Status:

WITHDRAWN

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

Lead Sponsor:

University of Louisville

Collaborating Sponsors:

Dynavax Technologies Corporation

Conditions:

Hepatitis B Virus

Eligibility:

All Genders

18+ years

Phase:

NA

Brief 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 ...

Detailed Description

Background 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 2...

Eligibility Criteria

Inclusion

  • Healthcare personnel age 18-64 years of age who have documentation of prior receipt of two rounds of the traditional 3-dose series of Hepatitis B vaccine and having serologic testing demonstrating quantitative Hepatitis B antibody level of less than 10 iU and a negative Hepatitis B antigen.

Exclusion

  • Pregnancy
  • Allergy to the adjuvanted vaccine or a vaccine component
  • Sensitivity to yeast
  • Persons unable to provide consent

Key Trial Info

Start Date :

June 1 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 28 2021

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT04385524

Start Date

June 1 2020

End Date

February 28 2021

Last Update

April 30 2021

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