Study to Evaluate Induction of HBV Virus Neutralizing Antibodies Using VVX001
NCT03625934 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 84
Last updated 2021-04-06
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.
Conditions
Interventions
- BIOLOGICAL
-
VVX001
5 s.c. injections of 20 micrograms of VVX001 four weeks apart
- BIOLOGICAL
-
5 s.c. injections of matching Placebo four weeks apart
Sponsors & Collaborators
-
Gouya Insights
collaborator UNKNOWN -
KKS MedUni Vienna
collaborator UNKNOWN -
Viravaxx AG
lead INDUSTRY
Principal Investigators
-
Petra Munda, MD · Medical University Vienna
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-08-06
- Primary Completion
- 2023-09-30
- Completion
- 2023-12-31
Countries
- Austria
Study Locations
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