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Vaccine Responses in Patients With B Cell Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05170399
Recruitment Status : Recruiting
First Posted : December 28, 2021
Last Update Posted : February 8, 2023
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Lymphoma Biological: PNEUMOVAX 23 Biological: Fluarix Biological: FluLaval Biological: Pfizer-COVID-19 Vaccine Biological: Heplisav -B Biological: PREVNAR 13 Biological: Afluria Biological: Flucelvax Biological: Shingrix Biological: Fluzone Phase 4

Detailed Description:

Description:

This study aims to determine vaccine titers in B-cell malignancies; specifically, in chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), or other non-Hodgkin lymphomas (NHL) [follicular lymphoma (FL), mantle cell lymphoma (MCL), marginal zone lymphomas (MZLs) and indolent NHL not otherwise specified (NOS)], or in Waldenstrom Macroglobulinemia (WM).

Note: Since CLL and SLL are considered the same disease, CLL/SLL will be referred to as CLL hereafter, unless otherwise specified.

Objectives: Primary Objective:

Determine vaccine titers following vaccination in patients with B-cell malignancies who are either receiving targeted therapies or not receiving active treatment

Secondary Objectives:

  1. Determine vaccine titers in patients with CLL that are treatment naive, not receiving active treatment, or receiving targeted therapies
  2. Determine whether interruption of Bruton tyrosine kinase inhibitor (BTKi) therapy around the time of vaccination improves vaccine titers in patients with CLL
  3. Determine vaccine titers in patients with NHL (FL, MCL, MZL, NHL NOS) or WM that are not receiving active treatment, or receiving targeted therapies

Endpoints:

The primary efficacy endpoint will be the serologic titer against each administered vaccine following completion of the vaccine series in each study arm

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Vaccine Responses in Patients With B Cell Malignancies
Actual Study Start Date : September 14, 2022
Estimated Primary Completion Date : August 9, 2023
Estimated Study Completion Date : August 16, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma Vaccines

Arms and Interventions
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Arm Intervention/treatment
Experimental: Chronic Lymphocytic Leukemia Not Receiving Active Treatment
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.
 Biological: PNEUMOVAX 23
Pneumococcal Polysaccharide Vaccine (PPSV23)

Biological: Fluarix
Annual Influenza Vaccine

Biological: FluLaval
Annual Influenza Vaccine

Biological: Pfizer-COVID-19 Vaccine
COVID-19 Vaccine

Biological: Heplisav -B
Recombinant, adjuvanted Hepatitis (HepB-CpG)

Biological: PREVNAR 13
Pneumococcal Conjugate Vaccine (PCV13)

Biological: Afluria
Annual Influenza Vaccine

Biological: Flucelvax
Annual Influenza Vaccine

Biological: Shingrix
Recombinant, adjuvanted Zoster Vaccine (RZV)

Biological: Fluzone
Annual Influenza Vaccine
Experimental: Chronic Lymphocytic Leukemia Treatment Break for BTKi
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.
 Biological: PNEUMOVAX 23
Pneumococcal Polysaccharide Vaccine (PPSV23)

Biological: Fluarix
Annual Influenza Vaccine

Biological: FluLaval
Annual Influenza Vaccine

Biological: Pfizer-COVID-19 Vaccine
COVID-19 Vaccine

Biological: Heplisav -B
Recombinant, adjuvanted Hepatitis (HepB-CpG)

Biological: PREVNAR 13
Pneumococcal Conjugate Vaccine (PCV13)

Biological: Afluria
Annual Influenza Vaccine

Biological: Flucelvax
Annual Influenza Vaccine

Biological: Shingrix
Recombinant, adjuvanted Zoster Vaccine (RZV)

Biological: Fluzone
Annual Influenza Vaccine
Experimental: Chronic Lymphocytic Leukemia Treatment Naive
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.
 Biological: PNEUMOVAX 23
Pneumococcal Polysaccharide Vaccine (PPSV23)

Biological: Fluarix
Annual Influenza Vaccine

Biological: FluLaval
Annual Influenza Vaccine

Biological: Pfizer-COVID-19 Vaccine
COVID-19 Vaccine

Biological: Heplisav -B
Recombinant, adjuvanted Hepatitis (HepB-CpG)

Biological: PREVNAR 13
Pneumococcal Conjugate Vaccine (PCV13)

