Thermostable formulations of a hepatitis B vaccine and a meningitis A polysaccharide conjugate vaccine produced by a spray drying method

Chen, D.; Kapre, Subhash V.; Goel, Akshay; Suresh, K.; Beri, Suresh; Hickling, Julian; Jensen, Jani R.; Lal, Manjari; Preaud, J.M.; LaForce, Marc; Kristensen, Debra

doi:10.1016/j.vaccine.2010.04.112

Cited by 53 publications

(27 citation statements)

References 24 publications

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“…The enhanced thermostability of a vaccine is thereby supposed to reduce its validity loss during storage and transportation. Robust liquid vaccines produced with less dependence on cold chains can provide benefits by reducing waste, ensuring potency, and decreasing financial cost, which are highly helpful to expand the global coverage of vaccination programs (44,45).…”

Section: Discussionmentioning

confidence: 99%

Rational design of thermostable vaccines by engineered peptide-induced virus self-biomineralization under physiological conditions

Wang

Cao

Chen

et al. 2013

Proc. Natl. Acad. Sci. U.S.A.

142

127

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The development of vaccines against infectious diseases represents one of the most important contributions to medical science. However, vaccine-preventable diseases still cause millions of deaths each year due to the thermal instability and poor efficacy of vaccines. Using the human enterovirus type 71 vaccine strain as a model, we suggest a combined, rational design approach to improve the thermostability and immunogenicity of live vaccines by self-biomineralization. The biomimetic nucleating peptides are rationally integrated onto the capsid of enterovirus type 71 by reverse genetics so that calcium phosphate mineralization can be biologically induced onto vaccine surfaces under physiological conditions, generating a mineral exterior. This engineered self-biomineralized virus was characterized in detail for its unique structural, virological, and chemical properties. Analogous to many exteriors, the mineral coating confers some new properties on enclosed vaccines. The self-biomineralized vaccine can be stored at 26°C for more than 9 d and at 37°C for approximately 1 wk. Both in vitro and in vivo experiments demonstrate that this engineered vaccine can be used efficiently after heat treatment or ambient temperature storage, which reduces the dependence on a cold chain. Such a combination of genetic technology and biomineralization provides an economic solution for current vaccination programs, especially in developing countries that lack expensive refrigeration infrastructures.genetic engineering | vaccine design | shell

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Section: Discussionmentioning

confidence: 99%

Rational design of thermostable vaccines by engineered peptide-induced virus self-biomineralization under physiological conditions

Wang

Cao

Chen

et al. 2013

Proc. Natl. Acad. Sci. U.S.A.

142

127

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“…Such a process could potentially reduce the in-vivo immunogenicity [66]. In contrast, spray drying does not seem to cause particle aggregation of aluminum hydroxide in the absence of polymers [67].…”

Section: Storage and Process Stability Of Aluminum Saltsmentioning

confidence: 99%

Selection of Adjuvants for Enhanced Vaccine Potency

Wang¹,

Singh²

2011

WJV

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“…Even though vaccine antigenicity in vitro may decrease upon freezing or excessive heat exposure as documented by some reports, this does not necessarily mean that vaccine immunogenicity is likewise impaired [11,20]. In this work, a three-injection vaccination program was employed.…”

Section: Discussionmentioning

confidence: 97%

“…Current HBV vaccines are of a liquid formulation, the stability of which is influenced by solution conditions such as pH, ionic strength, osmolarity, and the presence of excipients. Various studies have been performed to optimize the solution conditions in order to create thermostable HBV vaccines [11,19,20]. These thermostable vaccines contain all the components of the original HBV vaccines plus other specific components.…”

Section: Discussionmentioning

confidence: 99%

Unimpaired immunogenicity of yeast-expressed hepatitis B surface antigen stored at elevated temperatures

Shen

Rao

Tao

et al. 2016

Acta Biochim Biophys Sin

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Global adoption of hepatitis B virus (HBV) vaccines has greatly reduced new HBV infections. Current HBV vaccines are liquid suspensions containing recombinant hepatitis B surface antigen (HBsAg) particles mixed with aluminum phosphate or aluminum hydroxide. Refrigeration (2-8°C) as recommended for vaccine transport and storage may be unachievable in certain HBV-prevalent developing countries or regions. In this study, we stored yeast-expressed HBsAg and aluminum hydroxide separately at the standard (4°C) and elevated temperature (25, 37, or 45°C) for 14, 23, and 30 days, then mixed them and used the mixture to vaccinate mice with a prime-boost program. The antisera from all the vaccinated mice successfully inhibited HBV infection of HepG2 cells stably expressing HBV receptor sodium taurocholate cotransporting polypeptide. Furthermore, no serum HBsAg was detected in vaccinated mice on Day 1 post-hydrodynamic injection (HDI) of an HBV replicon plasmid and onwards, accompanied with an increasing anti-HBsAg antibody (HBsAb) level. In contrast, serum HBsAg in phosphate-buffered saline (PBS)-injected mice peaked on Day 4 post-HDI and was cleared on Day 14 post-HDI, which coincided with appearance of HBsAb on Day 7 post-HDI, suggesting a typical HBV acute infection process. HBV DNA peaked on Day 4 post-HDI in vaccinated mice, its level significantly lower than that in PBS-injected mice on Day 7 post-HDI, and showed a higher clearance rate. Taken together, we conclude that storing recombinant HBsAg at 25, 37, or 45°C for 14-30 days does not impair its immunogenicity in mice.

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Thermostable formulations of a hepatitis B vaccine and a meningitis A polysaccharide conjugate vaccine produced by a spray drying method

Cited by 53 publications

References 24 publications

Rational design of thermostable vaccines by engineered peptide-induced virus self-biomineralization under physiological conditions

Rational design of thermostable vaccines by engineered peptide-induced virus self-biomineralization under physiological conditions

Selection of Adjuvants for Enhanced Vaccine Potency

Unimpaired immunogenicity of yeast-expressed hepatitis B surface antigen stored at elevated temperatures

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