Johns Hopkins Transplant Vaccine study

[PrimeTimer]

Sorry if this bit has already been posted/discussed here. I saw it and immediately thought I should share it.  I am on immunosuppressive meds too and am concerned. Reading that maybe a third dose would help kind of offers some hope but it doesn't exactly give a peace of mind.


https://www.ksat.com/health/2021/06/14/extra-covid-vaccine-may-help-protect-transplant-patients/

[iolaire]

Thanks PT. I just jumped on to share the same. 1/3 had positive after the third dose so not great but an improvement.

https://www.acpjournals.org/doi/10.7326/L21-0282
https://www.nbcnews.com/health/health-news/third-dose-covid-vaccine-may-help-protect-immunocompromised-patients-small-n1270809

[tigtink]

Not any new info here but a nice summary of where we are with all of this.

https://www.wired.com/story/the-challenge-of-covid-19-vaccines-for-the-immunosuppressed/

[iolaire]

I did my three month post second Pfizer shot follow-up antibody test (and about 2 months post J&J shot) yesterday and my SARS-CoV-2 Semi-Quant Total Ab results (LabCorp) are 2.3 with the following interpretation guidelines!  (I'm still positive for antibodies and its above the minimum level.)  My April one month post Pfizer levels were <0.40.

Current 2.3
Interpretation:
      Negative    <0.8
Sample does NOT contain detectable antibodies against the SARS-Cov-2 spike protein receptor binding domain (RBD).
      Positive    >0.7
Sample contains detectable antibodies against the SARS-Cov-2 spike protein receptor binding domain (RBD).
test: https://www.labcorp.com/tests/164090/sars-cov-2-semi-quantitative-total-antibody-spike

I've been at work since the 7th in a fully vaccinated building/office and am still wearing a medical mask around when away from my cube.  In stores I double mask.  But when I quickly pop-in to pickup a Starbucks order its a single mask. 

I won Starbucks for a year!  So since June 15th I've been picking up a cold no sugar iced coffee/expresso/cold brew per day.  When I order it for my wife she gets a salted caramel cold brew with half the syrup pumps.

[MooseMom]

So much good news here, iolaire!!!  Fantastic!  I'm glad to read, though, that you are still using precautionary measures.  Enjoy your Starbucks!

[iolaire]

Ok, sat in on today's webinar.  From what I can tell my antibodies' level is a very low positive, some people posted in the chat antibody numbers over 100 (can not tell if its on same scale).  Main message is even if you have antibodies you should act like you are un vaccinated but that also doesn't mean (depending on your risk level) that you have to stay home and order groceries.

Here is my laundry list of notes, un edited:

Dr Jennifer Alejo taking over (younger looking doctor great to see the next generation of smart people helping our cause)
Dr Dorry Segev
Dr Robin Avery
Dr William Werbel

Dr Borwarski moved back to surgery

7/8/2021 Vaccine study



Delta variant vs antibodies seen in transplant pts please comment
Hi, this is very important to study, and we will be doing so, but there are not available data yet in transplant patients. Delta variant tends to require ~2-10x more antibody to neutralize in the general population

Facebook group https://www.facebook.com/groups/466673867776866 for people in study with third doses (not associated with Hopkin’s)

1 month post Jassen (J&J) vaccination only two participants 17% had Ab response versus 430 59% in the mRNA group (p=0.005)
Media antibody titers: 2.39 (Janssen J&J), versus 106.9 (mRNA) U/mL (p=0.047)

EUROIMMUN    
A negative     <1.1 arbitrary units anti-S1 IgG
A low-positive   1.1 to 4 arbitrary units   anti-S1 IgG 
A high-positive   >4 arbitrary units anti-S1 IgG 

Time since transplant affects antibody response, medications, and other chronic conditions

Take home
Vaccines are safe
Get vaccinated
Avoid contact with unvaccinated
Transplant patients should not assume immunity after vaccination

Do what an unvaccinated person should be doing

Do not make medication modifications without consulting with your transplant doctor.

* Delta Variant
We can not prove you have protection even with antibodies.  Act unvaccinated, until we better understand correlates of protection for patients, i.e., what would we need to measure to prove protection.   We are not protected from Delta variant.

