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A Study to Determine the Immunogenicity and Oral Tolerance to Keyhole Limpet Hemocyanin (KLH)

NCT01489956 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2016-04-12

Study results available
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Summary

The purpose of this study is to test the oral tolerance of Keyhole Limpet Hemocyanin (KLH) and to determine if Immucothel by itself is strong enough to trigger the immune response. If not, Immucothel will be tested in combination with an adjuvant to determine if an adequate immune response can be seen.

Conditions

Interventions

BIOLOGICAL

Immucothel Alone (Part A)

100 ug at day 0 (priming dose) and day 9(booster dose)

BIOLOGICAL

Immucothel+Montanide (Part A)

100 ug SQ Immucothel plus Montanide at day 0 (priming dose) and day 9 (booster dose)

BIOLOGICAL

Immucothel Alone or Immucothel+Montanide (Part B)

50 mg of native KLH on days 0-4 and 10-14 (total of 500 mg). Immunization on days 26 and 35.

Sponsors & Collaborators

  • Immune Tolerance Network (ITN)

    collaborator NETWORK

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Lloyd Mayer, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01489956 on ClinicalTrials.gov