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Cancer Vaccine

Hepatitis B Vaccine Recombinant, Adjuvanted Intramuscular Solution [HEPLISAV-B] for 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
Willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, and other study procedures.
>18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first vaccine to 12 months after last vaccine on study.
Awards & highlights

BOOST-9 Trial Summary

This study is evaluating whether a vaccine which contains a bacterial or viral DNA may help prevent hepatitis B.

Eligible Conditions
  • Hepatitis B

BOOST-9 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

BOOST-9 Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Anti-HBsAg seroconversion
B-Lymphocytes
Hepatitis B surface antigen (HBsAg) titers
+3 more
Other outcome measures
Anti-HBsAg Seroconversion
Hepatitis B surface antigen-specific antibodies

BOOST-9 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.

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
687 Previous Clinical Trials
374,646 Total Patients Enrolled
7 Trials studying Hepatitis B
762 Patients Enrolled for Hepatitis B
Lydia Tang, MBChBPrincipal InvestigatorUniversity of Maryland, Baltimore
1 Previous Clinical Trials
550 Total Patients Enrolled
1 Trials studying Hepatitis B
550 Patients Enrolled for Hepatitis B

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
TLR-9 Adjuvanted Vaccination for Chronic Hepatitis B
Lydia Tang 2022. "TLR-9 Adjuvanted Vaccination for Chronic Hepatitis B". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04843852.
~0 spots leftby Apr 2025
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