Johns Hopkins Transplant Vaccine study

[iolaire]

Apologies, iolaire, as I must be having some sort of brain fog, but to make sure I am understanding, you are in a J&J study that is not affiliated with Hopkins?  Is that right?  Who's conducting the study?  The J&J vaccine is easily available (or, so I understand) here where I live, so I am seriously considering getting it, too.  I can't see where it would hurt, but I think I'd talk to my clinic first.

Please keep up updated on this!  Thanks, and good luck!

John Hopkin's is doing the J&J.  I learned about it when I told them I was getting it as a booster. Remember I'm in a study already and submitting via LabCorp data for my Pfizer shots.  If you are going to get it reach out via https://transplantvaccine.org/ and see if they want your data.  Keep in mind the John Hopkin's J&J study is shipped vials to you that you need to get filled somewhere.  At this point it feels like why not...

[MooseMom]

OK, I understand now.  Thanks for your patient explanation!  I didn't realize that JH was undertaking this study; it makes sense that you are participating.  I can't wait to hear more from you about this.  Enjoy your "vacation"!

[iolaire]

I received the J&J shot (booster for me) yesterday, had a bit of a sore arm initially but it was mostly gone by the nighttime.  I was unable to do the blood draw for the study prior to vaccination but they still want my blood two weeks after.

[MooseMom]

I received the J&J shot (booster for me) yesterday, had a bit of a sore arm initially but it was mostly gone by the nighttime.  I was unable to do the blood draw for the study prior to vaccination but they still want my blood two weeks after.

Thank you for being our IHD guinea pig!  I can't wait to hear what you find out.

[iolaire]

Sorry folks the study results are out for patients one month past the second vaccination - 54% built antibodies, usally younger people who received the Modena vaccine.


https://medicalxpress.com/news/2021-05-transplant-recipients-vulnerable-covid-vaccination.html
"While there was an increase in those with detectable antibodies—54% overall—after the second shot, the number of transplant recipients in our second study whose antibody levels reached high enough levels to ward off a SARS-CoV-2 infection was still well below what's typically seen in people with healthy immune systems," says study lead author Brian Boyarsky, M.D., a surgery resident at the Johns Hopkins University School of Medicine.

"Based on our findings, we recommend that transplant recipients and other immunocompromised patients continue to practice strict COVID-19 safety precautions, even after vaccination," Boyarsky says.
...
The researchers also found that among the participants, the most likely to develop an antibody response were younger, did not take immunosuppressive regimens including anti-metabolite drugs and received the Moderna vaccine. These were similar to the associations seen in the March single-dose study.


https://pubmed.ncbi.nlm.nih.gov/33859151/
https://www.news-medical.net/news/20210506/Study-Second-vaccine-dose-still-makes-organ-transplant-recipients-vulnerable-to-COVID-19.aspx

[iolaire]

Also I wanted to call out this quote:
https://pubmed.ncbi.nlm.nih.gov/33859151/
Participants who experienced pain (aIRR= 1.111.662.47, p=0.01) or redness (aIRR= 1.833.928.41, p<0.01) were more likely to develop an antibody response to D1 of mRNA vaccines.
Based on member reports this might be good news for some of transplanted members.  Unfortunately my pain on all three shots has been short lived.

And since I'm posting again here is an NPR story from today on transplants and vaccines: https://www.npr.org/sections/health-shots/2021/05/07/994260770/vaccination-against-covid-does-not-mean-immunity-for-people-with-organ-transplan

[MooseMom]

I was waiting for you to post today, iolaire, because I read about the latest results only yesterday.  I thought the NPR piece was concise and appreciated the participation of Dr. Segev in the interview.  I was eager to get your take on all this.  So, thanks for posting.

So, it's time to move forward as the bright sparks figure out a way to help us.  People need to understand that it's not only tx patients who got the end of the stick, but also many other patients who are immunosuppressed by specific drugs that block specific parts of the immune system to combat other specific diseases.  We can become viral vectors, so it is worth taking the time and effort to protect us.

My question now becomes one about treatment because I'm coming to terms with the probability of getting covid.  As everyone else takes advantage of opening up, it is going to get harder to maintain social distance and avoid non-mask wearing people.  Does anyone know if monoclonal antibody treatments work for us?  I've not seen any information on this.

