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TLR-9 Adjuvanted Vaccination for Chronic Hepatitis B

NCT04843852 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-10-20

No results posted yet for this study

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.

Conditions

Interventions

DRUG

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

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

Sponsors & Collaborators

  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • Lydia Tang, MBChB · University of Maryland, Baltimore

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-16
Primary Completion
2026-10-31
Completion
2027-04-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04843852 on ClinicalTrials.gov