Abstract: Monoclonal antibodies, or antigen-binding fragments thereof, that bind to Clostridium difficile (C. difficile) toxin A or toxin B and methods of using the same to detect or treat C. difficile infections and/or C. difficile-associated disease.

Abstract: Provided are novel vaccines for prophylactic treatment of SARS-COV-2 infections and COVID-19 and methods of making the vaccines, wherein the vaccines contain an oil-in-water emulsion comprising tocopherol and squalene.

Abstract: The present disclosure relates to an immunogenic composition comprising a combination of meningococcal antigens which comprises at least one factor H binding protein (fHBP) A protein, at least one fHBP B protein, at least one Neisseria adhesin A (NadA) protein, and at least one detergent-extracted Outer Membrane Vesicle (dOMV). The meningococcal antigens may be from a Neisseria meningitidis serogroup B. The combination of antigens provided a broad coverage of bacteria strains. Further, the present disclosure relates to the use of the immunogenic composition in methods for eliciting an immune response.

Abstract: 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.

Abstract: In one aspect, this disclosure describes methods of treating or preventing RSV infection in a patient in need thereof. The methods include dosing regiments for administering a composition including a fixed dose of an anti-RSV monoclonal antibody or an antigen binding fragment thereof. In another aspect, this disclosure describes pharmaceutical compositions for the treatment or prevention of RSV infection. In yet another aspect, this disclosure describes a pharmaceutical unit dose including nirsevimab.

Abstract: The present disclosure is directed to a method for cultivating a Bordetella species, comprising: cultivating a Bordetella species under aerobic conditions in a liquid culture medium; and maintaining a pH of the liquid culture medium by using a strong acid, such as nitric acid, or using a first and second acid, wherein the first acid is an inorganic acid that dissociates essentially completely in water, such as nitric acid, hydrochloric acid or sulfuric acid, and wherein the second acid is an inorganic acid having an acid dissociation constant (pKa) of greater than 1, such as phosphoric acid. Methods for increasing the yield of Bordetella fimbrial agglutinogen 2 and fimbrial agglutinogen 3 (FIM2/3) in a supernatant fraction from a Bordetella culture are also provided.

Abstract: The present invention is directed to an artificial nucleic acid and to a polypeptide suitable for use in the treatment or prophylaxis of an infection with a flavivirus, in particular an infection with yellow fever virus or with dengue virus, or of a disorder related to such an infection. The present invention is also directed to a composition, preferably an immunogenic composition, comprising the artificial nucleic acid or the inventive polypeptide. In particular, the present invention concerns an immunogenic composition against a flavivirus, such as yellow fever virus or dengue virus. Further, the invention concerns a kit, particularly a kit of parts, comprising the artificial nucleic acid, polypeptide or (immunogenic) composition.

Abstract: The present invention is directed to an artificial nucleic acid and to a polypeptide suitable for use in the treatment or prophylaxis of an infection with a flavivirus, in particular an infection with yellow fever virus or with dengue virus, or of a disorder related to such an infection. The present invention is also directed to a composition, preferably an immunogenic composition, comprising the artificial nucleic acid or the inventive polypeptide. In particular, the present invention concerns an immunogenic composition against a flavivirus, such as yellow fever virus or dengue virus. Further, the invention concerns a kit, particularly a kit of parts, comprising the artificial nucleic acid, polypeptide or (immunogenic) composition.

Abstract: Provided are mixed carrier, multivalent pneumococcal conjugate compositions comprising 21 different pneumococcal capsular polysaccharide-protein conjugates, wherein each of the conjugates includes a capsular polysaccharide from a different serotype of Streptococcus pneumoniae conjugated to either tetanus toxoid (TT) or CRM197, wherein the Streptococcus pneumoniae serotypes are selected from 1, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11 A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F, where the capsular polysaccharides of two of serotypes 1, 3, and 5 and one or both of serotypes 15B and 22F are conjugated to TT and the remaining capsular polysaccharides are conjugated to CRM197. Also provided are methods of producing the mixed carrier, multivalent pneumococcal conjugate compositions and methods of using the same for prophylaxis against Streptococcus pneumoniae infection or disease in a subject.

