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NCT03685708 · ClinicalTrials.gov registry record · Phase 2
HEPLISAV-B Hepatitis B 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
- 78
- Enrollment target
NCT03685708: Completed Phase 2 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT03685708 is a Phase 2 study that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 78 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03685708, a Phase 2 study, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 78 participants
- Enrollment target
Study Summary
Background: People with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) tend to get infections more easily. This is because their immune systems are weakened. Hepatitis B is a virus that can be transmitted when body fluids from an infected person enter the body of an uninfected person. This virus can be dangerous for people with leukemia and lymphoma. HEPLISAV-B is a new hepatitis B vaccine. Researchers want to see if it can protect people with CLL/SLL from getting hepatitis B. Objective: To learn how HEPLISAV-B works in people who have CLL or SLL. Eligibility: Adults 18 years and older with CLL (or SLL). They must be getting no treatment for their CLL, or getting ibrutinib or acalabrutinib for it. Design: This study lasts 6 months from the date of first vaccination. Participants may be screened with: Physical exam Blood tests Pregnancy test Visit 1 Participants will get blood drawn and the study vaccine. It will be given as an injection. If they get any symptoms within 7 days of the vaccine, they will write them in a diary. Visit 2 After 3 months, participants will come back to the NIH to get another blood draw and the second vaccine dose. Visit 3 Participants will return 3 months after the second vaccine dose was given. They will have blood drawn.
Primary Outcome
Determine the rate of hepatitis B seroprotective titer achievement (anti-HBs 10mIU/mL) following completion of the HEPLISAV-B 2-dose vaccine series (6 months after the first vaccine administration) among chronic lymphocytic leukemia (CLL) patients who are treatment naïve or receiving Bruton Tyrosine Kinase (BTK) inhibitors (Ibrutinib or Acalabrutinib).
Interventions
- BIOLOGICAL HEPLISAV-B
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2018-12-07 |
| Est. Completion | 2020-12-16 |
| Phase | Phase 2 |
What the finished NCT03685708 record still lists
NCT03685708 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% lower).
The record links to 0 conditions, and to 1 intervention - of which HEPLISAV-B is the first listed.
NCT03685708 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03685708 about?
NCT03685708 is a clinical study titled "HEPLISAV-B Hepatitis B Vaccine in Chronic Lymphocytic Leukemia (CLL) and CLL Treated With Bruton's-Tyrosine Kinase Inhibitor (BTK-I)". Background: People with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) tend to get infections more easily. This is because their immune systems are weakened. Hepatitis B is a virus that can be transmitted when body fluids from an infected person enter the body of an uninfect...
What is the current status of trial NCT03685708?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 78 participants. The study started on 2018-12-07. Estimated completion is 2020-12-16.
What interventions are being tested in trial NCT03685708?
The interventions under investigation include: HEPLISAV-B (BIOLOGICAL).
Who is sponsoring clinical trial NCT03685708?
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 NCT03685708's enrollment target sits among peer trials
78 884th of 2000 higher than 1,110 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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