Vaccines for Blood Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to evaluate vaccine efficacy in individuals with certain blood cancers, such as chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphomas. These patients often exhibit weaker immune responses to infections and vaccines, partly due to treatments like Bruton tyrosine kinase inhibitors (BTKis). Participants will receive vaccines for illnesses such as COVID-19, hepatitis B, and shingles, with some requiring a follow-up dose. Individuals with CLL, Waldenstrom macroglobulinemia, or specific types of non-Hodgkin lymphomas, whether on or off certain treatments, might be suitable candidates. The findings could enhance vaccine strategies for these patients. As a Phase 4 trial, the vaccines are already FDA-approved and proven effective, and this research aims to understand how they benefit a broader patient population.
Will I have to stop taking my current medications?
If you are receiving Bruton tyrosine kinase inhibitors (BTKis) for chronic lymphocytic leukemia (CLL), you may be asked to pause your treatment for up to 7 weeks around the time of each vaccination. For other medications, the trial protocol does not specify if you need to stop taking them.
What is the safety track record for these treatments?
Research shows that the vaccines in this study are safe for adults. For example, Afluria, a flu vaccine, received FDA approval and has been safely used since 2007, with side effects usually mild, such as a sore arm or slight fever.
Fluarix and Flucelvax, other flu vaccines, have similar safety records. Studies indicate they are well-tolerated, with common side effects like mild soreness or tiredness.
FluLaval and Fluzone, also included in the study, have proven safe for adults, with typical side effects like sore arms or a slight fever. Serious side effects are rare.
Heplisav-B, a hepatitis B vaccine, is effective with just two doses and is considered safe, with most side effects being mild, such as pain at the injection site.
For COVID-19 vaccines, both Moderna and Pfizer have been widely used. Although people with blood cancers might have a lower immune response, the vaccines remain safe. Common side effects include soreness, tiredness, or a mild fever.
PNEUMOVAX 23 and PREVNAR 13, pneumonia vaccines, are generally safe for adults. Some people may experience mild soreness or redness at the injection site.
Lastly, Shingrix, a shingles vaccine, is safe for people with weakened immune systems. Common side effects include a sore arm or mild flu-like symptoms.
Overall, these vaccines are well-tolerated, and serious side effects are rare.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about these vaccines for blood cancer patients because they aim to enhance immune response in individuals with compromised immune systems. Unlike traditional therapies that often focus on directly targeting cancer cells, these vaccines help boost the body's own defense mechanism. This approach is particularly promising for patients with conditions like Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia, where the immune system is often weakened. By potentially improving serologic and cellular responses, these vaccines could offer better protection against infections, which is crucial for the health and quality of life of blood cancer patients.
What evidence suggests that this trial's vaccines could be effective for blood cancer patients?
Research has shown that vaccines can still be effective for people with blood cancers, although their immune response might be weaker. In this trial, participants may receive one or more of the following vaccines: Shingrix, which has proven very effective in preventing shingles, even in those with weakened immune systems; the Pfizer and Moderna COVID-19 vaccines, which have also been effective, though individuals with chronic lymphocytic leukemia (CLL) might not respond as strongly; and flu vaccines like Afluria, Fluarix, and Flucelvax, which can still offer protection for many patients, even during cancer treatments. Pneumococcal vaccines such as PREVNAR 13 and PNEUMOVAX 23 help reduce the risk of pneumonia and its complications. Lastly, Heplisav-B has shown promise in generating an immune response against hepatitis B, though results can vary depending on specific treatments like BTK inhibitors, which block a protein involved in cancer cell growth.45678
Who Is on the Research Team?
Adrian U Wiestner, M.D.
Principal Investigator
National Heart, Lung, and Blood Institute (NHLBI)
Are You a Good Fit for This Trial?
Adults 18+ with blood cancers like CLL, Waldenstrom macroglobulinemia, or certain non-Hodgkin lymphomas can join. Participants will choose vaccines for diseases such as COVID-19 and shingles to receive and provide blood samples before and after vaccination. Those on BTKis may need to pause treatment around vaccination.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Vaccination
Participants receive one or more vaccines for illnesses such as COVID-19, hepatitis B, and shingles. Blood samples are taken before and after vaccination.
Follow-up
Participants are monitored for serologic response 4 weeks after completing each vaccine series.
Long-term Follow-up
Participants may give follow-up blood samples up to 2 times a year for 5 years.
What Are the Treatments Tested in This Trial?
Interventions
- Afluria
- Fluarix
- Flucelvax
- FluLaval
- Fluzone
- Heplisav -B
- Moderna-COVID-19 Vaccine
- Pfizer-COVID-19 Vaccine
- PNEUMOVAX 23
- PREVNAR 13
- Shingrix
Afluria is already approved in United States, Canada for the following indications:
- Prevention of influenza A and B virus infection
- Prevention of influenza A and B virus infection
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Heart, Lung, and Blood Institute (NHLBI)
Lead Sponsor