HEPLISAV-B Hepatitis B Vaccine in Chronic Lymphocytic Leukemia (CLL) and CLL Treated With Bruton's-Tyrosine Kinase Inhibitor (BTK-I)
| Status: | Recruiting |
|---|---|
| Conditions: | Hepatitis, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 4/6/2019 |
| Start Date: | December 7, 2018 |
| End Date: | May 15, 2020 |
| Contact: | Susan Soto, R.N. |
| Email: | sotos@nhlbi.nih.gov |
| Phone: | (301) 402-0797 |
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
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.
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.
This study aims to determine the HEPLISAV-B hepatitis B vaccine efficacy in chronic
lymphocytic leukemia (CLL) patients that are treatment naive or receiving Bruton s-tyrosine
kinase inhibitor (BTK-I) therapy.
Key Eligibility Criteria:
1. Diagnosis of CLL
2. Cohort 1: Treatment naive CLL patients
3. Cohort 2: Subjects must be receiving ibrutinib monotherapy for at least 6 months prior
to administration of the first vaccine dose
4. Cohort 3: Subjects must be receiving acalabrutinib monotherapy for at least 6 months
prior to administration of the first vaccine dose
5. No known active or past hepatitis B infection
6. History of prior hepatitis B virus vaccination (approved or investigational)
7. Age greater greater than or equal to 18 years.
8. ECOG performance status of 0-1
Design:
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
administration).
Study Objectives:
Primary Objective:
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)
Secondary Objective:
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).
lymphocytic leukemia (CLL) patients that are treatment naive or receiving Bruton s-tyrosine
kinase inhibitor (BTK-I) therapy.
Key Eligibility Criteria:
1. Diagnosis of CLL
2. Cohort 1: Treatment naive CLL patients
3. Cohort 2: Subjects must be receiving ibrutinib monotherapy for at least 6 months prior
to administration of the first vaccine dose
4. Cohort 3: Subjects must be receiving acalabrutinib monotherapy for at least 6 months
prior to administration of the first vaccine dose
5. No known active or past hepatitis B infection
6. History of prior hepatitis B virus vaccination (approved or investigational)
7. Age greater greater than or equal to 18 years.
8. ECOG performance status of 0-1
Design:
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
administration).
Study Objectives:
Primary Objective:
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)
Secondary Objective:
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).
- INCLUSION CRITERIA:
- Diagnosis of CLL/SLL [hereafter CLL/SLL will be referred to as CLL] 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
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
301-496-2563
Phone: 800-411-1222
National Institutes of Health Clinical Center The National Institutes of Health (NIH) Clinical Center in...
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