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NCT05791851 · ClinicalTrials.gov registry record
Heplisav-B Revaccination for Hepatitis B Vaccine Nonresponders
A clinical trial, sponsored by University of Maryland, Baltimore.
- Completed
- Registry status
- 31
- Enrollment target
NCT05791851: Completed study, sponsored by University of Maryland, Baltimore.
NCT05791851 is a clinical trial that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 31 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05791851 has completed, sponsored by University of Maryland, Baltimore.
- COMPLETED
- Registry status
- 31 participants
- Enrollment target
Study Summary
The goal of this natural history study is to examine the immune responses to the Heplisav-B vaccine in Veterans living with HIV who were non-responders to prior HBV vaccination. A comparison group of HBV vaccine nonresponders without HIV infection will be enrolled to characterize the HIV-associated immune alterations that affect vaccine response. The investigators hypothesize that TLR9-mediated innate immune stimulation with Heplisav will elicit HBV seroprotection despite prior vaccination failures in persons living with HIV, compared to HIV uninfected individuals. Participants eligible for Heplisav-B vaccination will be asked to provide blood samples at multiple timepoints before and after their vaccination.
Primary Outcome
Characterize the change in B cell functional responses by ELISpot on day 30 compared to baseline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2019-10-23 |
| Est. Completion | 2022-06-14 |
What the finished NCT05791851 record still lists
NCT05791851 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 31 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT05791851 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05791851 about?
NCT05791851 is a clinical study titled "Heplisav-B Revaccination for Hepatitis B Vaccine Nonresponders". The goal of this natural history study is to examine the immune responses to the Heplisav-B vaccine in Veterans living with HIV who were non-responders to prior HBV vaccination. A comparison group of HBV vaccine nonresponders without HIV infection will be enrolled to characterize the HIV-associated ...
What is the current status of trial NCT05791851?
This trial is currently completed. The enrollment target is 31 participants. The study started on 2019-10-23. Estimated completion is 2022-06-14.
Who is sponsoring clinical trial NCT05791851?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
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