What the trial was testing
The trial enrolled 2,838 patients with hepatitis b. The study was sponsored by VBI Vaccines and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was a large trial designed to confirm whether the treatment works well enough for wider use. Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
90% protected after just 2 doses on the 3-antigen vaccine vs. 52%.
JAMA Network Open · 2021 · NCT03408730
These findings — that protected after 2 vaccine doses on the 3-antigen vs. single-antigen hepatitis B vaccine — were published in the JAMA Network Open and represent the headline result of the study.
Researchers tracked outcomes across 2,838 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with hepatitis b, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
PreHevbrio (the 3-antigen vaccine) is FDA-approved and available now for adults 18 and older. It works faster than the older single-antigen vaccine. Ask your primary care doctor whether you should get vaccinated, especially if you have diabetes, HIV, kidney disease, or other risk factors.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open hepatitis b trials
The Role and Regulatory Mechanism of Germinal Center Immune Response in Hepatitis B Virus Infection
The purpose of this observational study is to investigate the structure and composition of germinal centers in individuals with chronic HBV infection. The primary questions it aims to address are: What are the phenotypes, functions, and complexity of B cell clones of the immune cells within the germinal centers of chronic HBV-infected individuals? Do chronic HBV-infected individuals have ectopic germinal centers in the liver? This will be studied by collecting peripheral blood and discarded liver, lymph node, and tonsil tissues from chronic HBV patients undergoing lymph node surgery, hepatectomy, and tonsillectomy.
Acceptability and Feasibility of Simultaneous Screening for Viral Hepatitis B, C and HIV Among Drug Users and Vulnerable Populations, in Non-conventional Structures "Outside the Walls" by Dual Screening Method RTDs and FibroScan®
The "Scanvir" concept aims to achieve barriers to HCV screening and treating of marginalized patients. The concept is applicable to other various populations and territories and should effectively improve HCV patient's health outcomes. The main objective of the SCANVIR project was to evaluate the feasibility, acceptability and reproducibility of a "test, treat and cure" strategy for PWIDs and vulnerable populations during dedicated days in addiction care centers.