TLR-9 Adjuvanted Vaccination for Chronic Hepatitis B (BOOST-9 Trial)

Phase 1

Waitlist Available

Led By Lydia Tang, MBChB

Research Sponsored by University of Maryland, Baltimore

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first vaccine to 12 months after last vaccine on study.

Awards & highlights

No Placebo-Only Group

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.

Eligible Conditions

Hepatitis B

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first vaccine to 12 months after last vaccine on study.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first vaccine to 12 months after last vaccine on study.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first vaccine to 12 months after last vaccine on study. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Medically Attended Adverse Events

Occurrence of unsolicited adverse events

Safety and reactogenicity of the Hepatitis B Virus Surface Antigen, Recombinant (HEPLISAV-B; Dynavax Technologies Corporation) Vaccine in patients with chronic hepatitis B

Secondary study objectives

Anti-HBsAg seroconversion

B-Lymphocytes

Hepatitis B surface antigen (HBsAg) titers

+3 more

Other study objectives

Anti-HBsAg Seroconversion

Hepatitis B surface antigen-specific antibodies

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention - vaccinationExperimental Treatment1 Intervention

HEPLISAV-B is available in pre-filled, single-dose 0.5 mL vials. Each dose contains 20 μg of HBsAg and 3,000 μg of 1018 adjuvant. HEPLISAV-B is administered as an intramuscular injection in the deltoid region. Study subjects randomized to the vaccine group will receive a total of 2 injections, each administered at least 4 weeks apart - the same dosing schedule recommended for hepatitis B prevention. Once enrolled, participants will have study visits on days 0 (first injection), 14, 28, 56, and 196 with phone call follow ups on days 7, 35, and 393. Research blood samples will be collected at days 0, 14, 28, 56, 196.

Group II: No vaccinationActive Control1 Intervention

Participants randomized to the control group will have study visits on days 0, 14, 28, 56, and 196 with phone call follow ups on days 7, 35, and 393. Research blood samples will be collected at days 0, 14, 28, 56, 196.

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