Study to Evaluate Induction of HBV Virus Neutralizing Antibodies Using VVX001

NCT03625934 | Unknown Phase 2 DMC

• 1 other identifier: VVX001-CS001
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 2

Brief 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

Hepatitis B

Outcome Measures

Primary Outcomes (1)

• PreS specific IgG antibodies

  Titer of PreS specific IgG antibodies

  4 weeks after the last injection of study drug

Secondary Outcomes (7)

• PreS specific IgG, IgG1 and IgG4 antibodies

  4 weeks and 6 months after the last injection of study drug

• HbSAg specific antibodies

  4 weeks and 6 months after the last injection of study drug

• Suppression of HBV infection

  4 weeks and 6 months after the last injection of study drug

• T cell proliferation

  4 weeks and 6 months after the last injection of study drug

• HbSAg titers

  4 weeks and 6 months after the last injection of study drug

Other Outcomes (1)

• Adverse events

  up to 52 weeks

Study Arms (2)

VVX001 (20 micrograms)

EXPERIMENTAL

Subjects will receive 5 injections of 20 micrograms each over a period of 4 months

Biological: VVX001

Placebo

PLACEBO COMPARATOR

Subjects will receive 5 s.c. injections of matching placebo over a period of 4 months

Biological: Placebo

Interventions

VVX001 BIOLOGICAL

5 s.c. injections of 20 micrograms of VVX001 four weeks apart

VVX001 (20 micrograms)

Placebo BIOLOGICAL

5 s.c. injections of matching Placebo four weeks apart

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Cohort 1: hepatits B vaccine naive subjects Seronegative for anti-HBs and anti-HBc antibodies and for HBs Antigen
• Cohort 2: Subjects who failed to develop a protective immune response upon standard vaccination with a licensed hepatitis B vaccine (\<10 IU/L anti HbS antibodies) Seronegative for anti-HbS (\<10 IU/L) and anti-HBc antibodies and for HbSAg
• Cohort 3: Parameters confirmed at screening during the past 12 months
• HBeAg negative;
• HbSAg positive at screening \<3000 IU/ml;
• HBV viral load \<2000 IU/ml
• ALT Levels ≤ULN at screening
• Cohort 4a: Parameters confirmed at screening during the last 12 months
• HBeAg negative;
• HbSAg positive \<1000 IU/ml
• HBV DNA not detectable for at least 2 years
• History of nucleos(t)die Treatment for at least 3 years
• Willingness to discontinue NUC treatment during study
• ALT levels ≤ULN at screening
• Cohort 4b: in addition to cohort 4a:

You may not qualify if:

• Pregnant or breast-feeding females, adequate contraception required during the treatment phase
• History of grass pollen allergy
• Co-infection with HCV, HDV, HIV
• History of auto-immune hepatitis
• Elevated Levels of Alpha-Fetoprotein (AFP) \>100 ng/ml
• Documented history of decompensated liver disease (albumin \<3.5 g/dl and bilirubin \>1.3 mg/dl)
• Autoimmune disorders, transplant recipients, use of immunosuppressive or immune modulating agents
• Oral corticosteroids of 20 mg/week within the past 4 weeks prior to screening
• History of treatment with PEG-IFN of IFN for at least 1 year prior to screening
• History of evidence or conditions associated with chronic liver disease
• Acute fever at time of enrolment
• History of alcohol abuse
• Planned administration of a vaccine not foreseen by study protocol in the period starting 30 days before first product administration and during the entire study period with exception of influenza vaccine
• History of Cancer
• Other severe co-morbid conditions and concurrent medication making the subject unsuitable for participation

Sponsors & Collaborators

• Viravaxx AG: lead
• Gouya Insights: collaborator
• KKS MedUni Vienna: collaborator

Study Sites (2)

Medical University of Graz

Graz, 8036, Austria

RECRUITING

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

Related Publications (2)

• 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.

  PMID: 27568223 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.

  PMID: 32855110 BACKGROUND

Related Links

• Sponsor website

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Petra Munda, MD

  Medical University Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Helmut Brunar, PhD

CONTACT

+43 664 415 9511; h.brunar@viravaxx.com

Ghazaleh Gouya, MD

CONTACT

+43 650 470 4206; gouya@gouya-insights.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: August 10, 2018
• Study Start: August 6, 2018
• Primary Completion: September 30, 2023
• Study Completion: December 31, 2023
• Last Updated: April 6, 2021

Record last verified: 2021-04

Locations

AU (2)