Synthetic nanocarrier combination vaccines

a technology of synthetic nanocarriers and vaccines, applied in the direction of viruses, powder delivery, inorganic non-active ingredients, etc., can solve the problems of inability to comfortably and/or safely combine the number of antigens in a single dosage form, the total liquid volume of the dosage form becomes too large to comfortably and/or safely, and the existing vaccine formulation is limited in coverage or physical incompatibility with one another

Inactive Publication Date: 2011-12-01
SELECTA BIOSCI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0019]In one embodiment of any of the methods provided, the dosage form is administered by oral, subcutaneous, pulmonary, intranasal, intradermal or intramuscular administration. In yet another aspect, any of the dosage forms is provided for use in therapy or prophylaxis. In still another aspect, any of the dosage forms for use in any of the methods provided is provided. In yet another aspect, any of the dosage forms for use in a method of treating or preventing cancer is provided. In a further aspect, any of the dosage forms for use in a method of treating or preventing infection or infectious disease is provided. In one embodiment of any of the dosage forms, the method comprises administration of the dosage form by oral, subcutaneous, pulmonary, intranasal, intradermal or intramuscular administration. In still another aspect, use of any of the dosage forms for the manufacture of a medicament for use in any of the methods is provided.

Problems solved by technology

The number of antigens that can be combined in a single dosage form may be limited by the amount of each antigen required to elicit the desired immune response and the aqueous solubility of the antigen.
At some point, the total liquid volume of the dosage form becomes too large to comfortably and / or safely administer the vaccine by an intramuscular and / or subcutaneous route.
Another limitation of existing vaccine formulations is their limited coverage or their physical incompatibility with one another which may preclude simple blending of two existing vaccines to create a new, combination vaccine.
These vaccines do not provide protection against all strains of HPV.
It certain circumstances it may not be possible to simply blend in additional conventionally produced antigens to an existing vaccine because of undesirable interactions between the additional conventionally produced antigens and the existing vaccine (which may lead to precipitation, aggregation, etc.).

Method used

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  • Synthetic nanocarrier combination vaccines
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  • Synthetic nanocarrier combination vaccines

Examples

Experimental program
Comparison scheme
Effect test

example 1

Synthetic Nanocarriers with Covalently Coupled Adjuvant

[0134]Nanocarriers comprising PLGA-R848, PLA-PEG-N3, and ova peptide were prepared via double emulsion method wherein the ova peptide was encapsulated in the nanocarriers.

[0135]The polyvinyl alcohol (Mw=11 KD-31 KD, 87-89% partially hydrolyzed) was purchased from JT Baker. Ovalbumin peptide 323-339 was obtained from Bachem Americas Inc. (3132 Kashiwa Street, Torrance Calif. 90505. Part # 4065609). PLGA-R848, and PLA-PEG-N3 conjugates were synthesized and purified.

[0136]The above materials were used to prepare the following solutions:

[0137]1. PLGA-R848 conjugate in methylene chloride @ 100 mg / mL

[0138]2. PLA-PEG-N3 in methylene chloride @ 100 mg / mL

[0139]3. Ovalbumin peptide 323-339 in 0.13N HCl @ 70 mg / mL

[0140]4. Polyvinyl alcohol in 100 mM pH 8 phosphate buffer @50 mg / mL

[0141]Solution #1 (0.75 mL) and solution #2 (0.25 mL) were combined and solution #3 (0.1 mL) or 0.13N HCl (0.1 mL) was added in a small vessel and the mixture was...

example 2

Composition with Synthetic Nanocarriers and Uncoupled Antigen (Prophetic)

[0144]A 4 mL portion of the synthetic nanocarrier suspension from Example 1 containing 8 mg of L2 substituted nanocarriers is centrifuged to settle the particles. The supernatant is discarded and a 0.5-mL suspension of Gardasil®, Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine containing purified virus-like particles (VLPs) of the major capsid (L1) protein of HPV Types 6, 11, 16, and 18 is added. The combination vaccine is agitated to re-suspend the nanocarriers and the resulting suspension is stored at −20° C. prior to use.

