Phase I/II Study to Determine the Safety, Immunogenicity and Efficacy of the Therapeutic Hepatitis B Virus Synthetic Long Peptide Vaccination ISA104
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: f
View:
• cHBV
• Active treatment with NUCs and HBV DNA \< limit of quantification
Locations
Other Locations
Netherlands
Erasmus MC
RECRUITING
Rotterdam
Contact Information
Primary
Roel Pieterman, MD
r.pieterman@erasmusmc.nl
0107040704
Time Frame
Start Date: 2023-08-04
Estimated Completion Date: 2025-11-01
Participants
Target number of participants: 24
Treatments
Active_comparator: ISA104
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Collaborators: ISA Pharmaceuticals B.V.
Leads: Erasmus Medical Center