Covid-19 Antibody Tests for CLL patients

Covid-19 Vaccine

It is important to note that these vaccines are not made by genetically-modifying technology. They do not make permanent genetic changes to our DNA. They do not work on our stem cells – only our immune cells.

After taking the Covid-19 vaccine, you may want to be tested to see if your body has developed any antibodies. What is important to know is that it may take longer for your body to produce antibodies than it is for a person who does not have CLL or who is not immune-compromised. You may want to wait at least a month.

A number of CLL patients (including me) signed up for the Leukemia and Lymphoma Society (LLS) clinical trial so that Dr. L. Saltzman could run some antibody tests on them to see the response of the vaccines: (1) SARS-CoV-2, Nucleocapsid; SARS-CoV-2 Semi-Quant Total Ab; Venipuncture; and (2) SARS-Cov-2 Semi-Quant Total Ab.

One of the tests is the nucleocapsid antibody test and the other test is the antibody spike protein test. You may need a prescription from a doctor to have these tests run in your local lab. These tests give you more information.

The nucleocapsid antibody test shows whether or not you have been exposed to Covid-19. If the nucleocapsid antibody test results are NEGATIVE, it means you have not been exposed to Covid-19.

The antibody spike protein test will show the number of antibodies you have developed. The antibody spike protein test indicates any titers produced by being exposed to the vaccine. Titer testing tests immunity. The importance of this is if it is POSITIVE, then you have had a response. That is good news. As to how protected you are if you have a small number, no one knows for sure right now.

Many CLL patients have not been able to produce antibodies or the number is so low that it appears to offer no protection. But this is only part of the solution to being protected against Covid infections. Don’t forget about your T-cells. They help protect you as well. Even if your numbers are so low that you essentially think you have no protection, it’s possible your T-cells can respond and protect you from future infections.

T-Cell Clinical Trial

LLS will be starting a T-cell clinical trial soon. The T-cell test is available in research labs but it is not commercially available right now. LLS will be testing patients who are taking Imbruvica, Rutuxan, Gazyva, etc. Patients with a response will be tested against patients who did not respond.

And now what?

What CLL patients are ultimately hoping for is an anamnestic response, which means that there will be an immune response after serum antibodies can no longer be detected in the blood.

The answers will be found right around the corner…

To booster or not to booster?

Dr. Gwen Nichols, Chief Medical Officer at Leukemia & Lymphoma Society (LLS) states that blood cancer patients are at increased risk of serious illness and death from Covid-19. She recommends avoiding poorly ventilated indoor spaces, wearing masks, social distancing, and staying away from crowds. When others get vaccinated and wear masks, they are protecting those people with compromised immune systems.

But what if you are a cancer patient and you have been inoculated? After taking the antibody test, many inoculated blood cancer patients found out that they do not have protection against the Covid-19 virus.

The Leukemia & Lymphoma Society examined the safety of the Covid-19 vaccine and they also tested the number of antibodies produced by blood cancer patients who had been vaccinated. The results showed that the Covid-19 vaccine is safe, but according to the results of the clinical study (NCT04794387), a number of blood cancer patients do not produce detectable antibodies. They were found to be seronegative.

Thirty-six percent of CLL participants were found to be seronegative after being vaccinated; however, a much higher percentage were found to have no antibodies in the sub-group of CLL patients who within the last two years had taken BTK inhibitors such as ibrutinib, a BCL2 inhibitor such as venetoclax, anti-CD20 antibodies or combination therapies.

Why is that so? We know that B-cells help to make antibodies when a person is vaccinated. Each of these blood cancer therapies affects B-cells. This leads us to deduce that the possibility exists that these cancer drugs could be preventing Covid-19 antibodies from multiplying. And will there be clinical trials with patients on these therapies?

July 8, 2021 Pfizer and Moderna publicly stated that boosters may be in the future. Dr. Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases, recently indicated that that booster doses may be authorized in the USA for the immunocompromised patients.

July 28, 2021 Pfizer/BioNTech announced that a third dose of the Covid -19 vaccine can boost protection against the Delta variant. Data suggests that if you are 18 to 55 years of age, a third dose can boost your antibody protection five times greater than your second dose (Howard, J., CNN). If you are 65 to 85 years of age, a third dose can boost your antibody levels against the Delta variant 11-fold following your second dose. In addition to the Delta variant protection, the third dose also increases protection against the original coronavirus variant and the Beta variant.

The CDC is in discussion about recommending booster doses for patients with compromised immune systems. Emerging data in two studies have reported an increase in antibody numbers after being given a booster shot following the full vaccine dosage. One study consists of solid organ transplant participants and another consists of blood cancer participants.

