HepB-CpG Series for Healthcare Workers Who Are Hepatitis B Vaccine Nonresponders

Healthcare Worker, Hepatitis B Vaccine, Nonresponder Clinical Trial

Official title:

HepB-CpG Series for Healthcare Workers Who Are Hepatitis B Vaccine Nonresponders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04456504
• Other study ID #: 2020-0631
• Secondary ID: A561000PHARM/PHA
• Status: Completed
• Phase: Phase 4
• Start date: September 15, 2020
• Est. completion date: December 6, 2023

Study information

• Verified date: December 2023
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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)

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: December 6, 2023
• Est. primary completion date: December 6, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Willing to provide informed consent

• Willing to comply with all study procedures and be available for the duration of the study

• Healthcare workers who have received at least 5 doses of hepatitis B vaccine with aluminum adjuvant and have antiHBs < 10mIU/ml

• Females of childbearing potential will be asked about the possibility of pregnancy as is the standard of care for immunization services. If a female indicates that she may be pregnant, study participation will be postponed until pregnancy is completed or the female reports that she is not pregnant.

Exclusion Criteria:

• Women who are pregnant or planning on becoming pregnant during the study

• Allergy to the vaccine or a component of the vaccine

• Not suitable for study participation due to other reasons, such as inability or unwillingness to comply with the study procedures, at the discretion of the investigators

Related Conditions & MeSH terms

• Healthcare Worker, Hepatitis B Vaccine, Nonresponder
• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

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.

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Response is defined as AntiHBs >10 mIU/ml following two doses of hepB-CpG	one month after dose 2 (up to 84 days on study)
Secondary	Number of participants who respond to a single dose of hepB-CpG	Response is defined as AntiHBs >10 mIU/ml following a single dose of hepB-CpG	one month after dose 1 (up to 42 days on study)
Secondary	Proportion of participants who are nonresponders with each risk factor	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.	one month after dose 2 (up to 84 days on study)