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Evaluation of the safety and immunogenicity of the oral inactivated multivalent enterotoxigenic Escherichia coli vaccine ETVAX in Bangladeshi adults in a double-blind, randomized, placebo-controlled Phase I trial using electrochemiluminescence and ELISA assays for immunogenicity analyses

Highlights•The killed oral ETEC vaccine ETVAX ± dmLT adjuvant was safe in Bangladeshi adults. •All vaccinees responded to all 5 primary vaccine antigens in ALS specimens. •A majority of vaccinees responded to ≥4 antigens in plasma specimens. •A sensitive electrochemiluminescence assay was establishe... Full description

Journal Title: Vaccine 2018, Vol.37 (37), p.5645-5656
Main Author: Akhtar, Marjahan
Other Authors: Chowdhury, Mohiul I , Bhuiyan, Taufiqur R , Kaim, Joanna , Ahmed, Tasnuva , Rafique, Tanzeem A , Khan, Arifuzzaman , Rahman, Sadia I.A , Khanam, Farhana , Begum, Yasmin A , Sharif, Mir Z , Islam, Laila N , Carlin, Nils , Maier, Nicole , Fix, Alan , Wierzba, Thomas F , Walker, Richard I , Bourgeois, A. Louis , Svennerholm, Ann-Mari , Qadri, Firdausi , Lundgren, Anna
Format: Electronic Article Electronic Article
Language: English
Subjects:
AEs
Age
CFs
IgA
Quelle: Alma/SFX Local Collection
Publisher: Netherlands: Elsevier Ltd
ID: ISSN: 0264-410X
Zum Text:
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title: Evaluation of the safety and immunogenicity of the oral inactivated multivalent enterotoxigenic Escherichia coli vaccine ETVAX in Bangladeshi adults in a double-blind, randomized, placebo-controlled Phase I trial using electrochemiluminescence and ELISA assays for immunogenicity analyses
format: Article
creator:
  • Akhtar, Marjahan
  • Chowdhury, Mohiul I
  • Bhuiyan, Taufiqur R
  • Kaim, Joanna
  • Ahmed, Tasnuva
  • Rafique, Tanzeem A
  • Khan, Arifuzzaman
  • Rahman, Sadia I.A
  • Khanam, Farhana
  • Begum, Yasmin A
  • Sharif, Mir Z
  • Islam, Laila N
  • Carlin, Nils
  • Maier, Nicole
  • Fix, Alan
  • Wierzba, Thomas F
  • Walker, Richard I
  • Bourgeois, A. Louis
  • Svennerholm, Ann-Mari
  • Qadri, Firdausi
  • Lundgren, Anna
subjects:
  • Adult
  • Adults
  • adverse events
  • AEs
  • AEs, adverse events
  • Age
  • Age groups
  • Allergy and Immunology
  • ALS, antibodies in lymphocyte supernatant
  • Antibodies
  • Antibodies in lymphocyte supernatant
  • Antibody
  • Antibody-secreting cell
  • Antigens
  • Article
  • ASC, antibody-secreting cell
  • Assaying
  • b-subunit vaccine
  • Bacteria
  • CFs
  • CFs, colonization factors
  • Children
  • cholera toxin B
  • cholera vaccination
  • Clinical trials
  • Colonization
  • colonization factors
  • CTB, cholera toxin B-subunit
  • developing-countries
  • Diarrhea
  • dmLT
  • dmLT, double mutant heat labile toxin
  • double mutant heat labile toxin
  • E coli
  • ECL, electrochemiluminescence
  • Electrochemiluminescence
  • ELISA
  • enterotoxigenic Escherichia coli
  • Enzyme-linked immunosorbent assay
  • Escherichia coli
  • ETEC
  • etec vaccine
  • ETEC, enterotoxigenic Escherichia coli
  • factors
  • heat
  • heat labile toxin
  • humans
  • IgA
  • Immunogenicity
  • Immunoglobulin A
  • Immunoglobulins
  • Immunologi inom det medicinska området
  • Immunology
  • Immunology in the medical area
  • infants
  • intestinal immune-responses
  • Intestine
  • LCTBA, CTB
  • LT, heat labile toxin
  • LTB hybrid protein
  • Lymphocytes
  • Meso Scale Discovery
  • Microbiology in the medical area
  • Mikrobiologi inom det medicinska området
  • MSD, Meso Scale Discovery
  • mucosal
  • PBMC, peripheral blood mononuclear cells
  • peripheral blood mononuclear cells
  • Product development
  • Randomization
  • SAE, serious adverse event
  • Safety
  • secreting cell
  • Secretions
  • secretory IgA
  • serious adverse event
  • SIgA
  • SIgA, secretory IgA
  • ST, heat-stable toxin
  • stable toxin
  • Statistical analysis
  • Studies
  • subunit
  • Vaccine
  • Vaccines
ispartof: Vaccine, 2018, Vol.37 (37), p.5645-5656
description: Highlights•The killed oral ETEC vaccine ETVAX ± dmLT adjuvant was safe in Bangladeshi adults. •All vaccinees responded to all 5 primary vaccine antigens in ALS specimens. •A majority of vaccinees responded to ≥4 antigens in plasma specimens. •A sensitive electrochemiluminescence assay was established for small sample volumes. •ALS responses measured by electrochemiluminescence and ELISA assays correlated well.
