Disclosed herein is a formulation capable of enhancing thermostability and shelf-life of a biological product, the formulation comprising: a tertiary amine N-oxide or a derivative thereof represented by the formulae: ##STR00001## wherein R.sup.1, R.sup.2, and R.sup.3 may be identical or different and each is a straight or branched lower alkyl group having from 1 to 4 carbon atoms; an inorganic salt; glutamic acid or a salt thereof; a polyol; a physiologically acceptable buffer, and a pharmaceutically acceptable carrier. The tertiary amine N-oxide may be trimethylamine-N-oxide, (CH.sub.3).sub.3NO. The formulation is useful for vaccine stabilization.

The present invention relates to immunogenic compositions comprising RSV F protein, methods for preparing compositions that contain RSV F protein ecto-domain polypeptides, and to certain engineered RSV F proteins and nucleic acids that encode the engineered RSV F proteins. Compositions prepared using the methods can contain RSV F protein ecto-domain polypeptides in a predominant or single desired form and conformation. The invention also relates to methods for inducing an immune response to RSV F.

Embodiments include a method of using inactivated human cold coronaviruses (HCoVs) particularly HCoV-299E, HCoV-OC43, HCoV-NL63 and HCoV-HKU1 as a booster, for the immunization against SARS-CoV-2 infections.

The invention pertains to a vaccine for use in protecting a pig against an infection with porcine endemic diarrhea virus (PEDV), the vaccine comprising non-live PEDV antigen and a non-metabolizable oil containing adjuvant, wherein the total amount of oil in the vaccine is less than 50% v/v, by administration of a dose of the antigen corresponding to at least 3.0E6 TCID50 killed whole PEDV. The invention also pertains to a method of protecting a pig against an infection with porcine endemic diarrhea virus.

The present invention relates to vaccine compositions that are useful in a method of protecting a human subject against dengue disease.

The presently disclosed subject matter relates to the fields of pharmacology and medicine, and provides vaccine compositions and methods of use, particularly influenza compositions and methods of use to treat neonatal subjects.

The invention relates to means and methods for preparing aqueous composition comprising aluminium and a protein said composition comprising less than 700 ppm heavy metal on the basis of weight with respect to the aluminium content. The invention further relates to aqueous compositions comprising a protein and an aluminium-salt, said composition comprising less than 350 ppb heavy metal based on the weight of the aqueous composition.

The present invention pertains to a vaccine for use in protecting offspring of a sow against an infection with porcine endemic diarrhea virus (PEDV), the vaccine comprising non-live PEDV antigen and an oil containing adjuvant, by administration of the vaccine to the pregnant sow at a dose of the antigen corresponding to at least 3.0E6 TCID50 killed whole PEDV. The invention also pertains to a method of protecting young piglets against an infection with porcine endemic diarrhea virus (PEDV).

In one aspect, the invention relates to a composition including a first polypeptide having the sequence set forth in SEQ ID NO: 1 and a second polypeptide having the sequence set forth in SEQ ID NO: 2. In one embodiment, the composition includes about 120 μg/ml of a first polypeptide including the amino acid sequence set forth in SEQ ID NO: 1, 120 μg/ml of a second polypeptide including the amino acid sequence set forth in SEQ ID NO: 2, about 2.8 molar ratio polysorbate-80 to the first polypeptide, about 2.8 molar ratio polysorbate-80 to the second polypeptide, about 0.5 mg/ml aluminum, about 10 mM histidine, and about 150 mM sodium chloride. In one embodiment, a dose of the composition is about 0.5 ml in total volume. In one embodiment, two-doses of the composition induce a bactericidal titer against diverse heterologous subfamily A and subfamily B strains in a human.

Provided are nanoparticles comprising heparin, chitosan, and at least one immunomodulatory agent, e.g. a cytokine. The cytokine can be selected from the group consisting of TNF, IL-12, IL-2, IL-23, IL-1α, IL-10, IL-18, and combinations thereof. Further provided are methods of making a nanoparticle comprising mixing a first composition comprising heparin with a second composition comprising chitosan in the presence of at least one cytokine to form a third composition. Further provided are methods of modulating an immune response comprising co-administering to a subject an antigen or vaccine with nanoparticles comprising heparin, chitosan, and at least one cytokine.