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NCT00435526 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Johns Hopkins Bloomberg School of Public Health.

Completed
Registry status
Phase 1
Development phase
30
Enrollment target

NCT00435526: Completed Phase 1 study, sponsored by Johns Hopkins Bloomberg School of Public Health.

NCT00435526 is a Phase 1 study that has completed, run by Johns Hopkins Bloomberg School of Public Health. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00435526, a Phase 1 study, has completed, sponsored by Johns Hopkins Bloomberg School of Public Health.

COMPLETED
Registry status
Phase 1
Development phase
30 participants
Enrollment target

Study 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.

Interventions

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

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2006-03
Est. Completion 2006-10
Phase Phase 1

What the finished NCT00435526 record still lists

NCT00435526 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).

The record links to 0 conditions, and to 1 intervention - of which anti-CFA/I bovine IgG, and anti-CfaE bovine IgG is the first listed.

NCT00435526 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00435526 about?

NCT00435526 is a clinical study titled "Efficacy of Anti-CFA/I and CfaE Bovine Milk Immunoglobulin Against Challenge With H10407 ETEC Expressing CFA/I". 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.

What is the current status of trial NCT00435526?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2006-03. Estimated completion is 2006-10.

What interventions are being tested in trial NCT00435526?

The interventions under investigation include: anti-CFA/I bovine IgG, and anti-CfaE bovine IgG (BIOLOGICAL).

Who is sponsoring clinical trial NCT00435526?

This trial is sponsored by Johns Hopkins Bloomberg School of Public Health, which has 187 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00435526's enrollment target sits among peer trials

30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00435526, the US trial registry maintained by the National Library of Medicine. NCT00435526 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.