Refinement of a Human Challenge Model for Evaluation of Enterotoxigenic Escherichia coli Vaccines
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| Published in | Clinical and Vaccine Immunology Vol. 18; no. 10; pp. 1719 - 1727 |
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| Main Authors | , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
American Society for Microbiology
01.10.2011
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| ISSN | 1556-6811 1556-679X 1556-679X |
| DOI | 10.1128/CVI.05194-11 |
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| AbstractList | Enterotoxigenic
Escherichia coli
(ETEC) strain H10407 (serotype O78:H11 producing heat-labile toxin [LT], heat-stable toxin [ST], and colonization factor I [CFA/I]) induces reliably high diarrheal attack rates (ARs) in a human challenge model at doses of ≥10
9
CFU. A descending-dose challenge study was conducted with changes to the standard fasting time and buffer formulation, seeking conditions that permit lower inocula while maintaining reproducibly high ARs. In cohort 1, 20 subjects were fasted overnight and randomized 1:1:1:1 to receive H10407 at doses of 10
8
CFU with bicarbonate, 10
8
CFU with CeraVacx, 10
7
CFU with bicarbonate, or 10
7
CFU with CeraVacx. Subsequent cohorts received H10407 (10
7
CFU with bicarbonate) with similar fasting conditions. Cohort 2 included 15 ETEC-naïve volunteers. Cohort 3 included 10 ETEC-naïve volunteers and 10 rechallenged volunteers. In all, 25/35 (71%) ETEC-naïve recipients of 10
7
CFU of H10407 developed moderate or severe diarrhea (average maximum stool output/24 h = 1,042 g), and most (97%) shed H10407 (maximum geometric mean titer = 7.5 × 10
7
CFU/gram of stool). Only one of 10 rechallenged volunteers developed diarrhea. These rechallenged subjects had reduced intestinal colonization, reflected by quantitative microbiology of fecal samples. Among the 35 ETEC-naïve subjects, anti-lipopolysaccharide (LPS) O78 serum antibody responses were striking, with positive IgA and IgG antibody responses in 33/35 (94%) and 25/35 (71%), respectively. Anti-heat-labile enterotoxin (LTB) serum IgA and IgG responses developed in 19/35 (54%) and 14/35 (40%) subjects, respectively. Anti-CFA/I serum IgA and IgG responses were detected in 15/35 (43%) and 8/35 (23%) subjects. After the second challenge, participants exhibited blunted anti-LPS and -LTB responses but a booster response to CFA/I. This ETEC model should prove useful in the future evaluation of ETEC vaccine candidates. Enterotoxigenic Escherichia coli (ETEC) strain H10407 (serotype O78:H11 producing heat-labile toxin [LT], heat-stable toxin [ST], and colonization factor I [CFA/I]) induces reliably high diarrheal attack rates (ARs) in a human challenge model at doses of 109 CFU. A descending-dose challenge study was conducted with changes to the standard fasting time and buffer formulation, seeking conditions that permit lower inocula while maintaining reproducibly high ARs. In cohort 1, 20 subjects were fasted overnight and randomized 1:1:1:1 to receive H10407 at doses of 108 CFU with bicarbonate, 108 CFU with CeraVacx, 107 CFU with bicarbonate, or 107 CFU with CeraVacx. Subsequent cohorts received H10407 (107 CFU with bicarbonate) with similar fasting conditions. Cohort 2 included 15 ETEC-naive volunteers. Cohort 3 included 10 ETEC-naive volunteers and 10 rechallenged volunteers. In all, 25/35 (71%) ETEC-naive recipients of 107 CFU of H10407 developed moderate or severe diarrhea (average maximum stool output/24 h = 1,042 g), and most (97%) shed H10407 (maximum geometric mean titer = 7.5 x 107 CFU/gram of stool). Only one of 10 rechallenged volunteers developed diarrhea. These rechallenged subjects had reduced intestinal colonization, reflected by quantitative microbiology of fecal samples. Among the 35 ETEC-naive subjects, anti-lipopolysaccharide (LPS) O78 serum antibody responses were striking, with positive IgA and IgG antibody responses in 33/35 (94%) and 25/35 (71%), respectively. Anti-heat-labile enterotoxin (LTB) serum IgA and IgG responses developed in 19/35 (54%) and 14/35 (40%) subjects, respectively. Anti-CFA/I serum IgA and IgG responses were detected in 15/35 (43%) and 8/35 (23%) subjects. After the second challenge, participants exhibited blunted anti-LPS and -LTB responses but a booster response to CFA/I. This ETEC model should prove useful in the future evaluation of ETEC vaccine candidates. Classifications Services CVI Citing Articles Google Scholar PubMed Related Content Social Bookmarking CiteULike Delicious Digg Facebook Google+ Mendeley Reddit StumbleUpon Twitter current issue CVI About CVI Subscribers Authors Reviewers Advertisers Inquiries from the Press Permissions & Commercial Reprints ASM Journals Public Access Policy CVI RSS Feeds 1752 N Street N.W. • Washington DC 20036 202.737.3600 • 202.942.9355 fax • journals@asmusa.org Print ISSN: 1556-6811 Online ISSN: 1556-679X Copyright © 2014 by the American Society for Microbiology. For an alternate route to CVI .asm.org, visit: CVI Enterotoxigenic Escherichia coli (ETEC) strain H10407 (serotype O78:H11 producing heat-labile toxin [LT], heat-stable toxin [ST], and colonization factor I [CFA/I]) induces reliably high diarrheal attack rates (ARs) in a human challenge model at doses of ≥10(9) CFU. A descending-dose challenge study was conducted with changes to the standard fasting time and buffer formulation, seeking conditions that permit lower inocula while maintaining reproducibly high ARs. In cohort 1, 20 subjects were fasted overnight and randomized 1:1:1:1 to receive H10407 at doses of 10(8) CFU with bicarbonate, 10(8) CFU with CeraVacx, 10(7) CFU with bicarbonate, or 10(7) CFU with CeraVacx. Subsequent cohorts received H10407 (10(7) CFU with bicarbonate) with similar fasting conditions. Cohort 2 included 15 ETEC-naïve volunteers. Cohort 3 included 10 ETEC-naïve volunteers and 10 rechallenged volunteers. In all, 25/35 (71%) ETEC-naïve recipients of 10(7) CFU of H10407 developed moderate or severe diarrhea (average maximum stool output/24 h = 1,042 g), and most (97%) shed H10407 (maximum geometric mean titer = 7.5 × 10(7) CFU/gram of stool). Only one of 10 rechallenged volunteers developed diarrhea. These rechallenged subjects had reduced intestinal colonization, reflected by quantitative microbiology of fecal samples. Among the 35 ETEC-naïve subjects, anti-lipopolysaccharide (LPS) O78 serum antibody responses were striking, with positive IgA and IgG antibody responses in 33/35 (94%) and 25/35 (71%), respectively. Anti-heat-labile enterotoxin (LTB) serum IgA and IgG responses developed in 19/35 (54%) and 14/35 (40%) subjects, respectively. Anti-CFA/I serum IgA and IgG responses were detected in 15/35 (43%) and 8/35 (23%) subjects. After the second challenge, participants exhibited blunted anti-LPS