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Atopic DermatitisPhase 1NCT00614731

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

A Phase 1 study testing KLH carrier-protein in people with Atopic Dermatitis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Atopic Dermatitis
What is being tested?
KLH carrier-protein
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteUnited States
Study dates
Dec 2007to Dec 2008
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy and nonatopic as defined by the ADVN Standard Diagnostic Criteria
  • Willing to use appropriate forms of contraception

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Jewish Health

    Denver, Colorado, 80206

Other trials in United States

About this study

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.

Read the detailed 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.

Being tested
KLH carrier-protein
Keywords
Keyhole Limpet Hemocyanin, KLH, atopic dermatitis, IgG antibodies, scarification
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KLH carrier-proteinBiological

    Also called Immucothel, Vacmune

    KLH carrier-protein vaccination containing no other protein or antibodies

Study groups in NCT00614731
Study groupRoleWhat they receive
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.
Receives: Biological: KLH carrier-protein
Scarification by 3 jabsExperimentalParticipants 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.
Receives: Biological: KLH carrier-protein
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.
Receives: Biological: KLH carrier-protein
Scarification by 15 jabsExperimentalEnrollment 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.
Receives: Biological: KLH carrier-protein

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in anti-KLH IgG antibody response to two vaccinations of KLH in nonatopic participants

    Measured: At baseline and Day 47

  2. 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

    Measured: Throughout study

Secondary outcomes (7)

  1. Change in anti-KLH antibody responses in IgG subclasses 1 to 4, IgA, IgM, and IgE.

    Measured: At baseline and Day 47

  2. Incidence of all adverse events (AEs)

    Measured: Throughout study

  3. Change in diameter of delayed type hypersensitivity (DTH) responses to KLH

    Measured: At Day 2 and 49

  4. 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.

    Measured: At Days 2 and 49

  5. 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.

    Measured: At Days 0 and 47

  6. Changes pre- versus post-administration of KLH in quantitative levels of clinical labs (CBC, liver function [AST, ALT], renal function [creatinine, BUN])

    Measured: At Days 0 and 47

  7. Changes pre- versus post-administration of KLH in quantitative levels of vital signs (body temperature, heart rate, respirations, blood pressure)

    Measured: At Days 0 and 47

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2008 (estimated)
  2. Study startDec 2007
  3. Primary completionDec 2008
  4. Study completionDec 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00614731
Sponsor's protocol ID
DAIT ADVN KLH 07
Other IDs
Contract No. HHSN266200400029C
Status last verified
Jan 2017
First submitted
11 Feb 2008
Last updated
11 Jan 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 22042247

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing KLH carrier-protein in people with Atopic Dermatitis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in anti-KLH IgG antibody response to two vaccinations of KLH in nonatopic participants (time frame: At baseline and Day 47). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00614731, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2017.

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