HepB-CpG Series for Healthcare Workers Who Are Hepatitis B Vaccine Nonresponders

Phase 4

Completed

Interventions: Biological: Recombinant hepatitis B vaccine with CpG adjuvant

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-CpG two dose series on a 0 and 1 month schedule. Antibody to the surface antigen will be measured after the first dose during the visit for the administration of the second dose. One month after completion of the series, each immunized individual will have another anti-HBs measured.

Total Number of Subjects Up to 130 individuals will be recruited and enrolled. Study Population Healthcare workers who have received at least 5 doses of hepatitis B vaccine with aluminum adjuvant and have antiHBs \< 10mIU/ml.

Recruitment & Eligibility

Inclusion Criteria

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 Criteria

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

Arm && Interventions

Group	Intervention	Description
Healthcare worker	Recombinant hepatitis B vaccine with CpG adjuvant	Healthcare worker who has previously received at least 5 doses of hepatitis B vaccine with aluminum adjuvant (Recombivax B or Engerix B) and has an antibody to the hepatitis B surface antigen (antiHBs) that is less than 10 mIU/ml.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Failed to Respond to 5 or More Doses of Hepatitis B Vaccine With Aluminum Adjuvant Who Respond to Hepatitis B Vaccine With CpG Adjuvant Series	one month after dose 2 (up to 84 days on study)	Response is defined as AntiHBs \>10 mIU/ml following two doses of hepB-CpG

Secondary Outcome Measures

Name	Time	Method
Proportion of Participants Who Are Nonresponders With Each Risk Factor	one month after dose 2 (up to 84 days on study)	A multivariate model will be developed by measuring the proportion of participants who are nonresponders with each risk factor. Potential risk factors include including age, smoking status, sex, diabetes, immunosuppression.
Number of Participants Who Respond to a Single Dose of hepB-CpG	one month after dose 1 (up to 42 days on study)	Response is defined as AntiHBs \>10 mIU/ml following a single dose of hepB-CpG