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Hyperimmune Bovine Colostral Anti-CS17 Antibodies Protect Against Enterotoxigenic Escherichia coli Diarrhea in a Randomized, Doubled-Blind, Placebo-Controlled Human Infection Model.
Savarino, Stephen J; McKenzie, Robin; Tribble, David R; Porter, Chad K; O'Dowd, Aisling; Sincock, Stephanie A; Poole, Steven T; DeNearing, Barbara; Woods, Colleen M; Kim, Hye; Grahek, Shannon L; Brinkley, Carl; Crabb, Joseph H; Bourgeois, A Louis.
Afiliación
  • Savarino SJ; Naval Medical Research Center, Silver Spring, Maryland.
  • McKenzie R; Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
  • Tribble DR; Johns Hopkins School of Medicine, Baltimore, Maryland.
  • Porter CK; Naval Medical Research Center, Silver Spring, Maryland.
  • O'Dowd A; Naval Medical Research Center, Silver Spring, Maryland.
  • Sincock SA; Naval Medical Research Center, Silver Spring, Maryland.
  • Poole ST; Naval Medical Research Center, Silver Spring, Maryland.
  • DeNearing B; Naval Medical Research Center, Silver Spring, Maryland.
  • Woods CM; Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
  • Kim H; Naval Medical Research Center, Silver Spring, Maryland.
  • Grahek SL; Johns Hopkins School of Medicine, Baltimore, Maryland.
  • Brinkley C; Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
  • Crabb JH; Walter Reed Army Institute of Research, Silver Spring, Maryland.
  • Bourgeois AL; ImmuCell Corporation, Portland, Maine.
J Infect Dis ; 220(3): 505-513, 2019 07 02.
Article en En | MEDLINE | ID: mdl-30897198
BACKGROUND: Enterotoxigenic Escherichia coli (ETEC) commonly cause diarrhea in children living in developing countries and in travelers to those regions. ETEC are characterized by colonization factors (CFs) that mediate intestinal adherence. We assessed if bovine colostral IgG (bIgG) antibodies against a CF, CS17, or antibodies against CsbD, the minor tip subunit of CS17, would protect subjects against diarrhea following challenge with a CS17-expressing ETEC strain. METHODS: Adult subjects were randomized (1:1:1) to receive oral bIgG against CS17, CsbD, or placebo. Two days prior to challenge, subjects began dosing 3 times daily with the bIgG products (or placebo). On day 3, subjects ingested 5 × 109 cfu ETEC strain LSN03-016011/A in buffer. Subjects were assessed for diarrhea for 120 hours postchallenge. RESULTS: A total of 36 subjects began oral prophylaxis and 35 were challenged with ETEC. While 50.0% of the placebo recipients had watery diarrhea, none of the subjects receiving anti-CS17 had diarrhea (P = .01). In contrast, diarrhea rates between placebo and anti-CsbD recipients (41.7%) were comparable (P = 1.0). CONCLUSIONS: This is the first study to demonstrate anti-CS17 antibodies provide significant protection against ETEC expressing CS17. More research is needed to better understand why anti-CsbD was not comparably efficacious. Clinical Trials Registration. NCT00524004.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Calostro / Sustancias Protectoras / Vacunas contra Escherichia coli / Diarrea / Infecciones por Escherichia coli / Escherichia coli Enterotoxigénica / Anticuerpos Antibacterianos Tipo de estudio: Clinical_trials / Prognostic_studies Límite: Adult / Animals / Female / Humans / Male Idioma: En Revista: J Infect Dis Año: 2019 Tipo del documento: Article Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Calostro / Sustancias Protectoras / Vacunas contra Escherichia coli / Diarrea / Infecciones por Escherichia coli / Escherichia coli Enterotoxigénica / Anticuerpos Antibacterianos Tipo de estudio: Clinical_trials / Prognostic_studies Límite: Adult / Animals / Female / Humans / Male Idioma: En Revista: J Infect Dis Año: 2019 Tipo del documento: Article Pais de publicación: Estados Unidos