Antibody levels will change over time, don’t get too worried if levels decrease, studies will prove more.

Act as if you are unvaccinated.

If you are a vaccinated that lives with a transplant patient, you should still be wearing masks out.  Doctor wears mask to store and is healthy etc..  If you are in transplant bubble, still be careful.

We don’t know how to interpret TC response, there are tests, we can do studies but don’t know what they mean.

No transplant info, but post-covid patients received vaccine has strong response

Should I sleep with my partner, sex, what about kids going back to school, etc.  – They don’t have good recommendations, think about your risk, and talk to your doctors and such.  The CDC would say an unvaccinated person is safe getting on the plane masked.

Good information rumor working with NIC to fund a single-center Baltimore/multi-center study national as third doses as booster patients.  Will get good information and will allow them to officially give second doses.  Also, full approval should come so your doctor can give you an off label prescription that’s approved/legal.

[MooseMom]

Thank you, iolaire, for taking notes and sharing with us.  The "rumor" about the Baltimore center is a hopeful note.

[UkrainianTracksuit]

I should have posted this in one of the generic vaccine threads, but it has an important lesson in regard to breakthrough infections and antibodies (any antibodies at all..).

It truly strikes me how this little cohort here have taken corona so seriously and this young man (a three time lung transplant recipient now with so many other issues) didn't feel the same way.

Not much to learn, but an interesting first hand take on it all.

https://www.cnn.com/videos/tv/2021/07/12/travis-flores-covid-immunocompromised-newsroom.cnn

[MooseMom]

I have to wonder if any of this young man's doctors (and he must have so many) told him to be careful because of his immunosuppressed status.  We've known since mid-March that we might not be well served by the vaccines, and this man got sick well after that.  I am concerned about the apparent lack of communication.

[UkrainianTracksuit]

Excellent point, MM.

That young man is apparently famous to some extent being a disability advocate, motivational speaker, and even featured on some sappy tv show. If there is anyone that should have received a warning, it should have been this guy, because his livelihood is innately tied to people and health is sort of his gig.

I know that my doctors haven't been explicit in their post-vaccine advice (just keep wearing a mask was their advice), but they have their reasons (low rate here). A lot of information came from self research and discussions with other patients (like on here.) I guess when you have a busy schedule, doctors not mentioning much (but also, patient perhaps not asking), and not really taking the time to source knowledge the message isn't really clear.

MM, you said it best: I am concerned about the apparent lack of communication.

[iolaire]

I am concerned about the apparent lack of communication.

++ Yes, my center started giving Pfizer doses as soon as they could which was after March when it was starting to be known that they were not effective.  I wonder what they were telling the patients they were vaccinating in the transplant center.  I've received no mailing or email saying be careful.  Last year a few months into the epidemic they sent a mailing about whatever the CDC recommended at that time.  (Thanks UkrainianTracksuit.)

[iolaire]

My center finally sent out something about vaccine efficacy to the support group email.


I wanted to inform you of a transplant webinar regarding the COVID-19 vaccine efficacy in transplant patients.
This webinar is hosted by the Gift of Life organ procurement organization and is taking place virtually tomorrow, Wednesday July 14th from 3pm-4pm. 
 
Transplant Webinar: COVID-19: Updates in Solid Organ Transplantation
Description: Join us to learn the current state of the COVID-19 pandemic, the COVID-19 vaccines and their efficacy and safety in transplant recipients, and current federal and local regulations around mitigation strategies (e.g. masking, cleaning, social distancing).
Dr. Judith Anesi is an infectious diseases doctor at the University of Pennsylvania who specializes in caring for transplant recipients. She also performs clinical research evaluating the impact of infections on transplant recipient outcomes.
 
Register Here:
https://www.giftoflifefamilyhouse.org/upcoming-support-groups-and-education-sessions-for-transplant-2/
 
I found this information today so I apologize for the late notice!  I hope that some of you are able to attend.

