Atopic Dermatitis Research Network (ADRN) Influenza Vaccine Study
A Randomized Open Label Mechanistic Study in Atopic Dermatitis to Assess the Immunogenicity of Fluzone® Intradermal and Intramuscular Vaccines
1 other identifier
interventional
368
1 country
5
Brief Summary
Atopic dermatitis, also called eczema, is a disease in which the skin is dry and scaly with severe itching. People who have atopic dermatitis often have complications from skin infections; these can include eczema herpeticum after herpes simplex virus infection or eczema vaccinatum after smallpox vaccination. People with atopic dermatitis may suffer from skin infections and may therefore respond differently to vaccinations. A new flu vaccine which is injected into the skin instead of into muscle has recently been approved by the Food and Drug Administration for vaccination of the general population including patients with atopic dermatitis. 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 main purpose of this study is to compare how people with atopic dermatitis respond to this new flu vaccine compared to non-atopic volunteers without atopic dermatitis. The second purpose is to look at how people with atopic dermatitis respond to the new vaccine which is injected into the skin compared to the vaccine which is injected into muscle.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2012
Shorter than P25 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 27, 2012
CompletedFirst Posted
Study publicly available on registry
November 29, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedResults Posted
Study results publicly available
January 6, 2017
CompletedMarch 29, 2017
February 1, 2017
7 months
November 27, 2012
November 8, 2016
February 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Seroprotection, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza B
The difference in the percent of participants that achieved seroprotection against influenza B at Day 28 between non-AD and moderate to severe AD participants, following a single dose (0.1mL) of the seasonal 2012 - 2013 Fluzone Intradermal vaccine. Seroprotection is defined as having a serum hemagglutination-inhibition (HAI) antibody titer of 1:40 or greater, which represents a sufficient antibody amount to avoid disease in half of the individuals infected with influenza B. Participants who achieved seroprotection prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percent of participants who achieved seroprotection at Day 28 who were not seroprotected prior to vaccination.
Day 28 post vaccination
Seroprotection, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza H1N1
The difference in the percentage of participants that achieved seroprotection against influenza H1N1 at Day 28 between non-AD and moderate to severe AD participants, following a single dose (0.1mL) of the seasonal 2012 - 2013 Fluzone Intradermal vaccine. Seroprotection is defined as having a serum hemagglutination-inhibition (HAI) antibody titer of 1:40 or greater, which represents a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H1N1. Participants who achieved seroprotection prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroprotection at Day 28 who were not seroprotected prior to vaccination.
Day 28 Post Vaccination
Seroprotection, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza H3N2
The difference in the percentage of participants that achieved seroprotection against influenza H3N2 at Day 28 between non-AD and moderate to severe AD participants, following a single dose (0.1mL) of the seasonal 2012 - 2013 Fluzone Intradermal vaccine. Seroprotection is defined as having a serum hemagglutination-inhibition (HAI) antibody titer of 1:40 or greater, which represents a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H3N2. Participants who achieved seroprotection prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroprotection at Day 28 who were not seroprotected prior to vaccination.
Day 28 Post Vaccination
Secondary Outcomes (12)
Fold-difference in Geometric Mean Serum Hemagglutination-inhibition (HAI) Antibody Titers, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza B
Day 28 post vaccination
Fold-difference in Geometric Mean Serum Hemagglutination-inhibition (HAI) Antibody Titers, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza H1N1
Day 28 post vaccination
Fold-difference in Geometric Mean Serum Hemagglutination-inhibition (HAI) Antibody Titers, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza H3N2
Day 28 post vaccination
Seroprotection, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza B
Day 28 post vaccination
Seroprotection, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza H1N1
Day 28 Post Vaccination
- +7 more secondary outcomes
Study Arms (5)
92 Non-atopic controls vaccinated with Fluzone® Intradermal
EXPERIMENTALNon-atopic controls who will receive a single dose of the seasonal 2012-2013 Fluzone® Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
Moderate to severe AD vaccinated with Fluzone® Intradermal
EXPERIMENTAL92 moderate to severe atopic dermatitis participants who will receive a single dose of the seasonal 2012-2013 Fluzone® Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
Moderate to severe AD vaccinated with Fluzone® (Intramuscular)
ACTIVE COMPARATOR92 moderate to severe atopic dermatitis participants who will receive a single dose of the seasonal 2012-2013 Fluzone® (Intramuscular) influenza vaccine from 0.5 mL single dose vials.
Non-atopic controls vaccinated with Fluzone® (Intramuscular)
ACTIVE COMPARATOR20 non-atopic controls who will receive a single dose of the seasonal 2012-2013 Fluzone® (Intramuscular) influenza vaccine from 0.5 mL single dose vials.
Mild AD participants vaccinated with Fluzone® Intradermal
EXPERIMENTAL20 mild atopic dermatitis participants who will receive a single dose of the seasonal 2012-2013 Fluzone® Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
Interventions
A 0.1mL single-dose, in a latex-free, pre-filled microinjection system with an ultra-fine micro-needle. The active substance is prepared from influenza viruses propagated in embryonated chicken eggs. Fluzone® Intradermal is approved for use in persons 18 through 64 years of age and will be purchased from Sanofi Pasteur, Inc.