Biological: Afluria
Annual Influenza Vaccine

Biological: Flucelvax
Annual Influenza Vaccine

Biological: Shingrix
Recombinant, adjuvanted Zoster Vaccine (RZV)

Biological: Fluzone
Annual Influenza Vaccine
Experimental: Chronic Lymphocytic Leukemia Treatment with BTKi
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.
 Biological: PNEUMOVAX 23
Pneumococcal Polysaccharide Vaccine (PPSV23)

Biological: Fluarix
Annual Influenza Vaccine

Biological: FluLaval
Annual Influenza Vaccine

Biological: Pfizer-COVID-19 Vaccine
COVID-19 Vaccine

Biological: Heplisav -B
Recombinant, adjuvanted Hepatitis (HepB-CpG)

Biological: PREVNAR 13
Pneumococcal Conjugate Vaccine (PCV13)

Biological: Afluria
Annual Influenza Vaccine

Biological: Flucelvax
Annual Influenza Vaccine

Biological: Shingrix
Recombinant, adjuvanted Zoster Vaccine (RZV)

Biological: Fluzone
Annual Influenza Vaccine
Experimental: Follicular Lymphoma
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.
 Biological: PNEUMOVAX 23
Pneumococcal Polysaccharide Vaccine (PPSV23)

Biological: Fluarix
Annual Influenza Vaccine

Biological: FluLaval
Annual Influenza Vaccine

Biological: Pfizer-COVID-19 Vaccine
COVID-19 Vaccine

Biological: Heplisav -B
Recombinant, adjuvanted Hepatitis (HepB-CpG)

Biological: PREVNAR 13
Pneumococcal Conjugate Vaccine (PCV13)

Biological: Afluria
Annual Influenza Vaccine

Biological: Flucelvax
Annual Influenza Vaccine

Biological: Shingrix
Recombinant, adjuvanted Zoster Vaccine (RZV)

Biological: Fluzone
Annual Influenza Vaccine
Experimental: Follicular Lymphoma Treatment Naive
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.
 Biological: PNEUMOVAX 23
Pneumococcal Polysaccharide Vaccine (PPSV23)

Biological: Fluarix
Annual Influenza Vaccine

Biological: FluLaval
Annual Influenza Vaccine

Biological: Pfizer-COVID-19 Vaccine
COVID-19 Vaccine

Biological: Heplisav -B
Recombinant, adjuvanted Hepatitis (HepB-CpG)

Biological: PREVNAR 13
Pneumococcal Conjugate Vaccine (PCV13)

Biological: Afluria
Annual Influenza Vaccine

Biological: Flucelvax
Annual Influenza Vaccine

Biological: Shingrix
Recombinant, adjuvanted Zoster Vaccine (RZV)

Biological: Fluzone
Annual Influenza Vaccine
Experimental: Other Non-Hodgkin Lymphoma and Waldenstrom Macroglobulinemia
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.
 Biological: PNEUMOVAX 23
Pneumococcal Polysaccharide Vaccine (PPSV23)

Biological: Fluarix
Annual Influenza Vaccine

Biological: FluLaval
Annual Influenza Vaccine

Biological: Pfizer-COVID-19 Vaccine
COVID-19 Vaccine

Biological: Heplisav -B
Recombinant, adjuvanted Hepatitis (HepB-CpG)

Biological: PREVNAR 13
Pneumococcal Conjugate Vaccine (PCV13)

Biological: Afluria
Annual Influenza Vaccine

Biological: Flucelvax
Annual Influenza Vaccine

Biological: Shingrix
Recombinant, adjuvanted Zoster Vaccine (RZV)

Biological: Fluzone
Annual Influenza Vaccine
Experimental: Other Non-Hodgkin Lymphoma and Waldenstrom Macroglobulinemia - Treatment with Targeted Therapies
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.
 Biological: PNEUMOVAX 23
Pneumococcal Polysaccharide Vaccine (PPSV23)

Biological: Fluarix
Annual Influenza Vaccine

Biological: FluLaval
Annual Influenza Vaccine

Biological: Pfizer-COVID-19 Vaccine
COVID-19 Vaccine

Biological: Heplisav -B
Recombinant, adjuvanted Hepatitis (HepB-CpG)

Biological: PREVNAR 13
Pneumococcal Conjugate Vaccine (PCV13)

