LLS Covid-19 Vaccine Trial: Antibody response to SARS-CoV-2 vaccines in patients with hematologic malignancies

[lankisterguy]

Posted July 29, 2021 by Dr. Brian Koffman

cllsociety.org/2021/07/lls-...

This content was current as of the date it was released. In science and medicine, information is constantly changing and may become out-of-date as new data emerge.

There have been several small trials that have already reported that CLL patients don’t do a great job of forming antibodies after being fully vaccinated, but the Leukemia & Lymphoma Society (LLS) lls.org/ trial was much bigger and the data more robust.

The study covered all blood cancer. I will highlight some of both the general and CLL specific findings:

Nearly 250,000 blood cancer patients in the U.S. may not have detectable antibodies following COVID-19 vaccination

64% of CLL patients formed antibodies to the SARS-CoV-2 spike (S) protein when tested two weeks or more after the second vaccination. This was a much better number than seen in other trials.

For comparison, 97% of CML (chronic myelogenous leukemia) patients responded to the shots. 100% of the immunocompetent form antibodies.

Treatment in the last two years with a BTKi such as ibrutinib or acalabrutinib lowers the chances of responding.

The numbers were small, but patients who received anti-CD19 CAR-T therapy that is used in CLL or anti-CD20 monoclonal antibodies (rituximab and obinutuzumab) in the last year respond poorly to vaccination.

The Moderna vaccine had a slight but statistically significant better response rate. It does contain 3x the mRNA as does the Pfizer.

Females responded better than males. Reasons are unclear, and this has not been seen in most other trials.

The data are still being parsed and will be updated. T cell function will be studied next. We will keep you informed as results become available. I hope to soon interview my friend and fellow family doctor, Dr. Larry Saltzman, one of the key investigators in this important research.

One more thing. To their credit, LLS shared the results of the semi-quantitative antibodies to the spike (S) protein with the patients. I was one of those patients.

While there is active debate (see this editorial by Dr. John Byrd cllsociety.org/2021/05/moni...

and this by Drs. Kay and Skarbnik) cllsociety.org/2021/05/more...

as to whether patients should be tested for their antibody results, CLL Society believes that LLS did the right thing: it is better to know. Our understanding on how to best use this information will only grow over time. For right now, no matter what the results, we are in step with the CDC’s recently updated recommendations that the immunocompromised such as those with chronic lymphocytic leukemia should get vaccinated but should act as if they are not. That means masking and social distancing.

With this data we can now firmly state that it is unwise for a CLL patient to assume that to be vaccinated is to be protected.

Making everyone aware of and sensitive to CLL patients’ increased risk of contracting COVID-19 is our first step.

The next step is what to do about that potential increased risk. CLL Society and others are working on solutions. There are reasons to be hopeful.

Here are links to three prior trials on vaccine responses in CLL patients:

Antibody responses after first and second Covid-19 vaccination in patients with Chronic Lymphocytic Leukemia. papers.ssrn.com/sol3/papers...

COVID-19 vaccine efficacy in patients with chronic lymphocytic leukemia

nature.com/articles/s41375-...

Efficacy of the BNT162b2 mRNA COVID-19 Vaccine in Patients with Chronic Lymphocytic Leukemia pubmed.ncbi.nlm.nih.gov/338...

Here is a link to the pre-proof of the much bigger LLS trial: Antibody response to SARS-CoV-2 vaccines in patients with hematologic malignancies and to its associated tables.

lls.org/sites/default/files...

lls.org/sites/default/files...

Thanks to LLS for organizing and funding this important effort and thanks to everyone who volunteered in the trial.

Stay strong. We are all in this together.

Brian

Brian Koffman MDCM (retired) MS Ed

Co-Founder, Executive VP and Chief Medical Officer

CLL Society, Inc.

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Len

[Bar68]

Looking forward to booster or 3rd shots like they are doing in Israel and Germany. The delta spikes are like Lucy moving the football on Charlie Brown. I am glad DeBlasio will require proof of vaccination at gyms. Would love to go back to the Y. Wondering if double masking in that environment would make it ok for me.

[lankisterguy Volunteer in reply to Bar68]

Hi Bar68,-

I would submit that to protect yourself - using a properly fitted / tight N-95 / FFP-2 respirator / mask is far superior to wearing 2 of the flimsy masks that leak around the edges.

IMO- any mask with earloops cannot be made to seal correctly, and if your glasses fog up, you do not have a proper fit.

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Anyone that has worked in the chemical industry that use industrial respirators, first responders that use SCBAs ("Scott packs), or even SCUBA divers know that getting a mask to fit without leaking is tough.

(I've breathed in more banana oil than I want to recall, but it drives home the need to make certain respirators fit properly).

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Here is a link to a YouTube video

youtube.com/watch?v=pGXiUyA...(Not working as expected?)

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Len

[Bar68 in reply to lankisterguy]

Hi Len, I found a very good fit with a KN95 mask that I like. Dr. Furman’s PA commented that she thought it was a really good one and had a great fit. On subway I had put a surgical mask over it.

[lankisterguy Volunteer in reply to Bar68]

A surgical over an N-95 can help keep it clean and if you change the surgical for each new environment, you may be protecting others. Say hi to Leslie from me the next time you see her. Len

[Bar68 in reply to lankisterguy]

Yes, my new practice. Will do re Leslie, but, fingers crossed, hopefully will not see her for another 6 months

[beanlake14 in reply to Bar68]

Could you share the brand of that mask? Thank you

[Bar68 in reply to beanlake14]

On Amazon- out of stock right now:

Visit the WWDOLL Store

4.6 out of 5 stars 4,938 Reviews

White KN95 Face Mask - 50 Pack, WWDOLL New GB2626-2019 KN95 Mask 5-Layer Breathable Mask White

[beanlake14 in reply to Bar68]

Thank you!

[lankisterguy Volunteer]

I have KN-95s masks but they don't seal well due to the ear loops. So I use them for visitors etc. -

I strongly prefer the respirator versions with headbands and NIOSH rating.

3M Personal Protective Equipment Particulate Respirator 8210, N95, Smoke, Dust, Grinding, Sanding, Sawing, Sweeping, 20/Pack

smile.amazon.com/3M-Particu...

for the version without an exhaust valve (protects me and protects others- but gets wet and hard to breathe in 30-60 minutes)

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and for the valved version that protects me only - but I can wear these for several hours :

3M 8511 Paint Sanding Valved Cool-Flow Respirator $20.99

smile.amazon.com/Woodworkin...

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Len