waiting to see if I grew a third eye or some other immediate reaction. So far, all I have experienced is a pretty sore shoulder, similar to what I experienced with my latest flu shot. Wether that means I got the placebo or vaccine, is unknown.

One thing that may not have been noted before is that as the trial lasts two years, in the event the Moderna vaccine (or any other vaccine(s)) are approved for general release, I can obtain the approved vaccine. If I got a placebo in this trial, and Moderna has been approved, I can get the actual vaccine. If one of the other potentials is approved, I can take that one if I choose. How this will work out is hazy to both the Folks conducting the trial and me but I don’t have to wait two years for the Moderna trial to complete if one is approved before.

This first visit was one of a total of some seven over the two years. Each has a stipend attached. Yesterday I recieved a reloadable debit card with $125 for the first combo visit. There’s varying stipends for wellness phone calls, the two injections, regular visits and other contacts. Nice but not the reason to participate :cool:

More to post as the time passes.

Cheers
Thanks for taking part in this important study. It's people who volunteer who are the one's who will make a vaccine accessible for all of us! Cheers to you!
 

amy241

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Had my first visit for the Moderna Trial yesterday. The plan was to spend a couple hours on paperwork, discussions about the process and return next week for the first dose of the placebo or vaccine. I asked if we could do both on the first visit and this was ok (after some consultations with all the staff).

We spent two hours going over the paperwork and the process of the trial. I also got an app for my phone to report my temperature and symptoms, if any, daily for 7 days after the first injections and then weekly. After the second injection, this sequence is repeated. After that, there was the blood draw, a total of 8 vials. Then, I got the injection and sat around for 30 minutes waiting to see if I grew a third eye or some other immediate reaction. So far, all I have experienced is a pretty sore shoulder, similar to what I experienced with my latest flu shot. Wether that means I got the placebo or vaccine, is unknown.

One thing that may not have been noted before is that as the trial lasts two years, in the event the Moderna vaccine (or any other vaccine(s)) are approved for general release, I can obtain the approved vaccine. If I got a placebo in this trial, and Moderna has been approved, I can get the actual vaccine. If one of the other potentials is approved, I can take that one if I choose. How this will work out is hazy to both the Folks conducting the trial and me but I don’t have to wait two years for the Moderna trial to complete if one is approved before.

This first visit was one of a total of some seven over the two years. Each has a stipend attached. Yesterday I recieved a reloadable debit card with $125 for the first combo visit. There’s varying stipends for wellness phone calls, the two injections, regular visits and other contacts. Nice but not the reason to participate :cool:

More to post as the time passes.

Cheers
I asked my location if we would be given the real vaccine if it was approved during the study period and my lab tech did not know the answer to this. An article on the AstraZeneca trial appeared in my local paper and said anyone that received the placebo would be given the real vaccine at the end of the study - I thought it was nice they were recognizing their contribution to the study and taking care of those that ended up in the control group as opposed to the test group. It made me disappointed that Moderna didn’t seem to be doing anything similar for its control group.

I thought they took a lot of blood but this confirms it. My phlebotomist kept swapping out vials and I wondered why they needed so much. I think the literature they gave me said blood draws would be about 3 tablespoons but they collected a lot more than that.
 
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SusanRN

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amy241: " I asked my location if we would be given the real vaccine if it was approved during the study period and my lab tech did not know the answer to this. "

Hi, Amy:
I started the Moderna trial today and received the first vaccine dose. I asked the above question and was told that if this vaccine is approved, the study will end and all participants receiving the placebo will be given the vaccine. Actually, I am pretty sure that is Standard Operating Procedure for all Phase 3 vaccine trials.
I also asked about being able to take a different vaccine if it is approved. They said that isn't clear yet, but probably it would mean withdrawing from this study, which certainly makes sense. We always have the right to withdraw at any time.
I did have several tubes of blood drawn, but I wasn't counting the tubes. Total blood taken over the 25 months of the study is less than a pint, we were told in the intro.
I read in the newspaper today that the Moderna vaccine is expected to be one of the first approved (if it is, in fact, effective). They need to continue the study until at least 150 study members are diagnosed with Covid and there is an effectiveness rate demonstrated of at least 50%. That's out of the 23,000 in it now (and aiming for 30,000).
What's disconcerting is that since effectiveness of a vaccine is unlikely to be near 100%, we should all be continuing with masks and social distancing for quite a while.
 

