Safety, immunogenicity, and transmissibility in humans of CVD 1203, a live oral Shigella flexneri 2a vaccine candidate attenuated by deletions in aroA and virG

Infection and Immunity

Volumn 64, Issue 11, 1996, Pages 4542-4548

  Kotloff, Karen L ^a   Noriega, Fernando ^a   Losonsky, Genevieve A ^a   Sztein, Marcelo B ^a   Wasserman, Steven S ^a   Nataro, James P ^a   Levine, Myron M ^a  

^a UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CVD 1203; SHIGELLA VACCINE; UNCLASSIFIED DRUG;

ADULT; ARTICLE; CELL PROLIFERATION; CELL SPREADING; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE TRANSMISSION; DOUBLE BLIND PROCEDURE; DRUG SAFETY; EPITHELIUM CELL; GENE DELETION; HUMAN; HUMAN EXPERIMENT; IMMUNIZATION; IMMUNOGENICITY; NORMAL HUMAN; ORAL DRUG ADMINISTRATION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SEROCONVERSION; SHIGELLA FLEXNERI; SHIGELLOSIS;

EID: 0029859443     PISSN: 00199567     EISSN: None     Source Type: Journal    
DOI: 10.1128/iai.64.11.4542-4548.1996     Document Type: Article

References (39)