and -LTB responses but a booster response to CFA/I. This ETEC model should prove useful in the future evaluation of ETEC vaccine candidates.Enterotoxigenic Escherichia coli (ETEC) strain H10407 (serotype O78:H11 producing heat-labile toxin [LT], heat-stable toxin [ST], and colonization factor I [CFA/I]) induces reliably high diarrheal attack rates (ARs) in a human challenge model at doses of ≥10(9) CFU. A descending-dose challenge study was conducted with changes to the standard fasting time and buffer formulation, seeking conditions that permit lower inocula while maintaining reproducibly high ARs. In cohort 1, 20 subjects were fasted overnight and randomized 1:1:1:1 to receive H10407 at doses of 10(8) CFU with bicarbonate, 10(8) CFU with CeraVacx, 10(7) CFU with bicarbonate, or 10(7) CFU with CeraVacx. Subsequent cohorts received H10407 (10(7) CFU with bicarbonate) with similar fasting conditions. Cohort 2 included 15 ETEC-naïve volunteers. Cohort 3 included 10 ETEC-naïve volunteers and 10 rechallenged volunteers. In all, 25/35 (71%) ETEC-naïve recipients of 10(7) CFU of H10407 developed moderate or severe diarrhea (average maximum stool output/24 h = 1,042 g), and most (97%) shed H10407 (maximum geometric mean titer = 7.5 × 10(7) CFU/gram of stool). Only one of 10 rechallenged volunteers developed diarrhea. These rechallenged subjects had reduced intestinal colonization, reflected by quantitative microbiology of fecal samples. Among the 35 ETEC-naïve subjects, anti-lipopolysaccharide (LPS) O78 serum antibody responses were striking, with positive IgA and IgG antibody responses in 33/35 (94%) and 25/35 (71%), respectively. Anti-heat-labile enterotoxin (LTB) serum IgA and IgG responses developed in 19/35 (54%) and 14/35 (40%) subjects, respectively. Anti-CFA/I serum IgA and IgG responses were detected in 15/35 (43%) and 8/35 (23%) subjects. After the second challenge, participants exhibited blunted anti-LPS and -LTB responses but a booster response to CFA/I. This ETEC model should prove useful in the future evaluation of ETEC vaccine candidates. Enterotoxigenic Escherichia coli (ETEC) strain H10407 (serotype O78:H11 producing heat-labile toxin [LT], heat-stable toxin [ST], and colonization factor I [CFA/I]) induces reliably high diarrheal attack rates (ARs) in a human challenge model at doses of ≥10(9) CFU. A descending-dose challenge study was conducted with changes to the standard fasting time and buffer formulation, seeking conditions that permit lower inocula while maintaining reproducibly high ARs. In cohort 1, 20 subjects were fasted overnight and randomized 1:1:1:1 to receive H10407 at doses of 10(8) CFU with bicarbonate, 10(8) CFU with CeraVacx, 10(7) CFU with bicarbonate, or 10(7) CFU with CeraVacx. Subsequent cohorts received H10407 (10(7) CFU with bicarbonate) with similar fasting conditions. Cohort 2 included 15 ETEC-naïve volunteers. Cohort 3 included 10 ETEC-naïve volunteers and 10 rechallenged volunteers. In all, 25/35 (71%) ETEC-naïve recipients of 10(7) CFU of H10407 developed moderate or severe diarrhea (average maximum stool output/24 h = 1,042 g), and most (97%) shed H10407 (maximum geometric mean titer = 7.5 × 10(7) CFU/gram of stool). Only one of 10 rechallenged volunteers developed diarrhea. These rechallenged subjects had reduced intestinal colonization, reflected by quantitative microbiology of fecal samples. Among the 35 ETEC-naïve