Vaccine Program

Hepatitis B Vaccine

Key Facts on Hepatitis B

Hepatitis B virus (HBV) is a DNA virus that infects liver cells and can become chronic if the immune system is not able to clear the virus after an acute infection. Patients with chronic HBV infections, cannot be cured and have an elevated risk of developing liver cirrhosis and hepatocellular carcinoma.

Approved therapies for treatment of chronic HBV include interferons and nucleoside analogues (NUCs). These only treat symptoms but cannot cure the infection. Around 450 million people worldwide live with chronic HBV, with close to 1 million deaths due to HBV-related illnesses per year.

 

The Viravaxx VVX001 Study

Viravaxx’ lead product is VVX001, a clinical phase II (NCT03625934) candidate for Hepatitis B therapeutic vaccination. VVX001 is a recombinant fusion protein composed of PreS from the large surface antigen of HBV and synthetic peptides.

In its ongoing double-blind, placebo-controlled phase II study (n=84), Viravaxx studies if VVX001 vaccination induces a preS-specific antibody response in vaccine naïve adults and in patients chronically infected with HBV. 

  • Cohort 1: vaccine naïve subjects.
  • Cohort 2: subjects having failed to seroconvert upon vaccination with a licensed HBV vaccine.
  • Cohort 3: patients (HBeAg negative; HbSAg positive <3000 IU/ml) who are chronically infected with HBV, but are classified as inactive carriers.
  • Cohort 4: patients (HBeAg negative; HbSAg positive <1000 IU/ml) with active chronic HBV infection chronically treated with NUCs.

Note: cohort 4 is divided in sub-cohorts 4a and 4b relative to the timing of NUC cessation in this study arm. Recruitment of cohort 4a is completed. Recruitment of cohort 4b has started. Cohort 1 (n=12) and cohort 3 (n=12) have been completed.

 

Background publications

  • Steindl-Munda P.E., Tulaeva I, Aberle JH, Kozbial K, Holzmann H, Wiedermann-Schmidt U, Brunar H, Trauner M.H., Valenta R, Ferenci P. VVX001 induces robust preS-specific immunity in patients chronically infected with hepatitis B. Abstract submitted for publication at the AASLD conference (Nov. 2021).
  • 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). https://doi.org/10.1016/j.ebiom.2020.102953.
  • Gerlich WH and Glebe D. Development of an Allergy Immunotherapy Leads to a New Type of Hepatitis B Vaccine. EBioMedicine (2016)https://dx.doi.org/10.1016%2Fj.ebiom.2016.07.032.
  • Cornelius C, Schöneweis 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). https://pubmed.ncbi.nlm.nih.gov/27568223/.

 

 

Viravaxx also advances in basic- & translational research activities which may result into vaccine candidates at later development stage:

SARS-CoV-2 Vaccine

As a result of research funded by Viravaxx, MedUni Vienna recently published important advances regarding the characteristics of a protective antibody response, and demonstrates how it can be induced by vaccination in experimental animals (Allergy, 2021, in press).

Background publications:

  • Gattinger P, Niespodziana K, Stiasny K, Sahanic S, Tulaeva I, Borochova K, Dorofeeva Y, Schlederer T, Löffler-Ragg J, Sonnweber T, Hofer G, Kiss R, Kratzer B, Trapin D, Tauberg P.A., Rottalg A, Körmöczig U, Feichterg M, Weber M, Focke-Tejkl M, Mühl B, Kropfmüller A, Keller W, Stolz F, Henning R, Tancevski I, Puchhammer-Stöckl E, Pickl FW, Valenta R. Neutralization of SARS-CoV-2 requires antibodies against conformational receptor-binding domain epitopes. Allergy (2021). https://doi.org/10.1111/all.15066

  • Gattinger P, Borochova K, Dorofeeva Y, Henning R, Kiss R, Kratzer B, Mühl B, Perkmann T, Trapin D, Trella M, Ettel P, Tulaeva I, Pickl W, Valenta R. Antibodies in serum of convalescent patients following mild COVID‐19 do not always prevent virus‐receptor binding. Allergy (2020)https://doi.org/10.1111/all.14523.

RSV Vaccine

As part of Viravaxx-funded research, MedUni Vienna currently investigates several RSV candidate vaccine constructs in immunological testing experiments. Contact Viravaxx for business development inquiries at info@viravaxx.com.

Background publications:

  • Borochova K, Niespodziana K, Focke-Tejkl M, Hofer G, Keller W, Valenta R. Dissociation of the respiratory syncytial virus F protein-specific human IgG, IgA and IgM responseScientific Reports (2021). https://www.nature.com/articles/s41598-021-82893-y.
  • Borochova K, Niespodziana K, Stenberg Hammar K, van Hage M, Hedlin G, Söderhäll C, Focke-Tejkl M, Valenta R. Features of the Human Antibody Response against Respiratory Syncytial Virus Surface Glycoprotein G. Vaccines (2020). https://doi.org/10.3390/vaccines8020337.

HRV Vaccine

As part of Viravaxx-funded research, MedUni Vienna succeded in defining binding sites for human rhinovirus by use of neutralizing antisera. Contact Viravaxx for business development inquiries at info@viravaxx.com

Background publications:

  • Pazderova P, Waltl EE, Niederberger-Leppin V, Flicker S, Valenta R, Niespodziana K. ELISA-Based Assay for Studying Major and Minor Group Rhinovirus-Receptor Interactions. Vaccines (2020). https://doi.org/10.3390/vaccines8020315.
  • Sam Narean J, Glanville N, Nunn CM, Niespodziana K, Valenta R, Johnston SL, McLean GR. Epitope mapping of antibodies induced with a conserved rhinovirus protein generating protective anti-rhinovirus immunity. Vaccine (2019). https://doi.org/10.1016/j.vaccine.2019.04.018.