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
Study of GST-HG131&141 Tablets Compared With Placebo in Patients With Chronic Hepatitis B
A randomized, double-blind, placebo-controlled Phase IIa clinical study to evaluate the safety and efficacy of GST-HG131/GST-HG141 tablets in patients with chronic hepatitis B
Decentralization of Hepatitis B Care in Sub-Saharan Africa: a Pilot Program in Ethiopia
The goal of this observational study is to study models of care for decentralized hepatitis B treatment in Ethiopia. Three different models of decentralized HBV care (standard model, simplified model, test-and-treat model) will be implemented at primary hospitals or health clinics in Ethiopia. Treatment will be given for free to patients who meet the treatment criteria. We will compare clinical outcome, laboratory outcomes and programmatic outcome measures between the 3 models.