Safety and immunogenicity in humans of an attenuated Salmonella typhi vaccine vector strain expressing plasmid-encoded hepatitis B antigens stabilized by the Asd-balanced lethal vector system

Infection and Immunity

Volumn 65, Issue 8, 1997, Pages 3381-3385

  Tacket, Carol O ^a,d   Kelly, Sandra M ^b   Schödel, Florian ^c,e   Losonsky, Genevieve ^a   Nataro, James P ^a   Edelman, Robert ^a   Levine, Myron M ^a   Curtiss III, Roy ^b  

^a University of Maryland School of Medicine Center for Vaccine Development   (United States)

^b WASHINGTON UNIVERSITY   (United States)

^c WALTER REED ARMY INSTITUTE OF RESEARCH   (United States)

^d Center for Vaccine Development   (United States)

^e MERCK RESEARCH LABORATORIES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

HEPATITIS B ANTIGEN; HEPATITIS B VACCINE; VIRUS VECTOR;

ADULT; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG SAFETY; HEPATITIS B; HUMAN; IMMUNOGENICITY; NORMAL HUMAN; ORAL DRUG ADMINISTRATION; PLASMID; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SALMONELLA TYPHI; SEROCONVERSION; VIRUS ATTENUATION;

EID: 0030758117     PISSN: 00199567     EISSN: None     Source Type: Journal    
DOI: 10.1128/iai.65.8.3381-3385.1997     Document Type: Article

References (28)

