A Heterologous Protein Prime/MVA Boost Therapeutic Hepatitis B Vaccine Candidate

Phase 1

Recruiting

• Conditions: Chronic Hepatitis B
• Interventions: Biological: TherVacB; Biological: HEPLISAV B; TherVacB

• Registration Number: NCT05727267
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief Summary

This study is an open-label, ascending dose phase 1a trial to assess the safety and immunogenicity of a heterologous protein prime/MVA boost therapeutic hepatitis B vaccine

Detailed Description

The clinical trial is divided into two overlapping parts (part I and part II) in 24 healthy male and female subjects aged 18-65 years.

Part I (N = 11) Protein prime vaccinations two times (day 0 and 28) and MVA based boost vaccination 1 x (day 56) 3 subjects will be allocated to A0 and receive HEPLISAV B® and a boost with MVA-HBVac high dose 3 subjects will be allocated to B0.1 and receive HEPLISAV B® \& HBcoreAg low dose and a boost with MVA-HBVac low dose 5 subjects will be allocated to B0.2 and receive 2 x HEPLISAV B® \& HBcoreAg medium dose and a boost with MVA-HBVac high dose Part II (N = 13) Protein prime vaccinations two times (day 0 and 28) and MVA based boost with MVA-HBVac high dose on day 56 3 subjects will be allocated to C0.1 and receive HBsAg high dose \& HBcoreAg high dose plus boost 5 subjects will be allocated to C0.2 and receive HBsAg medium dose + adjuvant low dose \& HBcoreAg medium dose plus boost 5 subjects will be allocated to C0.3 and receive HBsAg high dose + adjuvant \&HBcoreAg high dose plus boost

Study Timeline

• Study First Submitted: 2022-11-06
• Study First Submitted QC: 2023-02-03
• Study First Posted: 2023-02-14
• Study Start: 2024-01-23
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-21
• Last Update Posted: 2025-04-24
• Primary Completion: 2026-02
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm C0.1	TherVacB	HBsAg high dose \& HBcoreAg high dose and MVA-HBVac high dose
Arm C0.3	TherVacB	HBsAg high dose + adjuvant high dose \& HBcoreAg high dose and MVA-HBVac high dose
Arm A0	HEPLISAV B; TherVacB	HEPLISAV B® and MVA-HBVac high dose
Arm B0.1	HEPLISAV B; TherVacB	HEPLISAV B® \& HBcoreAg low dose and MVA-HBVac low dose
Arm B0.2	HEPLISAV B; TherVacB	2 x HEPLISAV B® \& HBcoreAg medium and MVA-HBVac high dose
Arm C0.2	TherVacB	HBsAg medium dose + adjuvant low dose \& HBcoreAg medium dose and MVA-HBVac high dose
Arm A0	HEPLISAV B; TherVacB	HEPLISAV B® and MVA-HBVac high dose
Arm B0.1	HEPLISAV B; TherVacB	HEPLISAV B® \& HBcoreAg low dose and MVA-HBVac low dose
Arm B0.2	HEPLISAV B; TherVacB	2 x HEPLISAV B® \& HBcoreAg medium and MVA-HBVac high dose
Arm C0.1	TherVacB	HBsAg high dose \& HBcoreAg high dose and MVA-HBVac high dose
Arm C0.2	TherVacB	HBsAg medium dose + adjuvant low dose \& HBcoreAg medium dose and MVA-HBVac high dose
Arm C0.3	TherVacB	HBsAg high dose + adjuvant \& HBcoreAg high dose and MVA-HBVac high dose

Primary Outcome Measures

Name	Time	Method
occurence of unsolicited local reactogenicity signs and symptoms	up to day 84	numbers of of unsolicited AEs for 28 days after each vaccination
nature, frequency and severity of adverse events associated with the vaccine	up to day 224	numbers and severity grade of SAEs throughout the period of the clinical trial
changes of safety laboratory measures	up to day 224	changes of values from safety laboratory measures from baseline
occurence of solicited local reactogenicity signs and symptoms (AEs)	up to day 63	numerbers of solicited AEs for 7 days after each vaccination

Secondary Outcome Measures

Name	Time	Method
Percentage of participants who seroconvert to anti-HBs (>10 IU/l), anti-HBc or anti-HBs and anti-HBc	day 0,day 7,day 28,day 35,day 56,day 63,day 70,day 84,day 224	determined by an accredited serological immuno-assay
Magnitude of HBV-specific T-cell responses	day 0,day 7,day 28,day 35,day 56,day 63,day 70,day 84,day 224	determined by cytokine release assays
Magnitude of anti-HBs antibody responses	day 0,day 7,day 28,day 35,day 56,day 63,day 70,day 84,day 224	determined by an accredited serological immuno-assay

Trial Locations

Locations (2)

Division of Infectious Diseases and Tropical Medicine, LMU Klinikum; 🇩🇪 Munich, Germany

Bernhard Nocht Centre for Clinical Trials (BNCCT); 🇩🇪 Hamburg, Germany