Another ray of hope:

https://www.theguardian.com/world/2021/may/06/drug-change-course-pandemic-trialled-for-use-european-commission?fbclid=IwAR3uPSsIlEHr2rELeMa8K1S2SVh1LovhhpLHflBe_l42W7CwHFneIW7xCeA

Again, the question will be does it work for us?

I admit that I'm beginning to feel sad and anxious and rather left behind.

[UkrainianTracksuit]

Excuse my bad typing.

Have you seen this article? I saved it for future reference but now it is fitting to the question, MM.

https://onlinelibrary.wiley.com/doi/10.1111/ctr.14245

[UkrainianTracksuit]

This is older and more of a news story than scientific. But, in trials earlier on, SOT recipients were one of the groups earmarked for monoclonial antibody therapy:
https://www.prnewswire.com/news-releases/hundreds-of-people-at-risk-for-severe-covid-19-avoid-hospitalization-with-new-treatment-301231079.html

I will have to dig through all my stuff (lots...) but I recall one paper that stated pausing the use of mycophenolate was also part of the wider treatment program of hospitalized tx patients.

[MooseMom]

Excuse my bad typing.

Have you seen this article? I saved it for future reference but now it is fitting to the question, MM.

https://onlinelibrary.wiley.com/doi/10.1111/ctr.14245

Thanks for this as I had not seen it.  What I find interesting about it is that there were "other interventions", ie medication modulation.

[MooseMom]

This is older and more of a news story than scientific. But, in trials earlier on, SOT recipients were one of the groups earmarked for monoclonial antibody therapy:
https://www.prnewswire.com/news-releases/hundreds-of-people-at-risk-for-severe-covid-19-avoid-hospitalization-with-new-treatment-301231079.html

I will have to dig through all my stuff (lots...) but I recall one paper that stated pausing the use of mycophenolate was also part of the wider treatment program of hospitalized tx patients.

I'm not surprised that SOT patients would "qualify" for treatment, but I'd still like to know if it was successful.  I still don't know.  Let us know if you find further information.  Thanks for showing me this, You Tea.

[UkrainianTracksuit]

This is not even my country so it cannot help me much. But this is a good document. It discusses the therapies/medications when to use/not to use with transplant patients. For the most part the cocktail is remdesivir, dexamethasone, and tocilizumab. As well it notes that treatment of corona in tx patients does not differ much than the rest of the population, minus the management of immunosuppression. That took me for a loop.

The thing that strikes me with the monoclonal anitbodies is that they need to be started asap in high risk people so another reminder that we need to stay on top of how we feel. Though the asymptomatic  tx patients stump me.

https://www.covid19treatmentguidelines.nih.gov/special-populations/transplant/

[iolaire]

Full one months past vaccination published at
https://jamanetwork.com/journals/jama/fullarticle/2779852
They will have a participant webinar on Friday, May 14, 2021 at 3:00PM EST.  I'll report back.

I also found the LabCorp allows you to request your own antibody test at:
https://www.labcorp.com/coronavirus-disease-covid-19/individuals/antibody-test
costs:
To complete your request, enter your payment information below to cover the PWNHealth fee of $10 that will be charged today. If your health plan or government program does not cover the cost of the test, you may receive an invoice from Labcorp for up to $42.13.
Even if you answer all the questions No they still recommend a test. 

I was looking into self testing because this month I will not have study based antibody testing so I'll want to get my own.  But I already had orders from last year via my work so I'll use those for this month.  I plan to do the test on Monday the 24th.  We leave for a trip to Utah on the 29th (Canyonlands and Arches National Parks) and I'd like to know if I have any protection.  Plus I plan to talk to my nephrologist about return to work when I return and if I built antibodies that discussion will be different.  (Remember I have the J&J booster that hopefully could change things.)

[UkrainianTracksuit]

Hey iolaire,

I am truly looking forward to - and even excited about - any information you can provide about the J&J booster once all your data comes back. It will be definitely interesting to see if it is a positive point in all of this.

We currently don't have access to J&J but I am indeed curious to learn about its efficacy in the tx population in regard to a booster. Hopefully, in the near future, that option will be on the table here.

I'm awaiting to hear the results of the study being conducted in the UK about dose/vaccine mixing. It might open doors to getting a second shot sooner rather than later over here.

Please do share what your neph believes is the safe route in the return to work. I'd like to wait until things are more concrete in regard to remote/office before I jump back into the job market.

