Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT04385524 |
| Other study ID # |
191219 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2020 |
| Est. completion date |
February 28, 2021 |
Study information
| Verified date |
April 2021 |
| Source |
University of Louisville |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