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 0264-410X
fulltext: fulltext
issn:
  • 0264-410X
  • 1873-2518
url: Link


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titleEvaluation of the safety and immunogenicity of the oral inactivated multivalent enterotoxigenic Escherichia coli vaccine ETVAX in Bangladeshi adults in a double-blind, randomized, placebo-controlled Phase I trial using electrochemiluminescence and ELISA assays for immunogenicity analyses
sourceAlma/SFX Local Collection
creatorAkhtar, Marjahan ; Chowdhury, Mohiul I ; Bhuiyan, Taufiqur R ; Kaim, Joanna ; Ahmed, Tasnuva ; Rafique, Tanzeem A ; Khan, Arifuzzaman ; Rahman, Sadia I.A ; Khanam, Farhana ; Begum, Yasmin A ; Sharif, Mir Z ; Islam, Laila N ; Carlin, Nils ; Maier, Nicole ; Fix, Alan ; Wierzba, Thomas F ; Walker, Richard I ; Bourgeois, A. Louis ; Svennerholm, Ann-Mari ; Qadri, Firdausi ; Lundgren, Anna
creatorcontribAkhtar, Marjahan ; Chowdhury, Mohiul I ; Bhuiyan, Taufiqur R ; Kaim, Joanna ; Ahmed, Tasnuva ; Rafique, Tanzeem A ; Khan, Arifuzzaman ; Rahman, Sadia I.A ; Khanam, Farhana ; Begum, Yasmin A ; Sharif, Mir Z ; Islam, Laila N ; Carlin, Nils ; Maier, Nicole ; Fix, Alan ; Wierzba, Thomas F ; Walker, Richard I ; Bourgeois, A. Louis ; Svennerholm, Ann-Mari ; Qadri, Firdausi ; Lundgren, Anna ; Sahlgrenska akademin ; Institute of Biomedicine, Department of Microbiology and Immunology ; Göteborgs universitet ; Gothenburg University ; Institutionen för biomedicin, avdelningen för mikrobiologi och immunologi ; Sahlgrenska Academy
descriptionHighlights•The killed oral ETEC vaccine ETVAX ± dmLT adjuvant was safe in Bangladeshi adults. •All vaccinees responded to all 5 primary vaccine antigens in ALS specimens. •A majority of vaccinees responded to ≥4 antigens in plasma specimens. •A sensitive electrochemiluminescence assay was established for small sample volumes. •ALS responses measured by electrochemiluminescence and ELISA assays correlated well.
identifier
0ISSN: 0264-410X
1EISSN: 1873-2518
2DOI: 10.1016/j.vaccine.2018.11.040
3PMID: 30473185
languageeng
publisherNetherlands: Elsevier Ltd
subjectAdult ; Adults ; adverse events ; AEs ; AEs, adverse events ; Age ; Age groups ; Allergy and Immunology ; ALS, antibodies in lymphocyte supernatant ; Antibodies ; Antibodies in lymphocyte supernatant ; Antibody ; Antibody-secreting cell ; Antigens ; Article ; ASC, antibody-secreting cell ; Assaying ; b-subunit vaccine ; Bacteria ; CFs ; CFs, colonization factors ; Children ; cholera toxin B ; cholera vaccination ; Clinical trials ; Colonization ; colonization factors ; CTB, cholera toxin B-subunit ; developing-countries ; Diarrhea ; dmLT ; dmLT, double mutant heat labile toxin ; double mutant heat labile toxin ; E coli ; ECL, electrochemiluminescence ; Electrochemiluminescence ; ELISA ; enterotoxigenic Escherichia coli ; Enzyme-linked immunosorbent assay ; Escherichia coli ; ETEC ; etec vaccine ; ETEC, enterotoxigenic Escherichia coli ; factors ; heat ; heat labile toxin ; humans ; IgA ; Immunogenicity ; Immunoglobulin A ; Immunoglobulins ; Immunologi inom det medicinska området ; Immunology ; Immunology in the medical area ; infants ; intestinal immune-responses ; Intestine ; LCTBA, CTB ; LT, heat labile toxin ; LTB hybrid protein ; Lymphocytes ; Meso Scale Discovery ; Microbiology in the medical area ; Mikrobiologi inom det medicinska området ; MSD, Meso Scale Discovery ; mucosal ; PBMC, peripheral blood mononuclear cells ; peripheral blood mononuclear cells ; Product development ; Randomization ; SAE, serious adverse event ; Safety ; secreting cell ; Secretions ; secretory IgA ; serious adverse event ; SIgA ; SIgA, secretory IgA ; ST, heat-stable toxin ; stable toxin ; Statistical analysis ; Studies ; subunit ; Vaccine ; Vaccines
ispartofVaccine, 2018, Vol.37 (37), p.5645-5656
