Leukemia & Lymphoma Society COVID-19 vaccine safety data is now available ; vaccine antibody data expected later in 2021

[lankisterguy]

On behalf of the Leukemia & Lymphoma Society, thank you again for joining the LLS National Patient Registry, a project of the Michael J. Garil Patient Data Collective, and a special thanks to those of you who are participating in our COVID-19 study. This study is giving us unique information and insights into how people with blood cancer respond to COVID-19 and COVID-19 vaccines.

COVID-19 vaccine safety data is now available on our website

lls.org/news/covid-19-vacci...

With the help of citizen scientists like you, we have collected and analyzed vaccine safety data from more than 3,500 Registry participants. The results show that vaccine side effects in blood cancer patients are very similar to side effects in healthy volunteers who took part in the vaccine clinical trials. This should help reassure cancer patients yet to be vaccinated about vaccine safety and tolerability and give their healthcare professionals important initial safety data specific to this at-risk population.

COVID-19 vaccine antibody data expected later in 2021

We continue to gather and analyze the antibody data from thousands of study participants. Full results are expected later in 2021 and we will share results with participants. But in the meantime, we are seeing evidence that some blood cancer patients do not mount a measurable antibody response to the COVID-19 vaccine.

The next step in this study is for participants who are more than three months from their final COVID-19 vaccination to have one additional follow-up blood test. These invitations will be sent at the beginning of each month to those who are due based on the date of their final COVID-19 vaccine. If you are part of this study, please watch for your invitation in the coming months.

A follow-up T-cell study is beginning in mid-June

Finally, we wanted to let you know about a follow-up study kicking off this month to assess another type of immune response to COVID-19 vaccines. This follow up study, which is invitation only, is looking at T-cell responses in a subset of people who are participating in the antibody study.

T-cells are the part of our immune system that create “killer cells,” another line of defense against infections like COVID-19. Because it is possible that people without antibody responses mount T-cell responses, we are inviting people with and without antibody responses to be part of this study. We are also inviting a diverse group representing a range of cancer diagnoses and treatments, as well people across a spectrum of age, gender, race and ethnicity. The total enrollment for the follow-up study is capped at 1,000.

Because T-cell testing is reserved for research purposes, we will not be able to provide individual T-cell results. If you are invited to join this trial, be assured your participation will help us gather vital information to improve care and safety of people like you. And, as always, we will share our findings with you as soon as they are available.

Invitations for this follow-up study will be sent soon. If you receive one, we hope you will strongly consider joining us.

An important note about COVID-19 Antibody and T-cell tests

Right now, we don't fully know what seronegative antibody tests mean, but what we've seen so far tells us that immunocompromised patients, including those with certain blood cancers or undergoing certain treatments, are different than the general population and may be at risk. This does NOT mean that vaccination is futile. It does mean blood cancer patients should continue to follow good prevention guidelines, including wearing masks, social distancing, frequent hand washing, avoiding crowds and poorly ventilated indoor spaces.

Once again, thank you for participating in our patient registry. Your participation will have far-reaching impact on improving care for everyone with blood cancer.

Sincerely,

The Leukemia & Lymphoma Society and Ciitizen

[cajunjeff]

"Because T-cell testing is reserved for research purposes, we will not be able to provide individual T-cell results. If you are invited to join this trial, be assured your participation will help us gather vital information to improve care and safety of people like you. And, as always, we will share our findings with you as soon as they are available".

I was happy to participate in the antibody testing part of the trial and was not surprised, but nevertheless disappointed, to learn I was negative for covid antibodies. I am on a btk drug and most of us on btk drugs do not create measurable covid antibodies to the vaccine. Should they select me to be in the t cell testing follow up, I shall volunteer again.

I do not understand, however, this explanation as to why I would not get to learn the results of my t cell testing. What does the testing being reserved for research purposed have to do with me learning if I have a t cell response?

And its probably incorrect to put in the same paragraph that "as always, we will share our findings with you" when you just said you would not.

Of course I know they are referring to the general findings of the study and not my individual results.

And all that said, I appreciate the LLS and anyone else who sponsored this study. I just do not understand why we would get our antibody results and not our t cell test results.

[Hidden in reply to cajunjeff]

Well said!

