NCT04456504CompletedPhase 4
HepB-CpG Series for Healthcare Workers Who Are Hepatitis B Vaccine Nonresponders
Source: ClinicalTrials.gov · Last updated 16 Jul 2024
Brief summary (registry, in English)
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)
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 49 (actual)
- First submitted
- 16 Jun 2020
- Start date
- 15 Sept 2020
- Primary completion date
- 6 Dec 2023
- Lead sponsor
- University of Wisconsin, Madison
- Diseases
- Hepatitis B
- NCT number
- NCT04456504
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 49
- From 15 Sept 2020 to the primary completion date, 6 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Allergy to the vaccine or a component of the vaccine
Other
- Women who are pregnant or planning on becoming pregnant during the study
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Wisconsin Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.