Last week, the CDC's Advisory Committee on Immunization Practices (ACIP) met and discussed immunocompromised individuals receiving a third booster dose. Its members seemed to be supportive of allowing this if recommended by their doctors; however, as of July 28, 2021 the official stance of the CDC and FDA is that a third booster of Covid-19 vaccines are not needed.

Earlier this month Israel and France began to give third booster doses of the Pfizer-BioNTech vaccine to some immunocompromised individuals. France is also including hospital staff over the age of 50 and older individuals.

Another 200 million doses of the Pfizer vaccine have been purchased by the United States. Are these future boosters?

My blood brother Joe's afib issues with ibrutinib

My friend Joe is a guest blogger today. He has just been taken off ibrutinib because of afib issues with his heart. Here is his story:

In May 2005, after an annual check-up with my PCP, I got a call from him asking me to come in again. He told me I had leukemia, chronic lymphocytic leukemia (CLL) and that he’d set up an appointment for me with a local oncologist. The oncologist confirmed the diagnosis and told me I wouldn’t likely need treatment for several years, if at all.

About seven years later, due to a large and uncomfortable spleen, a very high white cell count, many large lymph nodes and an apparent infiltration of CLL cells in my bowel, treatment was next. I went to a CLL expert and along with my local oncologist we decided on a clinical trial at a major clinical center with the drug then called PCI-32765.

I started the drug and fairly quickly my symptoms decreased. I was taking three 140mg capsules a day, all together in the morning. Some time later, I had episode of afib. I had a couple of these before starting the new drug but it was decided to reduce dosing to two capsules a day just to be safe as the drug had shown to have some possible cardiac side effects. The drug was later called ibrutinib and later still Imbruvica and achieved FDA approval for treatment of CLL. For several more years I continued on ibrutinib with few side effects and successful symptom treatment. My white cell count was in the normal range.

Early this year, I had another episode of afib. This was while on 50mg of metoprolol prescribed by my cardiologist to hopefully head off any other afib events. I called the clinical center to inform them. They suggested a Zio monitor which I used for 30 days. The monitor picked up an episode of V-tack and even though quite brief (four beats apparently while sleeping) the recommendation was to stop the ibrutinib – “a drug holiday” for three months, then to follow up with a second Zio monitor and evaluate our next options from there.

When I had a telehealth visit with my doctor, she said all looks well with one exception not related to white cells but hemoglobin. She just said to follow that up locally for now. I might not eat enough meat.

There are also other newer drugs one of which I’d been reading about called LOXO-305 which is in trials. I thought that it might even be possible to return to the lower dose of ibrutinib but that is unlikely with cardiac concerns. We discussed venetaclax, acalabrutinib and even that LOXO-305. I am looking into clinical trials. There is a venetaclax ramp up trial (short-term later to be followed locally) and one other trial currently on hold.

The doctor verified that I will be coming off ibrutinib. The risk for me with cardiac issues is apparently not worth continuing.

So, for the time being, I am once again not being treated for CLL. My doctor and I are once again developing our next plan to cope with this intrusive visitor. So, it looks like watch and wait again from here.

-- Joe

CLL patients developing antibodies from vaccines

Today I would like to chat with you about the antibody response to vaccines given to CLL patients. The first part of my post is an anecdote and further studies are ongoing. The second part of this post include the scientific results of two other vaccines given to CLL patients, two studies in which I participated.

PART 1: My friend Anne is in the same clinical trial at National Institutes of Health (NIH) as I am. We have been both been taking Ibrutinib since 2012. She got both shots of the Pfizer vaccine and was curious if her body would respond by creating antibodies.

In a normal healthy person, the Covid-19 immunity process typically takes two weeks after the second dose of the vaccine. One month after Anne’s second dose the total IgG/IgM antibodies to SARSCoV-2 Nucleocapsid protein test results were nonreactive, which means no antibodies were found. However, eight weeks after Anne got the second dose antibodies were finally detected: Positive >0.79. There’s a little hope here. It will be interesting to see if the antibodies continue to increase in number.

As a cancer survivor and Ibrutinib user, I am interested in my own immunity process. NIH will soon be opening a CLL vaccine clinical trial on antibodies. As soon as I am notified that their proposal has been approved, I will post the information to the NIH clinical study on the antibody response to the vaccine in CLL patients.