[lankisterguy Volunteer in reply to cajunjeff]

Hi Jeff.

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We got the Antibody & T-spike results from Lab-Corp's automated system, likely because they are already set up with a HIPPA compliant system, and it didn't cost extra. -

I would expect that the T-cell test is NOT an automated test by Labcorp and being done in a research lab where reporting back to us individually would add a significant bureaucratic burden. ( HIPPA likely adds a lots of rules to protect our medical records). Vs. anonomyzing all the samples before testing and not tracking the results per individual.

-

We did get far more than we paid for from participating, and the general findings will help us all.

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I don't know if Larry Saltzman MD linkedin.com/in/larry-saltz... is here on Health Unlocked CLL Support, but I bet that bkoffman could venture an opinion or confirm my wild guess.

-

Len

[cajunjeff in reply to lankisterguy]

Len, I assume they have some cause for not telling us the results and I have said I am appreciative of their efforts wit the overall study.

I suspect you might be right, they dont want the hassle or expense of getting our results out to us. Perhaps there are liability concerns too. I still think they probably could have set it up in some way to get us our results, I would be happy to pay for mine. And I think its fair for us to be disappointed we would not get results which could be very important to us in our respective plans to protect from covid.

[SeymourB in reply to lankisterguy]

I suspect that LLS cut a low cost deal with Adaptive Biotechnologies. That company's big strength is not so much the method they use (gene sequencing), but the proprietary database they have.

I paid for the T-Detect test developed by Adaptive Biotechnologies, and paid the direct-to-consumer price myself. I did get results, and found out that I was positive for SARS-CoV-2 T-Cells. I gave them feedback, though, that I was disappointed that the result was only qualitative. There was no count reported, nor did they say which SARS-CoV-2 epitopes I matched. That would give a better indication of spike vs nucleocapsid, etc.

The T-Detect test is only available in the U.S., by the way. My blood draw was done at LabCorp the same day as my antibody tests. My antibody tests were negative, alas.

The positive test on the T-Detect did make me feel better. Not sure it was worth the $200 cost to most people. But I'm a nerd, and enjoy this sort of thing more than most people.

The positive T-cell result is nothing that I would change my behavior on. There's no indication at all that T-cells alone provide neutralizing protection from any specific level of disease. I'm sure they help a little, though. Together with properly functioning B-cells, T-cells are vital, yet not as well studied as B-cells due to difficulty - until recently.

Antibody tests are so easy, they're very inexpensive in research. At $200 consumer cost, the T-cell tests is actually only twice as expensive as typical direct to consumer SARS-CoV-2 antibody tests from Quest or LabCorp. I'm not sure if that's a temporary deal to drum up interest, though.

=seymour=

[WinJ3 in reply to cajunjeff]

It's probably about the cost, but you would think it would be a courtesy.

[GMa27]

Disappointed we won't get T cell testing results. Makes no sense since they will get results on each individual person.

[Jonquiljo in reply to GMa27]

Perhaps people should ask around to find out where people might get their own “laboratory-based” test done? I will bet, at least in the USA, that many insurances will pay for it.

Personally, I am staying away from the LLS-Ciitizen “collaboration”, as I hear of many requirements to release private health information to others. It seems odd that they can do a test, but don’t want to release the information to individual sample donors.

Perhaps they (LLS-Ciitizen) don’t want to be exposed to the liability of their “unknown” laboratory based test. The best way to avoid liability on their part would be to keep all individual data to themselves.

Ironically in all of this, I see no way it can ever be concluded from these measurements - how safe a CLL patient is from COVID dangers when vaccinated. Do they just want information (samples) from us and not want to provide an explanation of their goals in return?

Sorry to be negative on this, but all I see is a lot of fear and confusion generated by these LLS studies - and no real or potentially helpful answers. It doesn’t help that very little is known about Ciitizen, but they want people to waive many medical rights to them.

Is this a bunch of people looking for samples to play research games - or is there anything in It for the blood donors?

[GMa27 in reply to Jonquiljo]

My insurance company paid for the Spike Protein Semi Quantative Antibody test. I got that test 2 weeks after second vaccine. The LLS study was good timing for me cuz it was 3 months after vaccine and my results improved. I don't know if my insurance company would pay for the T cell.

