NCT06513286

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

TherVacB - A Multi-center Phase 1b/2a Trial to Assess Safety, Tolerability and Immunogenicity of a Heterologous Protein Prime/MVA Boost Therapeutic Hepatitis B Vaccine Candidate

• Status: Enrolling By Invitation
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 81 (estimated)
• Sponsor: Michael Hoelscher · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is an open-label, ascending dose phase 1b/2a trial to assess the safety and immunogenicity of a heterologous protein prime/MVA boost therapeutic hepatitis B vaccine in patients with chronic HBV who are virally suppressed with oral anti-viral therapies.

Detailed description

This is a multi-centre study conducted in 81 participants. The clinical trial is divided into two overlapping parts (part A and B). All treatment groups of Part A will receive a single dose of HEPLISAV B on Day 1 and Day 29 and MVA-HBVac on Day 56. From study arm A2 on all participants also receive HBcoreAg, in a low dose in arms A2 and A3 and in a medium dose in arm A4. In arms A5 and A6 either the low or the medium dose will be applied to an extended number of participants. The MVA-HBVac booster dose will be given in a dose-escalating way with a low dose in arms A1 and A2 and a high dose in arms A3, A4, A5 and A6. The treatment group in Part B, study arm B1 will receive two doses of HEPLISAV B together with HBcoreAg in a high dose (on day 1 and 29), and a high booster dose of MVA-HBVac on day 56. In arm B2 either the regimen of B1 or A5 will be applied to an extended number of participants.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
BIOLOGICAL	TherVacB (HEPLISAV B +/- HBcoreAg + MVA-HBVac)	Administration of the described combinations via the intramuscular route
BIOLOGICAL	TherVacB (2xHEPLISAV B + HBcoreAg + MVA-HBVac)	Administration of the described combinations via the intramuscular route

Timeline

• Start date: 2025-06-12
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2024-07-22
• Last updated: 2025-07-25

Locations

6 sites across 1 country: Germany