LymphomaPhase 4NCT05170399
Vaccine Responses in Patients With B Cell Malignancies
A Phase 4 study testing AREXVY, ABRYSVO, PREVNAR 20 and PNEUMOVAX 23 in people with Lymphoma, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- AREXVY, ABRYSVO, PREVNAR 20 and PNEUMOVAX 23
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2022to 15 Nov 2036
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Patients with CLL AND one of the following:
- Arm 1: Must be treatment naive (no prior cancer directed therapy)
- Arm 2: Patients that have received prior cancer directed therapy and are currently not receiving active treatment
- Arm 3: Must be receiving treatment with a BTKi. This arm is not available to patients receiving the HEPLISAV-B vaccine
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- 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.
- Arm 5: Must be receiving treatment with a BCL-2 inhibitor
- Or
- Patients with FL, MCL, MZL, NHL NOS or WM AND one of the following:
- Arm 1: Must currently not be receiving active treatment (treatment na(SqrRoot) ve or previously treated)
- 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
Who cannot join
- Female patients who are currently pregnant
- History of severe allergic reaction to vaccines
- Concomitant inherited immunodeficiency
- 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.
- Receive cytotoxic chemotherapy within 2 weeks prior to vaccination
- Receive intravenous immunoglobulin (IVIG) within 2 months prior to vaccination
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- Receive anti-CD20 and/or anti-CD19 monoclonal antibody therapy within 6 months prior to vaccination
- Receive cellular therapy (e.g. CAR-T cells) within 12 months prior to vaccination
- History of allogeneic stem cell transplantation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
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.
Read more
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.
Read the detailed description
Study 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
Endpoints:
The primary efficacy endpoint will be the serologic titer against each administered vaccine following completion of the vaccine series in each study arm
Secondary Endpoints: N/A
- Conditions
- Lymphoma
- Being tested
- AREXVY, ABRYSVO, PREVNAR 20, PNEUMOVAX 23, Heplisav -B, PREVNAR 13
- Keywords
- CLL, SLL, Booster, Lymphoma, Vaccines
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AREXVY, ABRYSVODrug
Respiratory Syncytial Virus Vaccine
PREVNAR 20Drug
Pneumococcal 20-Valent Conjugate Vaccine (PCV20)
PNEUMOVAX 23Biological
Pneumococcal Polysaccharide Vaccine (PPSV23)
Heplisav -BBiological
Recombinant, adjuvanted Hepatitis (HepB-CpG)
PREVNAR 13Biological
Pneumococcal Conjugate Vaccine (PCV13)
ShingrixBiological
Recombinant, adjuvanted Zoster Vaccine (RZV)
| Study group | Role | What they receive |
|---|---|---|
| Chronic Lymphocytic Leukemia (CLL) - Treatment with BCL-2 Inhibitor | Experimental | 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. Receives: Drug: AREXVY, ABRYSVO; Drug: PREVNAR 20; Biological: PNEUMOVAX 23; Biological: Heplisav -B; Biological: PREVNAR 13; Biological: Shingrix |
| Chronic Lymphocytic Leukemia Not Receiving Active Treatment | Experimental | 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. Receives: Drug: AREXVY, ABRYSVO; Drug: PREVNAR 20; Biological: PNEUMOVAX 23; Biological: Heplisav -B; Biological: PREVNAR 13; Biological: Shingrix |
| Chronic Lymphocytic Leukemia Treatment Break for BTKi | Experimental | 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. Receives: Drug: AREXVY, ABRYSVO; Drug: PREVNAR 20; Biological: PNEUMOVAX 23; Biological: Heplisav -B; Biological: PREVNAR 13; Biological: Shingrix |
| Chronic Lymphocytic Leukemia Treatment Naive | Experimental | 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. Receives: Drug: AREXVY, ABRYSVO; Drug: PREVNAR 20; Biological: PNEUMOVAX 23; Biological: Heplisav -B; Biological: PREVNAR 13; Biological: Shingrix |
| Chronic Lymphocytic Leukemia Treatment with BTKi | Experimental | 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. Receives: Drug: AREXVY, ABRYSVO; Drug: PREVNAR 20; Biological: PNEUMOVAX 23; Biological: Heplisav -B; Biological: PREVNAR 13 |
