US 2020/0206331 A1 · AN IMMUNOGENIC COMPOSITION HAVING IMPROVED STABILITY, ENHANCED IMMUNOGENICITY AND REDUCED REACTOGENICITY AND PROCESS FOR PREPARATION THEREOF

Abstract

An immunogenic composition comprising of Diphtheria toxoid antigen (D), tetanus toxoid (T) antigen, Hepatitis B surface antigen (HBsAg), inactivated whole-cell B. pertussis (wP) antigen, Haemophilus influenzae type B (Hib) capsular saccharide conjugated to a carrier protein, Inactivated Polio Virus (IPV) antigen and additionally one or more antigens and the method of preparing the same. A fully liquid combination vaccine, showing improved immunogenicity, reduced reactogenicity and improved stability. Improved methods of formaldehyde inactivation, improved adsorption profile of Diphtheria toxoid antigen (D), tetanus toxoid (T) antigen and Hepatitis B (HepB) surface antigen adsorbed individually onto aluminium phosphate adjuvant, minimum total aluminum content (Al3+) and optimized concentration of 2-phenoxyethanol (2-PE) as preservative.

Claims35

Dependent claims

An immunogenic composition comprising:

(i) a diphtheria toxoid, (D);
(ii) a tetanus toxoid, (T);
(iii) an inactivated whole cell pertussis antigen (wP);
(iv) a hepatitis B virus surface antigen, (HBsAg);
(v) a Haemophilus influenzae type b (Hib) capsular saccharide conjugated to a carrier protein;
(vi) an inactivated polio virus antigen, (IPV);
(vii) an adjuvant;
(viii) a preservative;
and
(ix) a dilution medium or buffer,
wherein the composition is a fully liquid combination vaccine, showing improved immunogenicity, reduced reactogenicity and improved stability at 2-8° C. and room temperature.

8 more elements

A process of manufacturing a fully liquid combination vaccine composition showing improved immunogenicity, reduced reactogenicity and improved stability, the composition comprising:

(i) a diphtheria toxoid, (D);
(ii) a tetanus toxoid, (T);
(iii) an inactivated whole cell pertussis antigen, (wP),
(iv) a hepatitis B virus surface antigen, (HBsAg);
(v) a Haemophilus influenzae type b (Hib) capsular saccharide conjugated to a carrier protein;
and
(vi) an inactivated polio virus antigen, (IPV);
the process of manufacturing comprising the steps of:
a). Addition of Normal saline in a blending vessel/container;
b). Addition of Component-I comprising Diphtheria Toxoid;
c). Addition of Component-II comprising Tetanus Toxoid;
d). Addition of inactivated whole cell pertussis antigen;
e). Addition of Component-III comprising Hepatitis B surface Antigen;
f). Addition of Hib Antigen;
g). Addition of IPV antigen;
h). Addition of 2-Phenoxy Ethanol;
i). Adjusting pH to 6.0 to 7.0 with Sodium Hydroxide/Sodium Carbonate;
and
j). Adding normal saline to make up the volume.

16 more elements

Dependencies are inferred from the claim text.

An immunogenic composition having improved stability, enhanced immunogenicity and reduced reactogenicity and process for preparation thereof

Life of this patent

An immunogenic composition having improved stability, enhanced immunogenicity and reduced reactogenicity and process for preparation thereof

Life of this patent

Abstract

Claims35