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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04456504
Recruitment Status : Recruiting
First Posted : July 2, 2020
Last Update Posted : July 7, 2022
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Description
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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)

Condition or disease Intervention/treatment Phase
Healthcare Worker, Hepatitis B Vaccine, Nonresponder Biological: Recombinant hepatitis B vaccine with CpG adjuvant Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: HepB-CpG Series for Healthcare Workers Who Are Hepatitis B Vaccine Nonresponders
Actual Study Start Date : September 15, 2020
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04456504


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

Locations
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United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53792
Contact: Mary S Hayney, PharmD       mshayney@pharmacy.wisc.edu   
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
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Principal Investigator: Mary S Hayney, PharmD, MPH University of Wisconsin, Madison
More Information
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: 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 )
First Posted: July 2, 2020    Key Record Dates
Last Update Posted: July 7, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
 Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Hepadnaviridae Infections
DNA Virus Infections