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Trial record 3 of 11 for:    Heplisav-B | Hepatitis B

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

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ClinicalTrials.gov Identifier: NCT04385524
Recruitment Status : Not yet recruiting
First Posted : May 13, 2020
Last Update Posted : May 13, 2020
Sponsor:
Collaborator:
Dynavax Technologies Corporation
Information provided by (Responsible Party):
Ruth Carrico, University of Louisville

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 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.

Condition or disease Intervention/treatment Phase
Hepatitis B Virus Biological: Adjuvanted Hepatitis B Vaccine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Use of Dynavax Heplisav B in Healthcare Workers Previously Vaccinated With Standard 3-dose Vaccine Who Failed to Demonstrate Seroprotection
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : February 28, 2021


Arm Intervention/treatment
Vaccination

Heplisav B vaccine will be administered to subjects demonstrating completion of two prior series of standard 3-dose Hepatitis B vaccine but still without evidence of seroconversion.

One dose (20 mcg) of vaccine will be administered intramuscularly followed by Hepatitis B quantitative antibody titer 30-60 days later.

If still Hepatitis B antibody negative, a second dose (20 mcg) of vaccine will be administered intramuscularly followed by a Hepatitis B quantitative titer 30-60 days later.

If still no evidence of Hepatitis B immunity (10iU antibody or greater), will be deemed a non-responder to this vaccine

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




Primary Outcome Measures :
  1. Hepatitis B Seroconversion as Measured by Achievement of 10iU/ml on Quantitative Hepatitis B Titer [ Time Frame: within 3 months of acceptance into the study ]
    Demonstration of Hepatitis B immunity via achievement of 10iU/ml or greater on quantitative titer following 1 or 2 doses of the adjuvanted Hepatitis B vaccine


Secondary Outcome Measures :
  1. Reported Impact of Non-Response Status on Career and Personal Economics as Reported by Healthcare Worker [ Time Frame: within 6 months of acceptance into the study ]
    Impact of Hepatitis B non-response status on career and personal economics as perceived by the healthcare worker completing the survey. This includes metrics such as hourly wage, job promotion, career pathway



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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:

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 Criteria:

  1. Pregnancy
  2. Allergy to the adjuvanted vaccine or a vaccine component
  3. Sensitivity to yeast
  4. Persons unable to provide consent

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): NCT04385524


Contacts
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Contact: Ruth Carrico, PhD DNP 502-640-8026 ruth.carrico@louisville.edu

Sponsors and Collaborators
University of Louisville
Dynavax Technologies Corporation
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Responsible Party: Ruth Carrico, Professor, University of Louisville
ClinicalTrials.gov Identifier: NCT04385524    
Other Study ID Numbers: 191219
First Posted: May 13, 2020    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Ruth Carrico, University of Louisville:
Hepatitis B vaccine
Hepatitis B vaccine non-responder
Hepatitis B seroconversion
Additional relevant MeSH terms:
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Hepatitis B
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Hepadnaviridae Infections
DNA Virus Infections