NCT03625934

Study to Evaluate Induction of HBV Virus Neutralizing Antibodies Using VVX001

Study to Evaluate the Induction of HBV Virus Neutralizing Antibodies in Healthy Vaccine Naive Adults and Non-responders and in Patients Chronically Infected With HBV Using VVX001

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Viravaxx AG · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed description

VVX001 is a recombinant fusion Protein composed of PreS from the large surface antigen of HBV and Peptides derived from the grass pollen allergen Phl p 5. In a previous trial in allergic but otherwise healthy subjects the product has been shown to elicit a potent IgG response to the epitope of PreS1, which is responsible for binding to the cellular receptor NTCP. These antibodies prevent infection with HBV in a cell culture model. The present study will evaluate if such an immune response can also be achieved in four different patient populations: 1) vaccine naive subjects; 2) subjects having failed to seroconvert upon vaccination with a licensed HBV vaccine; 3) patients who are chronically infected with HBV, but are classified as inactive carriers; 4) patients with active chronic HBV infection who are HbEAg negative and chronically treated with nucleo(t)side (NUC) antiviral drugs. All subjects will receive 5 s.c. injections of VVX001, the time course of antibody response to PreS1 will be monitored in all of them. In cohort 4) NUC treatment will be withdrawn at different timepoints during the study and the effect of treatment with VVX001 on hepatitis B disease Parameters will be monitored. Subjects will be followed for 6 months after the of treatment for Evaluation of a long-term effect.

Conditions

• Hepatitis B

Interventions

Type	Name	Description
BIOLOGICAL	VVX001	5 s.c. injections of 20 micrograms of VVX001 four weeks apart
BIOLOGICAL	Placebo	5 s.c. injections of matching Placebo four weeks apart

Timeline

• Start date: 2018-08-06
• Primary completion: 2023-09-30
• Completion: 2023-12-31
• First posted: 2018-08-10
• Last updated: 2021-04-06

Locations

2 sites across 1 country: Austria