| Other Non-Hodgkin Lymphoma and Waldenstrom Macroglobulinemia - Not receiving active treatment | Experimental | 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. Receives: Drug: AREXVY, ABRYSVO; Drug: PREVNAR 20; Biological: PNEUMOVAX 23; Biological: Heplisav -B; Biological: PREVNAR 13; Biological: Shingrix |
| Other Non-Hodgkin Lymphoma and Waldenstrom Macroglobulinemia - Treatment with Targeted Therapies | Experimental | 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. Receives: Drug: AREXVY, ABRYSVO; Drug: PREVNAR 20; Biological: PNEUMOVAX 23; Biological: Heplisav -B; Biological: PREVNAR 13; Biological: Shingrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serologic response against each administered vaccine following completion of the vaccine series in each study arm
vaccine titer
Measured: 4 weeks after completing vaccine series
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2021
- Study start14 Sep 2022
- Primary completion15 Nov 2036 (estimated)
- Study completion15 Nov 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Adrian U Wiestner, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05170399
- Sponsor's protocol ID
- 10000444
- Other IDs
- 000444-H
- Status last verified
- 31 Jul 2026
- First submitted
- 24 Dec 2021
- Last updated
- 4 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The team will decide in the future.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaccine Responses in Patients With B Cell Malignancies
- ClinicalTrials.gov ID
- NCT05170399
- Acronym / sponsor ID
- 10000444
- Conditions
- Lymphoma
- Keywords
- CLL, SLL, Booster, Lymphoma, Vaccines
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 14 Sep 2022 (actual)
- Primary completion
- 15 Nov 2036 (estimated)
- Study completion
- 15 Nov 2036 (estimated)
- First posted
- 28 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study 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
Endpoints:
The primary efficacy endpoint will be the serologic titer against each administered vaccine following completion of the vaccine series in each study arm
Secondary Endpoints: N/A
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Chronic Lymphocytic Leukemia (CLL) - Treatment with BCL-2 Inhibitor | Experimental | Drug: AREXVY, ABRYSVO, Drug: PREVNAR 20, Biological: PNEUMOVAX 23, Biological: Heplisav -B, Biological: PREVNAR 13, Biological: ShingrixParticipants 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. |
| Chronic Lymphocytic Leukemia Not Receiving Active Treatment | Experimental | Drug: AREXVY, ABRYSVO, Drug: PREVNAR 20, Biological: PNEUMOVAX 23, Biological: Heplisav -B, Biological: PREVNAR 13, Biological: ShingrixParticipants 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. |
| Chronic Lymphocytic Leukemia Treatment Break for BTKi | Experimental | Drug: AREXVY, ABRYSVO, Drug: PREVNAR 20, Biological: PNEUMOVAX 23, Biological: Heplisav -B, Biological: PREVNAR 13, Biological: ShingrixParticipants 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. |
| Chronic Lymphocytic Leukemia Treatment Naive | Experimental | Drug: AREXVY, ABRYSVO, Drug: PREVNAR 20, Biological: PNEUMOVAX 23, Biological: Heplisav -B, Biological: PREVNAR 13, Biological: ShingrixParticipants 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. |
| Chronic Lymphocytic Leukemia Treatment with BTKi | Experimental | Drug: AREXVY, ABRYSVO, Drug: PREVNAR 20, Biological: PNEUMOVAX 23, Biological: Heplisav -B, Biological: PREVNAR 13Participants 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. |
| Other Non-Hodgkin Lymphoma and Waldenstrom Macroglobulinemia - Not receiving active treatment | Experimental | Drug: AREXVY, ABRYSVO, Drug: PREVNAR 20, Biological: PNEUMOVAX 23, Biological: Heplisav -B, Biological: PREVNAR 13, Biological: ShingrixParticipants 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. |
| Other Non-Hodgkin Lymphoma and Waldenstrom Macroglobulinemia - Treatment with Targeted Therapies | Experimental | Drug: AREXVY, ABRYSVO, Drug: PREVNAR 20, Biological: PNEUMOVAX 23, Biological: Heplisav -B, Biological: PREVNAR 13, Biological: ShingrixParticipants 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
- Or
- If prior exposure to Hepatitis-B vaccination, must have documentation of negative serologic response
- Age >= 18 years
Key exclusion criteria (9 listed)
- Female patients who are currently pregnant
- History of severe allergic reaction to vaccines
- Concomitant inherited immunodeficiency
- 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.
