500 Participants Needed

Vaccines for Blood Cancer

SS
CM
JJ
RA
SJ
RA
AU
Overseen ByAdrian U Wiestner, M.D.
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

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.12345

Why 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?

AU

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

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 17 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 for a Trial Participant

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

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
Trial Overview The 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.
How Is the Trial Designed?
9Treatment groups
Experimental Treatment
Group I: Participants diagnosed with Chronic Lymphocytic Leukemia (CLL)Experimental Treatment12 Interventions
Group II: Other Non-Hodgkin Lymphoma and Waldenstrom Macroglobulinemia - Treatment with Targeted TherapiesExperimental Treatment12 Interventions
Group III: Other Non-Hodgkin Lymphoma and Waldenstrom MacroglobulinemiaExperimental Treatment12 Interventions
Group IV: Follicular Lymphoma Treatment NaiveExperimental Treatment12 Interventions
Group V: Follicular LymphomaExperimental Treatment12 Interventions
Group VI: Chronic Lymphocytic Leukemia Treatment with BTKiExperimental Treatment12 Interventions
Group VII: Chronic Lymphocytic Leukemia Treatment NaiveExperimental Treatment12 Interventions
Group VIII: Chronic Lymphocytic Leukemia Treatment Break for BTKiExperimental Treatment12 Interventions
Group IX: Chronic Lymphocytic Leukemia Not Receiving Active TreatmentExperimental Treatment12 Interventions

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

🇺🇸
Approved in United States as Afluria Quadrivalent for:
🇨🇦
Approved in Canada as Afluria Quadrivalent for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Heart, Lung, and Blood Institute (NHLBI)

Lead Sponsor

Trials
3,987
Recruited
47,860,000+

Published Research Related to This Trial

The abstract lists a wide range of medical interventions and compounds, indicating a diverse array of potential treatments across various conditions.
However, no specific efficacy, safety, or mechanism-of-action details are provided for any individual intervention, making it difficult to draw concrete conclusions about their effectiveness.
Gateways to clinical trials.Bayes, M.[2007]
Cancer vaccines are being actively researched, with the human papillomavirus vaccine already approved for prevention, and Oncophage recently approved in Russia for certain kidney cancer stages, but none have yet been approved in Japan or the USA.
Recent clinical trials show promising progress in peptide and dendritic cell-based vaccines, emphasizing a personalized approach, combining chemotherapy, and shifting focus from tumor reduction to overall survival as crucial for developing effective therapeutic cancer vaccines.
Recent advances in cancer vaccines: an overview.Itoh, K., Yamada, A., Mine, T., et al.[2009]
Recent clinical trials of therapeutic vaccines like sipuleucel-T, PROSTVAC-VF-TRICOM, and BiovaxID show promising results, supporting their continued development for cancer treatment.
The findings from these trials offer valuable insights that can help improve future cancer vaccines and vaccination protocols.
A year of successful cancer vaccines points to a path forward.Morse, MA., Whelan, M.[2010]

Citations

Seasonal Influenza Vaccination in Patients With Chronic ...Up to 74% of patients achieved seroprotective titers against common influenza viruses after vaccination. Consequently, routine immunization against influenza ...
Influenza vaccines in immunosuppressed adults with cancerThe influenza vaccine protects against influenza and its complications. However, its effectiveness among people with cancer is unclear, as immune dysfunction ...
Flu Vaccination in Patients with Cancer: Emerging TrendsAfluria was approved by the FDA in September 2007 for the active immunization of persons ≥18 years of age against influenza disease caused by influenza subtypes ...
Seasonal Influenza Vaccination in Patients With Chronic ...Patients younger than 65 years received Fluzone high-dose or standard-dose Afluria vaccine (bioCSL) depending on availability of the vaccines.
Influenza Vaccination in Cancer Patients Undergoing Systemic ...1. To assess the efficacy of influenza vaccination in stimulating immunological response in patients with cancer during chemotherapy compared to control groups.
Package Insert - AFLURIA QUADRIVALENTClinical safety data for AFLURIA QUADRIVALENT in adults have been collected in one clinical trial, Study 1, a randomized, double-blind, active-controlled trial ...
Influenza Vaccination in Cancer Patients Undergoing ...In cancer patients, active immunization has been shown to confer protective immunity against several infections at similar rates to healthy ...
Package Insert - AFLURIAClinical safety data for AFLURIA QUADRIVALENT in adults have been collected in one clinical trial, Study 1 (NCT02214225), a randomized, double-blind, active ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security