1. Azim, T., R. C. Halder, M. S. Sarker, S. Ahmed, J. Hamadani, A. Chowdhury, F. Quadri, M. A. Salam, R. B. Sack, and M. J. Albert. 1995 Cytokines in the stools of children with complicated shigellosis. Clin. Diagn. Lab. Immunol. 2:492-495.
2. Bernardini, M. L., J. Mounier, H. D'Hauteville, M. Coquis-Rondon, and P. J. Sansonetti. 1989. Identification of icsA, a plasmid locus of Shigella flexneri that governs bacterial intra- and intercellular spread through interaction with F-actin. Proc. Natl. Acad. Sci. USA 86:3867-3871.
3. Black, R. E., M. M. Levine, M. L. Clements, G. Lusonsky, D. Herrington, S. Berman, and S. Formal. 1987. Prevention of shigellosis by a Salmonella typhi-Shigella sonnei bivalent vaccine. J. Infect. Dis. 155:1260-1265.
4. Cohen, D., M. S. Green, C. Block, R. Slepon, and I. Ofek. 1991. Prospective study of the association between serum antibodies to lipopolysaccharide O antigen and the attack rate of shigellosis. J. Clin. Microbiol. 29:386-389.
5. de Suva, D. G. H., L. N. Mendis, N. Sheron, G. J. M. Alexander, D. C. A. Candy, H. Chart, and B. Rowe. 1993. Concentrations of interleukin 6 and tumour necrosis factor in serum and stool of children with Shigella dysenteriae I infection. Gut 34:194-198.
6. DuPont, H. L., R. B. Hornick, A. T. Dawkins, M. J. Snyder, and S. B. Formal. 1969. The response of man to virulent Shigella flexneri 2a. J. Infect. Dis. 119:296-299.
7. DuPont, H. L., R. B. Hornick, M. J. Snyder, J. P. Libonati, S. B. Formal, and E. J. Gangarosa. 1972. Immunity in shigellosis. II. Protection induced by oral live vaccine or primary infection. J. Infect. Dis. 125:12-16.
8. Fasano, A., F. R. Noriega, D. R. Maneval, S. Chanasongeram, R. Russell, S. Guandalini, and M. M. Levine. 1995. Shigella enterotoxin 1: an enterotoxin of Shigella flexneri 2a active in rabbit small intestine in vivo and in vitro. J. Clin. Invest. 95:2853-2861.
9. Fong, Y., and S. F. Lowry. 1990. Tumor necrosis factor in the pathophysiology of infection and sepsis. Clin. Immunol. Immunopathol. 55:157-170. (Review.)
10. Herrington, D. A., L. Van De Verg, S. B. Formal, T. L. Hale, B. D. Tall, S. J. Cruz, E. C. Tramont, and M. M. Levine. 1990. Studies in volunteers to evaluate candidate Shigella vaccines: further experience with a bivalent Salmonella typhi-Shigella sonnei vaccine and protection conferred by previous Shigella sonnei disease. Vaccine 8:353-357.
11. Hone, D. M., C. O. Tacket, A. M. Harris, B. Kay, G. Losonsky, and M. M. Levine. 1992. Evaluation in volunteers of a candidate live oral attenuated Salmonella typhi vector vaccine. J. Clin. Invest. 90:412-420.
12. Jung, H. C., L. Eckmann, S. K. Yang, A. Panja, J. Fierer, E. Morzycka-Wroblewska, and M. F. Kagnoff. 1995. A distinct array of proinflammatory cytokines is expressed in human colon epithelial cells in response to bacterial invasion. J. Clin. Invest. 95:55-65.
13. Kärnell, A., A. Li, C. R. Zhao, K. Karlsson, N. B. Minh, and A. A. Lindberg. 1995. Safety and immunogenicity study of the auxotrophic Shigella flexneri 2a vaccine SFL1070 with a deleted aroD gene in adult Swedish volunteers. Vaccine 13:88-99.
14. Keat, A. 1983. Reiter's syndrome and reactive arthritis in perspective. N. Engl. J. Med. 26:1606-1614.
15. Kotloff, K. L., D. A. Herrington, T. L. Hale, J. W. Newland, L. Van De Verg, J. P. Cogan, P. J. Snoy, J. C. Sadoff, S. B. Formal, and M. M. Levine. 1992. Safety, immunogenicity, and efficacy in monkeys and humans of invasive Escherichia coli K-12 hybrid vaccine candidates expressing Shigella flexneri 2a somatic antigen. Infect. Immun. 60:2218-2224.
16. Kotloff, K. L., G. A. Losonsky, J. P. Nataro, S. S. Wasserman, T. L. Hale, D. N. Taylor, J. W. Newland, J. C. Sadoff, S. B. Formal, and M. M. Levine. 1995. Evaluation of the safety, immunogenicity, and efficacy in adults of four doses of live oral hybrid Escherichia coli-Shigella flexneri 2a vaccine strain EcSf2a-2. Vaccine 13:495-502.
17. Kotloff, K. L., J. P. Nataro, G. A. Losonsky, S. S. Wasserman, T. L. Hale, D. N. Taylor, J. C. Sadoff, and M. M. Levine. 1995. Protection against shigellosis following homologous reinfection using a modified volunteer challenge model in which the inoculum is administered with bicarbonate buffer: clinical experience and implications for Shigella infectivity. Vaccine 13:1488-1494.
18. Levine, M. M., R. E. Black, M. L. Clements, C. Lanata, S. Sears, T. Honda, C. R. Young, and R. A. Finkelstein. 1984. Evaluation in humans of attenuated Vibrio cholerae El Tor Ogawa strain Texas Star-SR as a live oral vaccine. Infect. Immun. 43:515-522.
