Immune Response to Yellow Fever Vaccination in Adults With Atopic Dermatitis
This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00723489
First received: July 25, 2008
Last updated: November 28, 2011
Last verified: November 2011
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Purpose
The main objective of the Atopic Dermatitis and Vaccinia Immunization Network (ADVN) is to reduce the risk of the fatal reaction, eczema vaccinatum (EV), to the smallpox vaccination in those with atopic dermatitis (AD). Since vaccination with live vaccinia virus (VV) in individuals with AD increases the risk of EV, a yellow fever vaccine was chosen. The purpose of this study is to determine the immune response to a yellow fever vaccine in adults with AD.
| Condition | Intervention | Phase |
|---|---|---|
|
Atopic Dermatitis |
Biological: YFV-17D |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
| Official Title: | A Study of the Systemic and Cutaneous Immune Responses to Yellow Fever Vaccination in Atopic Dermatitis Subjects |
Resource links provided by NLM:
Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):
Primary Outcome Measures:
- Anti-YF antibody levels measured [ Time Frame: On Day 30 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time elapsed from time of vaccination until clearance of viremia as measured by reverse transcriptase polymerase chain reaction (RT-PCR) [ Time Frame: On Days 3, 5, 7, 10, and 14 ] [ Designated as safety issue: No ]
- Kinetics of antibody responses to YFV (CMax, TMax, area under the curve) [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Kinetics and magnitude of YFV-specific CD4 and CD8 T-cell responses as measured by intracellular cytokine staining [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Th1 and Th2 cytokine production [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- NK cell enumeration [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Detection of virus shedding at the TC vaccination site [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Local inflammation at vaccination site [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Clinical laboratory tests (blood count, liver function, renal function) [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
- Adverse events [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
- Measurement of complement levels and function [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
| Enrollment: | 80 |
| Study Start Date: | August 2008 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Participants will receive a 0.5 ml dose of YFV-17D by subcutaneous administration in the right deltoid and receive one dose of placebo by transcutaneous administration in the left deltoid
|
Biological: YFV-17D
YFV-17D administered subcutaneously (5.5 x 10^4 PFU) and transcutaneously (placebo [sodium chloride])
|
|
Experimental: 2
Participants will receive a 0.5 ml dose of placebo by subcutaneous administration in the right deltoid and receive one dose of YFV-17D vaccine transcutaneously in the left deltoid
|
Biological: YFV-17D
Placebo (sodium chloride) administered subcutaneously and transcutaneously (1 x 10^3 PFU)
|
Detailed Description:
AD is a chronic inflammatory skin disorder characterized by recurrent viral skin infections. The purpose of this study is to understand the immune response to a yellow fever vaccine in adults with AD. This study will provide substantial information about normal and defective cutaneous immunity in participants with AD in response to a live virus vaccine, which is critical for understanding the EV reaction.
An individual's participation in the study will last up to 13 weeks. Participants will be randomized into one of two arms. Arm 1 will consist of 20 adults with AD and 20 healthy adults. They will receive one dose of YFV-17D by subcutaneous administration in the right deltoid and receive one dose of YFV-17D placebo by transcutaneous administration in the left deltoid. Arm 2 will consist of 20 adults with AD and 20 healthy adults. They will receive one dose of YFV-17D placebo by subcutaneous administration in the right deltoid and receive one dose of YFV-17D vaccine transcutaneously in the left deltoid.
This study will consist of 6 follow-up visits over a 35 day period after study entry.
Eligibility| Ages Eligible for Study: | 27 Years to 43 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Diagnosis of Atopic Dermatitis or Non-atopic control
- Born and currently residing in the United States
- Weight of at least 110 lbs at the Screening Visit
- Not previously vaccinated for YFV, tick-borne encephalitis (TBEV), Japanese encephalitis virus (JEV), or dengue fever
- Agree to use adequate contraception 30 days prior to and until their participation in the study is completed. More information on this criterion can be found in the protocol.
