500 Participants Needed

Vaccines for Blood Cancer

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Overseen ByShellin Jose
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Must be taking: BTKis, BCL-2 inhibitors
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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?

Research shows that a third dose of Pfizer's or Moderna's COVID-19 mRNA vaccine can improve immune response in patients with blood cancers, suggesting these vaccines may help boost immunity in such patients.12345

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

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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

I have CLL.
I am currently being treated with a BTK inhibitor and not receiving the HEPLISAV-B vaccine.
I've been on BTK inhibitor treatment for 6+ months and can pause it for vaccinations, without prior treatment issues.
See 18 more

Exclusion Criteria

I have not had chemotherapy within the last 2 weeks.
I have received IVIG treatment within the last 2 months.
I have a genetic condition that weakens my immune system.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

3-6 weeks
2-3 visits per vaccine

Follow-up

Participants are monitored for serologic response 4 weeks after completing each vaccine series.

4 weeks

Long-term Follow-up

Participants may give follow-up blood samples up to 2 times a year for 5 years.

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
Trial OverviewThe trial is testing how well people with specific blood cancers respond to various vaccines including those for flu, pneumonia, COVID-19, hepatitis B, and shingles. It involves multiple study visits over up to five years with optional booster doses.
Participant Groups
9Treatment groups
Experimental Treatment
Group I: Participants diagnosed with Chronic Lymphocytic Leukemia (CLL)Experimental Treatment12 Interventions
Participants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, Fluzone, Afluria, Fluarix, Flucelvax, FluLaval, PREVNAR 13, PNEUMOVAX 23, Pfizer-COVID-19, Moderna-COVID-19 and receive assessment of serologic and cellular response following completion of each vaccine series.
Group II: Other Non-Hodgkin Lymphoma and Waldenstrom Macroglobulinemia - Treatment with Targeted TherapiesExperimental Treatment12 Interventions
Participants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, Fluzone, Afluria, Fluarix, Flucelvax, FluLaval, PREVNAR 13, PNEUMOVAX 23, Pfizer-COVID-19, and receive assessment of serologic and cellular response following completion of each vaccine series.
Group III: Other Non-Hodgkin Lymphoma and Waldenstrom MacroglobulinemiaExperimental Treatment12 Interventions
Participants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, Fluzone, Afluria, Fluarix, Flucelvax, FluLaval, PREVNAR 13, PNEUMOVAX 23, Pfizer-COVID-19, Moderna-COVID-19 and receive assessment of serologic and cellular response following completion of each vaccine series.
Group IV: Follicular Lymphoma Treatment NaiveExperimental Treatment12 Interventions
Participants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, Fluzone, Afluria, Fluarix, Flucelvax, FluLaval, PREVNAR 13, PNEUMOVAX 23, Pfizer-COVID-19, Moderna-COVID-19 and receive assessment of serologic and cellular response following completion of each vaccine series.
Group V: Follicular LymphomaExperimental Treatment12 Interventions
Participants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, Fluzone, Afluria, Fluarix, Flucelvax, FluLaval, PREVNAR 13, PNEUMOVAX 23, Pfizer-COVID-19, Moderna-COVID-19 and receive assessment of serologic and cellular response following completion of each vaccine series.
Group VI: Chronic Lymphocytic Leukemia Treatment with BTKiExperimental Treatment12 Interventions
Participants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, Fluzone, Afluria, Fluarix, Flucelvax, FluLaval, PREVNAR 13, PNEUMOVAX 23, Pfizer-COVID-19, Moderna-COVID-19 and receive assessment of serologic and cellular response following completion of each vaccine series.
Group VII: Chronic Lymphocytic Leukemia Treatment NaiveExperimental Treatment12 Interventions
Participants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, Fluzone, Afluria, Fluarix, Flucelvax, FluLaval, PREVNAR 13, PNEUMOVAX 23, Pfizer-COVID-19, Moderna-COVID-19 and receive assessment of serologic and cellular response following completion of each vaccine series.
Group VIII: Chronic Lymphocytic Leukemia Treatment Break for BTKiExperimental Treatment12 Interventions
Participants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, Fluzone, Afluria, Fluarix, Flucelvax, FluLaval, PREVNAR 13, PNEUMOVAX 23, Pfizer-COVID-19, Moderna-COVID-19 and receive assessment of serologic and cellular response following completion of each vaccine series.
Group IX: Chronic Lymphocytic Leukemia Not Receiving Active TreatmentExperimental Treatment12 Interventions
Participants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, Fluzone, Afluria, Fluarix, Flucelvax, FluLaval, PREVNAR 13, PNEUMOVAX 23, Pfizer-COVID-19, Moderna-COVID-19 and receive assessment of serologic and cellular response following completion of each vaccine series.