SusanRN

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amy241: " I asked my location if we would be given the real vaccine if it was approved during the study period and my lab tech did not know the answer to this. "

Hi, Amy:
I started the Moderna trial today and received the first vaccine dose. I asked the above question and was told that if this vaccine is approved, the study will end and all participants receiving the placebo will be given the vaccine. Actually, I am pretty sure that is Standard Operating Procedure for all Phase 3 vaccine trials.
I also asked about being able to take a different vaccine if it is approved. They said that isn't clear yet, but probably it would mean withdrawing from this study, which certainly makes sense. We always have the right to withdraw at any time.
I did have several tubes of blood drawn, but I wasn't counting the tubes. Total blood taken over the 25 months of the study is less than a pint, we were told in the intro.
I read in the newspaper today that the Moderna vaccine is expected to be one of the first approved (if it is, in fact, effective). They need to continue the study until at least 150 study members are diagnosed with Covid and there is an effectiveness rate demonstrated of at least 50%. That's out of the 23,000 in it now (and aiming for 30,000).
What's disconcerting is that since effectiveness of a vaccine is unlikely to be near 100%, we should all be continuing with masks and social distancing for quite a while.
BTW, I am doing this at the Center for Vaccine Development at the University of Maryland Medical School. They asked why I am participating. I said (1)my father used to teach at the med school there in the1950's, (2) I'm a nurse, (3) my mother was a participant in the Shingrix Phase 3 study (which has helped many of us, I'm sure). I almost consider it a "civic duty" to participate, if qualified. I'm not sure the younger generation understands the term "civic duty," but maybe I am being cynical.
Susan
 

amy241

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amy241: " I asked my location if we would be given the real vaccine if it was approved during the study period and my lab tech did not know the answer to this. "

Hi, Amy:
I started the Moderna trial today and received the first vaccine dose. I asked the above question and was told that if this vaccine is approved, the study will end and all participants receiving the placebo will be given the vaccine. Actually, I am pretty sure that is Standard Operating Procedure for all Phase 3 vaccine trials.
I also asked about being able to take a different vaccine if it is approved. They said that isn't clear yet, but probably it would mean withdrawing from this study, which certainly makes sense. We always have the right to withdraw at any time.
I did have several tubes of blood drawn, but I wasn't counting the tubes. Total blood taken over the 25 months of the study is less than a pint, we were told in the intro.
I read in the newspaper today that the Moderna vaccine is expected to be one of the first approved (if it is, in fact, effective). They need to continue the study until at least 150 study members are diagnosed with Covid and there is an effectiveness rate demonstrated of at least 50%. That's out of the 23,000 in it now (and aiming for 30,000).
What's disconcerting is that since effectiveness of a vaccine is unlikely to be near 100%, we should all be continuing with masks and social distancing for quite a while.
Thank you for the information - that is nice to hear that they will provide the control group with the vaccine if it is approved. Yes, I had read that the 150 positive cases or so was the end result of the study.

I agree with you that it is disconcerting that effectiveness may only be between 50% - 70%, I have read many articles that state this. It appears we will not have the effectiveness of something like a polio vaccine that has an effectiveness rate in the high 90% because of the kind of virus this is. I want my pre-pandemic life back but it that is not going to happen anytime soon. I really hope we don’t have to wear masks for the rest of our lives.

I am glad to hear you are participating! Thank you for helping humanity.
 

x3 skier

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As a participant in the Moderna trial, I was told the same thing as SusanRN with the addition of a definite statement of being able to get whatever vaccine is approved at my choice.

if they are looking for 150 confirmed cases, that could happen soon since the typical infection rate is around 4%, at least in my state. So with 30000 subjects, 4% means 1200 infections would be expected if the vaccine is totally ineffective. If it’s 100% effective, 600 would be expected.

Cheers
 
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