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A Phase 1 dose escalating study of double mutant heat-labile toxin LTR192G/L211A (dmLT) from Enterotoxigenic Escherichia coli (ETEC) by sublingual or oral immunization.

Bernstein DI, Pasetti MF, Brady R, Buskirk AD, Wahid R, Dickey M, Cohen M, Baughman H, El-Khorazaty J, Maier N, Sztein MB, Baqar S, Bourgeois AL.

Vaccine. 2019 Jan 21;37(4):602-611. doi: 10.1016/j.vaccine.2018.12.011. Epub 2018 Dec 15.


Safety and immunogenicity of an improved oral inactivated multivalent enterotoxigenic Escherichia coli (ETEC) vaccine administered alone and together with dmLT adjuvant in a double-blind, randomized, placebo-controlled Phase I study.

Lundgren A, Bourgeois L, Carlin N, Clements J, Gustafsson B, Hartford M, Holmgren J, Petzold M, Walker R, Svennerholm AM.

Vaccine. 2014 Dec 12;32(52):7077-84. doi: 10.1016/j.vaccine.2014.10.069. Epub 2014 Nov 5.


Immunogenicity and Protective Efficacy against Enterotoxigenic Escherichia coli Colonization following Intradermal, Sublingual, or Oral Vaccination with EtpA Adhesin.

Luo Q, Vickers TJ, Fleckenstein JM.

Clin Vaccine Immunol. 2016 Jul 5;23(7):628-37. doi: 10.1128/CVI.00248-16. Print 2016 Jul.


Safety and immunogenicity of a single oral dose of recombinant double mutant heat-labile toxin derived from enterotoxigenic Escherichia coli.

El-Kamary SS, Cohen MB, Bourgeois AL, Van De Verg L, Bauers N, Reymann M, Pasetti MF, Chen WH.

Clin Vaccine Immunol. 2013 Nov;20(11):1764-70. doi: 10.1128/CVI.00464-13. Epub 2013 Sep 18. Erratum in: Clin Vaccine Immunol. 2014 Apr;21(4):602.


Development and preclinical evaluation of safety and immunogenicity of an oral ETEC vaccine containing inactivated E. coli bacteria overexpressing colonization factors CFA/I, CS3, CS5 and CS6 combined with a hybrid LT/CT B subunit antigen, administered alone and together with dmLT adjuvant.

Holmgren J, Bourgeois L, Carlin N, Clements J, Gustafsson B, Lundgren A, Nygren E, Tobias J, Walker R, Svennerholm AM.

Vaccine. 2013 May 7;31(20):2457-64. doi: 10.1016/j.vaccine.2013.03.027. Epub 2013 Mar 27.


Serum and mucosal antibody responses to inactivated polio vaccine after sublingual immunization using a thermoresponsive gel delivery system.

White JA, Blum JS, Hosken NA, Marshak JO, Duncan L, Zhu C, Norton EB, Clements JD, Koelle DM, Chen D, Weldon WC, Oberste MS, Lal M.

Hum Vaccin Immunother. 2014;10(12):3611-21. doi: 10.4161/hv.32253.


Live attenuated enterotoxigenic Escherichia coli (ETEC) vaccine with dmLT adjuvant protects human volunteers against virulent experimental ETEC challenge.

Harro C, Louis Bourgeois A, Sack D, Walker R, DeNearing B, Brubaker J, Maier N, Fix A, Dally L, Chakraborty S, Clements JD, Saunders I, Darsley MJ.

Vaccine. 2019 Mar 28;37(14):1978-1986. doi: 10.1016/j.vaccine.2019.02.025. Epub 2019 Feb 21.


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.

Lundgren A, Leach S, Tobias J, Carlin N, Gustafsson B, Jertborn M, Bourgeois L, Walker R, Holmgren J, Svennerholm AM.

Vaccine. 2013 Feb 6;31(8):1163-70. doi: 10.1016/j.vaccine.2012.12.063. Epub 2013 Jan 7.


Passive antibodies derived from intramuscularly immunized toxoid fusion 3xSTaN12S-dmLT protect against STa+ enterotoxigenic Escherichia coli (ETEC) diarrhea in a pig model.

Nandre RM, Duan Q, Wang Y, Zhang W.

Vaccine. 2017 Jan 23;35(4):552-556. doi: 10.1016/j.vaccine.2016.12.021. Epub 2016 Dec 22.


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.

Akhtar M, Chowdhury MI, Bhuiyan TR, Kaim J, Ahmed T, Rafique TA, Khan A, Rahman SIA, Khanam F, Begum YA, Sharif MZ, Islam LN, Carlin N, Maier N, Fix A, Wierzba TF, Walker RI, Bourgeois AL, Svennerholm AM, Qadri F, Lundgren A.

Vaccine. 2018 Nov 22. pii: S0264-410X(18)31563-9. doi: 10.1016/j.vaccine.2018.11.040. [Epub ahead of print]


Immunization with a Double-Mutant (R192G/L211A) of the Heat-Labile Enterotoxin of Escherichia coli Offers Partial Protection against Campylobacter jejuni in an Adult Mouse Intestinal Colonization Model.

Albert MJ, Haridas S, Ebenezer M, Raghupathy R, Khan I.

PLoS One. 2015 Nov 5;10(11):e0142090. doi: 10.1371/journal.pone.0142090. eCollection 2015.


The adjuvant double mutant Escherichia coli heat labile toxin enhances IL-17A production in human T cells specific for bacterial vaccine antigens.

Leach S, Clements JD, Kaim J, Lundgren A.

PLoS One. 2012;7(12):e51718. doi: 10.1371/journal.pone.0051718. Epub 2012 Dec 20.


Refinement of a human challenge model for evaluation of enterotoxigenic Escherichia coli vaccines.

Harro C, Chakraborty S, Feller A, DeNearing B, Cage A, Ram M, Lundgren A, Svennerholm AM, Bourgeois AL, Walker RI, Sack DA.

Clin Vaccine Immunol. 2011 Oct;18(10):1719-27. doi: 10.1128/CVI.05194-11. Epub 2011 Aug 18.


Induction of long term mucosal immunological memory in humans by an oral inactivated multivalent enterotoxigenic Escherichia coli vaccine.

Lundgren A, Jertborn M, Svennerholm AM.

Vaccine. 2016 Jun 8;34(27):3132-3140. doi: 10.1016/j.vaccine.2016.04.055. Epub 2016 Apr 28.


Safety and immunogenicity of escalating dosages of a single oral administration of peru-15 pCTB, a candidate live, attenuated vaccine against enterotoxigenic Escherichia coli and Vibrio cholerae.

Chen WH, Garza J, Choquette M, Hawkins J, Hoeper A, Bernstein DI, Cohen MB.

Clin Vaccine Immunol. 2015 Jan;22(1):129-35. doi: 10.1128/CVI.00560-14. Epub 2014 Nov 19.


Construction and phase I clinical evaluation of the safety and immunogenicity of a candidate enterotoxigenic Escherichia coli vaccine strain expressing colonization factor antigen CFA/I.

Turner AK, Beavis JC, Stephens JC, Greenwood J, Gewert C, Thomas N, Deary A, Casula G, Daley A, Kelly P, Randall R, Darsley MJ.

Infect Immun. 2006 Feb;74(2):1062-71.


Safety and immunogenicity of oral killed whole cell recombinant B subunit cholera vaccine in Barranquilla, Colombia.

Concha A, Giraldo A, Castañeda E, Martínez M, de la Hoz F, Rivas F, Depetris A, Svennerholm AM, Sack DA.

Bull Pan Am Health Organ. 1995 Dec;29(4):312-21.


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