example 3

Synthetic Nanocarriers with Non-Covalently Coupled Adjuvant [Prophetic]

[0145]DNA containing cationic disulfide PRINT nanocarriers are produced by the method described in the patent application of DeSimone, WO2008118861, example 16 with the exception that the ssDNA-fluorescein of example 16 is replaced by the phosphorothioated DNA CpG 7909. After isolation, the cationic nanocarriers are suspended in 1.0 mL of PBS solution containing 10 mg / mL of heparin. After stirring at room temperature for 2 hours, the nanocarriers are isolated by centrifugation and are washed twice with PBS by centrifugation and decantation. The nanocarriers containing CpG 7909 with surface adsorbed heparin are re-suspended in 1.0 mL of PBS and are stored at −20° C. prior to use.

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Abstract

Disclosed are dosage forms and related methods, that include a first population of synthetic nanocarriers that have one or more first antigens coupled to them, one or more second antigens that are not coupled to the synthetic nanocarriers, and a pharmaceutically acceptable excipient.

Description

RELATED APPLICATIONS[0001]This application claims the benefit under 35 U.S.C. §119 of U.S. provisional applications 61 / 348,713, filed May 26, 2010, 61 / 348,717, filed May 26, 2010, 61 / 348,728, filed May 26, 2010, and 61 / 358,635, filed Jun. 25, 2010, the entire contents of each of which are incorporated herein by reference.BACKGROUND OF THE INVENTION[0002]To either minimize the number of childhood vaccinations and / or to provide broader immune protection against different strains of a given pathogen, there often is a desire to combine multiple antigens in a single dosage form, the resulting vaccine being termed a multivalent vaccine. The number of antigens that can be combined in a single dosage form may be limited by the amount of each antigen required to elicit the desired immune response and the aqueous solubility of the antigen.[0003]At some point, the total liquid volume of the dosage form becomes too large to comfortably and / or safely administer the vaccine by an intramuscular an...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K9/14A61K39/385A61K39/12A61K39/10A61K39/145A61K39/29A61K39/25A61K39/165A61K39/20A61K39/09A61K39/13A61K39/205A61K39/15A61K39/285A61K39/235A61K39/125A61K39/155A61K39/106A61K39/118A61K39/08A61K39/05A61K39/108A61K39/04A61K39/095A61K39/104A61K39/112A61K39/085A61P35/00A61P31/00A61P31/04A61P31/10A61P31/12A61P31/14A61P31/16A61P31/20A61P31/22A61K38/21A61K39/00B82Y5/00
CPCA61K9/5153A61K2039/55522A61K31/7115A61K33/06A61K39/0013A61K39/385A61K39/39A61K45/06A61K47/02A61K47/22A61K47/24A61K47/48176A61K47/482A61K47/48215A61K47/48853A61K2039/555A61K2039/55511A61K2039/55555A61K2039/6093A61K31/4745A61K2300/00A61K47/34A61K39/12C12N2730/10134C12N2760/16134A61K2039/6031A61K2039/60A61K2039/55561A61K2039/70A61K2039/6087A61K47/60A61K47/58A61K47/593A61K47/6921A61P1/16A61P11/00A61P11/06A61P11/08A61P17/00A61P17/04A61P25/28A61P25/30A61P25/34A61P25/36A61P29/00A61P3/00A61P31/00A61P31/04A61P31/10A61P31/12A61P31/14A61P31/16A61P31/20A61P31/22A61P35/00A61P37/00A61P37/02A61P37/04A61P37/08A61P39/02A61P43/00A61P5/00Y02A50/30A61K9/16A61K39/00A61K38/00A61K38/17A61K39/395A61K2039/62A61K2039/545A61K39/0005A61K39/35A61K2039/54A61K2039/541A61K2039/542A61K2039/543A61K47/6931A61K47/68A61K47/646A61K47/6929
Inventor BRATZLER, ROBERT L.LIPFORD, GRAYSON B.JOHNSTON, LLOYDZEPP, CHARLES
Owner SELECTA BIOSCI
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