[iolaire]

Glad to see you on call XplantDad, this was the one side with new data that interested me:
Breakthrough infections in transplant recipients, one study
2197 recipients at Yale-New Haven Hospital received vaccine
6 COVID cases (6.12%) partially vaccinated
3 COVID cases (0.65%) fully vaccinated
   Of those 3 all were mild illnesses and were given monoclonal antibody therapy, and survived

Very small sample set above, I don't think we can assume we would have mild illnesses.  Later said the usual make sure your family and caregivers are vaccinated...

The one thing she recommends to her patients do is avoid the crowds and poorly ventilated spaces even if fully vaccinated.

[UkrainianTracksuit]

I attended the call too though I didn't say anything in the chat or asked a question.  It was really positive to see all the folks with transplants lasting for so long though!

This was the new data that perked my interest too. You're right, iolaire, that this sample set is much too small to make any viable hypotheses. One thing that keeps niggling me though is how the numbers seem a bit soothing (low percentages) but at the same time the need to stick with strict protocols in many ways. Obviously we don't know all the particulars why this small number had mild infections (vaccine variable omitted), such as their state of general health, age, etc. So best to be safe than sorry and keep on as we have been.

One bit of silver lining I learned (thanks to a question of a participant) is that we know monoclonal antibodies as well as drugs like tocilizumab have demonstrated actual real-life positive results in transplant patients (along with the high dose steroids). I remember having a discussion on here with MooseMom about the antibodies and whether they worked well (or at all) in tx patients. The doctor said they do..so, hooray, I guess.

The key takeaway I learned from the talk is what I heard all year (even from my infectious disease team): it's all too soon to know and research is going on. Stay tuned..

[Xplantdad]

Glad to see you on call XplantDad, this was the one side with new data that interested me:
Breakthrough infections in transplant recipients, one study
2197 recipients at Yale-New Haven Hospital received vaccine
6 COVID cases (6.12%) partially vaccinated
3 COVID cases (0.65%) fully vaccinated
   Of those 3 all were mild illnesses and were given monoclonal antibody therapy, and survived

Very small sample set above, I don't think we can assume we would have mild illnesses.  Later said the usual make sure your family and caregivers are vaccinated...

The one thing she recommends to her patients do is avoid the crowds and poorly ventilated spaces even if fully vaccinated.

Thanks for making us aware, Iolaire. I watched from work and my wife and daughter watched from home. I really questioned the lack of them wanting people to get tested for antibodies...as her answer really didn't make sense, "We wouldn't know what to do with the results". Huh? I would think that the transplant community as a whole (Doctors, nurses, transplant researchers, transplant coordinators, etc.) should all be pushing for their patients to get antibody testing....as the 30 person test group that they are currently working off of is much too small to do anything with. It would be in everybody's best interest. I posed the question on the Zoom call but they didn't cover it...what (If any or more) antibodies would a transplant patient have if they've had both vaccines and also had Covid...like my daughter. That would be interesting to know for sure.  I know that even though my daughter is immune suppressed, she's got a good immune system and when she does get sick with anything, she gets better quickly!

Thanks again for the heads up Iolaire. BTW, how is everything going with your transplant?

[iolaire]

I really questioned the lack of them wanting people to get tested for antibodies...as her answer really didn't make sense

Thanks again for the heads up Iolaire. BTW, how is everything going with your transplant?

Its a cop out but I understand why they are doing it - so much is unclear.  I feel like they don't have actionable guidance for people with or without antibodies so they don't even want to know - that allows them a blanket guidance of continue to maintain your production protocol.  I felt better about returning to work with low antibodies (at a fully vaccinated office/building) but still I don't think the CDC guidance about vaccinated people apply to me - it would be hard for a medical professional to deal with that type of question.  Not to mention they don't have the resources to answer one off questions for each patients unique situation so they need someone else to tell them how to respond to antibodies or not. 

I'm fortunate the transplant is doing well with no concerns beyond the COVID worry. 4 years in now.

[Simon Dog]

I rotate between two nephs - one every 3 months.   The hospital guy follows "guidance" and did not recommend the test.  I asked the neph I see outside the hospital about a 3rd shot and he wanted an antibody test (he is top dog at his practice so he sets the guidance), and told me the result will tell if I need the 3rd shot urgently or should get it at a convenient time.   The test came back strongly positive 

When I asked the hospital transplant neph about the local guy I see out in the burbs his reaction was "great doc, he trained me".

