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RECRUITING
NCT04843852
PHASE1

TLR-9 Adjuvanted Vaccination for Chronic Hepatitis B

Sponsor: University of Maryland, Baltimore

View on ClinicalTrials.gov

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.

Official title: Augmentation of Humoral Immunity Using Toll-Like Receptor (TLR) 9 Adjuvanted HBV Surface Antigen to Enhance Anti-HBSAg Response

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2025-10-16

Completion Date

2027-04-01

Last Updated

2025-10-20

Healthy Volunteers

No

Interventions

DRUG

Hepatitis B Vaccine Recombinant, Adjuvanted Intramuscular Solution [HEPLISAV-B]

one 0.5ml intramuscular injection on day 0 and week 4.

Locations (1)

Institute of Human Virology, University of Maryland School of Medicine

Baltimore, Maryland, United States