Single Center, Placebo Controlled Clinical Study in Desensitization vs Tolerance Induction in Peanut Allergy Subjects Study Protocol NCT02103270 January 24, 2018 PROTOCOL NUMBER AADCRC-STAN-001 LONG TITLE: Single Center, Placebo Controlled Clinical Study in Desensitization vs. Tolerance Induction in Peanut Allergy Subjects SHORT TITLE: Tolerance vs. Desensitization in Peanut-Allergic Individuals VERSION NUMBER / VERSION DATE: 7 / January 24, 2018 IND# Amendment 14 Study Sponsor(s): The National Institute of Allergy and Infectious Diseases (NIAID) NIAID Funding Mechanism: AADCRC (PI, Galli) IND Sponsor: Kari C. Nadeau, MD, PhD Study Drug Manufacturer/Provider: Stanford CFRU (Clinical Food Research Unit, 4th Floor and cGMP facility, 1st Floor, Stanford Packard El Camino Hospital, 2500 Grant Rd, Mountain View, CA. PROTOCOL STATISTICIAN , PhD Stanford University Department of Medicine Palo Alto, CA 94304 Phone: Fax: E-mail: PROTOCOL CHAIR- CO-CHAIR Kari C. Nadeau, MD, PhD R. Sharon Chinthrajah, MD Stanford University (same) (same) Stanford, CA 94305 (same) Phone: 650-723-5227 (same) Fax: 650-498-5560 (same) E-mail:
[email protected] [email protected] NIAID MEDICAL MONITOR- NIAID PROJECT MANAGER- REGULATORY OFFICER – , MD , RN, BSN Division of Allergy, Immunology, Division of Allergy, Immunology, and Division of Allergy, Immunology, and and Transplantation – NIAID/NIH Transplantation – NIAID/NIH Transplantation – NIAID/NIH Rockville, MD 20852 , USA Rockville, MD 20852, USA Rockville, MD 20852, USA Phone: Phone: Phone: E-mail: E-mail: Fax: E-mail: 1 Confidentiality Statement The information contained within this document is not to be disclosed in any way without the prior permission of the Protocol Chair, or the Division of Allergy, Immunology and Transplantation, National Institute of Allergy and Infectious Diseases of the National Institutes of Health.