As always, thanks for your information. I hope that you and your wife have an excellent vacation!

[iolaire]

Here are my notes from the call.  I had to wait until I had the recording password (PM if you want that) since I had another meeting during the presentation part.  One interesting item is they said they don't know what antibodies mean and they recommend it is NOT safe to assume immunity if you develop antibodies.

CDC despite opening things for vaccinated people to no masks, however they also say if you have a condition or are taking medications that we can your immune system, you may not be fully protected, even if you're fully vaccinated.

Studies looking at T and memory cell response to vaccination going on right now.

Post shot 1 only 17% developed antibodies
Younger and Modena and people further out from transplant developed antibodies and two immunosuppressive drugs resulted in less likely antibodies mycophenolate and azathioprine.

Linier response for time from transplant to building antibodies (likelihood accelerates with time from transplant)

Post shot 2 of population of 658 54% developed antibodies
Three groups’ antibodies 1 versus 2 shot
* Neg/Neg, non-responders 46%
* Neg/Pos, weak responders 39%
* Pos/Pos, boosted 15%

We don’t know what antibody level correlates with protection from infection or severe disease.  Antibodies are surrogate for protection – don’t know the exact quality of that surrogate.

Showed chart of levels antibody level, people with antibodies in does 1 shot up to high boosted level, people who developed them on shot 2 were all over, some ended up to high boosted level others were barely developed antibodies.  Good portion of the people had no detectable antibodies after the second dose.

No major safety issues with respect to the vaccines.  Still recommend vaccination because other factors may be in play. Also recommend social network to be vaccinated, family and friends.

One of the big points here is to not assume immunity after vaccination because there's so much that's unknown right now, and because we are seeing breakthrough infections, in other word, people who have been fully vaccinated and are still coming down with COVID and some severe enough to be hospitalized.  We do think it's important regardless of how robust your antibody response is to vaccination, regardless of if your antibody levels are very high, medium, or low, we do not think it's safe right now for you to assume immunity after vaccination so it's very important again to point out that the CDC recommendations.

Still be cautious even if we have antibodies
* We still feel that transplant recipients need to be extra careful.
* Outdoors is safer, transmission outdoors is far less
* Remain masked
* Remain distanced
* We worry about small indoor gatherings

France recommended opening for third does in France immune suppressed
* Working with partners to setup third does and study them
* Current vaccine approvals are not for third doses
* There are transplant patients getting third doses, we don’t know how
* If anyone is getting third does let us know so we can get blood and develop information
* Talk to your doctor

Don’t recommend adjusting antirejection drugs for vaccine.

[iolaire]

Great news on my side - Hopkins emailed me this afternoon with Positive Antibody results!  I went in this morning and got my own antibodies long with my monthly lab work at LabCorp because I didn't expect to hear from Hopkins until my month 3 test at the end of June.  They tested the blood I sent in last week for the two weeks post J&J shot. Somehow I never considered they would test that for antibodies as well since the test is all about T & B cell production and that is not approved by FDA so I'll only see aggregate study results.  Lets hope my LabCorp antibody test shows the same. 

I have a call out to my transplant center to talk to someone about how they feel about me returning to the office.  My office is highly motivating people to come in, and only allowing people two weeks post their first vaccine shot to come in.  No unvaccinated people are allowed in the building.

[tigtink]

This is so exciting Iolaire! I can't wait to hear the LabCorp results. You have given us all great information and great hope, Thank you!

[MooseMom]

This is great news, iolaire, but I'm not sure what it means.  Do you feel you are adequately protected now?  How strong was your immune response? 

I'm really eager to hear what your tx center has to say about you returning to the office.  And I also will like to hear what you decide to do next.

Thank you for posting!

[iolaire]

This is great news, iolaire, but I'm not sure what it means.  Do you feel you are adequately protected now?  How strong was your immune response? 

Hopkins doesn’t give levels as what the level means is unknown so only negative/positive information is reported.

I don’t know if LabCorp will have levels or not because this is a different antibody test put on file by my work last June.   

So, I don’t really know what it means other then I have some level of protection. So that’s the reason for reaching out to my clinic. I imagine I’m still not doing inside restaurants but will be less worried outdoors.

I’m most interested to hear GW Transplant’s views of exposure to a larger number of vaccinated people in the workplace. I would be fine/plan to wear masks in the public areas, even if others don’t need to now. But I don’t think wearing masks in the cube setting all day is something I’d want do if it’s recommended by the center - in that case continuing to work from home would be better.

