University of Wisconsin
Madison, Wisconsin, 53792, United States
NCT Number: NCT04456504
This study is being done to determine if healthcare workers who have previously failed to respond to hepatitis B vaccine series will respond to a hepatitis B with CpG adjuvant (hepB-CpG) (Heplisav-B)
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Madison, Wisconsin, 53792, United States
Study Intervention Each individual who has completed at least 5 doses hepB vaccine with aluminum adjuvant series but is anti-HBs negative will be contacted by EHS staff and invited to receive the hepB-CpG two dose series on a 0 and 1 month schedule. Antibody to the surface antigen will be measured after the first dose during the visit for the administration of the second dose. One month after completion of the series, each immunized individual will have another anti-HBs measured.
Total Number of Subjects Up to 130 individuals will be recruited and enrolled. Study Population Healthcare workers who have received at least 5 doses of hepatitis B vaccine with aluminum adjuvant and have antiHBs < 10mIU/ml.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Each participant will receive two doses of hepB-CpG separated by one month and blood draw to measure antibody to the hepatitis B surface antigen prior to dose 2 and one month after dose 2.
Time frame: one month after dose 2 (up to 84 days on study)
Response is defined as AntiHBs >10 mIU/ml following two doses of hepB-CpG
Time frame: one month after dose 1 (up to 42 days on study)
Response is defined as AntiHBs >10 mIU/ml following a single dose of hepB-CpG
Time frame: one month after dose 2 (up to 84 days on study)
A multivariate model will be developed by measuring the proportion of participants who are nonresponders with each risk factor. Potential risk factors include including age, smoking status, sex, diabetes, immunosuppression.
University of Wisconsin, Madison
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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