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| ID | Type | Description | Link |
|---|---|---|---|
| A561000 | Other Identifier | UW Madison | |
| PHARM/PHARMACY | Other Identifier | UW Madison | |
| Protocol Version 6/11/2020 | Other Identifier | UW Madison |
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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthcare worker | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant hepatitis B vaccine with CpG adjuvant | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Proportion of Participants Who Are Nonresponders With Each Risk Factor |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary S Hayney, PharmD, MPH | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38881506 | Result | 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. |
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Participants were enrolled from September 2020 to September 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 1 participant dropped out of the study prior to the second dose, and 1 participant dropped out of the study prior to data collection post-second dose | Posted | Count of Participants | Participants | one month after dose 2 (up to 84 days on study) |
|
Adverse events data collected while participants are on study, up to 12 weeks
Adverse Events are reported per dose, 49 participants for the first dose, and 47 of the 49 for the second dose as 2 participants were lost to follow up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthcare Worker - Dose 1 | 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. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site soreness | Injury, poisoning and procedural complications | CTCAE version 5.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary Hayney, PharmD, MPH, FCCP, BCPS | University of Wisconsin School of Pharmacy | 608-265-4666 | mary.hayney@wisc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 11, 2020 | Jun 4, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| ID | Term |
|---|---|
| D017325 | Hepatitis B Vaccines |
| ID | Term |
|---|---|
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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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) |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Number of Prior Vaccine Doses | Count of Participants | Participants |
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| Smoking Status | Count of Participants | Participants |
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| Immunocompromised | Immunocompromise was self-reported | Count of Participants | Participants |
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| Diabetes | Count of Participants | Participants |
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| Any Risk Factor | Male, age >60 years, current smoker, immunocompromised, or diabetes; participants may have more than one risk factor | Count of Participants | Participants |
|
|
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| 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 | Posted | Count of Participants | Participants | 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. | Number of non-responders | Posted | Count of Participants | Participants | one month after dose 2 (up to 84 days on study) |
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| 0 |
| 49 |
| 0 |
| 49 |
| 20 |
| 49 |
| EG001 | Healthcare Worker - Dose 2 | 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. 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. | 0 | 47 | 0 | 47 | 5 | 47 |
| Chills | General disorders | CTCAE version 5.0 | Systematic Assessment |
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| Headache | General disorders | CTCAE version 5.0 | Systematic Assessment |
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| Fatigue | General disorders | CTCAE version 5.0 | Systematic Assessment |
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| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D045424 |
| Complex Mixtures |
| Immunocomprised |
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| Diabetes |
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