A 0.5 mL single-dose delivered via syringe using single-dose vials. The active substance is prepared from influenza viruses propagated in embryonated chicken eggs. Fluzone® for intramuscular injection is approved for persons 6 months and older and will be purchased from Sanofi Pasteur, Inc.
Eligibility Criteria
You may qualify if:
- Enrolled in the ADRN Registry study;
- Active, mild to severe AD (lesions present) with or without a history of eczema herpeticum or who are non-atopic as diagnosed using the ADRN Standard Diagnostic Criteria; and
- Willing to sign the informed consent form prior to initiation of any study procedure.
You may not qualify if:
- 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;
- Have a known allergy to any component of the Fluzone® Intradermal or Fluzone® (Intramuscular) vaccines, including egg protein, or have had a severe allergic reaction to a previous dose of any influenza vaccine;
- known or suspected congenital or acquired immunodeficiency or who have had immunosuppressive therapy (excluding steroids) such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months;
- Received systemic steroid therapy for 2 or more weeks at a dose ≥ 20 mg/day prednisone equivalent within 1 month prior to the day of vaccination or expect to receive within 3 weeks post-vaccination;
- Received a cumulative dose of inhaled and/or intranasally administered corticosteroids ≥ 880 mcg/day fluticasone equivalent for 2 or more weeks within 1 month prior to the day of vaccination or expect to receive within 3 weeks post-vaccination;
- A neoplastic disease or any hematologic malignancy. Participants who have been disease free for at least six months will not be excluded;
- 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;
- 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);
- 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;
- Received previous vaccination (Fluzone® or another vaccine) against influenza in the past 6 months prior to vaccination;
- Received any other live vaccines within 4 weeks or inactivated vaccines within 2 weeks prior to study vaccination or who plan to receive any vaccination during the study period;
- Thrombocytopenia or bleeding disorder in the 3 weeks preceding vaccination;
- Personal or family history of Guillain-Barré Syndrome;
- A first degree relative already enrolled in the study;
- Determined to be ineligible based on the opinion of the Investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
National Jewish Health
Denver, Colorado, 80206, United States
Northwestern University
Chicago, Illinois, 60611, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Oregon Health & Science University
Protland, Oregon, 97239, United States
Related Publications (6)
Leung DY, Gao PS, Grigoryev DN, Rafaels NM, Streib JE, Howell MD, Taylor PA, Boguniewicz M, Canniff J, Armstrong B, Zaccaro DJ, Schneider LC, Hata TR, Hanifin JM, Beck LA, Weinberg A, Barnes KC. Human atopic dermatitis complicated by eczema herpeticum is associated with abnormalities in IFN-gamma response. J Allergy Clin Immunol. 2011 Apr;127(4):965-73.e1-5. doi: 10.1016/j.jaci.2011.02.010.
PMID: 21458658BACKGROUNDPrymula R, Siegrist CA, Chlibek R, Zemlickova H, Vackova M, Smetana J, Lommel P, Kaliskova E, Borys D, Schuerman L. Effect of prophylactic paracetamol administration at time of vaccination on febrile reactions and antibody responses in children: two open-label, randomised controlled trials. Lancet. 2009 Oct 17;374(9698):1339-50. doi: 10.1016/S0140-6736(09)61208-3.
PMID: 19837254BACKGROUNDPulendran B, Li S, Nakaya HI. Systems vaccinology. Immunity. 2010 Oct 29;33(4):516-29. doi: 10.1016/j.immuni.2010.10.006.
PMID: 21029962BACKGROUNDSchneider L, Weinberg A, Boguniewicz M, Taylor P, Oettgen H, Heughan L, Zaccaro D, Armstrong B, Holliday A, Leung DY. Immune response to varicella vaccine in children with atopic dermatitis compared with nonatopic controls. J Allergy Clin Immunol. 2010 Dec;126(6):1306-7.e2. doi: 10.1016/j.jaci.2010.08.010.
PMID: 20889193BACKGROUNDLeung 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: 28209343RESULTJalbert E, Lussier S, Johnson MJ, Jepson B, Calatroni A, David G, Leung D, Weinberg A. Lower influenza-specific cell-mediated immune responses in individuals with atopic dermatitis compared with healthy controls. Hum Vaccin Immunother. 2020 Nov 1;16(11):2727-2735. doi: 10.1080/21645515.2020.1747374. Epub 2020 Apr 29.
PMID: 32347777DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director, Clinical Research Operations Program
- Organization
- DAIT/NIAID
Study Officials
- STUDY CHAIR
Donald Leung, MD, PhD
National Jewish Health
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 27, 2012
First Posted
November 29, 2012
Study Start
October 1, 2012
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
March 29, 2017
Results First Posted
January 6, 2017
Record last verified: 2017-02