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

Primary Purpose

Healthcare Worker, Hepatitis B Vaccine, Nonresponder

Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Recombinant hepatitis B vaccine with CpG adjuvant
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Healthcare Worker, Hepatitis B Vaccine, Nonresponder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • University of Wisconsin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Healthcare worker

Arm 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.

Outcomes

Primary Outcome Measures

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
Response is defined as AntiHBs >10 mIU/ml following two doses of hepB-CpG

Secondary Outcome Measures

Number of participants who respond to a single dose of hepB-CpG
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
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.

Full Information

First Posted
June 16, 2020
Last Updated
September 27, 2023
Sponsor
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT04456504
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 15, 2020 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthcare Worker, Hepatitis B Vaccine, Nonresponder

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthcare worker
Arm Type
Experimental
Arm 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.
Intervention Type
Biological
Intervention Name(s)
Recombinant hepatitis B vaccine with CpG adjuvant
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
Response is defined as AntiHBs >10 mIU/ml following two doses of hepB-CpG
Time Frame
one month after dose 2 (up to 84 days on study)
Secondary Outcome Measure Information:
Title
Number of participants who respond to a single dose of hepB-CpG
Description
Response is defined as AntiHBs >10 mIU/ml following a single dose of hepB-CpG
Time Frame
one month after dose 1 (up to 42 days on study)
Title
Proportion of participants who are nonresponders with each risk factor
Description
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.
Time Frame
one month after dose 2 (up to 84 days on study)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary S Hayney, PharmD, MPH
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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