Elimination of the cold-chain dependence of a nanoemulsion adjuvanted vaccine against tuberculosis by lyophilization

Next-generation rationally-designed vaccine adjuvants represent a significant breakthrough to enable development of vaccines against challenging diseases including tuberculosis, HIV, and malaria. New vaccine candidates often require maintenance of a cold-chain process to ensure long-term stability a...

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Bibliographic Details
Published in:Journal of controlled release 2014-03, Vol.177, p.20-26
Main Authors: Orr, Mark T., Kramer, Ryan M., Barnes, Lucien, Dowling, Quinton M., Desbien, Anthony L., Beebe, Elyse A., Laurance, John D., Fox, Christopher B., Reed, Steven G., Coler, Rhea N., Vedvick, Thomas S.
Format: Article
Language:English
Subjects:
Adjuvant
Adjuvants, Immunologic - administration & dosage
Adjuvants, Immunologic - chemistry
Animals
Antibodies, Bacterial - immunology
Antigens, Bacterial - administration & dosage
Antigens, Bacterial - chemistry
B-Lymphocytes - immunology
Bacterial Load
Emulsions
Female
Freeze Drying
Human immunodeficiency virus
Leukocyte Count
Lung - microbiology
Lyophilization
Mice
Mice, Inbred C57BL
Mycobacterium tuberculosis
Mycobacterium tuberculosis - immunology
Nanoemulsion
Nanostructures - administration & dosage
Nanostructures - chemistry
Spleen - microbiology
T-Lymphocytes - immunology
Temperature
Tuberculosis - immunology
Tuberculosis - microbiology
Tuberculosis - prevention & control
Tuberculosis Vaccines - administration & dosage
Tuberculosis Vaccines - chemistry
Vaccine
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Description
Summary:Next-generation rationally-designed vaccine adjuvants represent a significant breakthrough to enable development of vaccines against challenging diseases including tuberculosis, HIV, and malaria. New vaccine candidates often require maintenance of a cold-chain process to ensure long-term stability and separate vials to enable bedside mixing of antigen and adjuvant. This presents a significant financial and technological barrier to worldwide implementation of such vaccines. Herein we describe the development and characterization of a tuberculosis vaccine comprised of both antigen and adjuvant components that are stable in a single vial at sustained elevated temperatures. Further this vaccine retains the ability to elicit both antibody and TH1 responses against the vaccine antigen and protect against experimental challenge with Mycobacterium tuberculosis. These results represent a significant breakthrough in the development of vaccine candidates that can be implemented throughout the world without being hampered by the necessity of a continuous cold chain or separate adjuvant and antigen vials. [Display omitted]
ISSN:0168-3659
1873-4995
DOI:10.1016/j.jconrel.2013.12.025