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Evaluation of the Novel Therapeutic Hepatitis B Virus Synthetic Long Peptide Vaccination ISA104

RECRUITINGPhase 1/2Sponsored by Erasmus Medical Center
Actively Recruiting
PhasePhase 1/2
SponsorErasmus Medical Center
Started2023-08-04
Est. completion2024-09-01
Eligibility
Age18 Years – 55 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT05841095

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

Age: 18 Years – 55 YearsHealthy volunteers accepted
Inclusion Criteria:

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

Exclusion Criteria:

* Immune-compromised
* Evidence of liver cirrhosis

Conditions2

Chronic Hepatitis bLiver Disease

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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