Johns Hopkins Transplant Vaccine study

[tigtink]

I second everything MooseMom said! This thread has been a great help to me in recognizing and processing some feelings I could not quite define. I've talked to friends and family, but they don't get it the way you guys do. UT, your sharing was important and helpful, so please stay. MooseMom is right: it is all hands on deck right now. Not everyone shares in the spirit of this board but we still need to keep it going. There is so much wisdom and compassion and experience that can be shared here.

[kristina]

Hello MooseMom and many thanks for your kind concern. I was fortunate enough to have had some medical assistance to have “it” checked-up and it is still ongoing, but fortunately some medical questions have already been“sorted” in a positive way. There is also the point that my body often reacts totally different to treatments, vaccinations etc. and that makes it often a bit “tricky” for doctors to find a diagnosis and hopefully there might be an answer soon. Take great care and I send you my best wishes from Kristina.

Hello UkrainianTracksuit, I can understand your concern and I beg you to please not take “it” too personally. This is a very difficult time we go through and hopefully we all “make it through” alright and I send you and your husband my kind regards from Kristina and please take great care.

Hello enginist and many thanks for your kind apology and I am sorry if I might have come over a bit as "a member of the Weeping Willows Club” ... I agree with your thought, that death has only as much importance as we choose to give it. But you see, right now we all have to deal with a threatening “unknown” and that is very unsettling indeed, especially since many of us not only had to fight hard with dialysis, but we also had to face the unknown outcome of an eventual kidney-transplant.
But ...  at least there are many documents we can read about dialysis and and study about kidney-transplant, which gives everyone a fair choice, but about Covid we know as much as nothing and so far there was hardly enough time for a thorough research. This situation leaves many people in a quandary, especially if they suddenly experience strange symptoms after their Covid- vaccination. So, if at the moment I might appear a bit overemotional etc. please don’t observe me too closely and hopefully, in the near future I might be back to my “own self” again, especially after my urgently needed repair-operation has been finally "sorted"... Please take great care and I send you my best wishes from Kristina. 

[UkrainianTracksuit]

Thank you, but I just feel as though I sullied the important data and posts in this whole thread with needing to blow off steam. I didn't want it to turn into that.

That said, this has left me thinking in the last few days, and my reasoning is probably wrong because I am not a scientist. I think there will be no vaccine development, even in the future, that will address our concerns about MMF. The vaccines rely on stimulation of specific T-cell and B-cell responses (there are lots of studies to look up). MMF suppresses their production (I am not speaking about specific cells as I am not trained and would lose my mind trying to learn), more so in comparison to tacrolimus.

But, we just have to wait for studies to come out to show vaccine efficacy after the second dose. After that, transplant professionals need to focus on vaccination protocols, like medication management in the vaccine period. That should be a short-term objective. Obviously a standard would take some time to come up with and disseminate.

[MooseMom]

kristina, I'm pleased you've already been in contact with your medical team and that they are on the case, so to speak.

UT, nothing has been sullied.  If I recall correctly, I was the first one to go all pear shaped in this discussion as I vented my disappointment.  I think we are all able to wind our way through this thread to sort out the facts from the emotions.  We can walk through the evidence and chew through our steam blowing at the same time.

I suspect you are right, though, in that no one is going to be looking at creating new vaccines for the myco people, and that is probably just as well since there probably won't be enough time for that, especially as we are starting to see more lockdowns in Europe, really horrible stats from Brazil, and other "proof" that this is not going away very soon.  I share your belief that medication management is probably the path to take on a short term basis.  Faffing about with an anti-rejection protocol that has been working for me is not my idea of a good time. 

[iolaire]

Here is a big list notes from the webinar. They implied they are seeing better results from the people 30 days post vaccination 2 but some people still have no antibodies. But those results are 6/8 weeks out. It sounds like they felt I’d you have the ability to get a third shot of same or different vaccine you might want to give that a try. There will be a recording of the voice and video.

I'm running through and adding some more details, my initial post was my note dump from my phone.  I think they still want participants and might even be interested in people who are already vaccinated.  For example not everyone gets blood tests, but the surveys results have made them feel the vaccines are safe for us.  On patient had acute rejection but they don't know the details on that.