Afluria is already approved in United States, Canada for the following indications:

🇺🇸
Approved in United States as Afluria Quadrivalent for:
  • Prevention of influenza A and B virus infection
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Approved in Canada as Afluria Quadrivalent for:
  • Prevention of influenza A and B virus infection

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Who Is Running the Clinical Trial?

National Heart, Lung, and Blood Institute (NHLBI)

Lead Sponsor

Trials
3,987
Recruited
47,860,000+

Findings from Research

In a study of 493 patients with hematologic malignancies, a third dose of the COVID-19 mRNA vaccine significantly increased seropositivity, with 55.6% remaining seropositive and 23.3% seroconverting after the third dose.
Patients with multiple myeloma showed a notably higher likelihood of seroconversion after the third vaccine dose compared to those with lymphoid leukemias, suggesting that oncologists should prioritize vaccination for these patients.
Real-World Third COVID-19 Vaccine Dosing and Antibody Response in Patients With Hematologic Malignancies.Thompson, MA., Hallmeyer, S., Fitzpatrick, VE., et al.[2022]
Aflunov, a pre-pandemic vaccine for the avian A/H5N1 virus, has a strong safety profile across all ages and induces high antibody levels that persist for 6-8 years, with effective boosting capabilities.
The vaccine triggers robust immunological memory and broad cross-reactivity with different H5N1 virus strains, making it a valuable option for pandemic preparedness and prevention.
Aflunov®: a vaccine tailored for pre-pandemic and pandemic approaches against influenza.Del Giudice, G., Fragapane, E., Della Cioppa, G., et al.[2013]
Poxviral vaccines, which have successfully eradicated smallpox, are being developed as cancer immunotherapies, with the promising PSA-TRICOM (PROSTVAC-V/F) currently in a Phase III trial for metastatic castration-resistant prostate cancer.
Early studies indicate that poxviral vaccines can be effective both alone and in combination with other treatments, but successful clinical application requires careful trial design, patient selection, and identification of relevant biomarkers.
Poxviral vectors for cancer immunotherapy.Kim, JW., Gulley, JL.[2023]

References

Real-World Third COVID-19 Vaccine Dosing and Antibody Response in Patients With Hematologic Malignancies. [2022]
Aflunov®: a vaccine tailored for pre-pandemic and pandemic approaches against influenza. [2013]
Poxviral vectors for cancer immunotherapy. [2023]
A randomized phase II trial of personalized peptide vaccine plus low dose estramustine phosphate (EMP) versus standard dose EMP in patients with castration resistant prostate cancer. [2020]
A phase I study of personalized peptide vaccination for advanced urothelial carcinoma patients who failed treatment with methotrexate, vinblastine, adriamycin and cisplatin. [2016]
Immunogenicity and safety of a quadrivalent inactivated influenza vaccine in children 6-59 months of age: A phase 3, randomized, noninferiority study. [2019]
Exposure to quadrivalent influenza vaccine during pregnancy: Results from a global pregnancy registry. [2022]
Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices - United States, 2019-20 Influenza Season. [2020]
Immunogenicity and safety of the adjuvanted recombinant zoster vaccine in adults with haematological malignancies: a phase 3, randomised, clinical trial and post-hoc efficacy analysis. [2020]
Immunogenicity and safety of a quadrivalent inactivated influenza vaccine in healthy subjects aged 3 to 17 years old: A phase III, open label, single-arm study. [2021]
Gateways to clinical trials. [2007]
Recent advances in cancer vaccines: an overview. [2009]
A year of successful cancer vaccines points to a path forward. [2010]
Technology evaluation: Onyvax-P, Onyvax. [2017]
Prostate cancer vaccines in clinical trials. [2020]