- Receive cytotoxic chemotherapy within 2 weeks prior to vaccination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AREXVY, ABRYSVORespiratory Syncytial Virus Vaccine | Drug | Chronic Lymphocytic Leukemia (CLL) - Treatment with BCL-2 Inhibitor, Chronic Lymphocytic Leukemia Not Receiving Active Treatment, Chronic Lymphocytic Leukemia Treatment Break for BTKi, Chronic Lymphocytic Leukemia Treatment Naive, Chronic Lymphocytic Leukemia Treatment with BTKi, Other Non-Hodgkin Lymphoma and Waldenstrom Macroglobulinemia - Not receiving active treatment, Other Non-Hodgkin Lymphoma and Waldenstrom Macroglobulinemia - Treatment with Targeted Therapies |
| PREVNAR 20Pneumococcal 20-Valent Conjugate Vaccine (PCV20) | Drug | Chronic Lymphocytic Leukemia (CLL) - Treatment with BCL-2 Inhibitor, Chronic Lymphocytic Leukemia Not Receiving Active Treatment, Chronic Lymphocytic Leukemia Treatment Break for BTKi, Chronic Lymphocytic Leukemia Treatment Naive, Chronic Lymphocytic Leukemia Treatment with BTKi, Other Non-Hodgkin Lymphoma and Waldenstrom Macroglobulinemia - Not receiving active treatment, Other Non-Hodgkin Lymphoma and Waldenstrom Macroglobulinemia - Treatment with Targeted Therapies |
| PNEUMOVAX 23Pneumococcal Polysaccharide Vaccine (PPSV23) | Biological | Chronic Lymphocytic Leukemia (CLL) - Treatment with BCL-2 Inhibitor, Chronic Lymphocytic Leukemia Not Receiving Active Treatment, Chronic Lymphocytic Leukemia Treatment Break for BTKi, Chronic Lymphocytic Leukemia Treatment Naive, Chronic Lymphocytic Leukemia Treatment with BTKi, Other Non-Hodgkin Lymphoma and Waldenstrom Macroglobulinemia - Not receiving active treatment, Other Non-Hodgkin Lymphoma and Waldenstrom Macroglobulinemia - Treatment with Targeted Therapies |
| Heplisav -BRecombinant, adjuvanted Hepatitis (HepB-CpG) | Biological | Chronic Lymphocytic Leukemia (CLL) - Treatment with BCL-2 Inhibitor, Chronic Lymphocytic Leukemia Not Receiving Active Treatment, Chronic Lymphocytic Leukemia Treatment Break for BTKi, Chronic Lymphocytic Leukemia Treatment Naive, Chronic Lymphocytic Leukemia Treatment with BTKi, Other Non-Hodgkin Lymphoma and Waldenstrom Macroglobulinemia - Not receiving active treatment, Other Non-Hodgkin Lymphoma and Waldenstrom Macroglobulinemia - Treatment with Targeted Therapies |
| PREVNAR 13Pneumococcal Conjugate Vaccine (PCV13) | Biological | Chronic Lymphocytic Leukemia (CLL) - Treatment with BCL-2 Inhibitor, Chronic Lymphocytic Leukemia Not Receiving Active Treatment, Chronic Lymphocytic Leukemia Treatment Break for BTKi, Chronic Lymphocytic Leukemia Treatment Naive, Chronic Lymphocytic Leukemia Treatment with BTKi, Other Non-Hodgkin Lymphoma and Waldenstrom Macroglobulinemia - Not receiving active treatment, Other Non-Hodgkin Lymphoma and Waldenstrom Macroglobulinemia - Treatment with Targeted Therapies |
| ShingrixRecombinant, adjuvanted Zoster Vaccine (RZV) | Biological | Chronic Lymphocytic Leukemia (CLL) - Treatment with BCL-2 Inhibitor, Chronic Lymphocytic Leukemia Not Receiving Active Treatment, Chronic Lymphocytic Leukemia Treatment Break for BTKi, Chronic Lymphocytic Leukemia Treatment Naive, Other Non-Hodgkin Lymphoma and Waldenstrom Macroglobulinemia - Not receiving active treatment, Other Non-Hodgkin Lymphoma and Waldenstrom Macroglobulinemia - Treatment with Targeted Therapies |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. The team will decide in the future.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adrian U Wiestner, M.D. principal investigator
National Heart, Lung, and Blood Institute (NHLBI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing AREXVY, ABRYSVO, PREVNAR 20 and PNEUMOVAX 23 in people with Lymphoma, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ingrid C Frey ((301) 402-0797, ingrid.frey@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.