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

被引：34

作者：

Chen, D. ^{[1
]}

Kapre, S. ^{[2
]}

Goel, A. ^{[2
]}

Suresh, K. ^{[2
]}

Beri, S. ^{[2
]}

Hickling, J. ^{[3
]}

Jensen, J. ^{[4
]}

Lal, M. ^{[1
]}

Preaud, J. M. ^{[1
]}

LaForce, M. ^{[1
]}

Kristensen, D. ^{[1
]}

机构：

[1] PATH, Seattle, WA 98121 USA

[2] Serum Inst India Ltd, Pune, Maharashtra, India

[3] Working Tandem Ltd, Cambridge, England

[4] GEA Niro, Soborg, Denmark

来源：

VACCINE | 2010年 / 28卷 / 31期

基金：

比尔及梅琳达.盖茨基金会;

关键词：

Vaccine; Stability; Spray dry; Formulation; COLD CHAIN; STABILIZATION; STABILITY; TREHALOSE; POWDER; VIRUS; PROTEINS; AFRICA; STATE; HEAT;

D O I：

10.1016/j.vaccine.2010.04.112

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

Thermostable vaccines promise to simplify the logistics of vaccine distribution and expand the immunization coverage. In this study, a pilot-scale spray drying process was developed and used to produce glassy state formulations of a recombinant hepatitis B (HepB) vaccine containing aluminum adjuvant and Neisseria meningitidis A (MenA) protein-polysaccharide conjugate vaccine, representing two common types of subunit vaccines in use today: the spray-dried HepB vaccine formulations were stable for at least 24 months at 37 degrees C while several MenA vaccine formulations exhibited complete stability at temperatures up to 60 degrees C. This study demonstrates the feasibility of producing thermostable vaccines with advanced processing and formulation technologies. (C) 2010 Elsevier Ltd. All rights reserved.

引用

页码：5093 / 5099

页数：7

共 26 条

[1] Rational design of an influenza subunit vaccine powder with sugar glass technology: Preventing conformational changes of haemagglutinin during freezing and freeze-drying
Amorij, J.-P.
Meulenaar, J.
Hinrichs, W. L. J.
Stegmann, T.
Huckriede, A.
Coenen, F.
Frijlink, H. W.
[J]. VACCINE, 2007, 25 (35) : 6447 - 6457
[2] Aerosolization properties, surface composition and physical state of spray-dried protein powders
Bosquillon, C
Rouxhet, PG
Ahimou, F
Simon, D
Culot, C
Préat, V
Vanbever, R
[J]. JOURNAL OF CONTROLLED RELEASE, 2004, 99 (03) : 357 - 367
[3] Characterization of a thermostable hepatitis B vaccine formulation
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
[J]. VACCINE, 2009, 27 (34) : 4609 - 4614
[4] Stabilizing formulations for inhalable powders of live-attenuated measles virus vaccine
Burger, Jessica L.
Cape, Stephen P.
Braun, Chad S.
Mcadams, David H.
Best, Jessica A.
Bhagwat, Pradnya
Pathak, Pankaj
Rebits, Lia G.
Sievers, Robert E.
[J]. JOURNAL OF AEROSOL MEDICINE AND PULMONARY DRUG DELIVERY, 2008, 21 (01) : 25 - 34
[5] Burke CJ, 1999, CRIT REV THER DRUG, V16, P1
[6] Opportunities and challenges of developing thermostable vaccines
Chen, Dexiang
Kristensen, Debra
[J]. EXPERT REVIEW OF VACCINES, 2009, 8 (05) : 547 - 557
[7] Characterization of the freeze sensitivity of a hepatitis B vaccine
Chen, Dexiang
Tyagi, Anil
Carpenter, John
Perkins, Shalimar
Sylvester, David
Guy, Mark
Kristensen, Debra D.
Braun, LaToya Jones
[J]. HUMAN VACCINES, 2009, 5 (01): : 26 - 32
[8] Fast dynamics and stabilization of proteins: Binary glasses of trehalose and glycerol
Cicerone, MT
Soles, CL
[J]. BIOPHYSICAL JOURNAL, 2004, 86 (06) : 3836 - 3845
[9] Spray drying of an attenuated live Newcastle disease vaccine virus intended for respiratory mass vaccination of poultry
Corbanie, E. A.
Remon, J. P.
Van Reeth, K.
Landman, W. J. M.
van Eck, J. H. H.
Vervaet, C.
[J]. VACCINE, 2007, 25 (49) : 8306 - 8317
[10] The trehalose myth revisited: Introduction to a symposium on stabilization of cells in the dry state
Crowe, JH
Crowe, LM
Oliver, AE
Tsvetkova, N
Wolkers, W
Tablin, F
[J]. CRYOBIOLOGY, 2001, 43 (02) : 89 - 105

← 1 2 3 →