Phase 4
Completed N=49
HepB-CpG Series for Healthcare Workers Who Are Hepatitis B Vaccine Nonresponders
Healthcare Worker, Hepatitis B Vaccine, Nonresponder
Source: ClinicalTrials.gov NCT04456504 ↗
Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcomePrimary: 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
◆ Published Evidence
Emerging
4citations · ~2 / year
Hepatitis B-CpG Vaccine Series for Healthcare Workers Who Are Hepatitis B Vaccine Nonresponders.
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)
Linked Publications
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Hepatitis B-CpG Vaccine Series for Healthcare Workers Who Are Hepatitis B Vaccine Nonresponders.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
43 | — |
| SECONDARY Number of Participants Who Respond to a Single Dose of hepB-CpG |
41 | — |
| SECONDARY Proportion of Participants Who Are Nonresponders With Each Risk Factor |
0; 3; 0; 1; 0 | — |
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
Data sourced from ClinicalTrials.gov (NCT04456504) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.