Provided herein are methods of inducing an immune response against Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2) in a subject in need thereof by administering an immunogenic composition to the subject, wherein the subject exhibits: an increase in antigen-specific cellular immune response as measured by Interferon-gamma (IFN-γ) Enzyme-linked Immunospot (ELISpot) assay relative to baseline; and/or an increase in neutralizing antibody response as measured by a pseudovirus neutralizing assay relative to baseline.

A pDNA-based vaccine against SARS-CoV-2 and methods for preventing or treating COVID-19 using it.

Compositions and methods for enhancing antigen-specific immunity in a subject are provided. Pharmaceutical compositions including an effective amount of an immuno-stimulatory cardiolipin as an adjuvant in combination with an antigen and methods of use thereof for stimulating protective immunity to the antigen in a subject are provided. Administration of the combination of the antigen and cardiolipin adjuvant is effective to enhance antigen-specific immunity in a subject to a greater degree than administering to the subject the same amount of the antigen alone. The active agents can be administered together or separately. In preferred forms the cardiolipin is cardiolipin species (C18:2).sub.4. In preferred forms the antigen is formulated as a vaccine, such as an influenza vaccine. A preferred amount by weight of each reagent is about 10-40% cardiolipin to about 90-60% antigen(s), inclusive.

A buffer free, acid stable, low dose volume rotavirus vaccine is disclosed. The vaccine is available in dose volume of less than 1 ml per dose for oral administration and it is without any buffer. The vaccine also does not require pre or post administration of any antacid at the time of oral administration of the vaccine to the subject to neutralize the stomach acid. The vaccine exemplifies nominal drop in vaccine titer at pH 2-4 for a time span of 30 minutes. The vaccine is stable at −20° C. for at least 60 months.

Recombinant paramyxoviruses including a viral genome encoding a heterologous gene are provided. In several embodiments, the recombinant paramyxovirus is a recombinant parainfluenza virus, such as a recombinant PIV3 including a viral genome encoding a heterologous respiratory syncytial virus F ectodomain linked to the transmembrane domain and the cytoplasmic tail of the F protein from the PIV3. Nucleic acid molecules including the genome of a recombinant paramyxoviruses are also provided. The recombinant viruses may advantageously be used in vaccine formulations, such as for vaccines against parainfluenza virus and respiratory syncytial virus.

The present invention relates to a biodegradable nanocomplex. The biodegradable nanocomplex comprises a first electrically charged substance, a charge-redistribution substance, a second electrically charged substance and a carried substance, for holding the carried substance inside. The first electrically charged substance and the carried substance have the same electrical polarity, and the biodegradable nanocomplex has a nonuniformally and positively charge distribution along a radial direction thereof. The nonuniformally and positively charge distribution comprises a first electrically charged portion having substantially electrical neutrality, a second electrically charged portion surrounding the first electrically charged portion, and a third electrically charged portion surrounding the second electrically charged portion, in which the third electrically charged portion comprises an outermost surface of the biodegradable nanocomplex, thereby modulating the carried substance towards the desired immune responses via the nonuniformally and positively charge distribution.

Amphiphilic oligonucleotide conjugates that enhance adjuvant function are disclosed. The conjugates typically include: a lipophilic component, and conjugated thereto (directly or indirectly) an immunomodulating oligonucleotide that, if it were not conjugated to the lipophilic component, would suppress TLR7 and/or TLR8 stimulation. In the presence of albumin, these conjugates significantly enhance adjuvant function, in particular the function of TLR7/8-mediated adjuvants such as an imidazoquinolinamine. The conjugates can be administered, along with an adjuvant compound, to a subject in order to cause and/or enhance an immune response (for instance, to an infectious agent or a cancer antigen) in the subject.

Embodiments of immunogens comprising a recombinant Mumps (MuV) F ectodomain trimer stabilized in a prefusion conformation or a recombinant Measles (MeV) F ectodomain trimer stabilized in a prefusion conformation are provided. Also provided are embodiments of immunogens comprising chimeric proteins comprising the recombinant MuV or MeV F ectodomain trimer and one or more MuV HN or MeV H ectodomains. Also disclosed are nucleic acids encoding the immunogens and methods of their production. Methods for inducing an immune response in a subject by administering a disclosed immunogen to the subject are also provided. In some embodiments, the immune response treats or inhibits MuV and/or MeV infection in a subject.

The invention relates to the novel use of an immunogenic formulation containing the bacillus Calmette-Guérin (BCG) strain at a concentration between 104-109 bacteria, expressing at least one protein or immunogenic fragment of respiratory syncytial virus (RSV, Human orthopneumovirus), in a pharmaceutically acceptable saline buffer solution because it serves to prepare a vaccine useful to prevent, treat, or attenuate human metapneumovirus (hMPV) infections.

The present invention includes a vaccine comprising a SARS-CoV-2 spike protein (S) or portion thereof, and methods of use thereof.