Responses to Immunization With Keyhole Limpet Hemocyanin Administered by Scarification and the Intradermal Route

Atopic Dermatitis Clinical Trial

Official title:

Responses to Immunization With Keyhole Limpet Hemocyanin Administered by Scarification and the Intradermal Route

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00614731
• Other study ID #: DAIT ADVN KLH 07
• Secondary ID: Contract No. HHS
• Status: Completed
• Phase: Phase 1
• First received: February 11, 2008
• Last updated: January 10, 2017
• Start date: December 2007
• Est. completion date: December 2008

Study information

• Verified date: January 2017
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

AD is characterized by skin inflammation and recurrent skin infections. In addition, people with AD may have a severe and sometimes fatal reaction to the smallpox vaccine called EV. KLH is a carrier protein that can be used to deliver antibodies to the body. However KLH itself, may cause an immune response. The purpose of this study is to determine the body's reaction to pure KLH in people without AD. This will be used to establish a baseline immune response and may be compared to the immune response in people with AD during future studies.

This study will last 8 weeks and will have 11 study visits. Participants in this study will be randomly assigned to 1 of 4 groups. All participants will receive their immunizations at Visits 5 and 6. Participants in Group 1A will receive 2 immunizations each with 100 mcg of KLH each. Participants in Group 2A will receive 2 immunizations through scarification (a shallow cut in the skin) with jabs, each containing 20 mg/mL of KLH. Adverse reactions will be monitored after each immunization. Once safety data from these 2 groups have been reviewed, the next 2 groups will be enrolled. Participants in Group 1B will receive 2 immunizations each with 250 mcg of KLH each. Participants in Group 2B will receive 2 immunizations through scarification with 15 jabs, each containing 20mg/mL of KLH. Other study visits will include allergy testing and blood and urine collection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Healthy and nonatopic as defined by the ADVN Standard Diagnostic Criteria

• Willing to use appropriate forms of contraception

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Biological:
• KLH carrier-protein
KLH carrier-protein vaccination containing no other protein or antibodies

Locations

Country	Name	City	State
United States	National Jewish Health	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Atopic Dermatitis and Vaccinia Network

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in anti-KLH IgG antibody response to two vaccinations of KLH in nonatopic participants		At baseline and Day 47	No
Primary	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	Yes
Secondary	Change in anti-KLH antibody responses in IgG subclasses 1 to 4, IgA, IgM, and IgE.		At baseline and Day 47	No
Secondary	Incidence of all adverse events (AEs)		Throughout study	Yes
Secondary	Change in diameter of delayed type hypersensitivity (DTH) responses to KLH		At Day 2 and 49	No
Secondary	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	No
Secondary	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	No
Secondary	Changes pre- versus post-administration of KLH in quantitative levels of clinical labs (CBC, liver function [AST, ALT], renal function [creatinine, BUN])		At Days 0 and 47	Yes
Secondary	Changes pre- versus post-administration of KLH in quantitative levels of vital signs (body temperature, heart rate, respirations, blood pressure)		At Days 0 and 47	Yes

External Links

•   Division of Allergy, Immunology, and Transplantation (DAIT)
•   National Institute of Allergy and Infectious Diseases (NIAID)