Here is my bug dump of notes.
Transplant vaccine safety study
1000+ on call of various transplant types
10 million plus US have immune suppression so study results will be beneficial beyond transplant community

Effectiveness measures antibodies, T Cells and Memory Cells

Not doing blood tests for everyone

Follow up testing
1/3/6/12 month post shot 2

They are doing two tests, the at home version is Euroimmun anti-sars-cov-2 elisa at home test sees if antibodies bind to the cell, this is the similar process as the LabCorp test, it sounded like they are processing the at home tests themselves and they are backed up due to the numbers

Counts of participants so far and the number of tests received 3200/573 baseline, 1611/854 dose 1, 926/300 dose 2

742 tests, side effect wise younger < 65 and female had more reactions ~10% had diarrhea or vomiting, one acute rejection

First result 17% antibodies detected, was scary 436 people, younger and moderna seemed to respond better

Just starting on post shot 2 30 days tests, results are more promising but still people without antibodies, don't know if lack of antibodies mean no protection because there is a chance the T Cells and Memory Cells are providing some sort of protection, right now only measuring antibodies

Q&A
If no after first is possible later have antibodies or protections? Yes maybe with #2 or even more months out. Also will learn more with T Cell studies.

If no antibodies is it possible that they may have protection? Yes multiple may be stimulated including memory cells may respond later, have seen that in non transplant, T cells may react differently.

Would a third dose help?  2 may have been enough, also may not be immune after two doses, antidotally around the transplant community they are starting to see transplant patients in hospitals with COVID after both doses so they know that we are at risk still. There are other vaccine examples where third doses helps.   If you have access to third dose let them know. They know of no one yet that had access to third dose or changed vendors.

Should we change our treatments around vaccination? We don’t know enough to recommend that. Patients with some medications don’t respond. Also doing know washout time and don’t know risk.

How careful should transplant post vaccination?  Difficult to know how protected you are and how safe it is for you. So don’t know if you can follow CDC. Maintain safety protocols.

Another webinar in 6-8 weeks with second dose results.

How does this data contrast with other vaccinations?  Tests are not same. Flu has good tests. Lots of studies on flu shots and booster, second and stronger shots. Flu has similar problems with mycophenolate.

Should transparent teams be testing regularly? Don’t know if they have platforms for data and don’t know what antibodies mean.

Should I tell my transplant friends to not get vaccine?  No all organizations say to get it. It might do something. Safety studies look good.

Do level thresholds from the antibody tests mean much?  They only report positive and negative because importance of levels.  Maybe later they will know more and the score itself will mean more.

If you are waiting for transplant should you do it before?  Probably get it in advance if transplant if you can but also people waiting may be sicker and not respond to vaccination.

In general terms, if you received two and have access to third dose email us directly so we can figure out how to study it.

[UkrainianTracksuit]

I learned that I will be getting the Pfizer shot once opened up to phase 2 groups. All our Moderna supply was used up in the early days vaccinating LTC residents. Eh, it is what it is. Will speak with tx team next week...

[MooseMom]

UT, good luck with that!!

Iolaire, thanks for that.  Do I understand correctly that there will be a recording of this webinar posted at some time?  I'd like to watch that.

We'll hang on for more data.  Again, thank you for your post.

[iolaire]

Received my second dose last night and feeling good so far. No antibody results from my Thursday labs yet.

[MooseMom]

Received my second dose last night and feeling good so far. No antibody results from my Thursday labs yet.

I'm glad you're feeling well, and thanks for taking the time to post all of this information.

[UkrainianTracksuit]

OK, so part one of tx appointments done.

This particular team still contends that Pfizer and Moderna are the best shots due to efficacy results. I pointed out that the comparison with the others is a moot point because their testing and phase processes were in different contexts/stages of the pandemic. They said yes but... it is doubtful that they would achieve over 90% efficacy (like the others) if they hover in 60-mid-70% at this point. Still, excellent rates for new vaccines, but since we’re dealing with an immune-suppressed situation, where we already know the vaccines don’t work as well, focus on the highest immunogenicity overall.

