Safety and Efficacy of Bovine Milk Immunoglobulin Against CS17 and CsbD

Summary

This is a Phase II, randomized, double-blind, placebo-controlled study designed to investigate whether hyperimmune bovine milk IgG products specific for CsbD and CS17, protect subjects against diarrhea upon challenge with a CS-17-ETEC strain LSN03-016011/A. The study will also evaluate safety and tolerability of these bovine milk IgG products and describe the immune responses following challenge. The primary study objectives are: 1) Assess safety of the anti-CsbD and anti-CS17 bovine milk IgG among healthy adult volunteers when orally administered three times a day over 7 days. 2) Determine efficacy of the anti-CsbD bovine milk IgG preparation against ETEC diarrhea upon challenge with CS17-ETEC, and 3)Determine efficacy of the anti-CS17 bovine milk IgG preparation against ETEC diarrhea upon challenge with CS17-ETEC. A secondary objective is to determine efficacy of the anti-CsbD and anti-CS17 bovine milk IgG preparations against moderate to severe ETEC diarrhea upon challenge with CS17-ETEC.

Timeline

Start

2007-01-30

Primary completion

2007-10-26

Completion

2007-10-26

Outcome

Mixed primary results

paper none of the subjects receiving anti-CS17 had diarrhea (P = .01). PMID 30897198 ↗

paper diarrhea rates between placebo and anti-CsbD recipients (41.7%) were comparable (P = 1.0). PMID 30897198 ↗

Publications

• Savarino SJ, McKenzie R, Tribble DR, Porter CK, O'Dowd A, Sincock SA, Poole ST, DeNearing B, Woods CM, Kim H, Grahek SL, Brinkley C, Crabb JH, Bourgeois AL. Hyperimmune Bovine Colostral Anti-CS17 Antibodies Protect Against Enterotoxigenic Escherichia coli Diarrhea in a Randomized, Doubled-Blind, Placebo-Controlled Human Infection Model. J Infect Dis. 2019 Jul 2;220(3):505-513. doi: 10.1093/infdis/jiz135.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Anti-CS17 Bovin IgG	Protein / enzyme biologic	—	Oral
Subject	Anti-CsbD Bovine IgG	Protein / enzyme biologic	—	Oral

Indications