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Use of Dynavax Heplisav B in Healthcare Workers Previously Vaccinated With 3-dose Vaccine Who Failed to Demonstrate Seroprotection

NCT04385524 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-04-30

No results posted yet for this study

Summary

Protection against Hepatitis B infection is a regulatory and safety cornerstone to infection prevention and control programs involving the healthcare workforce in the United States. Until 2018 when a new adjuvanted vaccine was released, immunization for this population has involved a three-dose series followed by an additional three-dose series for those demonstrating lack of seroprotection. If that lack continued following the second three-dose series, and verification of a negative Hepatitis B antigen status, that person has historically been deemed a non-responder to Hepatitis B vaccine and at potential risk for infection. This non-response status may be used to determine job responsibilities representing excessive risk for the healthcare worker resulting in potential career and practice limitations and decisions. With the release of the new adjuvanted vaccine, there is potential to determine the role that new vaccine may play in promoting an immune response among this non-responding subset of at-risk healthcare workers. The aims of this study include: 1) determining the effect of this adjuvanted vaccine in producing seropositivity in a population of healthcare personnel previously deemed as non-responders following administration of two rounds of the traditional 3-dose series of Hepatitis B vaccine and confirmation of negative Hepatitis B antigen; and 2) determining the personal and professional impact of the lack of immunity to Hepatitis B among healthcare personnel.

Conditions

  • Hepatitis B Virus

Interventions

BIOLOGICAL

Adjuvanted Hepatitis B Vaccine

Adjuvanted Hepatitis B vaccine will be provided to healthcare workers previously vaccinated with the standard 3-dose series of Hepatitis B vaccine but who have failed to respond to two complete 3-dose series

Sponsors & Collaborators

  • Dynavax Technologies Corporation

    collaborator INDUSTRY

  • University of Louisville

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2021-02-01
Completion
2021-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04385524 on ClinicalTrials.gov