subjects, anti-lipopolysaccharide (LPS) O78 serum antibody responses were striking, with positive IgA and IgG antibody responses in 33/35 (94%) and 25/35 (71%), respectively. Anti-heat-labile enterotoxin (LTB) serum IgA and IgG responses developed in 19/35 (54%) and 14/35 (40%) subjects, respectively. Anti-CFA/I serum IgA and IgG responses were detected in 15/35 (43%) and 8/35 (23%) subjects. After the second challenge, participants exhibited blunted anti-LPS and -LTB responses but a booster response to CFA/I. This ETEC model should prove useful in the future evaluation of ETEC vaccine candidates. |
| Author | Clayton Harro Alicia Cage Andrea Feller Barbara DeNearing August L. Bourgeois Malathi Ram Anna Lundgren David A. Sack Subhra Chakraborty Richard I. Walker Ann-Mari Svennerholm |
| Author_xml | – sequence: 1 givenname: Clayton surname: Harro fullname: Harro, Clayton – sequence: 2 givenname: Subhra surname: Chakraborty fullname: Chakraborty, Subhra – sequence: 3 givenname: Andrea surname: Feller fullname: Feller, Andrea – sequence: 4 givenname: Barbara surname: DeNearing fullname: DeNearing, Barbara – sequence: 5 givenname: Alicia surname: Cage fullname: Cage, Alicia – sequence: 6 givenname: Malathi surname: Ram fullname: Ram, Malathi – sequence: 7 givenname: Anna surname: Lundgren fullname: Lundgren, Anna – sequence: 8 givenname: Ann-Mari surname: Svennerholm fullname: Svennerholm, Ann-Mari – sequence: 9 givenname: August L. surname: Bourgeois fullname: Bourgeois, August L. – sequence: 10 givenname: Richard I. surname: Walker fullname: Walker, Richard I. – sequence: 11 givenname: David A. surname: Sack fullname: Sack, David A. |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/21852546$$D View this record in MEDLINE/PubMed https://gup.ub.gu.se/publication/159007$$DView record from Swedish Publication Index |
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| References | Ahren (key20180919073537_B1) 1985; 50 DuPont (key20180919073537_B6) 1995; 41 Sack (key20180919073537_B28) 1971; 123 Levine (key20180919073537_B16) 1979; 23 Evans (key20180919073537_B8) 1977; 18 Cohen (key20180919073537_B4) 2002; 70 Qadri (key20180919073537_B23) 2005; 18 Porter (key20180919073537_B22) 2011; 29 Sack (key20180919073537_B27) 1998; 66 McKenzie (key20180919073537_B20) 2008; 26 Evans (key20180919073537_B9) 1984; 87 Tacket (key20180919073537_B32) 1992; 47 Black (key20180919073537_B2) 1982; 4 McKenzie (key20180919073537_B18) 2007; 25 Graham (key20180919073537_B12) 1983; 85 Walker (key20180919073537_B34) 2007; 25 Levine (key20180919073537_B15) 1977; 17 Sack (key20180919073537_B24) 1978; 298 Levine (key20180919073537_B14) 1982; 33 Svennerholm (key20180919073537_B31) 2008; 7 McKenzie (key20180919073537_B19) 2008; 26 Sack (key20180919073537_B25) 1977; 135 World Health Organization. (key20180919073537_B35) 2006; 81 Evans (key20180919073537_B11) 1988; 1 Sack (key20180919073537_B26) 2007; 25 DuPont (key20180919073537_B7) 1971; 285 Tribble (key20180919073537_B33) 2009; 49 Coster (key20180919073537_B5) 2007; 75 Merson (key20180919073537_B21) 1976; 294 Kotloff (key20180919073537_B13) 1995; 13 Levine (key20180919073537_B17) 1980; 111 Clements (key20180919073537_B3) 1981; 20 Savarino (key20180919073537_B30) 1998; 177 Evans (key20180919073537_B10) 1978; 19 Sack (key20180919073537_B29) 1975; 292 6792978 - Antimicrob Agents Chemother. 1981 Jul;20(1):104-8 17313998 - Vaccine. 