What the trial was testing
The trial enrolled 223 patients with hepatitis b. The study was sponsored by Duke University and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was long-term safety (phase 4). 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
One in four vaccinated babies had a brief breathing pause, but none required serious medical help.
JAMA pediatrics · 2025 · NCT03530124
These findings — that had a brief breathing pause in the 48 hours after their 2-month vaccines — were published in the JAMA pediatrics and represent the headline result of the study.
Researchers tracked outcomes across 223 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 your premature baby is still in the hospital at two months, their breathing might pause briefly after vaccines — but this study found no serious problems. The pauses were short and didn't need extra treatment. Doctors say the vaccines are still safe and important for preemies. Talk to your care team about what to watch for after shots.
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
A Study to Evaluate Performance, Usability, and Contrived Result Interpretation of TruPlex HIV/HepB/Syphilis Rapid Test
The objectives of this study are as follows: To evaluate the clinical performance of the TruPlex test using capillary blood, EDTA whole blood, EDTA plasma, and SST serum samples collected by trained operators in point-of-care settings To evaluate the usability of the TruPlex test through: Structured usability assessments, via a questionnaire, completed by trained operators in point-of-care settings. To assess user interpretation accuracy through a contrived result interpretation questionnaire, where intended users evaluate a set of pre-defined test results (e.g., strong/weak positives, negatives, invalids). To monitor test system reliability, including invalid rates.
Phase 1 Study to Evaluate Safety and Antiviral Activity of PBGENE-HBV in Adult Patients With Chronic Hepatitis B
This is a Phase 1, open-label, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, and antiviral activity of PBGENE-HBV in adult participants with chronic hepatitis B.