[MooseMom]

On 22 July (next week!), the CDC vaccine committee (ACIP) will be holding a meeting, the second half of which will be a discussion about immunosuppressed people getting a third dose.  Here is the agenda.

https://www.cdc.gov/vaccines/acip/meetings/downloads/agenda-archive/agenda-2021-07-22-508.pdf?fbclid=IwAR2p6Qlq5hiCd9mhYxqGQw6ufsJyBKLtrqs0YKTwH-am2dfrrBPQIV5rSo4

If you want to submit a comment, you can use this link once a docket number has been assigned.

https://www.cdc.gov/vaccines/acip/meetings/index.html?fbclid=IwAR3YGYxA4BUjIeWA-DxTcdwkTVVdyELZ0ya8DB_EBD1X5gJ5wjJSdw7oJto

Here is a bit more information about what will be discussed, and why.

https://www.msn.com/en-us/health/medical/cdc-advisers-to-consider-additional-coronavirus-dose-for-immunocompromised-patients/ar-AAMbO6Z?ocid=msedgntp&fbclid=IwAR3u9TQqWCvjSr5VkGnyRyzQdVZPId0AXoW_ZcEyreBil8555LO5VhALWiY

[kristina]

... Hello again ...
Earlier this year I had "my" two Pfizer-vaccines within a "healthy" distance between the two vaccinations and I also had recently two Covid-check-ups (i.e. blood being taken and tested) and l feel very lucky so far, that nothing was found. (Touch wood it continues like that!!!).
Even though it is planned that from next week onwards "things" are planned to be getting easier in the UK, in terms of being social, meeting family and friends with or without wearing face-masks etc., I shall nevertheless ignore such promises and shall continue with all my strict precautions by continuing to wear my face-mask at all times outside my home and shall also continue with all my other precautions i.e. about public transport etc.. Better safe than sorry ...
Good luck to everyone and hopefully this terrible nightmare stops a.s.a.p. and I send you my best wishes from Kristina.

[UkrainianTracksuit]

Life is hilarious sometimes. My blood pressure is so low (84/76) today that I spent the day in bed. I realized that today was the CDC meeting that MooseMom posted about here so off I toddled to the computer. It was kismet that I logged in at EXACTLY the moment they started the discussion on immunocompromised people!

Anyway, I'm not American, so this doesn't mean much to me unless it flows down the pipeline to here, so consider this a tiny drop in the pot of friendly RUS - USA relations. 

The following are the main notes from the meeting. It may be a case of TLDR but it is in fact only 767 words of main points.

Immunocompromised people are at higher risk for prolonged COVID infection and viral shedding. The same group has low antibody and neutralization titers to the virus.



As much as we are concerned about the activities of others, we ourselves are more likely to transmit corona to members of our household, due to lack of vaccine efficacy and easier ability to get sick.



In the US, 44% of hospitalized cases are due to breakthrough infections in immunocompromised people. In Israel, it is similar, at 40%.



A big point of contention that arose is that immunocompromised people should not be treated as one monolithic group. For instance, those with inflammatory bowel disease presented an 80% reaction for antibodies once vaccinated after a second mRNA vaccine and hemodialysis patients actually had a very robust reaction to vaccination. In fact, hemodialysis patients did the best in a comparison with those with specific cancers, organ transplant and those on immunosuppressive therapies (not including tx). Organ transplant recipients fared the worst. There was supposed to be a reference list at the end to see the source of this data, but it never showed, still I will look.



33-50% of those without any antibody response to a first series of vaccination had a response after a third booster dose.

This was a big question from the last webinar that was mentioned here: Should immunocompromised people undergo antibody testing post-COVID-19 vaccination?



Word for word from the slides (with some word omissions):

- utility of serologic testing or cellular immune testing to assess immune response has not been established

- exact correlation between antibody level and protection remains unclear

- commercial antibody and cellular immune testing may not be consistent across laboratories * one doctor noted there is still a variety of thresholds and cut offs

- don't recommend unless in a research study



More evidence is needed in regard to vaccine mixing, though a Pfizer + AZ had better results than just two AZ.