Lots of unanswered questions about so much concerning the virus especially for immune compromised. 🙏

[SeymourB in reply to GMa27]

GMa27 -

How much did your antibody scores change from 2 week to 3 months?

=seymour=

[GMa27 in reply to SeymourB]

I went from >20.0 to >2500.Huge increase!

[SeymourB in reply to GMa27]

2 weeks is way too early to test antibodies, I think. Even so, it's an interetsing N=1 result. It interesting to see how someone like you, who has an apparently normal SARS-CoV-2 antibody level after 3 months started.

Do you mind sharing your markers and dx date? Have you had general IgG, IgM, and IgA levels checked in the last year or so?

[GMa27 in reply to SeymourB]

It was suggested in February on most CLL sites to get tested 2-3 weeks after second vaccine. So I went 15 days after. Then I volunteered for the LLS study & that test was 3 months after second vaccine.

I was dx in 2006. 13q mutated. W&W 12 years. Had 3 cycles of FCR 2018. In remission.

I just graduated from every 4 months to every 6 for hematologist check ups. Have a check up soon. All the Ig levels are in normal range.

Alice 💕

[Pin57 in reply to GMa27]

GMa27 - Hoping your scores been sky high all along which would’ve awesome.

Here’s a direct answer from LLS when I asked what’s up with our areas LabCorp max scores >250 vs the second round a-bodies testing >2500 max scores? Here’s what they said in an Email reply …

“It appears that the process has become more sensitive, and they are increasing the dilution factor in the blood to be able to look for smaller amounts. I have just recognized this very recent change.”

Larry Saltzman, MD

In other words they spend a few more dollars on the second test to dial in a better reflection of your a-bodies score. That’s my take.

So… your score situation could be two things (both end result awesome for you congrats bigtime :). )

You might have had a score first time >2500 but dilution in the test only could “show” >20 max score for first antibodies in your area (ours is >250 for first a-bodies max score).

Or… because you have no idea how much higher than >20 it was… it could of been 21 or 100 or 1000 or >2500… that’s an important point and because nobody knows it’s all speculation what you “had” .

The scoring sucks here we have a great case in point n nobody knows really what that first score “was” except it’s greater than 20…. But by how much?

Again your end game score(s) GMa27 is well deserving of joy… in either case.

We CLLers need any positive news we can get and yours is end result awesome positive. Congrats 🎉🎊!!!

[GMa27 in reply to Pin57]

Awesome explanation!Thanx

[SeymourB in reply to Jonquiljo]

The T-Detect test is FDA authorized, the same as all other COVID testing.

The technology has a fairly long trail of studies. I can provide links to papers, if anyone is interested.

[Jonquiljo in reply to SeymourB]

An FDA authorized test is no big deal - authorized for what is the question?

If T-detect tests are qualitative, I can't imagine they will yield a lot of useful data.

Also even if Ciitizen dropped $200,000 (1000 tests at 200 each), that is not a major expenditure for a company. I really wonder what Ciitizen gets out of all of this? Again, they are barely known and looking for ?????? with all these medical releases they have people sign.

Sorry, but I prefer privacy. I won't even join Facebook because I want to keep my life where I put it!

[SeymourB in reply to Jonquiljo]

Jonquiljo -

It's authorized for detection of infection, not for verification of vaccine.

In fact, the company running consumer side for Adapter, PWN Health, reported my positive result to the Louisiana Department of Public Health, who then called me, wanting to do contact tracing. I explained that I had bought the test after vaccination, and the DPH seemed to accept that.

I let PWN know that LA DPH had called me, and that people are using this test as after vaccines, too.

This is a new testing product, and I can find nothing about approval for our UK, Canadian, or Australian friends.

The T-Detect web page, t-detect.com/, has some FAQs:

What does the T-Detect COVID test measure?

The T-Detect COVID test can detect an immune response to SARS-CoV-2, the virus that causes COVID-19 disease, to assess recent or past infection. It is not intended for the diagnosis of active/current SARS-CoV-2 infection.

How accurate is the T-Detect test for COVID-19?