Biological: Afluria
Annual Influenza Vaccine

Biological: Flucelvax
Annual Influenza Vaccine

Biological: Shingrix
Recombinant, adjuvanted Zoster Vaccine (RZV)

Biological: Fluzone
Annual Influenza Vaccine
Experimental: Participants diagnosed with Chronic Lymphocytic Leukemia (CLL)
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.
 Biological: PNEUMOVAX 23
Pneumococcal Polysaccharide Vaccine (PPSV23)

Biological: Fluarix
Annual Influenza Vaccine

Biological: FluLaval
Annual Influenza Vaccine

Biological: Pfizer-COVID-19 Vaccine
COVID-19 Vaccine

Biological: Heplisav -B
Recombinant, adjuvanted Hepatitis (HepB-CpG)

Biological: PREVNAR 13
Pneumococcal Conjugate Vaccine (PCV13)

Biological: Afluria
Annual Influenza Vaccine

Biological: Flucelvax
Annual Influenza Vaccine

Biological: Shingrix
Recombinant, adjuvanted Zoster Vaccine (RZV)

Biological: Fluzone
Annual Influenza Vaccine


Outcome Measures
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Primary Outcome Measures :
  1. Serologic response against each administered vaccine following completion of the vaccine series in each study arm [ Time Frame: 4 weeks after completing vaccine series ]
    vaccine titer


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:
  • Diagnosis of CLL, FL, MCL, MZL, NHL NOS or WM

  • Must fulfil one of the following criteria to be enrolled in one study arm per vaccine received:

    1. Patients with CLL AND one of the following:

      i. Arm 1: Must be treatment naive (no prior cancer directed therapy)

      ii. Arm 2: Patients that have received prior cancer directed therapy and are currently not receiving active treatment

      iii. Arm 3: Must be receiving treatment with a BTKi. This arm is not available to patients receiving the HEPLISAV-B vaccine

      iv. Arm 4: Must be receiving treatment with a BTKi for >= 6 months prior to vaccination and be willing to hold their treatment for up to 7 weeks around the time of each vaccination. This arm is not available to patients who have had a prior episode of disease flare during periods of drug hold, or for patients with CLL that is actively progressing.

      v. Arm 5: Must be receiving treatment with a BCL-2 inhibitor

      Or

    2. Patients with FL, MCL, MZL, NHL NOS or WM AND one of the following:

      i. Arm 1: Must currently not be receiving active treatment (treatment na(SqrRoot) ve or previously treated)

      ii. Arm 2: Must be receiving treatment with targeted therapies (e.g. BTKi, BCL-2 inhibitors, PI3K inhibitors, immunomodulatory agents, proteasome inhibitors)

  • If prior exposure to Hepatitis-B vaccination, must have documentation of negative serologic response
  • Age >= 18 years
  • Able to comprehend the investigational nature of the protocol and provide informed consent

EXCLUSION CRITERIA:

  1. Female patients who are currently pregnant
  2. History of severe allergic reaction to vaccines
  3. Concomitant inherited immunodeficiency
  4. Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator s opinion, could compromise the subject s safety or put the study outcomes at undue risk.
  5. Receive cytotoxic chemotherapy within 2 weeks prior to vaccination
  6. Receive intravenous immunoglobulin (IVIG) within 2 months prior to vaccination
  7. Receive anti-CD20 and/or anti-CD19 monoclonal antibody therapy within 6 months prior to vaccination
  8. Receive cellular therapy (e.g. CAR-T cells) within 12 months prior to vaccination
  9. History of allogeneic stem cell transplantation
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05170399


Contacts
Layout table for location contacts
Contact: Jayson J Grey, R.N. (301) 496-5203 jayson.doubrava@nih.gov
Contact: Christopher MT Pleyer, M.D. (510) 709-6649 christopher.pleyer@nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY dial 711    ccopr@nih.gov   
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Christopher MT Pleyer, M.D. National Heart, Lung, and Blood Institute (NHLBI)
More Information
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Additional Information:

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Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT05170399    
Other Study ID Numbers: 10000444
000444-H
First Posted: December 28, 2021    Key Record Dates
Last Update Posted: February 8, 2023
Last Verified: February 3, 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: .The team will decide in the future.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ):
CLL
SLL
Booster
Lymphoma
Vaccines
Additional relevant MeSH terms:
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Lymphoma
Neoplasms
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs