About ADVN

ADVN is a consortium of medical centers and a data coordinating center sponsored by the National Institute of Allergy and Infectious Disease (NIAID). The primary goal of ADVN is to advance clinical research in the development of safer smallpox vaccines for individuals with Atopic Dermatitis (AD). People with AD should not receive smallpox vaccinations because of increased risk of a serious and potentially fatal complication called Eczema Vaccinatum.

ADVN Statistical and Data Coordinating Center

The Statistical and Data Coordinating Center (SDCC) is located at Rho, Inc and provides support to the ADVN Clinical and Animal Study Sites. The SDCC is responsible for:

Current Projects Supported by the SDCC

ADVN Biomarker Registry Study

The ADVN Biomarker Registry Study is a database with a minimum of 1,000 subjects who have voluntarily agreed to provide medical and demographic information about themselves and their health status. These data will be used to identify potential subjects for future studies designed to improve scientific understanding of the increased risk of complications after exposure to the smallpox vaccine for people with atopic dermatitis (AD).

Genetics of Atopic Dermatitis- Eczema Herpeticum

This project is designed to test for genetic determinants in the sub-phenotype of AD: ADEH+. The objective of this study is to use new genomic technologies using high-throughput genotyping and guided by gene expression profiling studies in skin samples infected with 2 different viruses (HSV and molluscum contagiosum virus [MCV]) to provide significant and novel information on the pathways responsible for the development of Eczema Herpeticum (EH) and possibly other relevant viral infections seen more commonly in AD subjects (e.g., Eczema Vaccinatum (EV) and MCV).

Role of Antimicrobial Peptides in Host Defense Against Vaccinia Virus

This study will assess immune mechanisms which predispose AD subjects to recurrent viral infections as compared to people with psoriasis, asthma, and healthy individuals. AD is a chronic inflammatory skin disorder characterized by recurrent skin infections. Recent studies have demonstrated that the T-Helper 2 cell (Th2) phenotype of AD skin suppresses antimicrobial peptides (AMP) (i.e., Human ß-Defensin-2 [HBD-2], Human ß-Defensin-3 [HBD-3], and LL-37) expression and may potentially explain the increased risk for AD patients to develop EV.

Analysis & Correlation of Cathelicidin Expression in Neutrophils & Saliva of Subjects with Atopic Dermatitis & Psoriasis

The purpose of this study is to obtain qualitative and quantitative data regarding systemic and local expression of the human cathelicidin hCAP18/LL-37 in subjects with AD, psoriasis, and controls. If blood and saliva accurately reflect cutaneous expression of cathelicidins, this will provide an alternative and simple source for evaluation of the potential for study subjects to mount an innate host response by antimicrobial peptides.

Risk Factors in Atopic Dermatitis for the Development of Eczema Herpeticum

The specific aim of this study is to determine risk factors in AD for the development of EH by evaluating myeloid and plasmacytoid dendritic cells (DCs) in AD subjects with EH+ Herpes Simplex Virus (HSV)+, EH-HSV+, EH-HSV-, and healthy volunteers.

Immune Response to Varicella Vaccination in Subjects with Atopic Dermatitis Compared to Nonatopic Controls

Young children have the highest prevalence of AD and are at significant risk for complications from vaccinia. It is believed that investigating the immune response to varicella vaccination will yield important information about alterations in the immune response to live virus vaccines in subjects with AD. The immune response to varicella will be assessed.

Responses to Immunization with Keyhole Limpet Hemocyanin (KLH) by Scarification and the Intradermal Route

The study will determine whether humoral/cellular immunological responses are provoked by KLH immunization and to determine the safety of administering KLH by the scarification route. Comparisons will be made between subject groups. This study will be used to determine whether immunization with KLH can be used to investigate immune and adaptive immune responses in the skin.

A Study of the Systemic & Cutaneous Immune Response to Yellow Fever Vaccination in Atopic Dermatitis Subjects

The main objective of the ADVN is to reduce the risk of EV following smallpox vaccination. Since direct vaccination of AD subjects with live vaccinia virus is contraindicated due to the heightened risk of EV, a surrogate virus, yellow fever (YF) was chosen. This study will provide substantial information about normal and defective cutaneous immunity in AD subjects, which will be critical for future development of therapeutic drugs aimed at preventing or alleviating EV, as well as other more common viral skin infections.

Clinical Study Sites and Principal Investigators

National Jewish Medical & Research Center
Principal Investigator: Donald Leung, M.D., PhD
Oregon Health & Science University
Principal Investigator: Jon Hanifin, M.D.
University of California at San Diego
Principal Investigator: Richard Gallo, M.D., PhD
Children's Hospital Boston
Principal Investigator: Lynda Schneider, M.D.
University of Rochester Medical Center
Principal Investigator: Lisa Beck, M.D.
University of Bonn, Germany
Principal Investigator: Thomas Bieber, M.D., PhD

Animal Study Sites and Principal Investigators

National Jewish Medical & Research Center
Principal Investigators: Donald Leung, M.D., PhD and Erwin Gelfand, M.D.
Harvard Skin Disease
Principal Investigators: Robert Fuhlbrigge, M.D. and Thomas Kupper, M.D.
Children's Hospital Boston
Principal Investigators: Raif Geha, M.D. and Hans Oettgen, M.D., PhD
La Jolla Institute for Allergy and Immunology
Principal Investigator: Toshiaki Kawakami, M.D., PhD

ADVN Statistical and Data Coordinating Center

Rho, Inc.
Principal Investigator: Susan Lieff, PhD