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
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis B Virus||Biological: Adjuvanted Hepatitis B Vaccine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
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
|Contact: Ruth Carrico, PhD DNPemail@example.com|