Vaccines for Blood Cancer
Trial Summary
What is the purpose of this trial?
Background: People with B cell malignancies (blood cancers) often cannot mount a full immune response to infections or certain vaccines. Bruton tyrosine kinase inhibitors (BTKis), which are used to treat blood cancers, may also negatively affect a person s response to certain vaccines. Researchers want to learn more about vaccine responses in people with certain types of blood cancers. The findings may help develop better vaccine strategies for people with these cancers. Objective: To learn how well vaccines work in people who have certain types of blood cancers. Eligibility: Adults aged 18 years or older who have chronic lymphocytic leukemia (CLL), Waldenstrom macroglobulinemia, or certain non-Hodgkin lymphomas. Design: Participants will get one or more vaccines for illnesses such as COVID-19, hepatitis B, and shingles. They can choose which vaccines they receive. They will give a blood sample before they get each vaccine. Some vaccines require a second dose 3-6 weeks later. Participants may give an optional blood sample with the second vaccine dose. About 4 weeks after they finish each vaccine series, they will give another blood sample. They will have 2-3 study visits per vaccine. Participants may receive a booster dose for some vaccines. The booster dose is optional. They will give another blood sample with the booster dose. Participants will have pregnancy tests, if needed. Participants with CLL who receive BTKis may be asked to pause treatment for up to 7 weeks. Participants may give follow-up blood samples up to 2 times a year for 5 years. These blood samples are optional. Participation will last for up to 5 years after each vaccine series is received.
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 data supports the effectiveness of the vaccines used in the treatment of blood cancer?
Is the vaccine generally safe for humans?
The quadrivalent influenza vaccines, like Afluria Quadrivalent and Fluzone Quadrivalent, have been studied for safety in various groups, including children and pregnant women, and are generally considered safe. The Shingrix vaccine has also been evaluated for safety in adults with blood cancers and is considered safe for use.678910
How does the vaccine treatment for blood cancer differ from other treatments?
The vaccine treatment for blood cancer is unique because it involves a combination of vaccines typically used for preventing infections like influenza, COVID-19, and shingles, rather than directly targeting cancer cells. This approach may help boost the immune system to better fight cancer, which is different from traditional cancer treatments that often focus on directly killing cancer cells.1112131415
Research Team
Christopher MT Pleyer, M.D.
Principal Investigator
National Heart, Lung, and Blood Institute (NHLBI)
Eligibility Criteria
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
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.
Treatment Details
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