HepB-CpG Series for Healthcare Workers Who Are Hepatitis B Vaccine Nonresponders
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|ClinicalTrials.gov Identifier: NCT04456504|
Recruitment Status : Recruiting
First Posted : July 2, 2020
Last Update Posted : July 7, 2022
|Condition or disease||Intervention/treatment||Phase|
|Healthcare Worker, Hepatitis B Vaccine, Nonresponder||Biological: Recombinant hepatitis B vaccine with CpG adjuvant||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||HepB-CpG Series for Healthcare Workers Who Are Hepatitis B Vaccine Nonresponders|
|Actual Study Start Date :||September 15, 2020|
|Estimated Primary Completion Date :||September 2022|
|Estimated Study Completion Date :||September 2022|
Experimental: Healthcare worker
Healthcare worker who has previously received at least 5 doses of hepatitis B vaccine with aluminum adjuvant (Recombivax B or Engerix B) and has an antibody to the hepatitis B surface antigen (antiHBs) that is less than 10 mIU/ml.
Biological: Recombinant hepatitis B vaccine with CpG adjuvant
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.
- Number of participants who failed to respond to 5 or more doses of hepatitis B vaccine with aluminum adjuvant who respond to hepatitis B vaccine with CpG adjuvant series [ 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
- Number of participants who respond to a single dose 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
- Proportion of participants who are nonresponders with each risk factor [ 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.
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): NCT04456504
|Contact: Mary S Hayney, PharmD, MPHemail@example.com|
|United States, Wisconsin|
|University of Wisconsin||Recruiting|
|Madison, Wisconsin, United States, 53792|
|Contact: Mary S Hayney, PharmD firstname.lastname@example.org|
|Principal Investigator:||Mary S Hayney, PharmD, MPH||University of Wisconsin, Madison|