Status:
COMPLETED
HepB-CpG Series for Healthcare Workers Who Are Hepatitis B Vaccine Nonresponders
Lead Sponsor:
University of Wisconsin, Madison
Conditions:
Healthcare Worker, Hepatitis B Vaccine, Nonresponder
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study is being done to determine if healthcare workers who have previously failed to respond to hepatitis B vaccine series will respond to a hepatitis B with CpG adjuvant (hepB-CpG) (Heplisav-B)
Detailed Description
Study Intervention Each individual who has completed at least 5 doses hepB vaccine with aluminum adjuvant series but is anti-HBs negative will be contacted by EHS staff and invited to receive the hepB...
Eligibility Criteria
Inclusion
- Willing to provide informed consent
- Willing to comply with all study procedures and be available for the duration of the study
- Healthcare workers who have received at least 5 doses of hepatitis B vaccine with aluminum adjuvant and have antiHBs \< 10mIU/ml
- Females of childbearing potential will be asked about the possibility of pregnancy as is the standard of care for immunization services. If a female indicates that she may be pregnant, study participation will be postponed until pregnancy is completed or the female reports that she is not pregnant.
Exclusion
- Women who are pregnant or planning on becoming pregnant during the study
- Allergy to the vaccine or a component of the vaccine
- Not suitable for study participation due to other reasons, such as inability or unwillingness to comply with the study procedures, at the discretion of the investigators
Key Trial Info
Start Date :
September 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 6 2023
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT04456504
Start Date
September 15 2020
End Date
December 6 2023
Last Update
July 16 2024
Active Locations (1)
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1
University of Wisconsin
Madison, Wisconsin, United States, 53792