# US 10,500,283 B2 · Vaccine composition capable of inducing memory antibody response from single point immunization

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- Number: US 10,500,283 B2
- Document ID: US10500283B2
- Status: Granted
- Kind: B2
- Application number: 14/122,923
- Filed: 2012-05-29
- Published: 2014-08-28
- Granted: 2019-12-10
- Earliest claimed: 2011-05-30
- Assignees: National Institute of Immunology
- Applicants: Anish Chakkumkal; Amulya Kumar Panda
- Inventors: Anish Chakkumkal; Amulya Kumar Panda
- Web page: https://patentgrep.com/patent/US10500283B2

## CPC

- A61K 47/34: Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers (A61K47/10 takes precedence)
- A61K 39/0275: {Salmonella}
- A61P 31/04: Antibacterial agents
- A61K 2039/545: {characterised by the dose, timing or administration schedule}
- A61K 2039/55544: {Bacterial toxins}
- A61K 2039/55555: {Liposomes; Vesicles, e.g. nanoparticles; Spheres, e.g. nanospheres; Polymers}
- A61K 2039/6093: {Synthetic polymers, e.g. polyethyleneglycol [PEG], Polymers or copolymers of (D) glutamate and (D) lysine}
- Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

The present investigation relates to entrapment of carbohydrate antigen such as Vi polysaccharide of Salmonella typhi in poly (DL) lactide (PDLLA) and polylactide-co-glycolide (PLGA) polymer particles. The formulated product not only elicits primary antibody titers from single dose application but also evokes memory antibody titer against the T independent antigen.

## Claims

### Claim 1

A vaccine composition consisting of a carbohydrate antigen Vi polysaccharide of Salmonella typhi entrapped in a polymer particle wherein said polymer particle is selected from poly (DL) lactide (PDLLA) and polylactide-co-glycolide (PLGA), said composition capable of inducing memory antibody response from a single immunization, by multivalent display of polysaccharide antigens on polymeric particles wherein the polymer particles are of a size distribution of 2-8 μm, the composition free of adjuvant.

### Claim 2 (depends on 1)

The vaccine composition as claimed in claim 1, wherein said polymer particle is biocompatible and biodegradable.

### Claim 3 (depends on 1)

The vaccine composition as claimed in claim 1, wherein said composition in addition to improving the immunogenicity of the carbohydrate antigen, also improves the secondary antibody response upon challenge with soluble Vi polysaccharide.

### Claim 4 (depends on 1)

The vaccine composition as claimed in claim 1, wherein said composition from single dose intramuscular immunization gave rise to two fold higher antibody titer (IgG) in mice, induces higher memory antibody titers (secondary antibody) than the primary response in immunized animals or both.

### Claim 5 (depends on 1)

A process for preparing a vaccine composition of claim 1 by using w/o/w double emulsion solvent, evaporation method, comprising the steps of
a. emulsifying internal aqueous phase (IAP) containing Vi antigen, CaCh and Tween 20 into organic phase (OP) 50 mg/ml, PLA solution in dichloromethane by sonication to get the primary emulsion,
b. adding the primary emulsion (W/O) of step (a) drop wise to external aqueous phase (EAP) containing 2% (w/v) PVP in deionized water,
c. mixture from step (b) is homogenized for getting micro particles,
d. the resulting particles from Step (c) is collected by centrifugation (15,000 rpm, 20 min), and
e. the product of step (d) is lyophilized to obtain free-flowing powder.

### Claim 6 (depends on 5)

The process as claimed in claim 5, wherein step (c) homogenization is carried out at 10,000 rpm for 10 min for preparing micro particles.

### Claim 7 (depends on 5)

The process as claimed in claim 5, wherein step (d) centrifugation is carried out at 15,000 rpm for 20 minutes.

### Claim 8 (depends on 1)

The composition according to claim 1 wherein the antigen load is from 0.366 μg/mg to 7.3 μg/mg.