1. Alper, M. D., and B. N. Ames. 1978. Transport of antibiotics and metabolite analogs by systems under cyclic AMP control: positive selection of Salmonella typhimurium cya and crp mutants. J. Bacteriol. 133:149-157.
2. Botsford, J. L., and J. G. Harman. 1992. Cyclic AMP in prokaryotes. Microbiol. Rev. 56:100-122.
3. Clements, J. D., and S. EI-Morshidy. 1984. Construction of a potential live-oral bivalent vaccine for typhoid fever and cholera-Escherichia coli-related diarrheas. Infect. Immun. 46:564-569.
4. Curtiss, R., III, and S. M. Kelly. 1987. Salmonella typhimurium deletion mutants lacking adenylate cyclase and cyclic AMP receptor protein are avirulent and immunogenic. Infect. Immun. 55:3035-3043.
5. Curtiss, R., III, S. M. Kelly, P. A. Gulig, and K. Nakayama. 1989. Selective delivery of antigens by recombinant bacteria. Curr. Top. Microbiol. Immunol. 146:35-49.
6. Curtiss, R., III, S. B. Porter, M. Munson, S. A. Tinge, J. O. Hassan, C. Gentry-Weeks, and S. M. Kelly. 1991. Nonrecombinant and recombinant avirulent live vaccines for poultry, p. 169-198. In L. C. Blankenship, N. A. Cox, N. J. Stern, and R. J. Meinersmann (ed.), Colonization control of human bacterial enteropathogens in poultry. Academic Press, Inc., New York, N.Y.
7. Delos, S., M. T. Villar, P. Hu, and D. L. Peterson. 1991. Cloning, expression and characterization of the pre-S domain of hepatitis B surface antigen. devoid of the S protein. Biochem. J. 276:411-416.
8. Forrest, B. D. 1988. Identification of an intestinal immune response using peripheral blood lymphocytes. Lancet i:81-83.
9. Gerlich, W. Unpublished method.
10. Hohmann, E. L., C. A. Oletta, K. P. Killeen, and S. I. Miller. 1996. PhoP/phoQ-deleted Salmonella typhi (Ty800) is a safe and immunogenic single-dose typhoid fever vaccine in volunteers. J. Infect. Dis. 173:1408-1414.
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. 90:412-120.
12. Hornick, R. B., S. E. Greisman, T. E. Woodward, H. L. DuPont, A. T. Dawkins, and M. J. Snyder. 1970. Typhoid fever: pathogenesis and immunologic control. N. Engl. J. Med. 283:686-691.
13. Kelly, S. M., B. A. Bosecker, and R. Curtiss III. 1992. Characterization and protective properties of attenuated mutants of Salmonella choleraesuis. Infect. Immun. 60:4881-4890.
14. Levine, M. M., J. Galen, E. Barry, F. Noriega, S. Chatfield, M. Sztein, G. Dougan, and C. Tacket. 1996. Attenuated Salmonella as live oral vaccines against typhoid fever and as live vectors. J. Biotechnol. 44:193-196.
15. Levine, M. M., D. Herrington, J. R. Murphy, J. G. Morris, G. Losonsky, B. Tall, A. A. Lindberg, S. Svenson, S. Baqar, M. F. Edwards, and B. Stocker. 1987. Safety, infectivity, immunogenicity, and in vivo stability of two attenuated auxotrophic mutant strains of Salmonella typhi, 541Ty and 543Ty, as live oral vaccines in humans. J. Clin. Invest. 79:888-902.
16. + expression-cloning vector: stable maintenance and high-level expression of cloned genes in a Salmonella vaccine strain. Bio/Technology 6:693-697.
17. Nardelli-Haefliger, D., J.-P. Kraehenbuhl, R. Curtiss III, F. Schödel, A. Potts, S. Kelly, and P. De Grand. 1996. Oral and rectal immunization of adult female volunteers with a recombinant attenuated Salmonella typhi vaccine strain. Infect. Immun. 64:5214-5224.
18. Peterson, D. Unpublished method.
19. Roberts, M., S. N. Chatfield, and G. Dougan. 1994. Salmonella as carriers of heterologous antigens, p. 27-58. In D. T. O'Hagan (ed.), Novel delivery systems for oral vaccines. CRC Press, Inc., Boca Raton, Fla.
20. Ross, E. M., and A. G. Gilman. 1980. Biochemical properties of hormone-sensitive adenylate cyclase. Annu. Rev. Biochem. 49:533-564.
21. Schödel, F., S. M. Kelly, D. L. Peterson, U. R. Milich, and R. Curtiss III. 1994. Hybrid hepatitis B virus core-pre-S proteins synthesized in avirulent Salmonella typhimurium and Salmonella typhi for oral vaccination. Infect. Immun. 62:1664-1676.
22. Schödel, F., D. R. Milich, and H. Will. 1990. Hepatitis B virus nucleosapsid/pre-S1 fusion proteins expressed in attenuated Salmonella for oral vaccination. J. Immunol. 145:4317-4321.
23. Schödel, F., D. Peterson, J. Hughes, and D. R. Milich. 1993. Avirulent Salmonella expressing hybrid hepatitis B virus core/preS genes for oral vaccination. Vaccine 11:143-148.
24. Schödel, F., H. Will, and D. R. Milich. 1991. Hybrid hepatitis B virus core/pre-S particles expressed in attenuated Salmonellae for oral immunization, p. 319-325. In F. Brown, R. M. Chanock, H. S. Ginsberg, and R. A. Lerner (ed.), Vaccines 91. Cold Spring Harbor Laboratory, Cold Spring Harbor, N.Y.
25. Schwartzel, E. H., Jr., S. Bachman, and R. A. Levine. 1977. Cyclic nucleotide activity in gastrointestinal tissues and fluids. Anal. Biochem. 78:345-405.
26. Tacket, C. O., D. M. Hone, R. Curtiss III, S. M. Kelly, G. Losonsky, L. Guers, A. M. Harris, R. Edelman, and M. M. Levine. 1992. Comparison of the safety and immunogenicity of δaroC δaroD and δcya δcrp Salmonella typhi strains in adult volunteers. Infect. Immun. 60:536-541.
27. Tacket, C. O., D. M. Hone, G. A. Losonsky, L. Guers, R. Edelman, and M. M. Levine. 1992. Clinical acceptability and immunogenicity of CVD 908 Salmonella typhi vaccine strain. Vaccine 10:443-446.
28. 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.