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0Akhtar, Marjahan
1Chowdhury, Mohiul I
2Bhuiyan, Taufiqur R
3Kaim, Joanna
4Ahmed, Tasnuva
5Rafique, Tanzeem A
6Khan, Arifuzzaman
7Rahman, Sadia I.A
8Khanam, Farhana
9Begum, Yasmin A
10Sharif, Mir Z
11Islam, Laila N
12Carlin, Nils
13Maier, Nicole
14Fix, Alan
15Wierzba, Thomas F
16Walker, Richard I
17Bourgeois, A. Louis
18Svennerholm, Ann-Mari
19Qadri, Firdausi
20Lundgren, Anna
21Sahlgrenska akademin
22Institute of Biomedicine, Department of Microbiology and Immunology
23Göteborgs universitet
24Gothenburg University
25Institutionen för biomedicin, avdelningen för mikrobiologi och immunologi
26Sahlgrenska Academy
title
0Evaluation of the safety and immunogenicity of the oral inactivated multivalent enterotoxigenic Escherichia coli vaccine ETVAX in Bangladeshi adults in a double-blind, randomized, placebo-controlled Phase I trial using electrochemiluminescence and ELISA assays for immunogenicity analyses
1Vaccine
addtitleVaccine
descriptionHighlights•The killed oral ETEC vaccine ETVAX ± dmLT adjuvant was safe in Bangladeshi adults. •All vaccinees responded to all 5 primary vaccine antigens in ALS specimens. •A majority of vaccinees responded to ≥4 antigens in plasma specimens. •A sensitive electrochemiluminescence assay was established for small sample volumes. •ALS responses measured by electrochemiluminescence and ELISA assays correlated well.
subject
0Adult
1Adults
2adverse events
3AEs
4AEs, adverse events
5Age
6Age groups
7Allergy and Immunology
8ALS, antibodies in lymphocyte supernatant
9Antibodies
10Antibodies in lymphocyte supernatant
11Antibody
12Antibody-secreting cell
13Antigens
14Article
15ASC, antibody-secreting cell
16Assaying
17b-subunit vaccine
18Bacteria
19CFs
20CFs, colonization factors
21Children
22cholera toxin B
23cholera vaccination
24Clinical trials
25Colonization
26colonization factors
27CTB, cholera toxin B-subunit
28developing-countries
29Diarrhea
30dmLT
31dmLT, double mutant heat labile toxin
32double mutant heat labile toxin
33E coli
34ECL, electrochemiluminescence
35Electrochemiluminescence
36ELISA
37enterotoxigenic Escherichia coli
38Enzyme-linked immunosorbent assay
39Escherichia coli
40ETEC
41etec vaccine
42ETEC, enterotoxigenic Escherichia coli
43factors
44heat
45heat labile toxin
46humans
47IgA
48Immunogenicity
49Immunoglobulin A
50Immunoglobulins
51Immunologi inom det medicinska området
52Immunology
53Immunology in the medical area
54infants
55intestinal immune-responses
56Intestine
57LCTBA, CTB
58LT, heat labile toxin
59LTB hybrid protein
60Lymphocytes
61Meso Scale Discovery
62Microbiology in the medical area
63Mikrobiologi inom det medicinska området
64MSD, Meso Scale Discovery
65mucosal
66PBMC, peripheral blood mononuclear cells
67peripheral blood mononuclear cells
68Product development
69Randomization
70SAE, serious adverse event
71Safety
72secreting cell
73Secretions
74secretory IgA
75serious adverse event
76SIgA
77SIgA, secretory IgA
78ST, heat-stable toxin
79stable toxin
80Statistical analysis
81Studies
82subunit
83Vaccine
84Vaccines
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1Chowdhury, Mohiul I
2Bhuiyan, Taufiqur R
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5Rafique, Tanzeem A
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7Rahman, Sadia I.A
8Khanam, Farhana
9Begum, Yasmin A
10Sharif, Mir Z
11Islam, Laila N
12Carlin, Nils
13Maier, Nicole
14Fix, Alan
15Wierzba, Thomas F
16Walker, Richard I
17Bourgeois, A. Louis
18Svennerholm, Ann-Mari
19Qadri, Firdausi
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titleEvaluation of the safety and immunogenicity of the oral inactivated multivalent enterotoxigenic Escherichia coli vaccine ETVAX in Bangladeshi adults in a double-blind, randomized, placebo-controlled Phase I trial using electrochemiluminescence and ELISA assays for immunogenicity analyses
