Hepatitis B Vaccine
Key Hepatitis B Facts
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.
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, 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 who are chronically infected with HBV, but are classified as inactive carriers
- Cohort 4: patients with active chronic HBV infection chronically treated with NUCs
To date, cohort 1 (n=12) and cohort 3 (n=12) have been completed.
- 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). 59: 102953; 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). 11: 5-6; doi: 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). 11: 58-67; https://pubmed.ncbi.nlm.nih.gov/27568223/
As a result of research funded by the Austrian Science Fund (FWF), the company currently investigates several RSV candidate vaccine constructs in immunological testing experiments. Contact Viravaxx for business development inquiries at firstname.lastname@example.org.
- 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 response. Scientific Reports (2021). Vol 11, 3551; 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). 8(2):337; https://doi.org/10.3390/vaccines8020337.
Viracaxx recently succeeded in defining binding sites for human rhinovirus by use of neutralizing antisera. Viravaxx is open to discuss its intellectual property base with interested companies. Contact Viravaxx for business development inquiries at email@example.com.
- 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). 8(2): 315; 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). 37(21): 2805-2813; https://doi.org/10.1016/j.vaccine.2019.04.018.
Viravaxx’ SARS-CoV-2 antibody test elicits if a COVID-19 convalescent patient or vaccinated person has developed neutralizing antibodies which block the interaction of RBD with ACE2. We used our proprietary assay to analyze serum samples from patients who recovered from COVID-19. The findings helped us to understand the requirements for a vaccine to induce “sterilizing immunity”. This is of utmost importance since a significant percentage of COVID-19 convalescent patients do not produce antibodies capable of completely blocking RBD binding to the receptor protein ACE2. Our pre-clinical data suggest that Viravaxx’ vaccine candidate is able to induce sterilizing immunity also in those patients who develop RBD-ACE2 blocking antibodies with only suboptimal capacity.
- 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). 00:1-6; https://doi.org/10.1111/all.14523.