Atopic DermatitisEarly Phase 1NCT01518478
Atopic Dermatitis Research Network (ADRN) Influenza Vaccine Pilot
A Early Phase 1 study testing Fluzone® Intradermal (Sanofi Pasteur Inc.) in people with Atopic Dermatitis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Fluzone® Intradermal (Sanofi Pasteur Inc.)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Mar 2012
- Phase
- Early 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 24Show fewer
- 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.
- Who have a first degree relative already enrolled in the study.
- Who are determined to be not eligible based on the opinion of the Investigator.
- Who require Class I or II topical corticosteroids or calcineurin inhibitors for long-term control of their eczema.
- Temporary Vaccination Exclusion Criteria:
- Should one of the conditions listed below occur, the Investigator will postpone vaccination until the condition is resolved.
- Signs and symptoms of an acute infectious respiratory illness.
- Febrile illness (temperature ≥ 37.5°C [or ≥ 99.5°F]) or moderate or severe acute illness/infection on the day of vaccination.
- Atopic dermatitis flare, a worsening of the AD participant's skin condition, requiring increased level of baseline treatment during the previous 7 days. Participant must not have applied Class I or II topical corticosteroids or calcineurin inhibitors to any part of the body in the 7 days prior to vaccination. Non-class I or II topical corticosteroids must not have been applied to the deltoid region of the extremity to be vaccinated in the 7 days prior to vaccination.
- Who have taken antipyretics and/or analgesics (e.g. acetaminophen, ibuprofen) within 24 hours prior to the time of vaccination.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label Study in Adults With Atopic Dermatitis to Assess Variability in Immune Response to Fluzone® Intradermal Vaccine
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.
Read the detailed description
This is a single center, open-label, mechanistic study designed to determine the variance of the antibody response in non-atopic and ADEH- participants receiving a single dose of the 2011-2012 seasonal Fluzone® Intradermal vaccine administered per label.
Twenty non-atopic and 20 ADEH- (mild to severe AD) adults aged 18 to 64 years will be enrolled. Enrollment will be closely monitored to ensure that there is a similar distribution of non-atopic and ADEH- participants by gender, age, and race/ethnicity.
Eligible study participants will provide a pre-vaccination blood sample (Day 0) for assessment of baseline HAI antibody titers, cellular immune response, total IgE, and allergen sensitization, and will then receive a single injection of the 2011-2012 seasonal Fluzone® Intradermal vaccine administered per label. A subset of participants will also provide blood for microarray analysis at Baseline (Day 0) and will return to the clinic 3 and 7 days post-vaccination to provide additional blood for microarray analysis. All participants will return to the study site 28 days post-vaccination for a blood draw for HAI antibody titers and cellular immune response assays.
Study participants will be followed for safety, including serious adverse events (SAEs), throughout the entire duration of the study and will be asked to record solicited AEs on a diary card (Days 0-7).
- Conditions
- Atopic Dermatitis
- Being tested
- Fluzone® Intradermal (Sanofi Pasteur Inc.)
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 20 Non-atopic | Other | Non-atopic, healthy control. Receives: Drug: Fluzone® Intradermal (Sanofi Pasteur Inc.) |
| 20 ADEH- (mild to severe AD) | Other | Atopic Dermatitis without previous or current Eczema Herpeticum. Receives: Drug: Fluzone® Intradermal (Sanofi Pasteur Inc.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Day 0) and Day 28
Secondary outcomes (3)
Change from Baseline (Day 0) Influenza-specific T Cell Populations
Influenza-specific effector CD4+ and CD8+ T cells pre-vaccination (Day 0) and post-vaccination (Day 28) as measured by flow cytometry for MIP1b, Ki67, CD107a, and CD103 expression.
Measured: Baseline (Day 0) and Day 28
Change from Baseline (Day 0) Influenza-specific Interferon Gamma and/or Granzyme B Producing Cells
Influenza-specific Interferon gamma and/or granzyme B producing cells measured pre-vaccination (Day 0) and post-vaccination (Day 28) by Enzyme-Linked Immunosorbent Spot (ELISPOT).