authorAkhtar, Marjahan ; Chowdhury, Mohiul I ; Bhuiyan, Taufiqur R ; Kaim, Joanna ; Ahmed, Tasnuva ; Rafique, Tanzeem A ; Khan, Arifuzzaman ; Rahman, Sadia I.A ; Khanam, Farhana ; Begum, Yasmin A ; Sharif, Mir Z ; Islam, Laila N ; Carlin, Nils ; Maier, Nicole ; Fix, Alan ; Wierzba, Thomas F ; Walker, Richard I ; Bourgeois, A. Louis ; Svennerholm, Ann-Mari ; Qadri, Firdausi ; Lundgren, Anna
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0Adult
1Adults
2adverse events
3AEs
4AEs, adverse events
5Age
6Age groups
7Allergy and Immunology
8ALS, antibodies in lymphocyte supernatant
9Antibodies
10Antibodies in lymphocyte supernatant
11Antibody
12Antibody-secreting cell
13Antigens
14Article
15ASC, antibody-secreting cell
16Assaying
17b-subunit vaccine
18Bacteria
19CFs
20CFs, colonization factors
21Children
22cholera toxin B
23cholera vaccination
24Clinical trials
25Colonization
26colonization factors
27CTB, cholera toxin B-subunit
28developing-countries
29Diarrhea
30dmLT
31dmLT, double mutant heat labile toxin
32double mutant heat labile toxin
33E coli
34ECL, electrochemiluminescence
35Electrochemiluminescence
36ELISA
37enterotoxigenic Escherichia coli
38Enzyme-linked immunosorbent assay
39Escherichia coli
40ETEC
41etec vaccine
42ETEC, enterotoxigenic Escherichia coli
43factors
44heat
45heat labile toxin
46humans
47IgA
48Immunogenicity
49Immunoglobulin A
50Immunoglobulins
51Immunologi inom det medicinska området
52Immunology
53Immunology in the medical area
54infants
55intestinal immune-responses
56Intestine
57LCTBA, CTB
58LT, heat labile toxin
59LTB hybrid protein
60Lymphocytes
61Meso Scale Discovery
62Microbiology in the medical area
63Mikrobiologi inom det medicinska området
64MSD, Meso Scale Discovery
65mucosal
66PBMC, peripheral blood mononuclear cells
67peripheral blood mononuclear cells
68Product development
69Randomization
70SAE, serious adverse event
71Safety
72secreting cell
73Secretions
74secretory IgA
75serious adverse event
76SIgA
77SIgA, secretory IgA
78ST, heat-stable toxin
79stable toxin
80Statistical analysis
81Studies
82subunit
83Vaccine
84Vaccines
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1Chowdhury, Mohiul I
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3Kaim, Joanna
4Ahmed, Tasnuva
5Rafique, Tanzeem A
6Khan, Arifuzzaman
7Rahman, Sadia I.A
8Khanam, Farhana
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10Sharif, Mir Z
11Islam, Laila N
12Carlin, Nils
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17Bourgeois, A. Louis
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20Lundgren, Anna
21Sahlgrenska akademin
22Institute of Biomedicine, Department of Microbiology and Immunology
23Göteborgs universitet
24Gothenburg University
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5Sahlgrenska Academy
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genrearticle
ristypeJOUR
atitleEvaluation of the safety and immunogenicity of the oral inactivated multivalent enterotoxigenic Escherichia coli vaccine ETVAX in Bangladeshi adults in a double-blind, randomized, placebo-controlled Phase I trial using electrochemiluminescence and ELISA assays for immunogenicity analyses
jtitleVaccine
addtitleVaccine
date2018
risdate2018
volume37
issue37
spage5645
epage5656
pages5645-5656
issn0264-410X
eissn1873-2518
abstractHighlights•The killed oral ETEC vaccine ETVAX ± dmLT adjuvant was safe in Bangladeshi adults. •All vaccinees responded to all 5 primary vaccine antigens in ALS specimens. •A majority of vaccinees responded to ≥4 antigens in plasma specimens. •A sensitive electrochemiluminescence assay was established for small sample volumes. •ALS responses measured by electrochemiluminescence and ELISA assays correlated well.
copNetherlands
pubElsevier Ltd
pmid30473185
doi10.1016/j.vaccine.2018.11.040
orcididhttps://orcid.org/0000-0001-9757-5596
oafree_for_read