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Phase 2 Randomized, Placebo-Controlled Official Title: Phase 2 Randomized, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of a Chikungunya Virus-Like Particle Vaccine, VRC-CHKVLP059-00-VP, in Healthy Adults ClinicalTrials.gov Identifier: NCT02562482 Document Type: Study Protocol, including Letters of Amendment (Informed Consent Template located in Appendix I of the Protocol Version 2.0) Statistical Analysis Plan Document/Date: Protocol Version 2.0: April 15, 2016 Protocol Version 2.0, Letter of Amendment #1: April 26, 2016 Protocol Version 2.0, Letter of Amendment #2: June 2, 2016 Statistical Analysis Plan Version 1.0: September 11, 2018 Phase 2 Randomized, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of a Chikungunya Virus-Like Particle Vaccine, VRC-CHKVLP059-00-VP, in Healthy Adults Protocol VRC 704 Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC) Bethesda, Maryland, USA BB-IND 14907 – held by VRC, NIAID, NIH NIAID Funding Mechanism Contract Number: 261200800001E Clinical Trial Management Leidos Biomedical Research, Inc. Frederick, Maryland, USA Version 2.0 April 15, 2016 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 NIAID (or others, as applicable), unless it is necessary to obtain informed consent from potential study participants. VRC 704, Version 2.0 April 15, 2016 TABLE OF CONTENTS ABBREVIATIONS ........................................................................................................... 5 PRÉCIS.............................................................................................................................. 6 1. INTRODUCTION ...................................................................................................... 7 1.1. Chikungunya: Etiology, Disease Course and Epidemiology............................ 7 1.2. Rationale for Development of VRC-CHKVLP059-00-VP............................... 8 1.3. Previous Human Experience with VRC-CHKVLP059-00-VP......................... 9 1.4. Rationale for Study Agent Dose and Schedule................................................. 9 1.5. Assessment of Immunogenicity........................................................................ 9 2. STUDY AGENTS .................................................................................................... 10 2.1. VRC-CHKVLP059-00-VP Study Agent ........................................................ 10 2.2. VRC-PBSPLA043-00-VP as Placebo............................................................. 10 3. STUDY OBJECTIVES ............................................................................................ 11 3.1. Primary Objective: .......................................................................................... 11 3.2. Secondary Objectives:..................................................................................... 11 3.3. Exploratory Objectives: .................................................................................. 11 4. STUDY DESIGN AND CLINICAL PROCEDURES............................................. 11 4.1. Study Population ............................................................................................. 11 4.1.1. Inclusion Criteria................................................................................... 12 4.1.2. Exclusion Criteria.................................................................................. 12 4.2. Study Schedule................................................................................................ 13 4.2.1. Pre-enrollment ....................................................................................... 14 4.2.2. Screening Visit(s) .................................................................................. 14 4.2.3. Enrollment Visit .................................................................................... 14 4.2.4. Administration of Injections.................................................................. 14 4.2.5. 7-Day Diary Card and Follow-Up......................................................... 15 4.2.6. Study Visits and Sample Collection...................................................... 15 4.3. Evaluation of Chikungunya Infection during the Study ................................. 15 4.3.1. Chikungunya Infection Diagnostic Visit............................................... 15 4.3.2. Clinical Management and Follow-Up of Chikungunya Infection......... 16 4.4. Concomitant Medications and Procedures...................................................... 16 4.5. Criteria for Discontinuing Subject Participation............................................. 16 4.5.1. Discontinuation of Study Injections ...................................................... 16 4.5.2. Discontinuation from Protocol Participation......................................... 17 4.6. Criteria for Pausing the Study......................................................................... 17 5. SAFETY AND ADVERSE EVENTS...................................................................... 18 5.1. Adverse Events................................................................................................ 18 5.1.1. Adverse Event Definition...................................................................... 18 5.1.2. Adverse Event Reporting in the Study Database .................................. 18 5.2. Serious Adverse Events................................................................................... 18 Page 2 of 55 VRC 704, Version 2.0 April 15, 2016 5.2.1. Serious Adverse Event Definition......................................................... 18 5.2.2. Reporting Serious Adverse Events to the IND Sponsor........................ 19 5.2.3. IND Sponsor Reporting to the FDA...................................................... 20 5.3. Reporting to Site IRBs and Relevant Regulatory Agencies............................ 20 5.3.1. Regulations Applicable to the French Study Sites Only ....................... 20 5.4. Data and Safety Monitoring Board ................................................................. 20 6. STATISTICAL CONSIDERATIONS AND SAMPLE ANALYSIS ...................... 21 6.1. Overview......................................................................................................... 21 6.2. Endpoints ........................................................................................................ 21 6.2.1. Safety..................................................................................................... 21 6.2.2. Immunogenicity..................................................................................... 21 6.3. Sample Size and Accrual ................................................................................ 22 6.3.1. Power Calculations for Evaluation of Safety ........................................ 22 6.3.2. Power Calculations for Evaluation of Immune Responses ................... 23 6.4. Statistical Analysis.......................................................................................... 24 6.4.1. Baseline Demographics......................................................................... 24 6.4.2. Safety Analysis...................................................................................... 25 6.4.3. Analysis of Immune Responses............................................................. 25 6.4.4. Analysis of Chikungunya Incidence...................................................... 25 6.4.5. Interim Analyses.................................................................................... 26 6.4.6. Randomization of Treatment Assignments and Unblinding Criteria .... 26 7. PHARMACY AND INJECTION ADMINISTRATION PROCEDURES.............. 27 7.1. Study Agents ................................................................................................... 27 7.2. Study Agent Presentation, Stability and Storage ............................................ 27 7.2.1. Labels .................................................................................................... 27 7.2.2. Storage................................................................................................... 28 7.3. Preparation of Study Agent for Injection........................................................ 28 7.3.1. Preparation of VRC-CHKVLP059-00-VP............................................ 28 7.3.2. Preparation of VRC-PBSPLA043-00-VP ............................................. 28 7.4. Study Agent Administration ........................................................................... 28 7.5. Study Agent Accountability............................................................................ 29 7.5.1. Documentation ...................................................................................... 29 7.5.2. Disposition............................................................................................. 29 8. HUMAN SUBJECTS PROTECTION ..................................................................... 29 8.1. Institutional Review Board ............................................................................. 29 8.2. Subject Recruitment and Enrollment .............................................................. 29 8.2.1. Participation of Children ......................................................................
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