They believe that since I’m “very young” (not true) and take a low dose of Myfortic, there is a very good chance that I will have a decent antibody spike after the vaccine. My maintenance immunosuppression is very low in general.

There’s not enough data or guidance for medication changes around vaccine time to clinically make changes.

Still, was advised to keep wearing a mask, avoid crowds, don’t put myself at unnecessary exposures.

All of that said, I think my tx doctor doesn’t even know who I am.  I get it, he’s busy (but doesn’t see a lot of tx patients outside of his main specialization, just those with a pancreas) but he seems to have this idea I was recently transplanted and should be seen more often, which isn’t the case once a patient is over a year post-tx. More statements gave me this clue too. To be clear, I’m not looking for some sort of hovering situation, but for a doctor to just not confuse me with another patient in his recollection. Do your tx docs have an understanding of your particular cases?

See what happens at the next appointments..

[MooseMom]

OK, thanks for that, YouTea.  May I ask what your dose of Myfortic is?  I'm not sure what qualifies as a "low dose" since I was under the impression that there was a "standard" dosage, but I understand we are not all "standard" patients.

I, too, have read that there just isn't enough data (or time) to study the effects of lowering the dosage of this drug on the creation of antispike antibodies.  I'm not sure I personally would be willing to be a participant in that sort of study, to be fair.

My tx team knows exactly who I am.  If I have a general inquiry, I contact my tx coordinator, and when I attend my annual checkup, I see the tx neph's assistant who acts like she remembers who I am!  What strikes me is that all throughout my tx experience which, counting the pre-ex years, I've been seen by only two men.  One was a cardiologist who reviewed my pre-tx stress test results, and the other was the surgeon himself.  Both had a rather dismissive attitude, which I was fine with.  But my tx team, the "day to day" team, are all women, and I am really happy with them.  Honestly, though, my case isn't all that memorable, thank goodness.

I'm looking forward to hearing about what you learn at your next appointment.  When will that be?

[UkrainianTracksuit]

Hey MM,

Yes, standard dose is 720 mg taken twice daily (1440 mg) but I just take 360 mg twice daily (720 mg — half of the regular dose) because on the standard dose, BK Virus showed up.

I agree that I wouldn’t be a participant in any such study unless they stuck me in a hospital and monitored graft function like a hawk!

To be honest, I think they only recognize my surname on the file because when I married my husband he bestowed me with a jumbled alphabet for a last name. But other than that, it seems like they have no clue.  Well, it is good to know that yours know exactly who you are and that must be comforting in a medical sense!

I have two appointments Thursday, so hopefully learn more then.

[MooseMom]

Hey Youdkjnofiesgnot Teaoinoblienves,

That's interesting about your myfortic. Makes sense.

Tomorrow Thursday, or next week Thursday?  Inquiring minds want to know!

[UkrainianTracksuit]

Tomorrow Thursday...

It’s also the same day the premier of the province will announce new restrictions. Please pray they don’t call for a lockdown until I am on the plane home on Saturday! Don’t want to be kicked out of the hotel!

[tigtink]

Thanks UT for the dosage info. I too am on 360 twice a day of the Myfortic. They reduced it not long after my transplant due to digestive issues. I had my second Pfizer shot yesterday. Fingers crossed!

[MooseMom]

Tomorrow Thursday...

It’s also the same day the premier of the province will announce new restrictions. Please pray they don’t call for a lockdown until I am on the plane home on Saturday! Don’t want to be kicked out of the hotel!

How awkward would it be to be stranded like that!  I'll pray that it doesn't happen.  We're all looking forward to hearing from you after your appointment.

So, tigtink, you're on a reduced dose of myfortic, too!  Oh, that's interesting.

I get my second Moderna shot tomorrow (Thursday).  I was really excited about getting the first one and didn't mind having a sore arm afterwards.  I thought protection would be worth the discomfort.  I'm not so excited about the second shot and will probably resent the injection site pain.  Harumph.

[UkrainianTracksuit]

Hey tigtink , can you tell me about your tummy troubles that led to the drop in Myfortic dosage?

