Clinical trial to evaluate safety and immunogenicity of an oral inactivated enterotoxigenic Escherichia coli prototype vaccine containing CFA/I overexpressing bacteria and recombinantly produced LTB/CTB hybrid protein

Vaccine

Volumn 31, Issue 8, 2013, Pages 1163-1170

  Lundgren, A ^a   Leach, S ^a   Tobias, J ^a   Carlin, N ^b   Gustafsson, B ^b   Jertborn, M ^a   Bourgeois, L ^c   Walker, R ^c   Holmgren, J ^a   Svennerholm, A M ^a  

^a UNIVERSITY OF GOTHENBURG   (Sweden)

^b Gunnar Asplunds allé   (Sweden)

^c PATH   (United States)

Author keywords

CFA I; ETEC; LTB; Mucosa; Secretory IgA; Vaccine

Indexed keywords

CHOLERA TOXIN; ESCHERICHIA COLI VACCINE; IMMUNOGLOBULIN A; IMMUNOGLOBULIN G; RECOMBINANT PROTEIN;

ADULT; ANTIBODY RESPONSE; ARTICLE; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG SAFETY; DRUG TOLERABILITY; ENTEROTOXIGENIC ESCHERICHIA COLI; FEMALE; HUMAN; HUMAN EXPERIMENT; IMMUNIZATION; IMMUNOGENICITY; MALE; MUCOSA; NONHUMAN; NORMAL HUMAN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL;

ADJUVANTS, IMMUNOLOGIC; ADMINISTRATION, ORAL; ADULT; ANTIBODIES, BACTERIAL; BACTERIAL TOXINS; CHOLERA TOXIN; COLICINS; DOUBLE-BLIND METHOD; ENTEROTOXIGENIC ESCHERICHIA COLI; ENTEROTOXINS; ESCHERICHIA COLI PROTEINS; ESCHERICHIA COLI VACCINES; FEMALE; HUMAN EXPERIMENTATION; HUMANS; IMMUNITY, MUCOSAL; IMMUNOGLOBULIN A; IMMUNOGLOBULIN G; MALE; MIDDLE AGED; VACCINES, INACTIVATED; VACCINES, SYNTHETIC; YOUNG ADULT;

EID: 84873100213     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2012.12.063     Document Type: Article

References (32)

