Phase 2
N=78
HEPLISAV-B Hepatitis B Vaccine in Chronic Lymphocytic Leukemia (CLL) and CLL Treated With Bruton's-Tyrosine Kinase Inhibitor (BTK-I)
Hepatitis · Safety and Tolerability
Bottom Line
View on ClinicalTrials.gov: NCT03685708 ↗Enrolled (actual)
78
Serious AEs
1.3%
Results posted
Dec 2021
Primary outcome: Primary: Number of Participants With HEPLISAV-B Seroprotective Titer (Anti-HBs 10mIU/mL) — 0; 1; 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- HEPLISAV-B (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With HEPLISAV-B Seroprotective Titer (Anti-HBs 10mIU/mL) |
0; 1; 9 | — |
| SECONDARY Number of Participants That Experienced Serious Adverse Events Following HEPLISAV-B Vaccine Among CLL Patients |
0; 0; 1 | — |
| SECONDARY Number of Participants That Did Not Complete Study Due to Intolerance of the HEPLISAV-B Vaccine Among CLL Patients. |
0; 0; 0 | — |
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.
Eligibility Criteria
- INCLUSION CRITERIA:
- Diagnosis of CLL/SLL which is made according to the updated criteria of the NCI Working Group.
- No known active or past hepatitis B infection
- No history of prior hepatitis B virus vaccination (approved or investigational)
- History of negative hepatitis B viral titers (negative HBsAg, HBsAb and HBcAb)
- Cohort 1: Treatment naive CLL patients
- Cohort 2: Subjects must be receiving ibrutinib monotherapy for at least 6 months prior to administration of the first vaccine dose
- Cohort 3: Subjects must be receiving acalabrutinib monotherapy for at least 6 months prior to administration of the first vaccine dose
- Age greater than or equal to 18 years.
- ECOG performance status of 0-1
- Able to comprehend the investigational nature of the protocol and provide informed consent.
EXCLUSION CRITERIA
- Female patients who are currently pregnant.
- Any uncontrolled active systemic infection
- 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
- History of severe allergic reaction to any component of HEPLISAV-B, including yeast
- Receive intravenous or subcutaneous immunoglobulin (IVIG) within 3 months prior to vaccination
- Concomitant use of immunosuppressive agents (e.g. steroids, radiotherapy, chemotherapy)
- Hereditary or acquired immunodeficiency syndrome unrelated to CLL
- Non-English speaking individuals will be excluded from the study
Data sourced from ClinicalTrials.gov (NCT03685708). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.