Testing a new vaccine for chronic hepatitis B
Phase I/II Study to Determine the Safety, Immunogenicity and Efficacy of the Therapeutic Hepatitis B Virus Synthetic Long Peptide Vaccination ISA104
PHASE1; PHASE2 · Erasmus Medical Center · NCT05841095
This study is testing a new vaccine for chronic hepatitis B to see if it can help boost the immune response in patients already receiving antiviral treatment.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Erasmus Medical Center (other) |
| Locations | 1 site (Rotterdam) |
| Trial ID | NCT05841095 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and immune response of a novel synthetic long peptide vaccine, ISA104, in patients with chronic hepatitis B. Participants receiving antiviral treatment will be administered different doses of ISA104, while a control group will receive a placebo. The study aims to determine how well ISA104 induces immunity against the hepatitis B virus and its overall safety profile.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with chronic hepatitis B who are currently undergoing antiviral treatment.
Not a fit: Patients who are immunocompromised or have evidence of liver cirrhosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this vaccine could provide a new therapeutic option for patients with chronic hepatitis B, potentially leading to improved immune responses and better management of the disease.
How similar studies have performed: Other studies have explored therapeutic vaccines for hepatitis B, showing promise, but this specific approach with ISA104 is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * cHBV * Active treatment with NUCs and HBV DNA \< limit of quantification Exclusion Criteria: * Immune-compromised * Evidence of liver cirrhosis
Where this trial is running
Rotterdam
- Erasmus MC — Rotterdam, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Dave Sprengers, MD, PhD — Erasmus Medical Center
- Study coordinator: Roel Pieterman, MD
- Email: r.pieterman@erasmusmc.nl
- Phone: 0107040704
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Hepatitis b, Immunotherapy, Therapeutic Vaccination, Hepatitis B cure