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NCT04843852Not yet recruiting

TLR-9 Adjuvanted Vaccination for Chronic Hepatitis B

Augmentation of Humoral Immunity Using Toll-Like Receptor (TLR) 9 Adjuvanted HBV Surface Antigen to Enhance Anti-HBSAg Response
University of Maryland, BaltimorePhase 1ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Hepatitis B
Drug/Device/Intervention
Hepatitis B Vaccine Recombinant, Adjuvanted Intramuscular Solution [HEPLISAV-B]
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
University of Maryland, Baltimore
Location
Baltimore,Falls Church, United States of America
Timeline & enrollment
Phase
Phase 1
Start date
Jul 01, 2022
End date
Jul 01, 2024
Enrollment
40 participants
Primary outcome

Safety and reactogenicity of the Hepatitis B Virus Surface Antigen, Recombinant (HEPLISAV-B; Dynavax Technologies Corporation) Vaccine in patients with chronic hepatitis B,Occurrence of unsolicited adverse events,Medically Attended Adverse Events

Summary

Unmethylated cystine-guanosine dinucleotide (CpG) motifs are pathogen-associated molecular
 patterns (PAMPs) associated with bacterial and viral-derived DNA that activate the innate and
 humoral immunity via toll-like receptor 9. This is a randomized controlled pilot study
 evaluating the clinical and immune correlates of a seroprotective immune response against a
 CpG-adjuvanted vaccine for hepatitis B.

ICD-10 classifications
Acute hepatitis BAcute hepatitis B without delta-agent and without hepatic comaAcute delta-(super)infection in chronic hepatitis BChronic viral hepatitis B without delta-agentChronic viral hepatitis B without delta-agent : other and unspecified phase
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT04843852
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT04843852 through Pure Global AI's free database. This Phase 1 trial is sponsored by University of Maryland, Baltimore and is currently Not yet recruiting. The study focuses on Hepatitis B. Target enrollment is 40 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.