Study to Evaluate Induction of HBV Virus Neutralizing Antibodies Using VVX001

Summary

The Study will evaluate the effects of VVX001, a novel vaccine for hepatitis B, to * elicit a robust protective IgG immune response in vaccine naive subjects * in subjects who failed to demonstrate seroconversion after treatment with a licensed hepatitis B vaccine and * in patients chronically infected with HBV.

Timeline

Start

2018-08-06

Primary completion

2023-09-30

Completion

2023-12-31

Publications

• Background Cornelius C, Schoneweis K, Georgi F, Weber M, Niederberger V, Zieglmayer P, Niespodziana K, Trauner M, Hofer H, Urban S, Valenta R. Immunotherapy With the PreS-based Grass Pollen Allergy Vaccine BM32 Induces Antibody Responses Protecting Against Hepatitis B Infection. EBioMedicine. 2016 Sep;11:58-67. doi: 10.1016/j.ebiom.2016.07.023. Epub 2016 Aug 8.
• Background Tulaeva I, Cornelius C, Zieglmayer P, Zieglmayer R, Schmutz R, Lemell P, Weber M, Focke-Tejkl M, Karaulov A, Henning R, Valenta R. Quantification, epitope mapping and genotype cross-reactivity of hepatitis B preS-specific antibodies in subjects vaccinated with different dosage regimens of BM32. EBioMedicine. 2020 Sep;59:102953. doi: 10.1016/j.ebiom.2020.102953. Epub 2020 Aug 24.

Drugs

Indications