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

• ClinicalTrials.gov Identifier: NCT04456504
• Recruitment Status: Recruiting
• First Posted: July 2, 2020
• Last Update Posted: July 7, 2022
• Sponsor: University of Wisconsin, Madison
• Information provided by (Responsible Party): University of Wisconsin, Madison

Tracking Information

• First Submitted Date: June 16, 2020
• First Posted Date: July 2, 2020
• Last Update Posted Date: July 7, 2022
• Actual Study Start Date: September 15, 2020
• Estimated Primary Completion Date: September 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 29, 2020)

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 [ Time Frame: 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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 29, 2020)

• Number of participants who respond to a single dose of hepB-CpG [ Time Frame: 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
• Proportion of participants who are nonresponders with each risk factor [ Time Frame: 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: HepB-CpG Series for Healthcare Workers Who Are Hepatitis B Vaccine Nonresponders
• Official Title: HepB-CpG Series for Healthcare Workers Who Are Hepatitis B Vaccine Nonresponders
• 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.

• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Healthcare Worker, Hepatitis B Vaccine, Nonresponder

Intervention

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.

Study Arms

Experimental: Healthcare worker

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.

Intervention: Biological: Recombinant hepatitis B vaccine with CpG adjuvant

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 29, 2020): 130
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 2022
• Estimated Primary Completion Date: September 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Mary S Hayney, PharmD, MPH; 6082654666; mary.hayney@wisc.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04456504
• Other Study ID Numbers: 2020-0631; A561000 ( Other Identifier: UW Madison ); PHARM/PHARMACY ( Other Identifier: UW Madison ); Protocol Version 6/11/2020 ( Other Identifier: UW Madison )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: University of Wisconsin, Madison
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Wisconsin, Madison
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Mary S Hayney, PharmD, MPH; University of Wisconsin, Madison

• PRS Account: University of Wisconsin, Madison
• Verification Date: July 2022