[iolaire]

More fun as always, the LabCorp test came back negative but its a different test than Johns Hopkins has been ordering.

This is the negative test: SARS-CoV-2 Antibody, IgG, Spike
https://www.labcorp.com/tests/164055/sars-cov-2-antibody-igg-spike

This is what Johns Hopkins orders: SARS-CoV-2 Semi-Quantitative Total Antibody, Spike
https://www.labcorp.com/tests/164090/sars-cov-2-semi-quantitative-total-antibody-spike

If I go to order my own test on LabCorp the offer me a test named "COVID-19 Semi-Quantitative Antibody Test" which sounds more like the Hopkins test.  I'm going to assume the tests Johns Hopkins run are similar to the ones they request from LabCorp.  For now I'm going to plan around test that Hopkins ran on my blood.

[fifal9]

Thank you for the links, iolaire.
This is really fascinating.
I'm no scientist, but from reading the links, it sounds like the igg spike test is looking at a response from exposure to the virus and the semi quantitative test is looking at immune response from exposure to the vaccine. It could just be the descriptions were written by different people. I'm not sure if they can really tell whether anti-bodies have developed as a result of the vaccine or the actual virus.

It'll be 4 weeks since my second shot on Saturday and I'll be going in to get another test for anti-bodies that morning. I'm hoping they find some this time, but since I'm on 2 immunosuppresents now and had no sickness from either shot I'm not expecting any.

[iolaire]

It'll be 4 weeks since my second shot on Saturday and I'll be going in to get another test for anti-bodies that morning. I'm hoping they find some this time, but since I'm on 2 immunosuppresents now and had no sickness from either shot I'm not expecting any.

Other than sore arms I had no dramatic sickness from any of the three shots.  I think I had lite cold symptoms from the first Pfizer but it really was not the symptoms that I hear my coworkers talk about. Best wishes for the antibody test, it made me feel much better to have a positive result.

Transplant center update:
I spoke with a physician’s assistant from the transplant center this morning.  She felt with antibodies and with a vaccinated workplace its ok to return to work (her personal opinion).  The doctors are willing to provide letters to people who are not comfortable returning to the office for all the reasons we know.

After we spoke a bit about how proactive my workplace is and that they only allow vaccinated people onsite, added air filters, and put glass cube dividers she was even more positive since it’s a controlled environment and wished more places would do the same.  I asked about worries about no mask use in the cubes and she said it should be ok, it’s not like I’d be working with the public.   I’d still mask well in common areas within the building due to the proximity and higher volume of people.  We are the only tenant in our building so the vaccine policies apply to all building in the building.  I expect the vaccine policy also applies to the contract security and janitorial staff.  I think about the only people we cannot apply it to would be delivery folks.

I’m leaning on returning to the office after our trip next week (~June 7th).  But I’m also due for an appointment with my Nephrologist (from the center), if I can get an appointment on the 9th I might wait to talk it over with him then.

[iolaire]

Another transplant study webinar will take place on July 8th.  I'd guess a few weeks in advance of that they will publish their next study result update so I'll be keeping a look at this page waiting for it: https://transplantvaccine.org/study-results-and-webinars/

[MooseMom]

Thanks for that, iolaire.  I'll be on the lookout for some updated information.  I know that Dr. Segev has been hinting around about some new vaccine news.

[iolaire]

Small study including T cells in both transplant and dialysis patients.
Immune responses after COVID-19 vaccination in kidney transplant and dialysis patients
https://medicalxpress.com/news/2021-06-immune-responses-covid-vaccination-kidney.html
Dominique Bertrand, MD (Rouen University Hospital, in France) and his colleagues examined immune responses after vaccination with the Pfizer-BioNTech COVID-19 mRNA vaccine in 45 kidney  transplants recipients and 10 patients undergoing chronic hemodialysis.... After the second vaccine dose, 88.9% of patient on dialysis and only 17.8% of kidney transplant recipients developed antibodies against the virus that causes COVID-19. A specific T-cell response against the virus was evident in 100% of patients on dialysis and 57.8% of kidney transplant recipients. The immune response seemed to be influenced by the immunosuppressive drugs that kidney transplant recipients took, with some drugs having a greater effect than others.

Lets hope Hopkin's has more T cell data on the July 8th call.