What the trial was testing
The BEE-HIVE enrolled 638 patients with hepatitis b. The study was sponsored by National Institute of Allergy and Infectious Diseases (NIAID) 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
93% of people with HIV who failed standard hepatitis B vaccine responded to just two doses of the new vaccine.
JAMA · 2025 · NCT04193189
These findings — that people with HIV who failed standard hep B vaccine responded to the newer vaccine — were published in the JAMA and represent the headline result of the study.
Researchers tracked outcomes across 638 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
If you have HIV and didn't respond to hepatitis B vaccine before, this newer vaccine is FDA-approved and widely available. Talk to your doctor about getting revaccinated — you may only need two shots instead of three, and it's much more likely to protect you from hepatitis B this time.
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
Non-interventional Study to Assess the Number of People With Untreated/Unknown HBV + HDV and HCV in South-East Austria
The HEAL-S study is a non-interventional study with retrospective data analysis. It consists of two parts. First a retrospective analysis based on nucleic acid testing (NAT) results will be performed. Two cohorts (HCV) and (HBV) will be established. Patients falling into one (or both) of the two cohorts will be invited to a prospective linkage-to-care study. In this part, patients are invited to the clinic, where the possibility of hepatitis treatment will be discussed.
Immune Dynamics in the Natural History of Chronic HBV Infection
The purpose of this observational study is to follow up on chronic HBV-infected patients over a long period of time to understand the changes in the immune status as age increases and the natural history of chronic HBV infection progresses. The main questions it aims to answer are: * Does the natural history of chronic HBV infection progress with changes in HBV-specific immunity? * What is the role of age in the natural history of chronic HBV infection? Patients with chronic HBV infection who are untreated and aged 1-80 years will be followed up every six months. During each follow-up, HBV-related serological and virological indicators will be tested. Peripheral blood samples will also be collected to test HBV-specific immunity and the immune environment.