Efficacy of Anti-CFA/I and CfaE Bovine Milk Immunoglobulin Against Challenge With H10407 ETEC Expressing CFA/I

NCT00435526 | Completed Phase 1

• 2 other identifiers: CIR 218HMJF Sub Award # 0000090523
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to assess anti-CFA/I and anti-CfaE BIgG safety and to determine protective efficacy of anti-CFA/I and anti-CfaE BIgG against diarrhea after challenge with H10407, a CFA/I-expressing ETEC strain.

Conditions

Diarrhea

Keywords

traveler's diarrhea; ETEC diarrhea; passive immunization; bovine milk prophylaxis

Outcome Measures

Primary Outcomes (1)

• Clinical diagnosis of diarrhea defined as 1 loose/liquid stool (≥ Grade 3) of >300 g OR ≥ 2 loose/liquid stools totaling ≥ 200 g during any 48-hour period within 120 hours of challenge with ETEC strain H10407.

Secondary Outcomes (1)

• Prevention of moderate to severe diarrhea.

Interventions

anti-CFA/I bovine IgG, and anti-CfaE bovine IgG BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female between 18 and 45 years of age.
• General good health, without significant medical illness, abnormal physical examination findings or clinical laboratory abnormalities as determined by principal investigator.
• Demonstrate comprehension of the protocol procedures and knowledge of ETEC illness by passing a written examination (pass grade ≥ 70%)
• Willing to participate after informed consent obtained.
• Available for all planned follow-up visits.
• Negative serum pregnancy test at screening and a negative urine pregnancy test on the day of admittance to the inpatient phase for female volunteers 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 volunteers unable to bear children must have this documented (e.g., tubal ligation or hysterectomy).

You may not qualify if:

• Presence of a significant medical condition, (e.g. psychiatric conditions or gastrointestinal disease, such as peptic ulcer, symptoms or evidence of active gastritis or gastroesophageal reflux disease, inflammatory bowel disease, alcohol or illicit drug abuse/dependency), or other laboratory 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, HBsAg, or HCV antibodies.
• Significant abnormalities in screening lab hematology, serum chemistry, urinalysis or EKG (EKG in volunteers ≥ 40 years), as determined by PI.
• Allergy to fluoroquinolones, trimethoprim-sulfamethoxazole, or ampicillin/penicillin (excluded if allergic to two of three).
• Abnormal stool pattern (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 defined as 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.
• Travel to countries where ETEC or cholera infection is endemic (most of the developing world) within two years prior to 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 CFA/I + ETEC or other bacterial enteric pathogens (Salmonella, Shigella and Campylobacter).
• Use of any investigational drug or any investigational vaccine within 30 days preceding the first dose of test article, 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 and others) within 30 days preceding the first dose of study vaccine, or planned use during the active study period.

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Naval Medical Research Center: collaborator
• Walter Reed Army Institute of Research (WRAIR): collaborator

Study Sites (2)

Johns Hopkins Bayview Medicial Center, Inpatient Unit

Baltimore, Maryland, 21224, United States

Location

General Clinical Research Center

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Robin McKenzie, M.D.

  Johns Hopkins School of Public

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 13, 2007
• First Posted: February 15, 2007
• Study Start: March 1, 2006
• Study Completion: October 1, 2006
• Last Updated: February 15, 2007

Record last verified: 2007-02

Locations

US (2)