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

• Published in: Vaccine Vol. 37; no. 37; pp. 5645 - 5656
• Main Authors: 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
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Ltd 03.09.2019; Elsevier Limited; Elsevier Science
• Subjects: Adult; Adults; Age; Age groups; Allergy and Immunology; Antibodies; Antibodies in lymphocyte supernatant; Antibody-secreting cell; Antigens; Assaying; b-subunit vaccine; Bacteria; Children; cholera vaccination; Colonization; developing-countries; Diarrhea; Double-blind studies; E coli; Electrochemiluminescence; ELISA; Enzyme-linked immunosorbent assay; Escherichia coli; ETEC; etec vaccine; factors; humans; IgA; Immunogenicity; Immunoglobulin A; Immunoglobulins; Immunologi inom det medicinska området; Immunology; Immunology in the medical area; infants; intestinal immune-responses; Intestine; Lymphocytes; Microbiology in the medical area; Mikrobiologi inom det medicinska området; mucosal; Randomization; Safety; Secretions; Statistical analysis; Vaccine; Vaccines; Bangladesh; colonization factors; LCTB A; IgA; ALS; LT; AEs; cholera toxin B-subunit; ASC; serious adverse event; Adult; secretory IgA; CTB/LTB hybrid protein; MSD; peripheral blood mononuclear cells; ST; heat labile toxin; Vaccine; Electrochemiluminescence; adverse events; ETEC; PBMC; heat-stable toxin; ECL; CTB; CFs; enterotoxigenic Escherichia coli; SAE; SIgA; Antibody-secreting cell; Antibodies in lymphocyte supernatant; double mutant heat labile toxin; Meso Scale Discovery; dmLT; ELISA; LCTBA
• ISSN: 0264-410X; 1873-2518
• DOI: 10.1016/j.vaccine.2018.11.040

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.