title: Characterization of a thermostable hepatitis B vaccine formulation.
abstract: Cold chain requirements for vaccine storage and distribution are both economic and logistical burdens for immunization programs, especially those in lower-resource settings. Inadvertent exposure of vaccines to both heat and freezing temperatures within such cold chains are frequently occurring problems in both developing and industrialized countries. Here we report on a new hepatitis B vaccine formulation that is stable against repeated freezing at -20 degrees C and is also stable for 12 months at 37 degrees C. The thermostable vaccine contains all the components of the original vaccine plus 7.5% (v/v) propylene glycol, 40mM phosphate, and 40mM histidine with a final pH of 5.2. The propylene glycol is responsible for the freeze stability while the other components are essential for the heat stability. This formulation was found to be well tolerated in rabbits without any significant local or systemic side effects. The improved stability of this hepatitis B vaccine could be a key factor in ensuring vaccine effectiveness, extending immunization coverage, simplifying immunization logistics, and reducing the costs associated with the cold chain.
authors.affiliation: University of Colorado Denver, School of Pharmacy, Aurora, CO 80045, USA.
authors.forename: LaToya Jones
authors.initials: LJ
authors.lastname: Braun
authors.forename: Jan
authors.initials: J
authors.lastname: Jezek
authors.forename: Sabrina
authors.initials: S
authors.lastname: Peterson
authors.forename: Anil
authors.initials: A
authors.lastname: Tyagi
authors.forename: Shalimar
authors.initials: S
authors.lastname: Perkins
authors.forename: David
authors.initials: D
authors.lastname: Sylvester
authors.forename: Mark
authors.initials: M
authors.lastname: Guy
authors.forename: Manjari
authors.initials: M
authors.lastname: Lal
authors.forename: Scott
authors.initials: S
authors.lastname: Priddy
authors.forename: Heidi
authors.initials: H
authors.lastname: Plzak
authors.forename: Debra
authors.initials: D
authors.lastname: Kristensen
authors.forename: Dexiang
authors.initials: D
authors.lastname: Chen
mesh_terms: D000818:Animals; D004355:Drug Stability; D005079:Excipients / Q000494:pharmacology*; D005260:Female; D005615:Freezing; D006510:Hepatitis B Antibodies / Q000097:blood; D017325:Hepatitis B Vaccines / Q000009:adverse effects / Q000276:immunology* / Q000528:radiation effects*; D008297:Male; D051379:Mice; D008807:Mice, Inbred BALB C; D011817:Rabbits; D013696:Temperature
chemical_list: D005079:Excipients; D006510:Hepatitis B Antibodies; D017325:Hepatitis B Vaccines