NCT05841095

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
7mo left

Started Aug 2023

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Aug 2023Mar 2027

First Submitted

Initial submission to the registry

March 27, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 3, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

August 4, 2023

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

June 12, 2026

Status Verified

August 1, 2025

Enrollment Period

3.3 years

First QC Date

March 27, 2023

Last Update Submit

June 10, 2026

Conditions

Chronic Hepatitis b

Keywords

ImmunotherapyTherapeutic VaccinationHepatitis B cure

Outcome Measures

Primary Outcomes (1)

  • Safety according to AEs, SAEs

    AEs, SAEs

    6 months

Secondary Outcomes (2)

  • HBV specific Immunogenicity- following ISA104 vaccination

    6 months

  • Efficacy of ISA104 vaccination by using conventional biomarkers

    6 monts

Other Outcomes (1)

  • To study novel HBV disease markers in the study patient population to assist with treatment decisions and/or therapy response monitoring in general

    6 months

Study Arms (2)

ISA104

ACTIVE COMPARATOR
Drug: ISA104

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

ISA104DRUG

SLP vaccine

ISA104
PlaceboDRUG

Saline solution (0.9% NaCl)

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Immune-compromised
  • Evidence of liver cirrhosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasmus MC

Rotterdam, Netherlands

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Dave Sprengers, MD, PhD

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Priniciple Investigator, MD PhD

Study Record Dates

First Submitted

March 27, 2023

First Posted

May 3, 2023

Study Start

August 4, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

June 12, 2026

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)