Hepatitis B Virus Clinical Trial
Official title:
Use of Dynavax Heplisav B in Healthcare Workers Previously Vaccinated With Standard 3-dose Vaccine Who Failed to Demonstrate Seroprotection
Protection against Hepatitis B infection is a regulatory and safety cornerstone to infection prevention and control programs involving the healthcare workforce in the United States. Until 2018 when a new adjuvanted vaccine was released, immunization for this population has involved a three-dose series followed by an additional three-dose series for those demonstrating lack of seroprotection. If that lack continued following the second three-dose series, and verification of a negative Hepatitis B antigen status, that person has historically been deemed a non-responder to Hepatitis B vaccine and at potential risk for infection. This non-response status may be used to determine job responsibilities representing excessive risk for the healthcare worker resulting in potential career and practice limitations and decisions. With the release of the new adjuvanted vaccine, there is potential to determine the role that new vaccine may play in promoting an immune response among this non-responding subset of at-risk healthcare workers. The aims of this study include: 1) determining the effect of this adjuvanted vaccine in producing seropositivity in a population of healthcare personnel previously deemed as non-responders following administration of two rounds of the traditional 3-dose series of Hepatitis B vaccine and confirmation of negative Hepatitis B antigen; and 2) determining the personal and professional impact of the lack of immunity to Hepatitis B among healthcare personnel.
Background Protection against Hepatitis B infection is a regulatory and safety cornerstone to infection prevention and control programs involving the healthcare workforce in the United States. Until 2018 when a new adjuvanted vaccine was released, immunization for this population has involved a three-dose series followed by an additional three-dose series for those demonstrating lack of seroprotection. If that lack continued following the second three-dose series, and verification of a negative Hepatitis B antigen status, that person has historically been deemed a non-responder to Hepatitis B vaccine and at potential risk for infection. This non-response status may be used to determine job responsibilities representing excessive risk for the healthcare worker resulting in potential career and practice limitations and decisions. With the release of the new adjuvanted vaccine, there is potential to determine the role that new vaccine may play in promoting an immune response among this non-responding subset of at-risk healthcare workers. Heplisav B is a standard of care vaccine that provides an alternative to a traditional 3-dose series by enabling use of a 2-dose series with doses one and two separated by one month. Work by Jackson and Janssen have indicated a greater than 90% seroprotection, perhaps closer to 100%, with the 2-dose series of this adjuvanted vaccine where hyporesponsiveness to 3-dose vaccines has been noted, principally in persons who smoke, are diabetic, obese, and male. This shorter administration schedule and reduced number of doses, combined with the seroconversion data make this vaccine ideal for situations where rapid induction of immunization occurs, such as those working in exposure-risk jobs such as healthcare. The aims of this study include: 1) determining the effect of this adjuvanted vaccine in producing seropositivity in a population of healthcare personnel previously deemed as non-responders following administration of two rounds of the traditional 3-dose series of Hepatitis B vaccine and confirmation of negative Hepatitis B antigen; and 2) determining the personal and professional impact of the lack of immunity to Hepatitis B among healthcare personnel. Use of Heplisav B will follow the FDA labeling and will not involve off-label use. Study personnel will work with the employee/occupational health and infection control departments to identify healthcare personnel working in a Louisville hospital, long term care facility, or clinic meeting the definition of a non-responder. Work will be done with University of Louisville Campus Health Services leadership to identify students, residents, fellows, or faculty who meet the definition of a non-responder. After gaining consent for participation in the study, titers will be drawn to document current Hepatitis B quantitative antibody and antigen levels. Enrolled participants (those with negative antibody and antigen) will be administered one dose of the adjuvanted vaccine followed by repeat antigen and antibody testing 30-60 days after receipt of that dose of vaccine. If results of the antibody and antigen are again negative, a second dose of the adjuvanted vaccine will be administered followed by repeat antibody and antigen testing 30-60 days after receipt of that dose of vaccine. For those healthcare personnel enrolled in the study, a questionnaire will be administered designed to understand the personal and professional impact of a non-responder status to hepatitis B. All doses of Heplisav B vaccine will be provided by Dynavax and will be at no cost to the participants. All labs drawn will also be at no cost to the participant. Study participants will be seen for a total of up to 9 visits with participation in the study lasting approximately 3 months. Visits involving labwork, vaccine administration, and the survey will occur in-person at the University of Louisville International Travel Clinic located in MedCenter One (501 East Broadway, Louisville Kentucky 40202). Visits gathering information regarding adverse reactions to vaccination will occur via telephone call visits as well as during in-person visits after the vaccine dose(s) have been administered. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03459521 -
Efficacy of HBVaxpro40© and Fendrix© in Patients With Chronic Liver Disease.