Another option is the Leukemia and Lymphoma Society (LLS) is setting up a patient registry and is paying for quantitative antibody testing at LabCorp. This study expands to more types of cancers. The link to their registry is: https://www.ciitizen.com/LLS/?utm_source=LLS&utm_medium=Partner%20Landing%20Page&utm_campaign=&utm_content=&utm_channel=LLS&utm_vehicle=

PART 2:

I was one of the participants in the NIH CLL HEPLISAV-B (hepatitis B) and SHINGRIX (shingles) vaccine studies. The recently published initial results from the vaccine studies has been published.

The full article can be found here: https://ashpublications.org/blood/article/137/2/185/474376/Effect-of-Bruton-tyrosine-kinase-inhibitor-on?searchresult=1

Below is a brief summary of the results from NIH:

SHINGRIX: Approximately 60 percent of untreated patients CLL patients and approximately 40 percent of BTK-inhibitor (ibrutinib or acalabrutinib) treated patients developed an antibody response against the shingles virus. This response rate is less than in the general population, however we are encouraged by these responses and recommend the SHINGRIX vaccine to CLL patients that have not yet received it. However, we do not know how long the antibody response lasts. The antibody response to the Shingrix vaccine is based on a research test and, therefore, is not part of your CRIS record.

HEPLISAV-B: Approximately 30 percent of untreated patients CLL patients and approximately 5 percent of BTK-inhibitor (ibrutinib or acalabrutinib) treated patients developed antibodies against the hepatitis-B virus. Patients treated with a BTK-inhibitor do not appear to reliably develop antibodies following vaccination with HEPLISAV-B. CLL patients that are untreated are still able to develop antibodies against the hepatitis-B virus, albeit at lower rates compared to the general population.

Side Effects: The side effects for both SHINGRIX and/or HEPLISAV-B were very similar compared to those observed in the general population – there is therefore no evidence to suggest that CLL patients suffer from more side effects following vaccination.

As cancer survivors we have some hopeful news. As Dr. Brian Koffman says, “We are all in this together.”

When Life Sucks, I Choose Joy

Good mourning! 2020 has been the year of “non-stop awfulness,” according to Dave Berry, a reporter for the Miami Herald.

But I believe Harriet Beecher Stowe says it best.

“When you get into a tight place and everything goes against you, till it seems as though you could not hang on a minute longer, never give up then, for that is just the place and time that the tide will turn.”

Life sucks when you have cancer and a pandemic. But I have made a decision to choose joy, even though I am such an imperfect human being.

Years ago I learned to turn my despair into hope. I learned to pray for those I love dearly and those I do not. I learned that forgiveness equals peace. I always believed in kindness and doing to others as you would have them do onto you. I believed in loving your neighbor.

But I find that I fall a little short of those goals today. The past few years have forever changed who I am. I have had to change who I choose to be in this world. I am not as good of a human being as I always strived to be. I am more cynical and more discriminating. I do not give my heart out freely anymore. I avoid toxic people like the plague.

As the Pandemic still looms over our heads, I have been faced with the deaths and sickness we have experienced in my family, the increased isolation, the constant irritation of people who live in La-La Land, others who judge, lie, and live in an alternative reality with no consequences … I could go on and on. But surprisingly I have become much stronger, more fearless, more resilient, and more authentic.

I often wondered why some problems (like a cancer diagnosis) or certain toxic people make your life a living hell, and I found the answer. Byron Katie, author of Loving What Is states, “It’s not the problem that causes our suffering: it’s our thinking about the problem.” So it’s our self-talk that needs to change, if we are ever to work our way through chronic pain, fear, rage and despair. You may not have control over what happens to you, but you own your attitude. I have some work to do.

Here is how I have had to deal with life:

• FRUSTRATION

Sometimes life does not feel real. It feels like we are living in the Twilight Zone. It’s okay to have a stinky day. Sometimes you just have to let your frustrations out by exercising, listening to music, venting or journaling – whatever works for you, but does not harm others or yourself.

But when you are ready, facing pain is what gets you through it. Allow yourself to feel the pain and be unhappy. PAUSE and allow yourself to feel it. Do not numb it. Do not run away from it. Do not distract yourself. Do not lash out and hurt others. Face it head on or the pain will be prolonged.

Giving ourselves permission to feel the disconnection, the anxiety, the rage, the hysteria, the fear, and the misery is necessary to process the tender feeling of just being alive. Accept the pain and process the feelings.

Do not focus on WHY? Why did this happen to me? It just is. So, the next question is “What are you going to do about it?”

• GRATITUDE

Having gratitude is a special power to change your mindset. I wake up every morning and count my blessings. It does not matter how small the blessing is, there is always someone who is worse off than me. Live in the now. In fact, sometimes I wake up in the morning and say to myself, “Halleluiah! I am still alive!”

