Research at the Center for Drug Safety and Immunology
The Center for Drug Safety and Immunology (CDSI) at Vanderbilt University Medical Center (VUMC) specializes in research investigating immunologically mediated adverse drug reactions (IM-ADR). CDSI studies the genetic, molecular, and cellular signals that lead to the development of IM-ADRs to predict and prevent these life-threatening reactions. We are pursuing novel research strategies to understand why these adverse drug reactions occur in specific patients and have several ongoing research studies focusing on IM-ADRs.
One of our current studies includes a first-of-its-kind multicenter clinical trial to determine whether two therapeutic interventions - cyclosporine and etanercept - will improve short-term outcomes associated with Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN) over the standard of care. This trial, the North American Therapeutics In Epidermal Necrolysis Syndrome (NATIENS), is actively recruiting and is led by CDSI founder and director, Dr. Elizabeth Phillips.
CDSI-led studies
Additional research initiatives spearheaded by CDSI faculty include:
- Understanding and Preventing HLA-associated Drug Reactions, overseen by Dr. Phillips. This study focuses on defining the mechanistic basis of HLA-associated drug hypersensitivity syndromes. Our long-standing collaborations with our valued partners, the Stevens-Johnson Syndrome Foundation and the DRESS Syndrome Foundation, have enabled our center to assemble two of the most extensive data and DNA biobanks of SJS/TEN and DRESS patients internationally.
- Stevens-Johnson Syndrome (SJS) Survivor Study, run by Dr. Phillips is designed to determine genetic risk factors and the long-term complications related to the most common drugs associated with SJS/TEN.
- DRESS Syndrome Survivor Study, led by Dr. Phillips. This study enrolls patients who have recovered from drug reaction with eosinophilia and systemic symptoms (DRESS). As with the SJS Survivor Study, specific aims include identifying the genetic risk factors and understanding the long-term complications of patients confirmed to have DRESS.
- Understanding and Monitoring Drug Induced Anaphylaxis, overseen by Dr. Cosby Stone. This work focuses on collecting DNA from individuals who have had an anaphylactic reaction from either medications or foods to determine if specific genetic sequences are implicated in certain reactions.
External Collaborations
CDSI also partners with several other investigators and institutions on ongoing studies to elucidate the mechanisms that drive IM-ADRs. Some of these essential partnerships include:
- ABO and Immunogenetic Variation in the Pathogenesis of Heparin-Induced Thrombocytopenia, overseen by Dr. Jason Karnes at The University of Arizona. This study focuses on the identification of intrinsic immune cell involvement in heparin-induced thrombocytopenia (HITT).
- Systemic Allergic Reactions to SARS-CoV-2 Vaccination (SARS-CoV-2), led by Dr. Jane Buckner at the Benaroya Research Institute. A principal aim of this study is to estimate the proportions of systemic allergic reactions to the Pfizer-BioNTech COVID-19 Vaccine and the Moderna COVID-19 Vaccine in a population with increased risk of developing severe and life-threatening allergic reactions.
- United States Drug Allergy Registry (USDAR), run by Dr. Kimberly Blumenthal at Massachusetts General. CDSI is a long-standing partner in this nationwide community research study to understand the impact of drug allergies and improve public health.
- The Australasian Registry for Severe Cutaneous Adverse Reactions (AUS-SCAR) and the African Severe Cutaneous Adverse Reactions (AFRI-SCAR) Network are registries that help physician-scientists develop new global strategies for the prevention and treatment of severe cutaneous adverse reactions (SCARs). Dr. Phillips has consulted on these essential efforts.
- Massachusetts General Brigham-Severe Cutaneous Adverse Reaction (MGB-SCAR), overseen by Dr. Li Zhou. An aim of MGB-SCAR is to discern who is at increased risk for severe cutaneous adverse reactions (SCARs) in the United States and to study the immediate and long-term consequences of SCARs on health and quality of life. CDSI research personnel process saliva samples to determine the clinical and genetic factors that increase an individual’s risk for SCARs.
Completed studies
Recent studies completed by CDSI in collaboration with our research partners include:
- Penicillin Allergy Clinical Decision Rule (PALACE), led by Dr. Phillips. Results from PALACE impact the more than 25 million Americans labeled with penicillin allergy and should change clinical practice for treating these at-risk patients.
- Immune-mediated Adverse Drug Reactions to Human Immunodeficiency Virus (HIV) and Tuberculosis (TB) Treatments in South Africa (IMARI), led by Dr. Jonny Peter at the University of Cape Town. This study has generated a biorepository of DNA and other samples from IM-ADR cases related to drugs used to treat HIV and TB, including underserviced areas in South Africa.