Atopic Dermatitis Research Network (ADRN) Influenza Vaccine Pilot

NCT01518478 | Completed Early Phase 1

• 1 other identifier: DAIT ADRN-03
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

A new flu vaccine which is injected into the skin instead of into the muscle has recently been approved by the Food and Drug Administration for vaccination of the general population including patients with atopic dermatitis (AD). This new vaccine has been shown to work as well as the vaccine which is injected into muscle when tested in people without atopic dermatitis. The primary endpoint of the study is to estimate the variance of the log fold change from baseline in HAI antibody titers for non-atopic controls and participants with atopic dermatitis without a history of eczema herpeticum (ADEH-), following administration of a single dose of the seasonal 2011-2012 Fluzone® Intradermal vaccine.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Change from Baseline (Day 0) HAI Antibody Titers

  The variance of the log fold change from baseline in HAI antibody titers for non-atopic controls and ADEH- participants, following administration per label of a single dose of the seasonal 2011-2012 Fluzone® Intradermal vaccine.

  Baseline (Day 0) and Day 28

Secondary Outcomes (3)

• Change from Baseline (Day 0) Influenza-specific T Cell Populations

  Baseline (Day 0) and Day 28

• Change from Baseline (Day 0) Influenza-specific Interferon Gamma and/or Granzyme B Producing Cells

  Baseline (Day 0) and Day 28

• Change from Baseline (Day 0) Microarray Analysis

  Baseline (Day 0), Day 3, and Day 7

Study Arms (2)

20 Non-atopic

OTHER

Non-atopic, healthy control.

Drug: Fluzone® Intradermal (Sanofi Pasteur Inc.)

20 ADEH- (mild to severe AD)

OTHER

Atopic Dermatitis without previous or current Eczema Herpeticum.

Drug: Fluzone® Intradermal (Sanofi Pasteur Inc.)

Interventions

Fluzone® Intradermal (Sanofi Pasteur Inc.) DRUG

Fluzone® Intradermal trivalent vaccine is a clear-to-slightly opalescent, preservative-free suspension containing formaldehyde-inactivated "split" influenza viruses for intradermal delivery of 0.1 mL via an ultra-fine micro-needle. The vaccine is supplied as a single-dose, in a latex-free, pre-filled microinjection system. The active substance is prepared from influenza viruses propagated in embryonated chicken eggs. Fluzone® Intradermal is standardized according to United States Public Health Service (US PHS) requirements and is formulated to contain HA of each of the following three influenza strains recommended for the 2011-2012 influenza season: A/California/07/2009 X-179A (H1N1)-like virus, A/Perth/16/2009 (H3N2)-like virus, and B/Brisbane/60/2008-like virus.

20 ADEH- (mild to severe AD); 20 Non-atopic

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants who meet all of the following criteria are eligible for enrollment.
• Who are males and females 18 to 64 years of age, inclusive, on the day of vaccination.
• Who are enrolled in the ADRN Registry study.
• Who have active, mild to severe AD without a history of EH or who are non-atopic as diagnosed using the ADRN Standard Diagnostic Criteria. Non-atopic status will be based on self-reported history and will not take total IgE or allergen sensitization results into account.
• Who are willing to sign the informed consent form prior to initiation of any study procedure.

You may not qualify if:

• Participants who meet any of the following criteria are not eligible for enrollment.
• Who are pregnant or lactating. Women of child bearing potential must avoid becoming pregnant (use of an effective method of contraception or abstinence) for the duration of their participation in the study.
• Who have a known allergy to any component of the Fluzone® Intradermal vaccine, including egg protein, or have had a severe allergic reaction to a previous dose of any influenza vaccine.
• Who have a known or suspected congenital or acquired immunodeficiency or who have had immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months.
• Who have received systemic steroid therapy at any dose or intra-articular administration of steroids within 3 months prior to the day of vaccination.
• Who have received a cumulative dose of inhaled and/or intranasally administered corticosteroids ≥ 880 mcg/day fluticasone equivalent within 3 months prior to the day of vaccination.
• Who have a chronic illness, including but not limited to, cardiac, renal, or auto-immune disorders, or diabetes, at a stage that could interfere with study conduct or completion, based on the opinion of the Investigator.
• Who have a neoplastic disease or any hematologic malignancy, (excluding uncomplicated non-melanoma skin cancer and participants who have a history of neoplastic disease and have been disease free for at least five years).
• Who have participated in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the four weeks preceding the study vaccination or who plan to participate in another clinical trial during the present study period.
• Who have any skin disease other than AD that might compromise the stratum corneum barrier (e.g., bullous disease, psoriasis, cutaneous T cell lymphoma \[also called Mycosis Fungoides or Sezary syndrome\], dermatitis herpetiformis, Hailey-Hailey, or Darier's disease).
• Who have received blood or blood-derived products that might interfere with the assessment of immune response in the past 3 months prior to vaccination or who plan to receive such products during the study period.
• Who have received previous vaccination (Fluzone® or another vaccine) against influenza in the past 6 months prior to vaccination.
• Who have received any other vaccinations in the 4 weeks preceding study vaccination or who plan to receive any vaccination in the 4 weeks following study vaccination.
• Who have had thrombocytopenia or bleeding disorder in the 3 weeks preceding vaccination.
• Who have had a personal or family history of Guillain-Barré Syndrome.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Atopic Dermatitis Research Network: collaborator

Study Sites (1)

National Jewish Health

Denver, Colorado, 80206, United States

Location

Related Publications (1)

• Leung DYM, Jepson B, Beck LA, Hanifin JM, Schneider LC, Paller AS, Monti K, David G, Canniff J, Lorenzo MG, Weinberg A. A clinical trial of intradermal and intramuscular seasonal influenza vaccination in patients with atopic dermatitis. J Allergy Clin Immunol. 2017 May;139(5):1575-1582.e8. doi: 10.1016/j.jaci.2016.12.952. Epub 2017 Feb 13.

  PMID: 28209343 BACKGROUND

Related Links

• Atopic Dermatitis Research Network (ADRN)
• National Institute of Allergy and Infectious Diseases (NIAID) website

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Donald Leung, MD, PhD

  National Jewish Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2011
• First Posted: January 26, 2012
• Study Start: November 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: March 1, 2012
• Last Updated: March 1, 2017

Record last verified: 2017-02

Locations

US (1)