Two New Free Vaccine Trials at the NIH

The National Institutes of Health were founded by Congress in 1887 and charged with being the preeminent research center in the world.

The CLL Society is proud of our educational partnership with one of the institutes, the NHLBI (NATIONAL HEART, LUNG, AND BLOOD INSTITUTE) as it serves the CLL community under the leadership of Dr. Adrian Wiestner.

The NIH does research that others don’t do, and they cover all the expenses related to their trials including help with the cost of travel.

I was excited to interview Dr. Chris Pleyer by submitting a series of questions that I hope will address most CLL patients’ concerns about their two new vaccine trials for prevention of shingles and hepatitis B.

Basically, if you have not had one or both of these important vaccines and are not on steroids or receiving IVIG, I strongly recommend you consider these free trials. Not only do you get the care for free, you will be helping researchers understand how the immune system functions in CLL patients.

Here is my Q+A with the researcher, Dr. Chris Pleyer:

Dr. Koffman:

Dr. Pleyer, you have recently initiated two studies with new vaccines in patients with CLL:

1. gov Identifier: NCT03702231: Response to the SHINGRIX Varicella Zoster Virus (VZV) Vaccine in Chronic Lymphocytic Leukemia (CLL) Patients that are Treatment Naïve or Receiving Bruton’s-tyrosine Kinase Inhibitor (BTK-I) Therapy ( https://www.clinicaltrials.gov/ct2/show/NCT03702231?term=Shingrix&cond=CLL&rank=2 )
2. gov Identifier: NCT03685708: Response to the HEPLISAV-B Hepatitis B Vaccine in Chronic Lymphocytic Leukemia (CLL) Patients that are Treatment Naïve or Receiving Bruton’s-tyrosine Kinase Inhibitor (BTK-I) Therapy ( https://www.clinicaltrials.gov/ct2/show/NCT03685708?term=Hepatitis&cond=CLL&rank=2 )

Why are you testing the shingles vaccine – do I need it?

Dr. Pleyer:

• Shingles can cause a painful rash. The pain from the rash can be excruciating, and in some cases can last a very long time and be difficult to treat.
• Shingles is a problem in CLL patients, not only because the risk of shingles increases with age, but it also increases in patients who are immunosuppressed. We know that the immune system in CLL patients is weaker compared to healthy individuals. Even patients that are treated for their CLL continue to have a weaker immune system. 1 in 3 people in the US will develop shingles in their lifetime.
• The SHINGRIX vaccine has proven to be very effective in healthy individuals and we hope that it will also help patients with CLL. It is a “killed” vaccine unlike the older shingles vaccine which was a live (attenuated) vaccine and contra-indicated for CLL patients.

Dr. K

Why are you testing the hepatitis B vaccine – do I need it?

Dr. P

• Hepatitis B is a serious infection that can cause liver failure or liver cancer. Hepatitis B is transmitted through exposure to infected blood, semen, and other body fluids. In the United States, an estimated 850,000 people have chronic hepatitis B.

Dr. K.

Who should get vaccinated?

Dr. P

• People with immunosuppressing conditions. That would include CLL.
• People with chronic health conditions
• Healthcare workers. All of our clinical staff, for example, have been vaccinated.
• International travelers to countries with high levels of endemic hepatitis B
• Anyone wanting protection from hepatitis B
• Although the overall risk of developing hepatitis B in the CLL population is low, the CDC recommends the hepatitis B vaccine for all patients who would like to seek protection from hepatitis B. The HEPLISAV-B vaccine has proven to be very effective in healthy individuals and we hope that it will also help patients with CLL.

Dr. K:

What do you hope to learn from doing these studies?

Dr. P:

• We want to learn more about how the immune system in CLL patients responds to vaccines. The shingles (VZ) virus is dormant in our bodies as almost all of us have been infected in childhood, and our immune system already “knows” the virus. The hepatitis B virus is new to the immune system unless patients have been previously infected or received the vaccine. We are trying to see if there is a difference in how the immune system responds if the body already knows the virus compared to when the system is exposed to a new virus for the first time.

Dr. K:

What are the side effects?

Dr. P:

• Local: redness, swelling, and tenderness are expected most commonly.
• Fever, joint and muscle pain and headaches have been reported.
• Learning from CLL patients already vaccinated on our studies, the vaccines have been well tolerated and we don’t see an increase in frequency or severity of any side effects.

Dr. K:

Patients worry they can get shingles from SHINGRIX?

Dr. P:

• It is impossible to get shingles from the SHINGRIX vaccine as it is not a live vaccine and only uses a small part of the virus to stimulate the immune system.

Dr. K:

Can I get both vaccines at the same time and is it safe?

Dr. P:

• It is not uncommon for patients to receive two or more vaccines at the same time (typically in kids or transplant patients).
• One vaccine will be given in each arm. There is no reason to think that the vaccines will negatively interfere with each other or that there will be more side effects. We will watch closely if patients develop more side effects, however we have not seen any worrisome signs.

Dr. K:

What are the goals of your study?

Dr. P

• Goals: To reduce the risk of patients developing shingles and/or hepatitis B. We will be doing blood tests on patients to see whether they have developed antibodies that can fight off/prevent an infection.
• For the SHINGRIX vaccine we will also look at how T cells behave after vaccinations, as T cells are believed to be an important player in protecting against shingles.

Dr. K:

Who should participate on these studies?

Dr. P:

• This treatment, we hope, will reduce the risk of developing shingles and/or hepatitis B. Basically all patients with CLL can participate. The study will enroll a group of patients who have never been treated, a group of patients on ibrutinib, and a group on acalabrutinib. Patients who receive IVIG or steroid therapy cannot participate because in these patients we could not test whether the vaccine worked. Also, patients who have been vaccinated for hepatitis B before would not be eligible to get the HEPLISAV-B vaccine but could get the SHINGRIX vaccine.