When the T-Detect COVID test was compared with serology testing:

In one study, 15 or more days after symptom onset with PCR-diagnosed COVID-19, the T-Detect COVID test identified 94.5% of patients, while leading serology (antibody) tests had a test range from 88.0 -90.4%.[1]

In another study, 5+ months after PCR diagnosis, the T-Detect COVID test detected 95% of COVID-19 positive patients, while the serology (antibody) test had a range of 52-71% in detection of COVID-19 positive patients.[2]

In studies, the T-Detect COVID test showed a specificity of >99%.[1]

1. Dalai, S, et al. Clinical Validation of a Novel T-cell Receptor Sequencing Assay for Identification of Recent or Prior SARS-CoV-2 Infection. medRxiv. 2021.

2. Adaptive data on file.

What does the T-Detect COVID test mean in regard to immunity?

A T cell response is typically detectable in blood several days after initial infection. How long this response lasts post-infection and the implications for immunity are not known. In one study, T cells were shown to persist in the blood for more than six months after initial infection and studies of other coronaviruses show T cell responses can persist for several years.[1,2,3]

To protect yourself and others, the CDC recommends you wear a mask, stay at least six feet from others whom you don’t live with, avoid crowds and wash your hands often with soap and water for at least 20 seconds (especially after you have been in a public place or after blowing your nose, coughing, or sneezing).

1. Zuo J, et al. Robust SARS-CoV-2-specific T-cell immunity is maintained at six months following primary infection. bioRxiv. 2020.

2. Channappanavar R, et al. Virus-specific memory CD8 T cells provide substantial protection from the lethal Severe Acute Respiratory Syndrome Coronavirus infection. J Virol. 2014.

3. Ng, O, et al. Memory T cell responses targeting the SARS coronavirus persist up to 11 years post-infection. Vaccine. 2016.

If I got the COVID-19 vaccine, will it affect my T-Detect COVID results?

We do not currently have information on how the SARS-CoV-2 vaccine may affect the T cell response and the results of the T-Detect COVID test, but we are actively gathering data and will provide updates as information becomes available.

Will insurance cover costs for the test?

The T-Detect COVID test is not currently covered by insurance. The patient is responsible for blood draw fees, copays for doctor visits, and any additional associated costs. The T-Detect COVID test is FSA/HSA eligible.

Eligible patients may qualify for discounted testing based on their income or medical expenses as part of Adaptive’s patient support program (Adaptive Assist). You can print an Adaptive Assist application and submit it to us at [e-mail] or fax to 440-788-2137. Alternatively, you can contact Adaptive at 855-236-9230 to find out if you might qualify for Adaptive Assist prior to placing your order.

If you have already purchased the test and your application for Adaptive Assist is approved to provide the test at a reduced cost, a refund will be processed to your credit card.

[KatieBlue in reply to Jonquiljo]

My doctor would not order the semi-quantitative and said most insurances are not covering antibody testing, currently, primarily because there is no specific action to take on the results.

[Hidden]

That's cool. But, here's my deal. You don't give me my results, I don't give you my T cells. Even Steven, okey dokey.

[neurodervish]

I wanted to do my bit so I signed onto the LLS study, but ended up backing out when I saw too many privacy red flags. I reached out to Ciitizen to ask why they needed access a lifetime of ALL my medical records and they responded that it was "critical" to the LLS researchers' work. It doesn't make sense to me. I know of no other clinical trial that demands so much private data.

From what I've read online, Ciitizen is a medical data management company, not a research company. I assume they're being paid by LLS to manage the digital data for this trial. They have stated that individual records will be "de-identified." What they don't tell you is that there is no law in the US preventing any company from re-identifying your data (nor is there a law against selling it). It's also worth noting that one's identity could easily be correlated with enough data points, and they will have ALL of them.

With all the ransomware attacks and hacks going on, the last thing I want to do is consolidate all my info into one digital record. Here's why it matters: staysafeonline.org/blog/hea...

If I've gotten anything wrong here, please correct me. I really don't mean to ruffle any feathers, but I am very concerned about this.

[KatieBlue in reply to neurodervish]

Thank you, Neurodervish, for bringing up an important concern whenever one is considering participating in research studies.

I too had looked at the LLS study, and while the study is important, the amount of personal data, medical records/ access in perpetuity— not just one’s CLL med records— was so far beyond the scope of what is necessary, I also chose not to participate.