Vaccine Responses in Patients With B Cell Malignancies

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Study ID
NCT05170399
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • AREXVY, ABRYSVO — DRUG
    Respiratory Syncytial Virus Vaccine
  • PREVNAR 20 — DRUG
    Pneumococcal 20-Valent Conjugate Vaccine (PCV20)
  • PNEUMOVAX 23 — BIOLOGICAL
    Pneumococcal Polysaccharide Vaccine (PPSV23)
  • Heplisav -B — BIOLOGICAL
    Recombinant, adjuvanted Hepatitis (HepB-CpG)
  • PREVNAR 13 — BIOLOGICAL
    Pneumococcal Conjugate Vaccine (PCV13)
  • Shingrix — BIOLOGICAL
    Recombinant, adjuvanted Zoster Vaccine (RZV)

Study Details

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 vaccines for hepatitis B, shingles, pneumonia, and respiratory syncytial virus (RSV). They may get more than 1 type of vaccine during the study. Not all participants will get all vaccines. Some vaccines require 2 doses. Participants will give a blood sample before they get each vaccine. About 4 weeks after they finish each vaccine series, they will give another blood sample. Some vaccines require a second dose 3-6 weeks later. For vaccines that require a second dose, participants may also have study procedures at that visit. Participants may have 2 to 3 study visits per vaccine series. Participants may receive a booster dose for some vaccines. The booster dose is optional. For this study, a booster means repeating the full vaccine series. Participants who receive a booster may have additional blood samples to measure their vaccine response. Participants will have pregnancy tests, if needed. Participants with CLL who receive BTKis may be assigned to either continue treatment or pause treatment around the time of vaccination. Participants may give follow-up blood samples once a year for up to 5 years after each vaccine series. These blood samples are optional. Participation will last for up to 5 years after each vaccine series is received.

Key Dates

First listed
Dec 28, 2021
Start date
Sep 14, 2022
Status verified
Jul 2026
Primary completion
Nov 15, 2036
Completion
Nov 15, 2036

Study Design

Enrollment
350 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Chronic Lymphocytic Leukemia (CLL) - Treatment with BCL-2 Inhibitor
    Participants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, PREVNAR 13, PNEUMOVAX 23, PREVNAR 20, AREXVY, ABRYSVO, and receive assessment of serologic and cellular response following completion of each vaccine series.
  • Experimental: Chronic Lymphocytic Leukemia Not Receiving Active Treatment
    Participants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, PREVNAR 13, PNEUMOVAX 23, AREXVY, ABRYSVO and receive assessment of serologic and cellular response following completion of each vaccine series.
  • Experimental: Chronic Lymphocytic Leukemia Treatment Break for BTKi
    Participants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, PREVNAR 13, PNEUMOVAX 23, PREVNAR 20, AREXVY, ABRYSVO and receive assessment of serologic and cellular response following completion of each vaccine series.
  • Experimental: Chronic Lymphocytic Leukemia Treatment Naive
    Participants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, PREVNAR 13, PNEUMOVAX 23, PREVNAR 20, AREXVY, ABRYSVO and receive assessment of serologic and cellular response following completion of each vaccine series.
  • Experimental: Chronic Lymphocytic Leukemia Treatment with BTKi
    Participants may receive one or more of the following vaccine types: Shingrix, PREVNAR 13, PNEUMOVAX 23, PREVNAR 20, AREXVY, ABRYSVO and receive assessment of serologic and cellular response following completion of each vaccine series.
  • Experimental: Other Non-Hodgkin Lymphoma and Waldenstrom Macroglobulinemia - Not receiving active treatment
    Participants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, PREVNAR 13, PNEUMOVAX 23, PREVNAR 20, AREXVY, ABRYSVO and receive assessment of serologic and cellular response following completion of each vaccine series.
  • 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, PREVNAR 13, PNEUMOVAX 23, PREVNAR 20, AREXVY, ABRYSVO, and receive assessment of serologic and cellular response following completion of each vaccine series.

Primary Outcome Measure

Serologic response against each administered vaccine following completion of the vaccine series in each study arm [ Time Frame: 4 weeks after completing vaccine series ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
[email protected]
800-411-1222

Find similar trials in Bethesda, MD

By research site
National Institutes of Health Clinical Center· Bethesda, MD

Related Studies