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OpenTrials
Completed

NCT Number: NCT04456504

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

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)

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Wisconsin

Madison, Wisconsin, 53792, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Recombinant hepatitis B vaccine with CpG adjuvant

Biological

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 2, 2020
Registry last updated
Jul 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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