NCT04456504

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthcare Worker, Hepatitis B Vaccine, Nonresponder

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant hepatitis B vaccine with CpG adjuvant	Each participant will receive two doses of hepB-CpG separated by one month and blood draw to measure antibody to the hepatitis B surface antigen prior to dose 2 and one month after dose 2.

Timeline

• Start date: 2020-09-15
• Primary completion: 2023-12-06
• Completion: 2023-12-06
• First posted: 2020-07-02
• Last updated: 2024-07-16
• Results posted: 2024-07-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study