Alright...

Here is the deal with the final appointments with Infectious Disease.

I kind of got into a little argument with a doctor as he believes if I have a letter from the tx team (they had all been sent out, but I didn’t receive one, sucks to be an out of town patient!), that I can be vaccinated now, no matter where my public health authorities are on their vaccination scheme, because as of now, transplant patients are at the top of the list. I disagreed because... bureaucracy. I just ended up agreeing to shut him up. We’ll see.

In regard to the Hopkins study, both doctors said it was very early, and more data still has to come out. While we should heed it, it needs to be taken into perspective, as well... it is early. We can’t put all our eggs in one basket and get depressed.

Before they make any kinds of decisions about changes in treatment regimens, they want more data about immunogenicity in tx patients and some more info about the drug interaction with the vaccine (as in, they understand basics, but I guess they want more actual details than generalities.) Since they don’t plan to run their own study, it’s a matter of waiting for more data and literature to come out scientifically and academically. They very much stand behind vaccination though.

Again, they stated the same as my appointment on Tuesday. I am young, on low maintenance immunosuppression, and my immune system is still in good shape, based on my overall health, so their bets are on an immune response. Maybe not a super duper immune response, but enough for some protection. All my other vaccines have currently worked.

One doc went as far to say take the first vaccine offered, doesn’t matter the name. Well, they aren’t giving Astra Zeneca to those under 55 in Canada, so that narrows it down.

I asked about follow up blood work after vaccination, but it’s a little complicated because I’m from such a far distance. It’s not necessary, but could be arranged if patients want it.

Then it just turned into a discussion of which other vaccines I should get. Probably going to be the most vaccinated person alive!

[tigtink]

Thanks for all the good information from your appointment. There is so much we do not know at this point. All we can do is wait and hope for more positive results.

As for my Myfortic story, it is not a pretty one. I was on the full dosage of two 360 mg twice per day for the first month and a half after my transplant. I did fine the first week, then started having a lot of gas followed by weeks of chronic diarrhea. They kept testing me for every kind of virus or infection they could think of, assuring me the results were negative and this would resolve with time. It did not resolve, and at my 3-week followup appointment they admitted me for severe dehydration and elevated creatinine. I was given IV fluids, sodium, magnesium, iron, and two blood transfusions to get my hemoglobin up while they did every test imaginable, including a CT scan, colonoscopy, upper endoscopy, endless blood and stool tests, and several consults with GI doctors. My creatinine came way down after my electrolytes were stabilized, just in time to avoid a biopsy, but the diarrhea never stopped. After days of pondering all of this, they finally dropped my Myfortic dose in half and within a couple of weeks the diarrhea began to subside. Then of course they raised the dose again and the diarrhea returned. Eventually they cut the dosage in half again  and I have been fine ever since.

So you can understand why Myfortic is my least favorite drug and why I thought to myself “Of course it is the Myfortic that interferes with the vaccine!”  My kidney is still going strong, so I am not complaining. Just not fond of that particular drug.

[jenb]

Had my second Pfizer covid vaccine on Tuesday.  Had it at 6 p.m. and at about midnight I got very cold (not chills) lasted five minutes.  Then my legs started hurting real bad and slight headache.  Lasted an hour or so.  Couldn't sleep.  By morning everything fine.  I coincidentally had forgotten to take my mycophenolic Tuesday night and Wednesday morning.  This never happens.  Anyway, I heard if you had a reaction to the vaccine that means your body is going to fight the virus.   I have to think we have some coverage.  By the way I am today, two years post transplant.

Just for your information, a nurse mentioned that when they had a patient with covid last summer, they stopped the rejection medication while treating them.

Be well.

[MooseMom]

UT, thanks for that summary.  I suppose we'll just all have to sit tight and wait for more data to emerge, but I want answers NOW!

tigtink, I'm surprised the docs didn't immediately suspect that it was one of your immunosuppressants that was the villain in your diarrhea saga.  It's awful that you had to be subjected to all of that testing.  Well, I suppose now you know.

jenb, what that nurse said to you about their covid patient is really interesting.  I've often wondered what they do regarding covid patients who are also tx patients. 

