Responses to Immunization With Keyhole Limpet Hemocyanin Administered by Scarification and the Intradermal Route
2 other identifiers
interventional
25
1 country
1
Brief Summary
Atopic dermatitis (AD) is a skin disorder in which people often have swelling and skin infections. People with this disease cannot receive the smallpox vaccine because it could cause them to have a fatal reaction known as eczema vaccinatum (EV). Keyhole limpet hemocyanin (KLH) is a protein that can be used to deliver vaccines to the body. The purpose of this study is to determine a baseline immune reaction to KLH in people without AD. Once this has been established, other studies can be designed to determine whether KLH can be used to give vaccines to people with AD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Dec 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 11, 2008
CompletedFirst Posted
Study publicly available on registry
February 13, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedJanuary 11, 2017
January 1, 2017
1 year
February 11, 2008
January 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in anti-KLH IgG antibody response to two vaccinations of KLH in nonatopic participants
At baseline and Day 47
Safety of administering KLH by scarification route as measured by proportion of subjects with any treatment-emergent abnormalities in vital signs (body temperature, heart rate, respirations, and blood pressure) and liver function
Throughout study
Secondary Outcomes (7)
Change in anti-KLH antibody responses in IgG subclasses 1 to 4, IgA, IgM, and IgE.
At baseline and Day 47
Incidence of all adverse events (AEs)
Throughout study
Change in diameter of delayed type hypersensitivity (DTH) responses to KLH
At Day 2 and 49
Induction of a T cell response as measured by a change from negative (smaller than 5 mm) to positive (5 mm or larger) DTH reaction.
At Days 2 and 49
Presence or absence of antibody response as measured by whether or not there is a greater than 2 fold increase in antibody (IgG, IgA, IgM, IgE) titers to two administrations of KLH.
At Days 0 and 47
- +2 more secondary outcomes
Study Arms (4)
ID immunizations (100 mcg)
EXPERIMENTALParticipants will receive a total of two 100 mcg intradermal (ID) KLH carrier-protein immunizations with 1 mg/ml KLH per immunization. Immunizations will be given 21 days apart at Visits 5 and 6.
Scarification by 3 jabs
EXPERIMENTALParticipants will receive two scarification immunizations by 3 jabs containing 20 mg/ml of KLH carrier-protein. The immunizations will occur 21 days apart at Visits 5 and 6.
ID immunizations (250 mcg)
EXPERIMENTALEnrollment will begin after the safety data for Groups 1A and 2A have been reviewed. Participants in this group will receive two 250 mcg ID KLH vaccinations containing 10 mg/ml of KLH carrier-protein. Immunizations will occur 21 days apart at Visits 5 and 6.
Scarification by 15 jabs
EXPERIMENTALEnrollment will begin after the safety data from groups 1A and 2A has been examined. Participants in this group will receive a total of two scarification immunizations by 5 needles used to administer 15 jabs, each containing, 20 mg/ml of KLH carrier-protein. Immunizations will occur 21 days apart at Visits 5 and 6.
Interventions
KLH carrier-protein vaccination containing no other protein or antibodies
Eligibility Criteria
You may qualify if:
- Healthy and nonatopic as defined by the ADVN Standard Diagnostic Criteria
- Willing to use appropriate forms of contraception
You may not qualify if:
- Active bacterial, viral, or fungal infection within 30 days prior to study entry
- Immunodeficiency
- Received Use of systemic corticosteroids, antibiotics, antivirals, anti-inflammatory biologics (e.g., alefacept, etanercept), calcineurin inhibitors, oral immunosuppressive agents, anxiolytic agents, antidepressants, or cancer chemotherapy within 30 days prior to KLH administration
- Use of topical corticosteroids, antibiotics, antivirals, immune enhancers, or calcineurin inhibitors within 7 days prior to study entry
- Allergy to shellfish
- Vaccination within 30 days prior to entering the study
- Skin rash
- Participation in a clinical trial within 4 weeks of study entry
- Positive response to DTH test prior to administration of KLH
- Previous exposure to KLH or products containing KLH
- Allergic or hypersensitivity to KLH
- Any condition that, in the opinion of the investigator, would interfere with the study
- Pregnant or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Jewish Health
Denver, Colorado, 80206, United States
Related Publications (1)
Milgrom H, Kesler K, Byron M, Harbeck R, Holliday R, Leung DY. Response to cutaneous immunization with low-molecular-weight subunit keyhole limpet hemocyanin. Int Arch Allergy Immunol. 2012;157(3):269-74. doi: 10.1159/000328784. Epub 2011 Oct 28.
PMID: 22042247RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Henry Milgrom, M.D.
National Jewish Health
- PRINCIPAL INVESTIGATOR
Donald Y Leung, M.D., Ph.D.
National Jewish Health
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2008
First Posted
February 13, 2008
Study Start
December 1, 2007
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
January 11, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will share
Participant level data and additional relevant materials are available to the public in the Immunology Database and Analysis Portal (ImmPort). ImmPort is a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.