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

• Sponsor: Erasmus Medical Center (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05841095
• Collaborator: ISA Pharmaceuticals B.V. (Industry)
• Enrollment: 24
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 30.1
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis b	Drug: ISA104; Drug: Placebo	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Phase I/II Study to Determine the Safety, Immunogenicity and Efficacy of the Therapeutic Hepatitis B Virus Synthetic Long Peptide Vaccination ISA104
• Anticipated Study Start Date: May 1, 2023
• Anticipated Primary Completion Date: Sep 1, 2024
• Anticipated Study Completion Date: Nov 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: ISA104	Drug: ISA104; SLP vaccine
Placebo Comparator: Placebo	Drug: Placebo; Saline solution (0.9% NaCl)

Outcome Measures

Primary Outcome Measures

1. Safety according to AEs, SAEs [6 months]

   AEs, SAEs

Secondary Outcome Measures

1. HBV specific Immunogenicity- following ISA104 vaccination [6 months]

   Number of IFN-y Elispots per well after 3 day stimulation with SLPs will correspond to immunogenicity. Elispots will be performed before (baseline) and after treatment

2. Efficacy of ISA104 vaccination by using conventional biomarkers [6 monts]

   Levels of HBsAg, HBsAb, HBeAg, HBV DNA

Other Outcome Measures

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]

   Levels of HBcrAg

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• cHBV

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

Exclusion Criteria:

• Immune-compromised

• Evidence of liver cirrhosis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Erasmus MC	Rotterdam		Netherlands

Sponsors and Collaborators

• Erasmus Medical Center
• ISA Pharmaceuticals B.V.

Investigators

• Principal Investigator: Dave Sprengers, MD, PhD, Erasmus Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dave Sprengers, Priniciple Investigator, MD PhD, Erasmus Medical Center
• ClinicalTrials.gov Identifier: NCT05841095
• Other Study ID Numbers: MEC22-0600
• First Posted: May 3, 2023
• Last Update Posted: May 3, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Dave Sprengers, Priniciple Investigator, MD PhD, Erasmus Medical Center: Immunotherapy; Therapeutic Vaccination; Hepatitis B cure
• Additional relevant MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis

Study Results

No Results Posted as of May 3, 2023