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NCT03702231 · ClinicalTrials.gov registry record · Phase 2
Response to the SHINGRIX Varicella Zoster Virus (VZV) Vaccine in Chronic Lymphocytic Leukemia (CLL) and CLL Treated With Bruton's Tyrosine Kinase Inhibitor (BTK-I)
A Phase 2 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 2
- Development phase
- 116
- Enrollment target
NCT03702231: Completed Phase 2 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT03702231 is a Phase 2 study that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 116 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03702231, a Phase 2 study, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 116 participants
- Enrollment target
Study Summary
Background: People who have cancer tend to get sick more often. This is in part because of the cancer treatments they get. Because of this, they may get shingles. Scientists had thought people with chronic lymphocytic leukemia (CLL) should not get the shingles vaccine. Now there is a new shingles vaccine that is not live and cannot cause shingles. The new shingles vaccine may protect people with weak immune systems from getting shingles. This is currently shown to be safe to give people 50 years and older to prevent shingles. Researchers want to test how safe the vaccine is and how it works in people with CLL. Objective: To learn how a new shingles vaccine works in people who have chronic lymphocytic leukemia or small lymphocytic lymphoma (SLL). Eligibility: Adults ages 18 years and older with CLL or SLL who are not being treated for CLL or who are getting certain treatments. Design: Participants will be screened with a chart review or through another protocol. Visit 1 At visit 1, participants may have a pregnancy test, blood test, or physical exam. Pregnant participants cannot be in the study. Eligible participants will get the shingles vaccine as an injection. Participants will receive a diary and write down any symptoms they have for 7 days after the vaccines. Visit 2 Visit 2 will be 3 months later. Participants will have blood taken and get another dose of the vaccine. Participants will receive a diary and write down any symptoms they have for 7 days after the vaccines. Visit 3 Visit 3 will be 3 months after visit 2. Participants will have blood taken. Participants may be able to get an additional vaccine the same day as the shingles vaccine.
Primary Outcome
Determine the rate of varicella zoster virus (VZV) seroprotective titer achievement in participants following completion of the SHINGRIX 2-dose vaccine series in Chronic Lymphocytic Leukemia (CLL) patients that are treatment naive or receiving therapy with a Bruton Tyrosine Kinase (BTK) Inhibitor (Ibrutinib or Acalabrutinib). The response criteria for achieving serologic response against VZV following the SHINGRIX vaccine are based on a validated luciferase immunoprecipitation assay detecting VZ
Interventions
- BIOLOGICAL Zoster Vaccine Recombinant, Adjuvanted
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2018-12-07 |
| Est. Completion | 2023-07-12 |
| Phase | Phase 2 |
What the finished NCT03702231 record still lists
NCT03702231 is an interventional study that assigns participants to a tested intervention. The registered 116 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% lower).
The record links to 0 conditions, and to 1 intervention - of which Zoster Vaccine Recombinant, Adjuvanted is the first listed.
NCT03702231 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03702231 about?
NCT03702231 is a clinical study titled "Response to the SHINGRIX Varicella Zoster Virus (VZV) Vaccine in Chronic Lymphocytic Leukemia (CLL) and CLL Treated With Bruton's Tyrosine Kinase Inhibitor (BTK-I)". Background: People who have cancer tend to get sick more often. This is in part because of the cancer treatments they get. Because of this, they may get shingles. Scientists had thought people with chronic lymphocytic leukemia (CLL) should not get the shingles vaccine. Now there is a new shingles v...
What is the current status of trial NCT03702231?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 116 participants. The study started on 2018-12-07. Estimated completion is 2023-07-12.
What interventions are being tested in trial NCT03702231?
The interventions under investigation include: Zoster Vaccine Recombinant, Adjuvanted (BIOLOGICAL).
Who is sponsoring clinical trial NCT03702231?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03702231's enrollment target sits among peer trials
116 623rd of 2000 higher than 1,375 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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