Measured: Baseline (Day 0) and Day 28
Change from Baseline (Day 0) Microarray Analysis
Gene expression profiles of PBMCs pre-vaccination (Day 0) and post-vaccination (Days 3 and 7) as measured by microarray analysis.
Measured: Baseline (Day 0), Day 3, and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2012 (estimated)
- Study startNov 2011
- Primary completionFeb 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Atopic Dermatitis Research Network
- Responsible party
- Sponsor
- Investigators
- Donald Leung, MD, PhD, Principal investigator, National Jewish Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01518478
- Sponsor's protocol ID
- DAIT ADRN-03
- Status last verified
- Feb 2017
- First submitted
- 14 Dec 2011
- Last updated
- 1 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28209343
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study in Adults With Atopic Dermatitis to Assess Variability in Immune Response to Fluzone® Intradermal Vaccine
- ClinicalTrials.gov ID
- NCT01518478
- Acronym / sponsor ID
- DAIT ADRN-03
- Conditions
- Atopic Dermatitis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Atopic Dermatitis Research Network
- Study start
- Nov 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 26 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a single center, open-label, mechanistic study designed to determine the variance of the antibody response in non-atopic and ADEH- participants receiving a single dose of the 2011-2012 seasonal Fluzone® Intradermal vaccine administered per label.
Twenty non-atopic and 20 ADEH- (mild to severe AD) adults aged 18 to 64 years will be enrolled. Enrollment will be closely monitored to ensure that there is a similar distribution of non-atopic and ADEH- participants by gender, age, and race/ethnicity.
Eligible study participants will provide a pre-vaccination blood sample (Day 0) for assessment of baseline HAI antibody titers, cellular immune response, total IgE, and allergen sensitization, and will then receive a single injection of the 2011-2012 seasonal Fluzone® Intradermal vaccine administered per label. A subset of participants will also provide blood for microarray analysis at Baseline (Day 0) and will return to the clinic 3 and 7 days post-vaccination to provide additional blood for microarray analysis. All participants will return to the study site 28 days post-vaccination for a blood draw for HAI antibody titers and cellular immune response assays.
Study participants will be followed for safety, including serious adverse events (SAEs), throughout the entire duration of the study and will be asked to record solicited AEs on a diary card (Days 0-7).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 20 Non-atopic | Other | Drug: Fluzone® Intradermal (Sanofi Pasteur Inc.)Non-atopic, healthy control. |
| 20 ADEH- (mild to severe AD) | Other | Drug: Fluzone® Intradermal (Sanofi Pasteur Inc.)Atopic Dermatitis without previous or current Eczema Herpeticum. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluzone® Intradermal (Sanofi Pasteur Inc.)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. | Drug | 20 ADEH- (mild to severe AD), 20 Non-atopic |
Primary outcome
Change from Baseline (Day 0) HAI Antibody Titers
Time frame: Baseline (Day 0) and Day 28
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.
3 secondary outcomes
Change from Baseline (Day 0) Influenza-specific T Cell Populations
Time frame: Baseline (Day 0) and Day 28
Change from Baseline (Day 0) Influenza-specific Interferon Gamma and/or Granzyme B Producing Cells
Time frame: Baseline (Day 0) and Day 28
Change from Baseline (Day 0) Microarray Analysis
Time frame: Baseline (Day 0), Day 3, and Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2017.
- Background: PubMed 28209343Leung 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.
- Atopic Dermatitis Research Network (ADRN)Link provided by the sponsor.
- National Institute of Allergy and Infectious Diseases (NIAID) websiteLink provided by the sponsor.
Related trials for Atopic Dermatitis
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald Leung, MD, PhD principal investigator
National Jewish Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Fluzone® Intradermal (Sanofi Pasteur Inc.) 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 5 inclusion and 24 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 1 Mar 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 from Baseline (Day 0) HAI Antibody Titers (time frame: Baseline (Day 0) and Day 28). 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 NCT01518478, 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 1 Mar 2017.