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 occurr...

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Bibliographic Details
Published in:Vaccine 2009-07, Vol.27 (34), p.4609-4614
Main Authors: Braun, LaToya Jones, Jezek, Jan, Peterson, Sabrina, Tyagi, Anil, Perkins, Shalimar, Sylvester, David, Guy, Mark, Lal, Manjari, Priddy, Scott, Plzak, Heidi, Kristensen, Debra, Chen, Dexiang
Format: Article
Language:English
Subjects:
Allergy and Immunology
Animals
Applied microbiology
Biological and medical sciences
Cold
Drug Stability
Excipients - pharmacology
Female
Formulation
Freezing
Fundamental and applied biological sciences. Psychology
Hepatitis
Hepatitis B
Hepatitis B Antibodies - blood
Hepatitis B vaccine
Hepatitis B Vaccines - adverse effects
Hepatitis B Vaccines - immunology
Hepatitis B Vaccines - radiation effects
Human viral diseases
Immunization
Infectious diseases
Male
Medical sciences
Mice
Mice, Inbred BALB C
Microbiology
Rabbits
Stability
Studies
Temperature
Vaccines
Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects)
Viral diseases
Viral hepatitis
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Summary: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 °C and is also stable for 12 months at 37 °C. The thermostable vaccine contains all the components of the original vaccine plus 7.5% (v/v) propylene glycol, 40 mM phosphate, and 40 mM 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.
ISSN:0264-410X
1873-2518
DOI:10.1016/j.vaccine.2009.05.069