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

University of Wisconsin (UW)

Status and phase: Completed; Phase 4

Conditions: Healthcare Worker, Hepatitis B Vaccine, Nonresponder

Treatments: Biological: Recombinant hepatitis B vaccine with CpG adjuvant

Study type: Interventional

Funder types: Other

Identifiers

NCT04456504

Protocol Version 6/11/2020 (Other Identifier)

PHARM/PHARMACY (Other Identifier)

A561000 (Other Identifier)

2020-0631

Details and patient eligibility

About

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)

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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49 participants in 1 patient group

Healthcare worker

Experimental group

Description:

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.

Treatment:

Biological: Recombinant hepatitis B vaccine with CpG adjuvant