A Phase 2a Study to Evaluate the Safety, Tolerability, and Immunogenicity of One Dose of NDV-3A Vaccine in Patients With STAT3-Mutated Hyper-IgE Syndrome NIAID Protocol Number: 17-I-0017 Version Number: 3.0 Date: August 13, 2018 Investigational New Drug (IND) Number: 17230 IND Sponsor: Office of Clinical Research Policy and Regulatory Operations (OCRPRO) Division of Clinical Research (DCR) National Institute of Allergy and Infectious Diseases (NIAID) National Institutes of Health (NIH) Sponsor Medical Monitor: H. Preston Holley, MD, FIDSA Medical Monitor Leidos Biomedical Research 5705 Industry Lane Frederick, MD 21701 Phone: 301 228-4005 Email:
[email protected] Pharmaceutical Support Provided by: NovaDigm Therapeutics, Inc. 4201 JaMes Ray Drive Technology Transfer Building Grand Forks, ND 58202 OHRP Assurance: FWA00011288 Principal Investigator: Alexandra FreeMan, MD Laboratory of Clinical IMMunology and Microbiology (LCIM) Building 10 Room 11N234 10 Center Drive Bethesda, MD 20814 Phone: 301-594-9045 Email:
[email protected] Conducted by: LCIM, NIAID, NIH NDV-3A Vaccine Study Protocol Version 3.0 August 13, 2018 Study Staff Roster Associate Investigators: Lisa Barnhart, RN, MSN PaMela Welch, RN, BSN LCIM/NIAID Leidos Biomedical Research, Inc Phone: (301) 496-5270 LCIM/NIAID Email:
[email protected] Phone: (301) 402-0449 Email:
[email protected] Angelique Biancotto, PhD Center for Human ImMunology AutoiMMunity, and InflaMMation External Collaborators: (CHI)/National Heart, Lung and Blood John P. Hennessey, Jr, PhD Institute (NHLBI) NovaDigm Therapeutics, Inc. Phone: (301) 594-0060 4201 JaMes Ray Drive Email:
[email protected] Technology Transfer Building Grand Forks, ND 58202 Jinguo Chen, MD Phone: (267) 640-5189 CHI/NHLBI Email:
[email protected] Phone: (301) 594-4636 Dr.