Preparation and evaluation of a freeze-dried oral killed cholera vaccine formulation

European Journal of Pharmaceutics and Biopharmaceutics

Volumn 79, Issue 3, 2011, Pages 508-518

  Borde, Annika ^a   Larsson, Anette ^a   Holmgren, Jan ^b   Nygren, Erik ^b  

^a CHALMERS UNIVERSITY OF TECHNOLOGY   (Sweden)

^b UNIVERSITY OF GOTHENBURG   (Sweden)

Author keywords

Freeze drying; Mannitol; Stabilization; Sucrose; Trehalose; Vibrio cholerae

Indexed keywords

BACTERIUM LIPOPOLYSACCHARIDE; CHOLERA VACCINE; IMMUNOGLOBULIN A; INACTIVATED VACCINE; SUCROSE; TREHALOSE;

ANIMAL EXPERIMENT; ANTIBODY RESPONSE; ARTICLE; DRUG FORMULATION; IMMUNOGENICITY; IMMUNOGLOBULIN BLOOD LEVEL; IN VITRO STUDY; IN VIVO STUDY; MOUSE; MUCOSAL IMMUNITY; NONHUMAN;

ADMINISTRATION, ORAL; ANIMALS; ANTIBODIES, BACTERIAL; CALORIMETRY, DIFFERENTIAL SCANNING; CHEMISTRY, PHARMACEUTICAL; CHOLERA TOXIN; CHOLERA VACCINES; ENZYME-LINKED IMMUNOSORBENT ASSAY; FREEZE DRYING; IMMUNOGLOBULIN A; INTESTINE, SMALL; LIPOPOLYSACCHARIDES; MICE; MICE, INBRED BALB C; MICROSCOPY, ELECTRON, SCANNING; SURFACE PROPERTIES; TECHNOLOGY, PHARMACEUTICAL; VACCINES, INACTIVATED; VIBRIO CHOLERAE; X-RAY DIFFRACTION;

EID: 80053982918     PISSN: 09396411     EISSN: 18733441     Source Type: Journal    
DOI: 10.1016/j.ejpb.2011.06.009     Document Type: Article

References (24)

1. WHO, Cholera, 2009, Weekly Epidemiological Report, 85, 2010, pp. 293-308.
2. J.N. Zuckerman, L. Rombo, and A. Fisch The true burden and risk of cholera: implications for prevention and control The Lancet Infectious Diseases 7 2007 521 530 (Pubitemid 47079151)
3. F. Qadri, G. Mohi, J. Hossain, T. Azim, A.M. Khan, M.A. Salam, R.B. Sack, M.J. Albert, and A.M. Svennerholm Comparison of the vibriocidal antibody response in cholera due to Vibrio cholerae O139 Bengal with the response in cholera due to Vibrio cholerae O1 Clinical and Diagnostic Laboratory Immunology 2 1995 685 688
4. W.I. Lencer, and B. Tsai The intracellular voyage of cholera toxin: going retro Trends in Biochemical Sciences 28 2003 639 645 (Pubitemid 37500898)
5. J. Sánchez, and J. Holmgren Cholera toxin structure, gene regulation and pathophysiological and immunological aspects Cellular and Molecular Life Sciences 65 2008 1347 1360
6. D. Vanden Broeck, C. Horvath, and M.J.S. De Wolf Vibrio cholerae: cholera toxin The International Journal of Biochemistry & Cell Biology 39 2007 1771 1775 (Pubitemid 47321356)
7. J.D. Clemens, J.R. Harris, D.A. Sack, J. Chakraborty, F. Ahmed, B.F. Stanton, M.U. Khan, B.A. Kay, N. Huda, and M.R. Khan Field trial of oral cholera vaccines in Bangladesh: results of one year of follow-up Journal of Infectious Diseases 158 1988 60 69
8. J.D. Clemens, D.A. Sack, J.R. Harris, J. Chakraborty, P.K. Neogy, B. Stanton, N. Huda, M.U. Khan, B.A. Kay, and M.R. Khan Cross-protection by B subunit-whole cell cholera vaccine against diarrhea associated with heat-labile toxin-producing enterotoxigenic Escherichia coli: results of a large-scale field trial Journal of Infectious Diseases 158 1988 372 377
9. J. Holmgren, and J.B. Kaper Oral cholera vaccines M.M. Levine, J.B. Kaper, R. Rappuoli, M.A. Liu, M.F. Good, New Generation Vaccines 2009 Marcel Dekker New York
10. M.J. Pikal Freeze drying J. Swarbrick, Encyclopedia of Pharmaceutical Technology 2006 Informa Healthcare New York 1807 1833
11. J.H. Crowe, L.M. Crowe, J.F. Carpenter, A.S. Rudolph, C.A. Wistrom, B.J. Spargo, and T.J. Anchordoguy Interactions of sugars with membranes Biochimica et Biophysica Acta 947 1988 367 384
12. S.B. Leslie, E. Israeli, B. Lighthart, J.H. Crowe, and L.M. Crowe Trehalose and sucrose protect both membranes and proteins in intact bacteria during drying Applied and Environmental Microbiology 61 1995 3592 3597
13. O. Westphal, and K. Jann Bacterial lipopolysaccharide extraction with phenol:water and further application of the procedure Methods in Carbohydrate Chemistry 5 1965
14. E. Nygren, J. Holmgren, and S.R. Attridge Murine antibody responses following systemic or mucosal immunization with viable or inactivated Vibrio cholerae Vaccine 26 2008 6784 6790
15. A.M. Svennerholm, and G. Wiklund Rapid GM1-enzyme-linked immunosorbent assay with visual reading for identification of Escherichia coli heat-labile enterotoxin Journal of Clinical Microbiology 17 1983 596 600 (Pubitemid 13160860)
16. E. Nygren, B.L. Li, J. Holmgren, and S.R. Attridge Establishment of an adult mouse model for direct evaluation of the efficacy of vaccines against Vibrio cholerae Infection and Immunity 77 2009 3475 3484
17. E.-L. Johansson, C. Rask, M. Fredriksson, K. Eriksson, C. Czerkinsky, and J. Holmgren Antibodies and antibody-secreting cells in the female genital tract after vaginal or intranasal immunization with cholera toxin B subunit or conjugates Infection and Immunity 66 1998 514 520 (Pubitemid 28074190)
18. C.J. Vindurampulle, and S.R. Attridge Impact of vector priming on the immunogenicity of recombinant salmonella vaccines Infection and Immunity 71 2003 287 297 (Pubitemid 36026032)
19. M.K. Franchini Particle engineering J. Swarbrick, Encyclopedia of Pharmaceutical Technology 2006 Informa Healthcare New York 2567 2581
20. J.H. Eldridge, C.J. Hammond, J.A. Meulbroek, J.K. Staas, R.M. Gilley, and T.R. Tice Controlled vaccine release in the gut-associated lymphoid tissues. I. Orally administered biodegradable microspheres target the Peyer's patches Journal of Controlled Release 11 1990 205 214 (Pubitemid 20070098)
21. J.D. Clemens, L.F. van, D.A. Sack, J. Chakraborty, M.R. Rao, F. Ahmed, J.R. Harris, M.R. Khan, M. Yunus, and S. Huda Field trial of oral cholera vaccines in Bangladesh: serum vibriocidal and antitoxic antibodies as markers of the risk of cholera Journal of Infectious Diseases 163 1991 1235 1242
22. M.M. Levine, and C.O. Tacket Recombinant live cholera vaccines P.A. Wachsmuth, P.A. Blake, O. Olsvik, Vibrio cholerae and Cholera: Molecular to Global Perspectives 1994 ASM Press Washington, DC 395 413
23. G.-e. Rhie, H.-M. Jung, B.S. Kim, and J.J. Mekalanos Construction of a Vibrio cholerae prototype vaccine strain O395-N1-E1 which accumulates cell-associated cholera toxin B subunit Vaccine 26 2008 5443 5448
24. W. Wang Lyophilization and development of solid protein pharmaceuticals International Journal of Pharmaceutics 203 2000 1 60 (Pubitemid 30627625)