Healthcare Worker, Hepatitis B Vaccine, Nonresponder
Conditions
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.
Interventions
BIOLOGICALRecombinant 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.
Sponsors
University of Wisconsin, Madison
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Respond to a Single Dose of hepB-CpG | 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 | 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. |
Countries
United States
Participant flow
Pre-assignment details
Participants were enrolled from September 2020 to September 2023.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 49 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | Healthcare Worker |
|---|---|
| Age, Customized 18-39 years old | 28 Participants |
| Age, Customized 40-59 years old | 16 Participants |
| Age, Customized equal to or greater than 60 years old | 5 Participants |
| Any Risk Factor No | 18 Participants |
| Any Risk Factor Yes | 31 Participants |
| Diabetes No | 45 Participants |
| Diabetes Yes | 4 Participants |
| Immunocompromised Missing Data | 1 Participants |
| Immunocompromised No | 42 Participants |
| Immunocompromised Yes | 6 Participants |
| Number of Prior Vaccine Doses 5 | 2 Participants |
| Number of Prior Vaccine Doses 6 | 44 Participants |
| Number of Prior Vaccine Doses 9 | 3 Participants |
| Race/Ethnicity, Customized American Indian / Alaska Native | 2 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants |
| Race/Ethnicity, Customized Black / African American | 2 Participants |
| Race/Ethnicity, Customized Hispanic / Latinx | 3 Participants |
| Race/Ethnicity, Customized White | 39 Participants |
| Region of Enrollment United States | 49 participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 20 Participants |
| Smoking Status Current Smoker | 3 Participants |
| Smoking Status Former Smoker | 7 Participants |
| Smoking Status Non-Smoker | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 47 |
| other Total, other adverse events | 20 / 49 | 5 / 47 |
| serious Total, serious adverse events | 0 / 49 | 0 / 47 |
Outcome results
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
Time frame: one month after dose 2 (up to 84 days on study)
Population: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Healthcare Worker | 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 | 43 Participants |
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
Time frame: one month after dose 1 (up to 42 days on study)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Healthcare Worker | Number of Participants Who Respond to a Single Dose of hepB-CpG | 41 Participants |
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.
Time frame: one month after dose 2 (up to 84 days on study)
Population: Number of non-responders
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Healthcare Worker | Proportion of Participants Who Are Nonresponders With Each Risk Factor | Male | 0 Participants |
| Healthcare Worker | Proportion of Participants Who Are Nonresponders With Each Risk Factor | Equal to or greater than 60 years old | 3 Participants |
| Healthcare Worker | Proportion of Participants Who Are Nonresponders With Each Risk Factor | Current Smoker | 0 Participants |
| Healthcare Worker | Proportion of Participants Who Are Nonresponders With Each Risk Factor | Immunocomprised | 1 Participants |
| Healthcare Worker | Proportion of Participants Who Are Nonresponders With Each Risk Factor | Diabetes | 0 Participants |