Immune Response to Yellow Fever Vaccination in Adults With Atopic Dermatitis

NCT ID: NCT00723489

Last Updated: 2014-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2011-04-30

Brief 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.

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. The first experimental arm 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. The second arm 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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

YFV-17D (Right Deltoid)

Participants will be randomized within each atopic dermatitis (AD) severity subgroup or as non-atopic controls to either subcutaneous (SC) or transcutaneous (TC) vaccine administration. In this arm, participants will receive a standard vaccine dose (5.5x10\^4 Plaque Forming Units) of YFV-17D administered subcutaneously in the right deltoid and placebo vaccination transcutaneously (then covered with a semi-occlusive dressing) in the left deltoid. The site pharmacist will maintain the blind and an unblinded (i.e., masked) site coordinator will administer assigned treatment: investigators, participants and assessors remain blinded to treatment assignments throughout the duration of the trial.

Group Type: EXPERIMENTAL

Live Yellow Fever Vaccine (YFV-17D)

Intervention Type: BIOLOGICAL

YFV-17D Placebo

Intervention Type: DRUG

YFV-17D (Left Deltoid)

Participants will be randomized within each atopic dermatitis (AD) severity subgroup or as non-atopic controls to either subcutaneous (SC) or transcutaneous (TC) vaccination. In this arm, participants will receive YFV-17D vaccination (1x10\^3 Plaque Forming Units) by transcutaneous administration (then covered with a semi-occlusive dressing to optimize YFV-17D absorption) in the left deltoid and placebo by subcutaneous administration in the right deltoid. The site pharmacist will maintain the blind and an unblinded (i.e., masked) site coordinator will administered treatment: investigators, participants and assessors remain blinded to treatment assignments throughout the duration of the trial.

Group Type: EXPERIMENTAL

Live Yellow Fever Vaccine (YFV-17D)

Intervention Type: BIOLOGICAL

YFV-17D Placebo

Intervention Type: DRUG

Interventions

Live Yellow Fever Vaccine (YFV-17D)

Intervention Type: BIOLOGICAL

YFV-17D Placebo

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 27 Years
• Maximum Eligible Age: 43 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jon Hanifin, M.D.

Role: STUDY_CHAIR

Oregon Health and Science University

Mark Slifka, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Eric Simpson, M.D.

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Henry Milgrom, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Jewish Health

Richard Gallo, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

University of California, San Diego

San Diego, California, United States

National Jewish Health

Denver, Colorado, United States

Oregon Health & Science University

Portland, Oregon, United States

Countries

United States

References

Slifka MK, Leung DY, Hammarlund E, Raue HP, Simpson EL, Tofte S, Baig-Lewis S, David G, Lynn H, Woolson R, Hata T, Milgrom H, Hanifin J. Transcutaneous yellow fever vaccination of subjects with or without atopic dermatitis. J Allergy Clin Immunol. 2014 Feb;133(2):439-47. doi: 10.1016/j.jaci.2013.10.037. Epub 2013 Dec 10.

Reference Type: DERIVED

PMID: 24331381 (View on PubMed)

Other Identifiers

HHSN266200400029C

Identifier Type: -

Identifier Source: secondary_id

DAIT ADVN YF08

Identifier Type: -

Identifier Source: org_study_id