1. World Health Organization. Diarrhoeal diseases. [consulted October 2012]. http://www.who.int/vaccine_research/diseases/diarrhoeal/en/index4.html.
2. Qadri F., Svennerholm A.M., Faruque A.S., Sack R.B. Enterotoxigenic Escherichia coli in developing countries: epidemiology, microbiology, clinical features, treatment, and prevention. Clin Microbiol Rev 2005, 18(3):465-483.
3. Walker R.I., Steele D., Aguado T. Analysis of strategies to successfully vaccinate infants in developing countries against enterotoxigenic E. coli (ETEC) disease. Vaccine 2007, 25(14):2545-2566.
4. Svennerholm A.M., Lundgren A. Recent progress toward an enterotoxigenic Escherichia coli vaccine. Expert Rev Vaccines 2012, 11(4):495-507.
5. Jertborn M., Ahren C., Holmgren J., Svennerholm A.M. Safety and immunogenicity of an oral inactivated enterotoxigenic Escherichia coli vaccine. Vaccine 1998, 16(2-3):255-260.
6. Svennerholm A.M., Tobias J. Vaccines against enterotoxigenic Escherichia coli. Expert Rev Vaccines 2008, 7(6):795-804.
7. Ahren C., Jertborn M., Svennerholm A.M. Intestinal immune responses to an inactivated oral enterotoxigenic Escherichia coli vaccine and associated immunoglobulin A responses in blood. Infect Immun 1998, 66(7):3311-3316.
8. Jertborn M., Ahren C., Svennerholm A.M. Dose-dependent circulating immunoglobulin A antibody-secreting cell and serum antibody responses in Swedish volunteers to an oral inactivated enterotoxigenic Escherichia coli vaccine. Clin Diagn Lab Immunol 2001, 8(2):424-428.
9. Savarino S.J., Hall E.R., Bassily S., Brown F.M., Youssef F., Wierzba T.F., et al. Oral, inactivated, whole cell enterotoxigenic Escherichia coli plus cholera toxin B subunit vaccine: results of the initial evaluation in children. PRIDE Study Group. J Infect Dis 1999, 179(1):107-114.
10. Savarino S.J., Hall E.R., Bassily S., Wierzba T.F., Youssef F.G., Peruski L.F., et al. Introductory evaluation of an oral, killed whole cell enterotoxigenic Escherichia coli plus cholera toxin B subunit vaccine in Egyptian infants. Pediatr Infect Dis J 2002, 21(4):322-330.
11. Qadri F., Ahmed T., Ahmed F., Bradley Sack R., Sack D.A., Svennerholm A.M. Safety and immunogenicity of an oral, inactivated enterotoxigenic Escherichia coli plus cholera toxin B subunit vaccine in Bangladeshi children 18-36 months of age. Vaccine 2003, 21(19-20):2394-2403.
12. Qadri F., Ahmed T., Ahmed F., Begum Y.A., Sack D.A., Svennerholm A.M. Reduced doses of oral killed enterotoxigenic Escherichia coli plus cholera toxin B subunit vaccine is safe and immunogenic in Bangladeshi infants 6-17 months of age: dosing studies in different age groups. Vaccine 2006, 24(10):1726-1733.
13. Sack D.A., Shimko J., Torres O., Bourgeois A.L., Francia D.S., Gustafsson B., et al. Randomised, double-blind, safety and efficacy of a killed oral vaccine for enterotoxigenic E. Coli diarrhoea of travellers to Guatemala and Mexico. Vaccine 2007, 25(22):4392-4400.
14. Isidean S.D., Riddle M.S., Savarino S.J., Porter C.K. A systematic review of ETEC epidemiology focusing on colonization factor and toxin expression. Vaccine 2011, 29(37):6167-6178.
15. Lebens M., Shahabi V., Backstrom M., Houze T., Lindblad N., Holmgren J. Synthesis of hybrid molecules between heat-labile enterotoxin and cholera toxin B subunits: potential for use in a broad-spectrum vaccine. Infect Immun 1996, 64(6):2144-2150.
16. Svennerholm A.M. From cholera to enterotoxigenic Escherichia coli (ETEC) vaccine development. Indian J Med Res 2011, 133(2):188-196.
17. Tobias J., Svennerholm A.M. Strategies to overexpress enterotoxigenic Escherichia coli (ETEC) colonization factors for the construction of oral whole-cell inactivated ETEC vaccine candidates. Appl Microbiol Biotechnol 2012, 93(6):2291-2300.
18. Holmgren J, Blomquist M, Bourgeois L, Carlin N, Clements J, Ekman A, et al. Preclinical evaluation of an oral inactivated ETEC vaccine, based on E. coli overexpressing CFA/I, CS3, CS5, and CS6 together with LTB/CTB subunit, and of the adjuvant effect of co-administration with dmLT. Vaccines for enteric diseases 2011; Cannes, France.
19. Tobias J., Lebens M., Bolin I., Wiklund G., Svennerholm A.M. Construction of non-toxic Escherichia coli and Vibrio cholerae strains expressing high and immunogenic levels of enterotoxigenic E. coli colonization factor I fimbriae. Vaccine 2008, 26(6):743-752.
20. Tobias J., Holmgren J., Hellman M., Nygren E., Lebens M., Svennerholm A.M. Over-expression of major colonization factors of enterotoxigenic Escherichia coli, alone or together, on non-toxigenic E. coli bacteria. Vaccine 2010, 28(43):6977-6984.
21. Gothefors L., Ahren C., Stoll B., Barua D.K., Orskov F., Salek M.A., et al. Presence of colonization factor antigens on fresh isolates of fecal Escherichia coli: a prospective study. J Infect Dis 1985, 152(6):1128-1133.
22. Sanchez J., Holmgren J. Recombinant system for overexpression of cholera toxin B subunit in Vibrio cholerae as a basis for vaccine development. Proc Natl Acad Sci USA 1989, 86(2):481-485.
23. Lundgren A., Kaim J., Jertborn M. Parallel analysis of mucosally derived B- and T-cell responses to an oral typhoid vaccine using simplified methods. Vaccine 2009, 27(33):4529-4536.
24. Wenneras C., Qadri F., Bardhan P.K., Sack R.B., Svennerholm A.M. Intestinal immune responses in patients infected with enterotoxigenic Escherichia coli and in vaccinees. Infect Immun 1999, 67(12):6234-6241.
25. Harro C., Sack D., Bourgeois A.L., Walker R., Denearing B., Feller A., et al. A combination vaccine consisting of three live attenuated enterotoxigenic Escherichia coli strains expressing a range of colonization factors and LTB is well tolerated and immunogenic in a placebo-controlled double-blind phase I trial in healthy adults. Clin Vaccine Immunol 2011, 18(12):2118-2127.
26. Carpenter C.M., Hall E.R., Randall R., McKenzie R., Cassels F., Diaz N., et al. Comparison of the antibody in lymphocyte supernatant (ALS) and ELISPOT assays for detection of mucosal immune responses to antigens of enterotoxigenic Escherichia coli in challenged and vaccinated volunteers. Vaccine 2006, 24(18):3709-3718.
27. Peltola H., Siitonen A., Kyronseppa H., Simula I., Mattila L., Oksanen P., et al. Prevention of travellers' diarrhoea by oral B-subunit/whole-cell cholera vaccine. Lancet 1991, 338(8778):1285-1289.
28. Clemens J.D., Sack D.A., Harris J.R., Chakraborty J., Neogy P.K., Stanton B., et al. 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. J Infect Dis 1988, 158(2):372-377.
29. Qadri F., Saha A., Ahmed T., Al Tarique A., Begum Y.A., Svennerholm A.M. Disease burden due to enterotoxigenic Escherichia coli in the first 2 years of life in an urban community in Bangladesh. Infect Immun 2007, 75(8):3961-3968.
30. Svennerholm A.M., Sack D.A., Holmgren J., Bardhan P.K. Intestinal antibody responses after immunisation with cholera B subunit. Lancet 1982, 1(8267):305-308.
31. Norton E.B., Lawson L.B., Freytag L.C., Clements J.D. Characterization of a mutant Escherichia coli heat-labile toxin, LT(R192G/L211A), as a safe and effective oral adjuvant. Clin Vaccine Immunol 2011, 18(4):546-551.
32. Tobias J., Svennerholm A.M., Carlin N.I., Lebens M., Holmgren J. Construction of a non-toxigenic Escherichia coli oral vaccine strain expressing large amounts of CS6 and inducing strong intestinal and serum anti-CS6 antibody responses in mice. Vaccine 2011, 29(48):8863-8869.