drugset / Trial / NCT04843852

TLR-9 Adjuvanted Vaccination for Chronic Hepatitis B

NCT04843852

Phase 1 Recruiting 10 enrolled University of Maryland, Baltimore
NaSingle-groupOpen-labelTreatment

Summary

The goal of this clinical trial is to learn if HEPLISAV-B, a vaccine that is approved to prevent hepatitis B infection in people that are not already infected, is safe in people already chronically infected with hepatitis B. The main quiestions it aims to answer are: 1. Is HEPLISAV-B safe in people with chronic hepatitis B? 2. What side effects, if any, could HEPLISAV-B cause in people with chronic hepatitis B? 3. How does HEPLISAV-B affect the cells that fight chronic hepatitis B? Participants will: * Receive HEPLISAV-B as an injection in the muscle, one injection every 4 weeks, for a total of 2 injections. * Visit the clinic a total of 5 times, and have 3 phone follow ups over 14 months. * Be asked if they are having any side effects from HEPLISAV-B. * Have blood samples collected.

Timeline

Start
2025-10-16
Primary completion
2026-10-31
Completion
2027-04-01

Drugs

EvaluationDrugModalityDoseRoute
Subject HEPLISAV-B Vaccine 0.5 ml Intramuscular