|
N/A | |
Completed |
NCT02060162 -
Antiretroviral Treatment Outcomes in HIV-HBV Co-infected Patients in Southern Africa
|
||
Completed |
NCT00912847 -
Validity and Cost-Effectiveness of a New Screening Test for Hepatocellular Carcinoma
|
N/A | |
Completed |
NCT04072211 -
Demonstration Project on Health Care Worker Protection Against Hepatitis B in Kalulushi District
|
Phase 4 | |
Completed |
NCT01204762 -
Dose Ranging Study of Pegylated Interferon Lambda in Patients With Hepatitis B and Positive for the Hepatitis B e Antigen
|
Phase 2 | |
Completed |
NCT00805675 -
Effects of Telbivudine and Tenofovir Disoproxil Fumarate Treatment on the Hepatitis B Virus DNA Kinetics in CHB
|
Phase 3 | |
Completed |
NCT02785835 -
Hepatocellular Carcinoma in HIV-infected Patients
|
||
Completed |
NCT03083821 -
A Study to Provide a Better Understanding of Baraclude's Pharmacokinetic Properties in a Real World Clinical Setting
|
Phase 1 | |
Recruiting |
NCT01083251 -
The Beneficial Effect of Vitamin D Supplement to Peg Interferon Alpha 2a or to Telbivudine Monotherapy in Patients With Chronic Hepatitis B Virus (HBV) Infection
|
N/A | |
Not yet recruiting |
NCT05752890 -
A Novel Biomarker for Response and Prognosis of HBV-related Hepatocellular Carcinoma
|
||
Recruiting |
NCT04231565 -
Nucleoside (Acid) Analogues Treatment in Patients With Normal ALT and Positive HBVDNA.
|
N/A | |
Terminated |
NCT00678587 -
Eltrombopag To Reduce The Need For Platelet Transfusion In Subjects With Chronic Liver Disease And Thrombocytopenia Undergoing Elective Invasive Procedures
|
Phase 3 | |
Completed |
NCT00739752 -
Interventions to Increase HBV Vaccinations in Sexually Transmitted Disease (STD) Clinics
|
N/A | |
Completed |
NCT03294798 -
Study of Recombinant Human Serum Albumin/Interferon alpha2b Fusion Protein in Hepatitis B Patient
|
Phase 1/Phase 2 | |
Enrolling by invitation |
NCT00663182 -
Entecavir for Patients With Decompensated Hepatitis B Virus (HBV)-Related Cirrhosis
|
Phase 4 | |
Completed |
NCT00769730 -
Evaluation the Possible Influence of Transcatheter Arterial Chemoembolization on Hepatitis B Viral Replication
|
N/A | |
Completed |
NCT01438424 -
Safety and Antiviral Activity of Entecavir in Participants With Chronic Hepatitis B Following Monotherapy in Other Entecavir Trials
|
Phase 2 | |
Withdrawn |
NCT04046107 -
Safety and Immunotherapeutic Activity of Cemiplimab in Participants With HBV on Suppressive Antiviral Therapy
|
Phase 1/Phase 2 | |
Completed |
NCT05406089 -
Effects of Antiviral Therapy on Patients With HBV-related HCC
|
||
Completed |
NCT03625258 -
Mutations of the Pre-core Region of Hepatite B Virus (HBV)
|