Protocol Number: VXA-G11-201.1 ________________________________________________________________________________ Clinical Study Protocol Protocol Title: Evaluation of Infectivity and Illness of Norwalk GI.1 Virus Lot 001-09NV in the Human Challenge Model Protocol Number: VXA-G11-201.1 IND Sponsor: WCCT Global 3545 Howard Way, Costa Mesa, CA 92626 Maria Apkarian Vice President, Early Clinical Development Email:
[email protected] Phone: 714-252-0700; ext: 1019 Funding Sponsor: Vaxart, Inc. Funding Sponsor POC: David N. Taylor, MD Chief Medical Officer Vaxart, Inc. 400 Oyster Point Blvd., Suite 222 South San Francisco, CA 94080 Email:
[email protected] Mobile phone: 919-349-6109 Protocol Version Number: 1.1 Amendment 1 Date: 21 September 2018 Confidentiality Statement This document is confidential and is to be distributed for review only to investigators, potential investigators, consultants, study staff, and applicable independent ethics committees or institutional review boards. The contents of this document shall not be disclosed to others without written authorization from Vaxart (or others, as applicable), unless it is necessary to obtain informed consent from potential study subjects. SIGNATURE PAGE/STATEMENT OF COMPLIANCE Version 1.1 Confidential Page 1 of 50 Date: 21Sept 2018 Protocol Number: VXA-G11-201.1 ________________________________________________________________________________ Protocol Title: Evaluation of Infectivity and Illness of Norwalk GI.1 Virus Lot 001-09NV in the Human Challenge Model Protocol Number: VXA-G11-201.1 Vaxart, Inc. ______________________________ ________________ David Taylor Date Chief Medical Officer The trial will be conducted in accordance with the International Conference on Harmonisation (ICH) E6 and the Code of Federal Regulations on the Protection of Human Subjects (45 CFR Part 46).