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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 : September 14, 2022
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Tracking Information
First Submitted Date  ICMJE June 16, 2020
First Posted Date  ICMJE July 2, 2020
Last Update Posted Date September 14, 2022
Actual Study Start Date  ICMJE September 15, 2020
Estimated Primary Completion Date March 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE HepB-CpG Series for Healthcare Workers Who Are Hepatitis B Vaccine Nonresponders
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Healthcare Worker, Hepatitis B Vaccine, Nonresponder
Intervention  ICMJE 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  ICMJE 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 29, 2020)
130
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2023
Estimated Primary Completion Date March 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Mary S Hayney, PharmD, MPH 6082654666 mary.hayney@wisc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04456504
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Current Responsible Party University of Wisconsin, Madison
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Wisconsin, Madison
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mary S Hayney, PharmD, MPH University of Wisconsin, Madison
PRS Account University of Wisconsin, Madison
Verification Date September 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP