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

Chronic Hepatitis B Clinical Trial

Official title:
TherVacB_Phase1a: Open Phase 1a Trial to Assess the Safety and Immunogenicity of a Heterologous Protein Prime/MVA Boost Therapeutic Hepatitis B Vaccine Candidate in Healthy Volunteers

Clinical Trial 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

Clinical Trial 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 high dose &HBcoreAg high dose plus boost ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05727267
Study type Interventional
Source Universitätsklinikum Hamburg-Eppendorf
Contact Marylyn M Addo, Prof
Phone +49 40 7410 51102
Email sekretariataddo@uke.de
Status Recruiting
Phase Phase 1
Start date January 23, 2024
Completion date August 2025
View Details
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