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 :
Withdrawn
(We decided to close this study. We are unable to perform this study due to the current pandemic.)
First Posted : May 13, 2020
Last Update Posted : April 30, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatitis B Virus | Biological: Adjuvanted Hepatitis B Vaccine | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 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 |
- 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
- 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 |
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:
- Pregnancy
- Allergy to the adjuvanted vaccine or a vaccine component
- Sensitivity to yeast
- Persons unable to provide consent
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: | April 30, 2021 |
Last Verified: | April 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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 |
Hepatitis B vaccine Hepatitis B vaccine non-responder Hepatitis B seroconversion |
Hepatitis B Hepatitis Hepatitis, Viral, Human Liver Diseases Digestive System Diseases Virus Diseases |
Infections Blood-Borne Infections Communicable Diseases Hepadnaviridae Infections DNA Virus Infections |