NUCLEIC ACID VACCINES

Smart overview of the Invention

The patent application discusses the development of nucleic acid vaccines (NAVs), specifically focusing on ribonucleic acid (RNA) vaccines, including mRNA vaccines. These vaccines aim to provide protection against a wide range of infectious agents, such as viruses, bacteria, fungi, protozoa, and parasites. The invention outlines compositions, methods, processes, kits, and devices that facilitate the selection, design, preparation, manufacture, formulation, and use of these vaccines.

Background

Vaccination is a crucial method for preventing infectious diseases like influenza, AIDS, hepatitis virus infection, cholera, malaria, and tuberculosis. Traditional vaccines often involve weakened or inactivated forms of pathogens to stimulate the immune system. However, challenges such as the lengthy production process and the rapid mutation of pathogens necessitate new approaches. Nucleic acid vaccines offer potential solutions by encoding antigens directly within polynucleotide molecules.

Compositions and Methods

The invention describes pharmaceutical compositions containing nucleic acid vaccines that encode wild type or engineered proteins. These NAVs can include chemically modified RNA molecules designed to elicit an immune response. The RNA sequences can be optimized for better expression of antigenic polypeptides derived from various infectious agents.

Formulation Details

The patent specifies formulations involving cationic lipid nanoparticles that encapsulate RNA polynucleotides. These nanoparticles are composed of specific ratios of cationic lipids, PEG-modified lipids, sterols, and non-cationic lipids. The formulations aim to enhance the delivery and stability of the vaccine components. Various embodiments detail different molar ratios and lipid compositions tailored for effective vaccine delivery.

Applications

The described NAVs target a broad spectrum of infectious agents, including numerous viral strains such as influenza virus and Human Immunodeficiency Virus (HIV). The invention provides a versatile platform for developing vaccines against rapidly evolving pathogens by encoding multiple antigenic polypeptides within RNA sequences. This approach aims to overcome limitations of traditional vaccines in terms of speed and breadth of protection.