2007 May 4;25(18):3684-91 1091855 - N Engl J Med. 1975 May 15;292(20):1041-5 7671645 - Chemotherapy. 1995;41 Suppl 1:33-9 17074855 - Infect Immun. 2007 Jan;75(1):252-9 19842970 - Clin Infect Dis. 2009 Nov 15;49(10):1512-9 342962 - N Engl J Med. 1978 Apr 6;298(14):758-63 6127806 - Scand J Infect Dis Suppl. 1982;33:83-95 4996788 - N Engl J Med. 1971 Jul 1;285(1):1-9 11895960 - Infect Immun. 2002 Apr;70(4):1965-70 772435 - N Engl J Med. 1976 Jun 10;294(24):1299-305 16020685 - Clin Microbiol Rev. 2005 Jul;18(3):465-83 4938945 - J Infect Dis. 1971 Apr;123(4):378-85 3078575 - FEMS Microbiol Immunol. 1988 Jan;1(1):9-18 7051247 - Rev Infect Dis. 1982 Mar-Apr;4(2):540-5 17224212 - Vaccine. 2007 Mar 30;25(14):2545-66 18665777 - Expert Rev Vaccines. 2008 Aug;7(6):795-804 6352386 - Gastroenterology. 1983 Nov;85(5):1017-22 346488 - Infect Immun. 1978 Mar;19(3):883-8 328397 - Infect Immun. 1977 Jul;17(1):78-82 9573077 - Infect Immun. 1998 May;66(5):1968-72 21616116 - Vaccine. 2011 Aug 11;29(35):5869-85 17448578 - Vaccine. 2007 May 30;25(22):4392-400 378834 - Infect Immun. 1979 Mar;23(3):729-36 336541 - Infect Immun. 1977 Nov;18(2):330-7 2864313 - Infect Immun. 1985 Oct;50(1):255-61 6381216 - Gastroenterology. 1984 Oct;87(4):934-40 6987863 - Am J Epidemiol. 1980 Mar;111(3):347-55 18602960 - Vaccine. 2008 Aug 26;26(36):4731-9 8578831 - Vaccine. 1995 Nov;13(16):1488-94 18468742 - Vaccine. 2008 Jun 19;26(26):3291-6 1524140 - Am J Trop Med Hyg. 1992 Sep;47(3):276-83 9498468 - J Infect Dis. 1998 Mar;177(3):796-9 320276 - J Infect Dis. 1977 Feb;135(2):275-80 16671213 - Wkly Epidemiol Rec. 2006 Mar 17;81(11):97-104 |
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Reddit... Enterotoxigenic Escherichia coli (ETEC) strain H10407 (serotype O78:H11 producing heat-labile toxin [LT], heat-stable toxin [ST], and colonization factor I... Enterotoxigenic Escherichia coli (ETEC) strain H10407 (serotype O78:H11 producing heat-labile toxin [LT], heat-stable toxin [ST], and colonization factor I... |
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| SubjectTerms | administration & dosage Antibodies Antibodies, Bacterial - blood Bacterial Biomedical Research Biomedical Research - methods blood Diarrhea Diarrhea - immunology Diarrhea - microbiology Diarrhea - prevention & control Drug Evaluation Drug Evaluation - methods Enterotoxigenic Escherichia coli Enterotoxigenic Escherichia coli - immunology Enterotoxigenic Escherichia coli - pathogenicity Escherichia coli Escherichia coli Infections Escherichia coli Infections - immunology Escherichia coli Infections - microbiology Escherichia coli Infections - prevention & control Escherichia coli Vaccines Escherichia coli Vaccines - administration & dosage Escherichia coli Vaccines - immunology Human Experimentation Humans Immunoglobulin A Immunoglobulin A - blood Immunoglobulin G Immunoglobulin G - blood immunology methods microbiology Microbiology in the Medical Area Mikrobiologi inom det medicinska området pathogenicity prevention & control Vaccine Research |
| Title | Refinement of a Human Challenge Model for Evaluation of Enterotoxigenic Escherichia coli Vaccines |
| URI | http://cvi.asm.org/content/18/10/1719.abstract https://www.ncbi.nlm.nih.gov/pubmed/21852546 https://www.proquest.com/docview/895857974 https://www.proquest.com/docview/911160316 https://pubmed.ncbi.nlm.nih.gov/PMC3187035 https://gup.ub.gu.se/publication/159007 |
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