Herpes simplex virus nanoemulsion vaccine
AssigneeNanoBio Corporation
InventorsAli I. Fattom, Jakub Simon, James R. Baker, Jr., Tarek Hamouda, Vira Bitko
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Abstract
The present application relates to the field of human immunology, in particular, a herpes simplex virus (HSV) vaccine. The subunit vaccine composition comprises isolated surface glycoproteins from herpes simplex viruses, fusion proteins or fragments thereof mixed in varied combination with a nanoemulsion, which is a potent immune enhancer.
Claims28
A mucosal herpes simplex virus (HSV) vaccine composition consisting essentially of:
- (a) an immune enhancing nanoemulsion suitable for mucosal administration, wherein the nanoemulsion comprises:
- (i) droplets having an average diameter of less than about 600 nm;
- (ii) an aqueous phase;
- (iii) about 12.6% of a pharmaceutically acceptable oil;
- (iv) about 1.18% of at least one surfactant, wherein the surfactant is Polysorbate 80, Polysorbate 20, or a combination thereof;
- (v) about 1.35% of at least one organic solvent, wherein the organic solvent is an alcohol;
- and
- (vi) about 0.2% of a cationic surfactant, wherein the cationic surfactant is cetylpyridinium chloride (CPC) or dioctyl dimethyl ammonium chloride;
- and
- (b) a combination comprising an isolated HSV gD antigen and an isolated HSV gB antigen within the nanoemulsion, wherein (i) the HSV gD antigen is an HSV-1 gD, HSV-2 gD, or an immunogenic fragment of HSV-1 gD or HSV-2 gD;
- and (ii) the HSV gB antigen is an HSV-1 gB, HSV-2 gB, or an immunogenic fragment of HSV-1 gB or HSV-2 gB.
A method for preparing a mucosal herpes simplex virus (HSV) vaccine useful for the treatment or prevention of an HSV infection in humans comprising:
- (a) synthesizing in a eukaryotic host one or more recombinant, full length or immunogenic fragment HSV antigens, wherein the HSV antigen is selected from the group consisting of HSV-1 gB, HSV-2 gB, HSV-1 gD, and HSV-2 gD;
- (b) isolating the one or more antigens or immunogenic fragments thereof from the eukaryotic host;
- and
- (c) formulating a combination comprising an isolated HSV gD antigen and an isolated HSV gB antigen with an oil-in-water nanoemulsion, wherein the nanoemulsion, or a dilution thereof, comprises:
- (i) droplets having an average diameter of less than about 600 nm;
- (ii) an aqueous phase;
- (iii) about 63% of a pharmaceutically acceptable oil;
- (iv) about 5.9% of at least one surfactant, wherein the surfactant is Polysorbate 80, Polysorbate 20, or a combination thereof;
- (v) about 6.75% of at least one organic solvent, wherein the organic solvent is an alcohol;
- and
- (vi) about 1% of a cationic surfactant.
A herpes simplex virus (HSV) mucosal subunit vaccine composition consisting essentially of:
- (a) an immune enhancing nanoemulsion, wherein the nanoemulsion comprises:
- (i) droplets having an average diameter of less than about 600 nm;
- (ii) an aqueous phase;
- (iii) about 63% of a pharmaceutically acceptable oil;
- (iv) about 5.9% of at least one surfactant, wherein the surfactant is Polysorbate 80, Polysorbate 20, or a combination thereof;
- (v) about 6.75% of at least one organic solvent, wherein the organic solvent is an alcohol;
- and
- (vi) about 1.0% of a cationic surfactant, wherein the cationic surfactant is cetylpyridinium chloride (CPC) or dioctyl dimethyl ammonium chloride;
- (b) a combination comprising an isolated multivalent HSV gD antigen and an isolated multivalent HSV gB antigen within the nanoemulsion, wherein (i) the HSV gD antigen is an HSV-1 gD, HSV-2 gD, or an immunogenic fragment of HSV-1 gD or HSV-2 gD;
- and (ii) the HSV gB antigen is an HSV-1 gB, HSV-2 gB, or an immunogenic fragment of HSV-1 gB or HSV-2 gB
- wherein the immune enhancing nanoemulsion is diluted to about 20% in an aqueous phase, thereby making it suitable for mucosal administration.
Dependencies are inferred from the claim text.