The invention provides a composition useful to prepare high titer influenza B viruses, e.g., in the absence of helper virus, which includes internal genes from an influenza B virus vaccine strain or isolate, e.g., one that is safe in humans, for instance, one that does not result in significant disease, that confer enhanced growth in cells in culture, such as MDCK cells, or in eggs.

The invention provides a composition useful to prepare high titer influenza B viruses, e.g., in the absence of helper virus, which includes internal genes from an influenza B virus vaccine strain or isolate, e.g., one that is safe in humans, for instance, one that does not result in significant disease, that confer enhanced growth in cells in culture, such as MDCK cells, or in eggs.

The present invention relates to a pharmaceutical composition comprising a modified mRNA that is stabilised by sequence modifications and optimised for translation. The pharmaceutical composition according to the invention is particularly well suited for use as an inoculating agent, as well as a therapeutic agent for tissue regeneration. In addition, a process is described for determining sequence modifications that promote stabilisation and translational efficiency of modified mRNA of the invention.

Provided are methods for reducing the risk of occurrence and/or the severity of transaminitis in a subject that is receiving a gene therapy.

The present invention provides, among other things, a novel and improved method for generating “mosaic” influenza antigenic polypeptides including hemagglutinin (HA) and neuraminidase (NA) polypeptides based on unique combination of epitope patterns that maximize exposure to epitopes present across multiple HA or NA sequences and therefore improved influenza strain coverage. In particular, the present invention provides engineered H1N1 influenza hemagglutinin (HA) polypeptides that are comprised of novel combinations of protective epitopes and antigenic regions from multiple H1N1 viral strains. Such engineered HA polypeptides have improved properties over HA polypeptides developed through conventional approaches that rely on consensus alignments of viral sequences.

Novel nanoparticle fusion proteins comprising proteins or peptides fused to Dps (DNA binding protein from starved cells) proteins are provided which bring forth distinct advantages for development of new and improved vaccines, diagnostic tests, and other biomedical products.

The present invention relates to a nucleic acid construct, a recombinant multiply-defective influenza virus, that promotes expression of an immunomodulatory protein in a host. This is applicable to the development of vaccines against infectious diseases, particularly those caused by influenza virus and Coronavirus.

Therapeutic or prophylactic compositions providing an active agent, such as an antigen or a vector that contains and expresses an antigen, encapsulated in or incorporated into a biodegradable polymeric particle are provided. The compositions can also provide an active agent that is not encapsulated in or incorporated into the biodegradable polymeric particle in order to provide an initial or prime delivery of the active agent. Particles or composites providing an active agent encapsulated by a first and second polymer are also provided, wherein polymers are distributed in a gradient from a core of the composite to a surface of the composite, and configured to provide a delayed release of the active agent by a period of 7 days to 6 months. Methods of producing composites are also provided. Pharmaceutical formulations providing a single dose composition are also provided, along with methods for administering the pharmaceutical compositions to a subject in need thereof a therapeutically effective amount of an active agent are provided.

In some embodiments the present invention provides influenza hemagglutinin (“HA”) polypeptides, proteins, and protein complexes that comprise a stalk domain that is engineered to facilitate maintenance of its native trimeric conformation, even if the head domain of the HA protein is removed or disrupted. In some embodiments, the present invention provides compositions comprising such polypeptides, proteins, and protein complexes, and methods of use of such proteins and compositions, for example as vaccine immunogens.

Methods of inducing a protective immune response against respiratory syncytial virus (RSV) and against influenza virus, without inducing a severe adverse event in human subjects are described. The methods include administering to the subjects an effective amount of an adenoviral vector encoding a recombinant RSV F polypeptide that is stabilized in a pre-fusion conformation, along with an effective amount of an influenza vaccine.