Clinical trial NCT04456504: HepB-CpG Series for Healthcare Workers Who Are Hepatitis B Vaccine Nonresponders
Official title: HepB-CpG Series for Healthcare Workers Who Are Hepatitis B Vaccine Nonresponders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthcare Worker, Hepatitis B Vaccine, Nonresponder
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2020-07-02
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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)

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: one month after dose 2 (up to 84 days on study)
Secondary outcomes:
measure: Number of Participants Who Respond to a Single Dose of hepB-CpG
timeFrame: one month after dose 1 (up to 42 days on study)
measure: Proportion of Participants Who Are Nonresponders With Each Risk Factor
timeFrame: one month after dose 2 (up to 84 days on study)
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Mary S Hayney, PharmD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Russ RK, Vandehei HM, Golovkina MI, Mogallapalli H, Caldera F, Hayney MS. Hepatitis B-CpG Vaccine Series for Healthcare Workers Who Are Hepatitis B Vaccine Nonresponders. Clin Infect Dis. 2024 Aug 16;79(2):562-563. doi: 10.1093/cid/ciae320.