Evaluation of the Novel Therapeutic Hepatitis B Virus Synthetic Long Peptide Vaccination ISA104 (HEB-PEP)

Erasmus University

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Chronic Hepatitis b

Treatments: Drug: ISA104; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05841095

MEC22-0600

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• cHBV
• Active treatment with NUCs and HBV DNA < limit of quantification

Exclusion criteria

• Immune-compromised
• Evidence of liver cirrhosis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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24 participants in 2 patient groups, including a placebo group

ISA104

Active Comparator group

Treatment:

Drug: ISA104

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo