Safety evaluation of recombinant cholera toxin B subunit produced by Bacillus brevis as a mucosal adjuvant

Vaccine

Volumn 18, Issue 20, 2000, Pages 2164-2171

  Goto, Norihisa ^a   Maeyama, Jun Ichi ^a   Yasuda, Yoko ^b   Isaka, Masanori ^b   Matano, Keiko ^b   Kozuka, Satoshi ^b   Taniguchi, Tooru ^b   Miura, Yutaka ^b   Ohkuma, Kunio ^c   Tochikubo, Kunio ^b  

^a NATIONAL INSTITUTE OF INFECTIOUS DISEASES   (Japan)

^b NAGOYA CITY UNIV MEDICAL SCHOOL   (Japan)

^c Chemo Sero Therapeutic Research Institute   (Japan)

Author keywords

Intranasal administration; Mucosal adjuvant; Recombinant cholera toxin B subunit (rCTB); Safety

Indexed keywords

ALUMINUM HYDROXIDE; CHOLERA TOXIN; CHOLERA TOXIN B SUBUNIT; IMMUNOLOGICAL ADJUVANT; LACTATE DEHYDROGENASE; RECOMBINANT CHOLERA TOXIN B SUBUNIT; UNCLASSIFIED DRUG;

ANIMAL CELL; ANIMAL EXPERIMENT; ANIMAL TISSUE; ARTICLE; BLOOD VESSEL PERMEABILITY; BREVIBACILLUS BREVIS; CELL INFILTRATION; CONTROLLED STUDY; DRUG SAFETY; FEMALE; GRAM POSITIVE BACTERIUM; GUINEA PIG; HISTOPATHOLOGY; INTESTINE LOOP; MOUSE; MUCOSA; NEUTROPHIL; NONHUMAN; NOSE MUCOSA; PERITONEUM MACROPHAGE; PRIORITY JOURNAL; RABBIT; RESPIRATORY EPITHELIUM;

ADJUVANTS, IMMUNOLOGIC; ADMINISTRATION, INTRANASAL; ALUMINUM HYDROXIDE; ANIMALS; BACILLUS; CAPILLARY LEAK SYNDROME; CAPILLARY PERMEABILITY; CELLS, CULTURED; CHOLERA TOXIN; FEMALE; GUINEA PIGS; INFLAMMATION; INJECTIONS; INJECTIONS, INTRAMUSCULAR; INTESTINAL MUCOSA; INTESTINE, SMALL; L-LACTATE DEHYDROGENASE; MACROPHAGES, PERITONEAL; MICE; MICE, INBRED BALB C; MUSCLE, SKELETAL; NASAL CAVITY; NASAL MUCOSA; PEPTIDE FRAGMENTS; RABBITS; RECOMBINANT FUSION PROTEINS; SAFETY;

EID: 0034012850     PISSN: 0264410X     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0264-410X(99)00337-0     Document Type: Article

References (27)

1. Clements J.D., Finkelstein R.A. Isolation and characterization of homogeneous heat-labile enterotoxins with high specific activity from Escherichia coli cultures. Infect. Immun. 24:1979;760-769.
2. Clements J.D., Yancey R.L., Finkelstein R.A. Properties of homogeneous heat-labile enterotoxin from Escherichia coli. Infect. Immun. 29:1980;91-97.
3. Clements J.D., Hartzog N.M., Lyon F.L. Adjuvant activity of Escherichia coli heat-labile enterotoxin and effect on the induction of oral tolerance in mice to unrelated protein antigens. Vaccine. 6:1988;269-277.
4. Lycke N., Tsuji T., Holmgren J. The adjuvant effect of Vibrio cholerae and Escherichia coli heat-labile enterotoxins is linked to their ADP-ribosyl transferase activity. Eur. J. Immunol. 22:1992;2277-2281.
5. Lycke N., Holmgren J. Strong adjuvant properties of cholera toxin on gut mucosal immune responses to orally presented antigens. Immunology. 59:1986;301-308.
6. Tamura S., Yamanaka A., Shimohara M., Tomita T., Komase K., Tsuda Y., et al. Synergistic action of cholera toxin B subunit (and E. coli heat-labile toxin B subunit) and a trace amount of cholera whole toxin as an adjuvant for nasal influenza vaccine. Vaccine. 12:1994;419-426.
7. Tochikubo K., Isaka M., Yasuda Y., Kozuka S., Matano K., Miura Y., Taniguchi T. Recombinant cholera toxin B subunit acts as an adjuvant for the mucosal and systemic responses of mice to mucosally co-administered bovine serum albumin. Vaccine. 16:1998;150-155.
8. Isaka M., Yasuda Y., Kozuka S., Miura Y., Taniguchi T., Matano K., Goto N., Tochikubo K. Systemic and mucosal immune responses of mice to aluminium-adsorbed or aluminium-non-adsorbed tetanus toxoid administered intranasally with recombinant cholera toxin B subunit. Vaccine. 16:1998;1920-1926.
9. Ichikawa Y., Yamagata H., Tochikubo K., Udaka S. Very efficient extracellular production of cholera toxin B subunit using Bacillus brevis. FEMS Microbiol. Lett. 111:1993;219-224.
10. Yasuda Y., Matano K., Asai T., Tochikubo K. Affinity purification of recombinant cholera toxin B subunit oligomer expressed in Bacillus brevis for potential human use as a mucosal adjuvant. FEMS Immunol. Med. Microbiol. 20:1998;311-318.
11. Goto N., Kato H., Maeyama J., Eto K., Yoshihara S. Studies on the toxicities of aluminium hydroxide and calcium phosphate as immunological adjuvants for vaccines. Vaccine. 11:1993;914-918.
12. Goto N., Moribayashi A., Arimitsu Y. Biological activities of lipid components of Leptospira interrogans serovar copenhageni avirulent strain Shibaura. Curr. Microbiol. 20:1990;353-357.
13. Korzeniewski C., Callewaert D.M. An enzyme-release assay for natural cytotoxicity. J. Immunol. Methods. 64:1983;313-320.
14. Chao E.S., Dunbar D., Kaminsky L.S. Intracellular lactate dehydrogenase concentration as an index of cytotoxicity in rat hepatocyte primary culture. Cell. Biol. Toxicol. 4:1988;1-11.
15. Jurisic V., Spuzic I., Konjevic G. A comparison of the NK cell cytotoxicity with effects of TNF-alpha against K-562 cells, determined by LDH release assay. Cancer Lett. 138:1999;67-72.
16. Mery S., Gross E.A., Joyner D.R., Godo M., Morgan K.T. Nasal diagrams: a tool for recording the distribution of nasal lesions in rats and mice. Toxicol. Pathol. 22:1994;353-372.
17. Gross E.A., Mellick P.W., Kari F.W., Miller F.J., Morgan K.T. Histopathology and cell replication responses in the respiratory tract of rats and mice exposed by inhalation to glutaraldehyde for up to 13 weeks. Fundam. Appl. Toxicol. 23:1994;348-362.
18. Lee K.P., Valentine R., Bogdanffy M.S. Nasal lesion development and reversibility in rats exposed to aerosols of dibasic esters. Toxicol. Pathol. 20:1992;376-393.
19. Zwart A., Woutersen R.A., Wilmer J.W.G.M., Spit B.J., Feron V.J. Cytotoxic and adaptive effects in rat nasal epithelium after 3-day and 13-week exposure to low concentrations of formaldehyde vapour. Toxicology. 51:1988;87-99.
20. Gizurarson S., Tamura S., Kurata K., Hasiguchi K., Ogawa H. The effect of cholera toxin and cholera toxin B subunit on the nasal mucosal membrane. Vaccine. 9:1991;825-832.
21. Goto N., Akama K. Histopathological studies of reactions in mice injected with aluminum-adsorbed tetanus toxoid. Microbiol. Immunol. 26:1982;1121-1132.
22. Goto N., Akama K. Local hitopathological reactions to aluminum-adsorbed tetanus toxoid. Naturwissenschaften. 71:1984;427-428.
23. Goto N., Kato H., Maeyama J., Shibano M., Saito T., Yamaguchi J., Yoshihara S. Local tissue irritating effects and adjuvant activities of calcium phosphate and aluminium hydroxide with different physical properties. Vaccine. 15:1997;1364-1371.
24. Delmas A., Partidos C.D. The binding of chimeric peptides to GM1 ganglioside enables induction of antibody responses after intranasal immunization. Vaccine. 14:1996;1077-1082.
25. Craig J.P. A permeability factor (toxin) found in cholera stools and culture filtrates and its neutralization by convalescent cholera sera. Nature. 207:1965;614-616.
26. Finkelstein R.A., LoSpalluto J.J. Pathogenesis of experimental cholera. Preparation and isolation of choleragen and choleragenoid. J. Exp. Med. 130:1969;185-202.
27. Isaka M., Yasuda Y., Kozuka S., Taniguchi T., Miura Y., Matano K., Goto N., Tochikubo K. Intranasal or subcutaneous co-administration of recombinant cholera toxin B subunit stimulates only a slight or no level of the specific IgE response in mice to tetanus toxoid. Vaccine. 17:1999;944-948.