Safety and Efficacy of Bovine Milk Immunoglobulin Against CS17 and CsbD

Completed · Phase 2 · Has a placebo group

Conditions studied: Travelers' Diarrhea

In brief

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.

Key facts

Study ID

NCT00524004

Run by

Johns Hopkins Bloomberg School of Public Health

People needed

36

Starts

2007-01-30

Expected to finish

2007-10-26

Last updated by the study team

2017-04-05

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female between 18 and 45 years of age
• General good health, without significant medical illness, abnormal physical exam findings or clinically significant lab abnormalities, as determined by the PI
• Demonstrate comprehension of the protocol procedures and knowledge of ETEC illness by passing a written exam (pass grade ≥ 70%)
• Willing to participate after informed consent obtained
• Available for all planned follow-up visits
• Negative serum pregnancy test at screening; on the day of admission to the inpatient phase for female subjects of childbearing potential. Females of childbearing potential must agree to use an efficacious hormonal or barrier method of birth control during the study. Abstinence is acceptable. Female unable to bear children must have this documented (e.g., tubal ligation or hysterectomy).

You may not qualify if…

• Presence of significant medical conditions such as psychiatric conditions, gastrointestinal disease (such as peptic ulcer, active gastritis or gastroesophageal reflux disease, inflammatory bowel disease), alcohol or illicit drug abuse/dependency, or lab abnormalities which in the opinion of the investigator precludes participation in the study
• Immunosuppressive illness or IgA deficiency (below the normal limits)
• Positive serology results for HIV or HCV antibodies, or HBsAg
• Significant abnormalities in screening hematology, serum chemistry, urinalysis or EKG (EKG in subjects ≥ 40 years), as determined by the PI
• Allergy to fluoroquinolones, trimethoprim-sulfamethoxazole, or ampicillin/penicillin (excluded if allergic to 2 of 3)
• Fewer than 3 stools per week or more than 3 stools per day on a regular basis.
• History of diarrhea in the 2 weeks prior to planned inpatient phase
• Regular use of laxatives, antacids, or other agents to lower stomach acidity (regular = at least weekly)
• Use of antibiotics during the 7 days before dosing or proton pump inhibitors, H2 blockers, or antacids within 48 hours of dosing (bovine milk IgG).
• Travel to countries where ETEC or cholera infection is endemic (most of the developing world) within 2 years prior to bovine milk IgG dosing
• History of vaccination for or ingestion of ETEC, cholera, or LT toxin.
• Stool culture (collected no more than 1 week prior to admission) positive for ETEC or other bacterial enteric pathogens (including Salmonella, Shigella and Campylobacter)
• Use of any investigational drug or any investigational vaccine within 30 days preceding the first dose of test article/placebo, or planned use during the active study period
• Clinical history of lactose intolerance or allergy to milk or milk products
• Use of any medication known to affect the immune function (e.g., corticosteroids) within 30 days preceding the first dose of test article/placebo, or planned use during the active study period. (Topical and intra-articular steroids will not exclude subjects.)
• Inability to tolerate an over-the-counter, lactose-free, infant, powder formula suspended in 150 mL sodium bicarbonate buffer (based on requirement for frequent dosing) Subjects will receive a dose of the test article 3 times daily 15 minutes (range 10-25 minutes) after each meal for 7 days. The dose will consist of 2.4 gm anti-CS17 bovine milk IgG, 2.3 gm anti-CsbD bovine milk IgG or 2.8 gm LactoFree® powder suspended in 150 mL of water containing 2 grams of sodium bicarbonate buffer.
• Breakfast and 1st daily dose of test article as described above
• Following a 90-minute fast, subjects will ingest 120 ml of sodium bicarbonate buffer to neutralize stomach acidity.
• One minute later (up to 2 minutes) subjects will ingest the CS17-ETEC challenge inoculum diluted in 30ml sodium bicarbonate buffer.
• Fifteen minutes (range: 10-25 minutes) after drinking the CS17-ETEC inoculum, subjects will ingest the second (Day 0) dose of bovine milk IgG test article or placebo.
• No IgG test articles will be administered immediately following lunch on the day of challenge.

Where it is running

• Center for Immunization Research — Baltimore, Maryland, United States
• Johns Hopkins Bayview Medicial Center, Inpatient Unit — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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