Overview

Immune Response to Yellow Fever Vaccination in Adults With Atopic Dermatitis

Status:
Completed
Trial end date:
2011-04-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Treatments:
Vaccines
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 less than 1000 lymphocytes per microliter