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HEPLISAV-B Hepatitis B Vaccine in Chronic Lymphocytic Leukemia (CLL) and CLL Treated With Bruton's-Tyrosine Kinase Inhibitor (BTK-I)

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ClinicalTrials.gov Identifier: NCT03685708
Recruitment Status : Recruiting
First Posted : September 26, 2018
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

Brief 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.


Condition or disease Intervention/treatment Phase
Hepatitis Safety and Tolerability Biological: HEPLISAV-B Phase 2

Detailed Description:

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 15, 2019
Estimated Study Completion Date : May 15, 2020


Arm Intervention/treatment
Experimental: 1
Patients with CLL
Biological: HEPLISAV-B
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.




Primary Outcome Measures :
  1. HEPLISAV-B seroprotective titer (anti-HBs 10mIU/mL) [ Time Frame: 6 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 (6 months after the first vaccine administration)


Secondary Outcome Measures :
  1. Safety and tolerability of the HEPLISAV-B vaccine among CLL patients who are treatment naive or receiving BTK-Is (ibrutinib or acalabrutinib) [ Time Frame: 6 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • 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

Information from the National Library of Medicine

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


Contacts
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Contact: Susan Soto, R.N. (301) 402-0797 sotos@nhlbi.nih.gov

Locations
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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    prpl@cc.nih.gov   
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Christopher MT Pleyer, M.D. National Heart, Lung, and Blood Institute (NHLBI)

Additional Information:
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Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT03685708     History of Changes
Other Study ID Numbers: 180145
18-H-0145
First Posted: September 26, 2018    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 29, 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ):
Ibrutinib
Acalabrutinib
Immunology

Additional relevant MeSH terms:
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Hepatitis
Hepatitis A
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Hepadnaviridae Infections
DNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs