Abstract

DEVELOPMENT OF STABLE HAEMOPHILUS TYPE b CONJUGATE AND WHOLE CELL PERTUSSIS COMBINED VACCINE

Sujana Prasad Chittineni*, Satish Chandra Maheshwari, Lakshmi Narasu Mangamoori

ABSTRACT

Haemophilus type b conjugate and whole cell pertussis liquid vaccines are freeze sensitive and also labile to heat. Freeze sensitivity is one of the major causes for wastage of vaccines during transport and storage in health care centers or pharmacy store. Currently Haemophilus type b conjugate vaccine is available in both liquid and lyophilized forms. Whole cell pertussis vaccines are available only in liquid form, in combination with diphtheria, tetanus, Hepatitis B and Haemophilus type b conjugate. The combination vaccines containing both these antigens are freeze and heat sensitive. Lyophilized Haemophilus type b conjugate vaccine is reconstituted with adjuvant or with DTP-Hepatitis B combination vaccine before injection. Reconstituted vaccines will become freeze and heat sensitive, cannot be stored for longer periods, to be used within 6 hours after reconstitution. This research work aimed to develop freeze stable and heat stability improved combination vaccine of Haemophilus type b conjugate and whole cell pertussis. Lyophilization is an excellent option to protect vaccine from freezing and heat effects. In general stability of the vaccines in lyophilized state is better compared to liquid state. Lyophilized combined vaccine of Haemophilus type b conjugate and whole cell pertussis vaccines were prepared with novel protective material polaxamer block copolymer as cryo protectant or combination of polaxamer polymer and a sugar. The developed lyophilized vaccines were resistant to freezing and heat stability was enhanced substantially when compared to commercially available vaccines. This lyophilized combination vaccine can be extemporaneously reconstituted before administration using suitable diluent. The lyophilized Haemophilus type

Keywords: b conjugate and whole cell pertussis combination vaccine can also be reconstituted with Diphtheria, tetanus and hepatitis B vaccines adsorbed to adjuvant or with aluminum phosphate adjuvant before administration. Additionally presence of polaxamer block c