TLR-9 Adjuvanted Vaccination for Chronic Hepatitis B
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Hepatitis B
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomized clinical trialMasking: Single (Outcomes Assessor)Masking Description: All data will be de-identified and group assignment will not be included in the data. Laboratory staff analyzing samples will be blinded as to treatment group.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This is an open-label, randomized, pilot study to assess the effect of CpG-adjuvanted vaccination among people with chronic hepatitis B. This study will evaluate the effect of CpG-adjuvanted vaccination on B-cells that produce anti-HBsAg antibody. The primary hypothesis is that TLR9 agonism with CpG...
This is an open-label, randomized, pilot study to assess the effect of CpG-adjuvanted vaccination among people with chronic hepatitis B. This study will evaluate the effect of CpG-adjuvanted vaccination on B-cells that produce anti-HBsAg antibody. The primary hypothesis is that TLR9 agonism with CpG-adjuvanted hepatitis B vaccine will increase the number of anti-HBsAg producing B-cells in people with chronic hepatitis B infection who are virally suppressed on nucleos(t)ide analogue (NUC) therapy. In this study, 40 people with chronic hepatitis B virally suppressed on NUC therapy will be randomized in a 1:1 fashion to receive an 0.5ml intramuscular injection of HEPLISAV-B vaccine - an FDA approved vaccine for preventing hepatitis B infection. Participants will receive a total of 2 injections, at day 0 and week 4. Participants will be evaluated at weeks 2, 4, 8 and 24 for adverse events, and blood sample collection to outcome evaluation.
Tracking Information
- NCT #
- NCT04843852
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Lydia Tang, MBChB University of Maryland, College Park
Get Well Soon