CLINICAL TRIALS PROFILE FOR HEPATITIS B VACCINE (RECOMBINANT) ADJUVANTED
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All Clinical Trials for hepatitis b vaccine (recombinant) adjuvanted
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT01951677 ↗ | Safety and Efficacy Study of Adjuvanted Prophylactic Hepatitis B Vaccine | Completed | Flinders Medical Centre | Phase 1 | 2013-07-01 | There is a need for more effective and better-tolerated hepatitis B vaccines for low responder high-risk populations including patients with renal impairment and/or diabetes mellitus and those aged over 40 years. Several approaches are available to enhance the potency of hepatitis B virus vaccines including use of the more highly immunogenic antigens, replacing alum with potentially more effective adjuvants, and increasing the dose of vaccine antigen. A combination of these strategies is being tested in this study to identify the most promising candidate approaches to take forward into advanced clinical development |
| NCT01951677 ↗ | Safety and Efficacy Study of Adjuvanted Prophylactic Hepatitis B Vaccine | Completed | Vaxine Pty Ltd | Phase 1 | 2013-07-01 | There is a need for more effective and better-tolerated hepatitis B vaccines for low responder high-risk populations including patients with renal impairment and/or diabetes mellitus and those aged over 40 years. Several approaches are available to enhance the potency of hepatitis B virus vaccines including use of the more highly immunogenic antigens, replacing alum with potentially more effective adjuvants, and increasing the dose of vaccine antigen. A combination of these strategies is being tested in this study to identify the most promising candidate approaches to take forward into advanced clinical development |
| NCT03866187 ↗ | A Study to Evaluate the Reactogenicity, Safety, Immunogenicity and Efficacy of GlaxoSmithKline (GSK) Biologicals' HBV (Hepatitis B Virus) Viral Vector Vaccines and Adjuvanted Proteins Vaccine (GSK3528869A) in Adult Patients With Chronic Hepatitis B | Recruiting | GlaxoSmithKline | Phase 1 | 2019-03-28 | A First-Time-In-Human study on GSK's therapeutic vaccines to evaluate the reactogenicity, safety, immunogenicity and efficacy on reduction of serum HBV surface antigen in HBV suppressed subjects under nucleo(s)tide treatment. |
| NCT04684914 ↗ | HepTcell Immunotherapy in Patients With Inactive Chronic Hepatitis B (CHB) | Recruiting | Altimmune, Inc. | Phase 2 | 2020-12-26 | A study to evaluate the antiviral effects, immunogenicity, and safety of HepTcell in treatment-naive patients with inactive Chronic Hepatitis B (CHB) and low Hepatitis B surface antigen (HBsAg) levels. |
| NCT04843852 ↗ | TLR-9 Adjuvanted Vaccination for Chronic Hepatitis B | Not yet recruiting | University of Maryland, Baltimore | Phase 1 | 2021-12-01 | 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. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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