Chronic Hepatitis b
Conditions
Keywords
Immunotherapy, Therapeutic Vaccination, Hepatitis B cure
Brief summary
The goal of this clinical trial is to test ISA104 in patients with chronic hepatitis B. The main question\[s\] it aims to answer are: * How safe is ISA104? * Does ISA104 induce immunity against hepatitis B virus? Different doses of the vaccine ISA104 will be administered to participants. These participants are chronic HBV patients being actively treated with antiviral drugs. Researchers will compare the ISA104 vaccine to a placebo.
Interventions
DRUGISA104
SLP vaccine
DRUGPlacebo
Saline solution (0.9% NaCl)
Sponsors
ISA Pharmaceuticals B.V.
Erasmus Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* cHBV * Active treatment with NUCs and HBV DNA \< limit of quantification
Exclusion criteria
* Immune-compromised * Evidence of liver cirrhosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety according to AEs, SAEs | 6 months | AEs, SAEs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HBV specific Immunogenicity- following ISA104 vaccination | 6 months | Number of IFN-y Elispots per well after 3 day stimulation with SLPs will correspond to immunogenicity. Elispots will be performed before (baseline) and after treatment |
| Efficacy of ISA104 vaccination by using conventional biomarkers | 6 monts | Levels of HBsAg, HBsAb, HBeAg, HBV DNA |
Countries
Netherlands
Contacts
PRINCIPAL_INVESTIGATORDave Sprengers, MD, PhD
Erasmus Medical Center
Outcome results
None listed