Exclusion Criteria:
- AD subjects with exfoliative erythroderma or lacking a minimum 10 cm diameter area of normal appearing skin on the deltoid or thigh vaccination sites
- Have a body mass index (BMI) of 30 or greater at the Screening Visit
- Known history of infection with YFV, dengue fever, TBEV, JEV, or West Nile Virus (WNV)
- A family history of severe reactions to the yellow fever vaccine
- Traveled to Africa or South America (including participants who plan to travel to these areas prior to completion of the study)
- History of egg allergy or have a positive egg allergy skin prick test that is administered at the Screening visit
- History of acute hypersensitivity reaction to any components of the yellow fever vaccine (including gelatin)
- Have latex allergy
- Have lidocaine allergy
- Are allergic or hypersensitive to TegadermTM
- Received systemic immunosuppressants within 30 days prior to receiving the vaccination
- Received systemic corticosteroids, anti inflammatory biologics (e.g., alefacept, etanercept, etc.), or calcineurin inhibitors within 30 days prior to receiving the vaccination
- Received systemic antibiotics or antivirals within 7 days of receiving the vaccination
- Received greater than 440 mcg of inhaled steroids per day within 6 months prior to receiving the vaccination
- Received Xolair (Omalizumab) within 1 year prior to receiving the vaccination
- Received immunotherapy within 30 days prior to receiving the vaccination
- Received any vaccine within 30 days prior to randomization or expected receipt 30 days after randomization
- Received topical antibiotics, antivirals, immune enhancers (e.g., imiquimod), or calcineurin inhibitors within 7 days prior to receiving the vaccination
- Received topical corticosteroids within 7 days prior to receiving the vaccination
- Received phototherapy (e.g., ultraviolet light B [UVB], psoralen plus ultraviolet light A [PUVA]) within 30 days prior to receiving the vaccination
- Acute febrile illness or active fungal, bacterial, or viral infections (subjects may be reconsidered for enrollment once the condition has resolved)
- Skin disease other than AD that might compromise the stratum corneum barrier (e.g., clinically evident ichthyosis, bullous disease, psoriasis)
- Current or past history of malignancy or of autoimmune or immunodeficiency diseases. More information on this criterion can be found in the protocol.
- Pregnant or breastfeeding
- Have an anti-nuclear antibody (ANA) titer that is equal to or greater than 1/160 at the Screening Visit
- Have a serum immunoglobulin (Ig)G, IgM, IgA, C3, or C4 level below the normal range at the Screening Visit
- Have a manual lymphocyte count that is <1000 lymphocytes per microliter
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00723489
Locations
| United States, California | |
| University of California, San Diego | |
| San Diego, California, United States, 92037 | |
| United States, Colorado | |
| National Jewish Health | |
| Denver, Colorado, United States, 80206 | |
| United States, Oregon | |
| Oregon Health & Science University | |
| Portland, Oregon, United States, 97239 | |
Sponsors and Collaborators
Investigators
| Study Chair: | Jon Hanifin, M.D. | Oregon Health and Science University |
| Principal Investigator: | Mark Slifka, Ph.D. | Oregon Health and Science University |
| Principal Investigator: | Eric Simpson, M.D. | Oregon Health and Science University |
| Principal Investigator: | Henry Milgrom, M.D. | National Jewish Health |
| Principal Investigator: | Richard Gallo, M.D., Ph.D. | University of California, San Diego |
More Information
Additional Information:
No publications provided
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00723489 History of Changes |
| Other Study ID Numbers: | DAIT ADVN YF08, HHSN266200400029C |
| Study First Received: | July 25, 2008 |
| Last Updated: | November 28, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
Yellow Fever Vaccine Scarification Method Atopic Dermatitis IgG antibodies |
Additional relevant MeSH terms:
|
Dermatitis Dermatitis, Atopic Yellow Fever Skin Diseases Skin Diseases, Genetic Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate |
Hypersensitivity Immune System Diseases Arbovirus Infections Virus Diseases Flavivirus Infections Flaviviridae Infections RNA Virus Infections |
ClinicalTrials.gov processed this record on May 21, 2013