I had my second Moderna vaccine earlier today, and whereas after the first shot I had a sore arm for a couple of days, so far today I feel absolutely nothing.  A big NADA.  I don't know if I'll have any sort of reaction as the evening wears on and the days go by.

Figuring that we'll all be wearing masks for the foreseeable future, I decided to go ahead and order some pretty ones for spring and summer.  And, I ordered 4 really cool stretchy headbands for my now long covid hair.  Oh, and a pair of ear cuffs.  I've just discovered the joys of Etsy.  This is a big deal for me because the last item of adornment or clothing I bought for myself was a new swimsuit in 2018.

[iolaire]

Hello all.  I can confirm that I'm on the mycophenolate 360*2 twice per day.  Its interesting to learn that that is a standard dosage.  I guess the manufacture does some testing and comes out with a recommended dosage and the individual programs only make changes if the transplant recipients are having problems.  I would think that the treatments of transplant patients are highly customized, but I guess they have standard templates they follow unless they are forced to make changes.

Regarding antibodies before my second dose - my results were negative to antibodies. 

When I went in last Thursday to LabCorp it was clear there were going to be issues, the computers were not printing labels, and then when they were able to and the tech printed labels for my monthly labs I asked if he had labels for the antibody test and he said no they have to do that manually and they will send the blood to the requestor directly   I could tell something was up there and the next day I didn't receive the results on the LabCorp site.  I waited until Wednesday to reach out to the study and luckily after I told them where I went they were able to follow up and the lab was going to fax them the results.  So last night after I week I received the results via the study - but unfortunately I don't have the LabCorp results which previously told me I was <40.  I had hoped I would be able to see if that number changed slightly to say <60...  So now I'll wait until the end of this month for my 1 month after labs to get the LabCorp version.

MooseMom the webinar is on their website here: https://transplantvaccine.org/study-results-and-webinars/ its under Webinars for study participants include study updates and Q&A: March 23, 2021

Random other positive personal note, my wife and I are both still working from home so we booked an AirBnB in Asheville NC for a month to work from somewhere else.  Call it a trial retirement - we are about 3 years out and this is a good opportunity to see if we enjoy going somewhere else for an extended living stay. We will pack up the two cats and drive down from the DC area next Thursday and Friday.  I'm glad to be in the study so I know I need to keep up my caution up post vaccinations but look forward to hiking, doing our daily walks in a new area and visiting a few of the numerous breweries and restaurants within walking distance of our place. As long as the outdoor tables are well separated and the venue is not crowded we have been willing to doing some outdoor eating or drinking. Asheville sounds fairly liberal so I hope people are masking up like they do around here.

[MooseMom]

Thank you for your post.  Regarding the standard cocktail of immunosuppressants, I have the impression that it is tacrolimus dosages that seem to vary from patient to patient.  In the early days after my tx, it was tac that they faffed about with until they found the right dosage for me.

OK, pre second dose antibodies negative.  Got it.

Looking forward to hearing your 1 month after labs.  I'm hoping for some improvement.

Thanks for the link to the webinar.  I'll have a look this evening.

Good for you for making a leap out into the world.  I think you and your wife are very cognizant of possible risks and can tweak your routines accordingly.  We've had dinner out a couple of times lately in restaurants we know well and trust in keeping to distance requirements.  Even if I had a stonking amount of antibodies, I'd still take those precautions.  I hope you enjoy your time in Asheville; it's a really nice part of the world. 

[Simon Dog]

The difference is mycophenolate is not measured in the blood, so the dose is a best guess.   I'm on 250 once a day.

Tacro levels are adjusted to obtain specific target values in the blood (higher shortly after transplant than later on), so that does can be calibrated more easily.  I take 1mb twice a day.

[tigtink]

I believe there are different standard dosages depending on whether you take the original Cellcept or the delayed release Myfortic. I am only familiar with the Myfortic dosing.

[MooseMom]

iolaire, it looks like one needs a passcode to access the recording.  Did you participate/have you seen the recording?  If so, is there anything we would learn from it that you have not shared with us already?  Thank you!