Monoclonal antibodies are a-okay for those at risk or severe corona or hospitalization.



At the current time, there has been no data submitted to the FDA for an EUA for third dose vaccination in this specific population. Clinics in turn have to wait for the FDA to give that EUA for their standards and protocols to be amended. 



As we expected, they need MORE DATA before moving forward, but more data in the respective types of immunocompromised populations. It is not one size fits all. Then, the whole interval and match schedules need to be decided.



I don't know anything about the liaison panel, but some of them had some pretty dismal questions, to be honest. It seems like they were on the fringes of immunosuppresant patient care, so I just took note of the important questions or quotes from the Q&A.



- Is there a role for a forth dose? (Yes, we seem to be in this territory.)


- How soon after monoclonal antibodies can be a patient be vaccinated?


- Since all immunocompromised people are different, there is a need to be careful with a third dose. Such as, it might not be beneficial to give a third dose to those on hemodialysis because they had a robust reaction. SO...what happens in patients with high antibodies and a third dose? Is this the source of myocarditis? (Long-time doc involved with immunocompromised patients)



Doctors that worked with transplant patients and other doctors focused on immunocompromised patients often mentioned that this whole issue is "running away from us" as the FDA is taking too much time.

One doctor noted that many tx patients have already taken matters into their own hands and finding third doses themselves, but this in turn leads to issues of equity. Those more highly educated are more likely to receive a third dose.

At the same time, doctors feel their hands are tied, because they don't have guidelines and protocols from the FDA.



Transplant patients are already scared as all hell. A patient that was infected in a healthcare setting was mentioned. Patient had to go because it seemed as though they were recently transplanted (kidney).



One said boosters may not be the answer. Rather, strong circles of protection should be implemented. (Have all close contacts vaccinated in other words)



Finally, Dr. Grace Lee said that there is sufficient data to move forward, but safety and monitoring by clinicians will be a key component. 

This was followed up with this can't only be a shared-decision making (doctor and patient discussion) process as the need for a broad guide is way more important, for reasons of timing and equity.

[MooseMom]

Thanks for that overview, You Tea.  You summed it up nicely.

I hope you feel better soon and that your bp stabilizes.  84/76 sounds perilous.  Is hypotension a chronic problem for you?

[UkrainianTracksuit]

Is hypotension a chronic problem for you?

It has been since transplant. However, I usually hover around 100/60-70. When it gets low like this though, it is my fault, such as I didn't stay hydrated like I should have the day before. I end up stuck in bed because the fatigue is overpowering. Rather than add on a medication, my tx doc told me to stay really hydrated and increase my sodium intake. That works well when I do what I should. 

[Simon Dog]

Thanks for that overview, You Tea.  You summed it up nicely.

I hope you feel better soon and that your bp stabilizes.  84/76 sounds perilous.  Is hypotension a chronic problem for you?

The issue with 84/76 is the pulse pressure of 8.  (Yikes!!)  PP=systolic - diastolic, and 40-60 is normal.  Definitely8 worth asking your MD abuot.

My BP was about 90/60 on dialysis, and rose to about 120/80 almost immediately after transplant.

[UkrainianTracksuit]

All my doctors know about it.

They know when it gets to this point, I messed up. The first time it happened I was sent right from clinic to the IV clinic for a couple bags of fluid.

After some re-hydration, I'm at 92/66 right now.

I know that low PP is related to cardiac failure, but my heart is apparently as good as it gets for a pre-menopausal woman, minus very minor tachycardia (born with it/natural/no underlying condition). It's just one of those things where doctors don't have an answer, even a cardiologist central to a major cardiology program in the country. He looked at my test results and said my heart is normal, good for my age.

On HD, my BP was so high even with oodles of drugs tossed at it, then it transitioned to hypotension. Seems to be a side effect of pancreatic transplantation, so they say.

[iolaire]

Thanks UkrainianTracksuit I appreciate the summary.