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OMNIVAX: Broadly Deployable Infection Vaccine Platform

Robust first-in-class immuno-material-based vaccine technology to create safe and effective therapeutic and prophylactic vaccines against viral and bacterial infections

Infectious diseases pose one of the greatest threats to public health, and vaccination campaigns with broad population coverage – arguably the most powerful strategy for preventing, controlling, and treating infectious diseases – have eradicated or significantly reduced the risk of contracting diseases such as smallpox, measles, polio, and tetanus. However, there is a constant need for new vaccines due to factors like rapid genetic change in bacterial and viral pathogens, the emergence of antibiotic-resistant bacterial strains, and zoonotic viruses that spontaneously jump from wildlife reservoirs to humans. The current vaccine development and manufacturing process is inadequate at addressing these significant threats to global health, the economy, and biosecurity.

OMNIVAX vaccine design

OMNIVAX: Broadly Deployable Infection Vaccine Platform
OMNIVAX vaccines can be easily injected, and generate robust and durable immune responses against pathogens without the need for frequent booster shots. Credit: Wyss Institute at Harvard University

Wyss Institute researchers have combined their multidisciplinary expertise from infectious diseases, immunology, drug delivery, materials science, and protein engineering to develop OMNIVAX, a broadly applicable infection vaccine platform with unique capabilities to help overcome these threats. The first generation of the technology was developed by Wyss Core Faculty member David Mooney and his team as a cancer vaccine, substantially derisked though a number of studies, and successfully tested in a human Phase I trial in patients with melanoma (for more details see Press and Publications below). Applied to infectious diseases, OMNIVAX (1) significantly amplifies the immunogenicity of weakly immunogenic antigens; (2) can combine multiple antigens in a single vaccination using simple modular technologies; and (3) provides prolonged antigen presentation and immune cell activation which can last years. As a result, robust and durable immune responses against pathogens can be induced without the need for frequent booster shots.

The modular OMNIVAX platform can be used to rapidly assemble a biocompatible and biodegradable immuno-material-based vaccine from three non-variable components (the base vaccine) that are combined with one or more pathogen-specific antigen(s) of choice in a simple and scalable aqueous manufacturing process. Known pathogen-derived antigens that simulate the immune system, such as surface glycoproteins from bacteria and viruses, can be easily incorporated directly into the base vaccine, which comprises the immune cell-attracting cytokine GM-CSF, and an immune cell-activating adjuvant adsorbed onto the surface of the mesoporous silica biomaterial scaffold. In addition, the OMNIVAX platform can incorporate complex antigens even from multiple antigen sources by utilizing different pathogen capture approaches, including the FcMBL pathogen capture technology developed at the Wyss Institute. OMNIVAX vaccines created with either well-defined or complex antigens increase immunogenicity, and provide safe and well-tolerated vaccination.

This video explains how OMNIVAX – an immuno-material-based vaccine technology can be used to rapidly create injectable vaccines against diverse viral and bacterial pathogens, and how the platform is used by the team to develop a vaccine against recurring urinary tract infections (UTIs) in their lead human application. Credit: Wyss Institute at Harvard University.

Programming immune action

Upon subcutaneous injection, the vaccine forms a porous scaffold that recruits dendritic cells, key immune cells that can shape entire immune responses, reprograms them to become pathogen-specific, and releases them again (R3 approach). The dendritic cells then migrate to nearby lymph nodes where they orchestrate a complex immune response encompassing antigen-directed T (cellular) and B cell (humoral) responses that can result in direct killing of the pathogen, and enable the formation of an immunological memory of the pathogen to prevent future infections.

OMNIVAX: Broadly Deployable Infection Vaccine Platform
The OMNIVAX infection vaccine approach incorporates pathogen-derived antigens into an injectable biomaterial scaffold which presents them together with immune cell attracting and activating factors to dendritic immune cells that then go on to orchestrate multi-faceted immune responses against the pathogen in nearby lymph nodes. Credit: Wyss Institute at Harvard University

Broad applications

In proof-of-concept studies, the Wyss team has designed OMNIVAX vaccines that were able to protect mice and pigs from septic shock caused by pathogenic E.coli, reduce the size and number of skin lesions caused by MRSA (methicillin-resistant Staphylococcus aureus) in mice, and created potentially effective vaccines by incorporating antigens from Human Immunodeficiency Virus (HIV), Influenza Virus A (universal influenza vaccine), and the SARS-CoV-2 coronavirus (COVID-19 vaccine). In addition, the team is pursuing vaccine approaches focused on animal diseases such as bovine tuberculosis.

As their lead human application, the Wyss researchers are currently developing a vaccine to treat recurring urinary tract infections (UTIs), which are caused by different E. coli strains, a growing number of which have become resistant to antibiotics and are thus becoming difficult to eliminate.

In response to the current COVID-19 crisis, the Wyss team is also leveraging the OMNIVAX platform to create an infection vaccine against the novel SARS-CoV-2 coronavirus. They have already begun the evaluation of several COVID-19 related proteins and components incorporated into the OMNIVAX vaccine system and is preparing for animal proof-of-concept studies.

The OMNIVAX vaccine platform has broad applicability in areas of human infection, global health and animal health, and can provide unique advantages in the creation of:

  • Prophylactic and therapeutic treatments against common bacterial and viral pathogens
  • Adaptable rapid deployment systems to confront future epidemics
  • Potential national strategies against bioterrorism threats
  • Vaccines against intractable animal diseases

The team at the Wyss institute has significantly de-risked the OMNIVAX technology, and is currently seeking venture capital investment to assist with its commercialization, and additional funding.

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