Abstract: The present invention provides, among other things, modified recombinant HA polypeptides with broadened immunogenic profile that extends coverage to antigenically distinct influenza strains and methods of making and using the same.

Abstract: The present invention is directed to an artificial nucleic acid and to polypeptides suitable for use in treatment or prophylaxis of an infection with Zika virus or a disorder related to such an infection. In particular, the present invention concerns a Zika virus vaccine. The present invention is directed to an artificial nucleic acid, polypeptides, compositions and vaccines comprising the artificial nucleic acid or the polypeptides. The invention further concerns a method of treating or preventing a disorder or a disease, first and second medical uses of the artificial nucleic acid, polypeptides, compositions and vaccines. Further, the invention is directed to a kit, particularly to a kit of parts, comprising the artificial nucleic acid, polypeptides, compositions and vaccines.

Abstract: Provided are novel vaccines for prophylactic treatment of SARS-CoV-2 infections and COVID-19 and methods of making the vaccines.

Abstract: The present invention relates to a liposome comprising a saponin, a sterol, a phospholipid and a Toll-like receptor 4 (TLR4) agonist of formula (I), to methods of preparing liposomes, to compositions comprising them and to uses thereof, and to immunogenic compositions comprising such liposomes as adjuvant.

Abstract: The disclosure provides methods for generating an optimized nucleotide sequence encoding an engineered influenza structural protein and the optimized nucleotide sequences obtained therefrom. The optimized nucleotide sequences can be used in a reverse genetics system to facilitate the rescue of infectious influenza virus containing the engineered structural proteins and/or enhance viral titers. Also provided are methods of preparing an influenza vaccine composition using the optimized nucleotide sequences, as well as methods of inducing an immune response using the influenza vaccine composition.

Abstract: Provided herein are compounds, compositions, formulations, kits, uses, and methods for vaccinating a subject against Neisseria meningitidis.

Abstract: The present invention is directed to an artificial nucleic acid and to polypeptides suitable for use in treatment or prophylaxis of an infection with Zika virus or a disorder related to such an infection. In particular, the present invention concerns a Zika virus vaccine. The present invention is directed to an artificial nucleic acid, polypeptides, compositions and vaccines comprising the artificial nucleic acid or the polypeptides. The invention further concerns a method of treating or preventing a disorder or a disease, first and second medical uses of the artificial nucleic acid, polypeptides, compositions and vaccines. Further, the invention is directed to a kit, particularly to a kit of parts, comprising the artificial nucleic acid, polypeptides, compositions and vaccines.

Abstract: Provided herein are compounds, compositions, formulations, kits, uses, and methods for vaccinating a subject against Neisseria meningitidis.

Abstract: The present invention is directed to a method of booster vaccination and to a vaccine composition for use in such a method, for inducing in a human subject a neutralizing antibody response, wherein said subject has previously received a primary vaccination against each of serotypes 1 to 4 of dengue virus and was dengue naïve before said primary vaccination, said composition comprising a dengue antigen of at least one of serotypes 1 to 4 or a nucleic acid construct capable of expressing said antigens in the subject, wherein said booster vaccination results in a 2-fold increase in the neutralizing antibody titre against each of serotypes 1 to 4.

Abstract: Disclosed herein are immunogenic compositions and vaccination regimes for immunizing humans against influenza disease.

Abstract: A process line for the production of freeze-dried particles under closed conditions is provided, the process line comprising a freeze-dryer for the bulkware production of freeze-dried particles under closed conditions, the freeze-dryer comprising a rotary drum for receiving the frozen particles, and a stationary vacuum chamber housing the rotary drum, wherein for the production of the particles under closed conditions the vacuum chamber is adapted for closed operation during processing of the particles; the drum is in open communication with the vacuum chamber; and at least one transfer section is provided for a product transfer between a separate device of the process line and the freeze-dryer, the freeze-dryer and the transfer section being separately adapted for closed operation, wherein the transfer section comprises a temperature-controllable inner wall surface.