19. Levine, M. M., H. I. DuPont, E. J. Gangarosa, R. B. Hornick, M. J. Snyder, J. P. Libonati, K. Glaser, and S. B. Formal. 1972. Shigellosis in custodial institutions. II. Clinical, immunologic and bacteriologic response of institutionalized children to oral attenuated Shigella vaccines. Am. J. Epidemiol. 96:40-49.
20. Levine, M. M., W. E. Woodward, S. B. Formal, P. Gemski, H. L. DuPont, R. B. Hornick, and M. J. Snyder. 1977. Studies with a new generation of oral attenuated Shigella vaccine: Escherichia coli hearing surface antigens of Shigella flexneri. J. Infect. Dis. 136:577-582.
21. Lindberg, A. A., A. Kärnell, T. Pal, H. Sweiha, K. Hultenby, and B. A. D. Stocker. 1990. Construction of an auxotrophic Shigella flexneri strain for use as a live vaccine. Microb. Pathog. 8:433-440.
22. Losonsky, G. A., M. B. Kennels, Y. Lim, G. Krall, A. Z. Kapikian, and M. M. Levine. 1988. Systemic and mucosal immune responses to rhesus rotavirus vaccine MMU 18006. Pediatr. Infect. Dis. J. 7:388-393.
23. McGhee, J. R., and H. Kiyona. 1993. New perspectives in vaccine development: mucosal immunity to infections. Infect. Agents Dis. 2:55-73.
24. 32-ISTRATI). Arch. Roum. Pathol. Exp. Microbiol. 43:251-278.
25. Mel, D., E. J. Gangarosa, M. L. Radovanovic, B. L. Arsic, and S. Litvinjenko. 1971. Studies on vaccination against bacillary dysentery. 6. Protection of children by oral immunization with streptomycin-dependent Shigella strains. Bull. W.H.O. 45:457-464.
26. Mel, D. M., A. L. Terzin, and L. Vuksic. 1965. Studies on vaccination against bacillary dysentery. 3. Effective oral immunization against Shigella flexneri 2a in a field trial. Bull. W.H.O. 32:647-655.
27. Nataro, J. P., J. Seriwatana, A. Fasano, D. R. Maneval, L. D. Guers, F. Noriega, F. Dubovsky, M. M. Levine, and J. G. Morris, Jr. 1995. Identification and cloning of a novel plasmid-encoded enterotoxin in enteroinvasive Escherichia coli and Shigella strains. Infect. Immun. 63:4721-4728.
28. Nicholls, S., S. Stephens, C. P. Braegger, J. A. Walker-Smith, and T. T. MacDonald. 1993. Cytokines in stools of children with inflammatory bowel disease or infective diarrhoea. J. Clin. Pathol. 46:757-760.
29. Noriega, F. R., G. Losonsky, J. V. Wang, S. B. Formal, and M. M. Levine. 1996. Further characterization of ΔaroA ΔvirG Shigella flexneri 2a strain CVD 1203 as a mucosal Shigella vaccine and as a live-vector vaccine for delivering antigens of enterotoxigenic Escherichia coli. Infect. Immun. 64: 23-27.
30. Noriega, F. R., J. Y. Wang, G. Losonsky, D. R. Maneval, D. M. Hone, and M. M. Levine. 1994. Construction and characterization of attenuated ΔaroA ΔvirG Shigella flexneri 2a strain CVD 1203, a prototype live oral vaccine. Infect. Immun. 62:5168-5172.
31. Oaks, E. V., T. L. Hale, and S. B. Formal. 1986. Serum immune response to Shigella protein antigens in rhesus monkeys and humans infected with Shigella spp. Infect. Immun. 53:57-63.
32. Raqib, R., A. A. Lindberg, B. Wretlind, P. K. Bardhan, U. Andersson, and J. Andersson. 1995. Persistence of local cytokine production in shigellosis in acute and convalescent stages. Infect. Immun, 63:289-296.
33. Raqib, R., B. Wretlind, J. Anderson, and A. A. Lindberg. 1995. Cytokine secretion in acute shigellosis is correlated with disease activity and directed more to stool than to plasma. J. Infect. Dis. 171:376-384.
34. Shahid, N. S., M. M. Rahaman, K. Haider, H. Banu, and N. Rahman. 1985. Changing pattern of resistant Shiga bacillus (Shigella dysenteriae type 1) and Shigella flexneri in Bangladesh. J. Infect. Dis. 152:1114-1119.
35. Sokal, R. R., and F. J. Rohlf. 1981. Biometry. The principles and practice of statistics in biological research. W. H. Freeman and Co., San Francisco.
36. Stocker, B. A. D. 1988. Auxotrophic Salmonella typhi as a live vaccine. Vaccine 6:141-145.
37. Tracey, K. J. 1994. Tumor necrosis factor-alpha, p. 289-304. In A. W. Thomson (ed.), The cytokine handbook, 2nd ed. Academic Press, New York.
38. Tuttle, J., A. A. Ries, R. M. Chimba, C. U. Perera, N. H. Bean, and P. M. Griffin. 1995. Antimicrobial-resistant epidemic Shigella dysenteriae type 1 in Zambia: modes of transmission. J. Infect. Dis. 171:371-375.
39. Van de Verg, L., D. A. Herrington, J. R. Murphy, S. S. Wasserman, S. B. Formal, and M. M. Levine. 1990. Specific immunoglobulin A-secreting cells in peripheral blood of humans following oral immunization with a bivalent Salmonella typhi-Shigella sonnei vaccine or infection by pathogenic S. sonnei. Infect. Immun. 58:2002-2004.