• BREATHE

Sometimes to battle stress take a big breath of air through your nose and slowly breathe it out through your mouth. I have believed in breathing through meditation for many years. It has helped me get through many things in my life. Even my Godson Ryan McBurney believes in the power of breath work. He has a facebook group called “Breath, mind, and body for high performers.”

• THE BLAME GAME

Pain lasts longer when you blame others. STOP! Don’t get stuck in the blame game cycle and the victim mentality. Move on or you will not find joy.

• PERSISTENCE

Do not surrender to grief and fear. Be persistent. Fake it until you make it. It ain’t over until the fat lady sings. And this fat lady ain’t singing yet!

• THIS TOO SHALL PASS

“This too shall pass” are words I have spoken in my head for many years. When life sucks, remember that this is temporary. Ask yourself: What can I learn from this experience? How can I respond better next time?

AND IN CONCLUSION

Life is complicated. Life is not always good. Sometimes it sucks. I have intentionally decided to choose joy in spite of it. It is a healthier and happier way to live my life.

Love & Gratitude,

Dr. La Verne

Cancer, Pain, Death, and Voting

Today is election day and it is probably the most important political election in my lifetime. But what does this have to do with cancer?

Well, being a cancer survivor changes your perspective of the world and the people in your life. You realize how fragile life is. You understand the cycle of life and the reality of death. You realize it is important to stand up for what you believe. You understand the importance of character, respect, kindness, and the journey for the truth. The people in your life become very precious.

When I was a child, I mistakenly believed that all grown-ups were good and acted like adults. Boy, was I wrong!

What being a cancer survivor really changes – at least for me – is the knowledge that some people you love can emotionally cause enough pain in your heart that they literally die in your life even though they are still alive. They become toxic.

When you have a catastrophic event happen in your life, it becomes a healthy choice for survival and wellbeing to stay away from toxic people. Sadly, sometimes those toxic people are family, friends, or neighbors.

My Dad always told me that arguing about religion or politics is a no-win situation. How wise he was! I never thought his wisdom could have a connection with cancer.

I have witnessed this pandemic and this election bringing out the worst in people. I had hoped it would bring out the best.

Be patient with me. I need to give you a little background to those of you who do not know me well: My mother was a German immigrant to the U.S. She had to have 86 documents signed to prove that she was not part of the Hitler Youth Organization before she could legally come with my father to America. My father was Nisei – first generation Japanese-American, born in this country. He told me many stories of intolerance, hatred, and division based upon the fact that he looked different.

Because I am half and half – half Asian and half White, I have had the benefit of White Privilege. That is, people assuming that I am Caucasian. I have been able to see and hear what people really think.

Having a blood cancer that does not always show itself to others, puts me in a similar position. Shortly after I was diagnosed with high-risk chronic lymphocytic leukemia, I heard these comments: “You don’t look like you have cancer.” “You have the good cancer.” “You really must not have cancer.”

Now with the pandemic, I am concerned because even though I am in remission, I have a compromised immune system. I wear a mask to protect you. Wearing a mask to protect me is a kind gesture to a cancer survivor. It is not political. It is human kindness.

I have gone to Congress several times to explain the importance of healthcare accessibility for every American, as well as to discuss the cost of cancer drugs and the value of these drugs. This is not political. This is how we repair the country I love.

So, on this day my thoughts are deep and a bit sad. After this election half the country will be rejoicing and half the country will not. The question is … what happens next? What behavior do we model to our children and our grandchildren? What legacy do we leave them? Will we ever become united? Will we ever again behave like grownups?

Please vote! The right to vote is an extraordinary privilege. Do not waste it.

Negative and Negative

I got the results of my tests.

Well, it looks like I am negative for COVID-19 and negative for having antibodies. That means that the upper respiratory infections I had off and on all November, December, and January were not the Coronavirus.

The state of Arizona is opening up, but look at how the number of cases are spiking. Here is an excerpt from The Washington Post:

“14 states and Puerto Rico hit highest seven-day average of new coronavirus infections”

By Kim Bellware and Jacqueline Dupree 

June 8, 2020

Since the start of June, 14 states and Puerto Rico have recorded their highest-ever seven-day average of new coronavirus cases since the pandemic began, according to data tracked by The Washington Post: Alaska, Arizona, Arkansas, California, Florida, Kentucky, New Mexico, North Carolina, Mississippi, Oregon, South Carolina, Tennessee, Texas and Utah.

So ... What happened to the CDC advisement of 14 days of no increases? Does the increase in numbers mean that more people are being tested? When is it safe for cancer survivors like me to go out and play? When is it safe for me to fly across the country to meet with my medical team in Bethesda, Maryland? Dr. Fauci!?!