HEPLISAV-B Hepatitis B Vaccine in Chronic Lymphocytic Leukemia (CLL) and CLL Treated With Bruton's-Tyrosine Kinase Inhibitor (BTK-I)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03685708|
Recruitment Status : Recruiting
First Posted : September 26, 2018
Last Update Posted : May 1, 2020
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.
To learn how HEPLISAV-B works in people who have CLL or SLL.
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.
This study lasts 6 months from the date of first vaccination.
Participants may be screened with:
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.
After 3 months, participants will come back to the NIH to get another blood draw and the second vaccine dose.
Participants will return 3 months after the second vaccine dose was given. They will have blood drawn.
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis Safety and Tolerability||Biological: HEPLISAV-B||Phase 2|
This study aims to determine the HEPLISAV-B hepatitis B vaccine efficacy in chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) lymphocytic patients that are treatment naive or receiving Bruton s-tyrosine kinase inhibitor (BTK-I) therapy. (Note: Since CLL and SLL are considered the same disease, CLL/SLL will be referred to as CLL hereafter, unless otherwise specified).
Key Eligibility Criteria:
- Diagnosis of CLL
- Cohort 1: Treatment naive CLL or SLL 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
- No known active or past hepatitis B infection
- No history of prior hepatitis B virus vaccination (approved or investigational)
- Age greater greater than or equal to 18 years.
- ECOG performance status of 0-1
Patients with CLL will enroll on the study for the purpose of determining the HEPLISAV-B vaccine efficacy in patients who are treatment naive ore receiving BTK-I therapy. A series of 2 doses of HEPLISAV-B will be given on a 0- and 3- month schedule by intramuscular injection. Subjects will be followed at regular intervals and receive serologic response assessment following completion of the HEPLISAV-B vaccine series (6 months after the first vaccine
a) Determine the rate of hepatitis B seroprotective titer achievement (anti-HBs greater than or equal to 10mIU/mL) following completion of the HEPLISAV-B 2-dose vaccine series (6 months after the first vaccine administration) in the following populations:
- CLL patients who are treatment naive (n=54)
- CLL patients receiving treatment with ibrutinib (n=27)
- CLL patients receiving treatment with acalabrutinib (n=27)
a) Determine the safety and tolerability of the HEPLISAV-B vaccine among CLL patients who are treatment naive or receiving BTK-Is (ibrutinib or acalabrutinib).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||108 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Response to the HEPLISAV-B Hepatitis B Vaccine in Chronic Lymphocytic Leukemia (CLL) Patients That Are Treatment Naive or Receiving Bruton S-tyrosine Kinase Inhibitor (BTK-I) Therapy|
|Actual Study Start Date :||December 7, 2018|
|Estimated Primary Completion Date :||May 13, 2025|
|Estimated Study Completion Date :||May 13, 2025|
Experimental: Arm 1
Patients with CLL
HEPLISAV-B (Hepatitis B Vaccine [Recombinant ], adjuvanted) vaccine - A series of 2 doses (0.5 ml each) will be given on a 0- and 3- month schedule via intramuscular injection.
- HEPLISAV-B seroprotective titer (anti-HBs 10mIU/mL) [ Time Frame: 3 months after the first vaccine administration ]Determine the rate of hepatitis B seroprotective titer achievement (anti-HBs 10mIU/mL) following completion of the HEPLISAV-B 2-dose vaccine series (3 months after the first vaccine administration)
- Safety and tolerability of the HEPLISAV-B vaccine among CLL patients who are treatment naive or receiving BTK-Is (ibrutinib or acalabrutinib) [ Time Frame: 3 months after the first vaccine administration ]Determine the safety and tolerability of the HEPLISAV-B vaccine among CLL patients who are treatment naive or receiving BTK-Is (ibrutinib or acalabrutinib).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03685708
|Contact: Susan Soto, R.N.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Christopher MT Pleyer, M.D.||National Heart, Lung, and Blood Institute (NHLBI)|