Regents Of The University Of Minnesota

NICHD: R&D: SPAN ANALYSIS 2026: NON-SEVERABLE

WP25-9775 REGENTS OF THE UNIVERSITY OF MINNESOTA ENTITLED DEMONSTRATION CENTER FOR CRITICAL MATERIAL RECAPTURE (DCCMR)

MS4 OPT2 - STUDY 3

OPTION 23C: 0258-A485-4609 OPTION 23D: 0258-A486-4609 THE UNIVERSAL INFLUENZA VACCINE TECHNOLOGY LANDSCAPE IS A UNIQUE, OPEN-ACCESS DATABASE OF INFORMATION ON UNIVERSAL, BROADLY PROTECTIVE, AND NEXT-GENERATION INFLUENZA VACCINES, AS DEFINED IN THE INFLUENZA VACCINES R&D ROADMAP, IN CLINICAL AND PRECLINICAL DEVELOPMENT. AS OF MAY 2024, THE LANDSCAPE PROFILED MORE THAN 200 VACCINE CANDIDATES IN THE R&D PIPELINE IN ACADEMIC, GOVERNMENT, AND INDUSTRY LABORATORIES, INCLUDING COVID-INFLUENZA COMBINATION VACCINES IN CLINICAL DEVELOPMENT, ACROSS SIX DIFFERENT VACCINE PLATFORMS. DATA ON EACH VACCINE CANDIDATE ARE SUMMARIZED BY PHASE, PLATFORM, TECHNICAL APPROACH, GOAL, AND STATUS OF DEVELOPMENT. THE LANDSCAPE IS ONLINE AND OPEN ACCESS, AND THE ENTIRE DATASET CAN BE DOWNLOADED AS A CSV FILE. A SMALL GROUP OF SUBJECT-MATTER EXPERTS IN INFLUENZA VACCINE R&D AND/OR VACCINE DATABASE DEVELOPMENT PROVIDES ADVICE ON THE DEVELOPMENT OF THE LANDSCAPE. THE OBJECTIVE OF THIS PROJECT IS TO CONTINUE DEVELOPING AND MAINTAINING INFORMATION ON THE LANDSCAPE TO INCLUDE AN UP-TO-DATE, COMPREHENSIVE, AND ACCURATE OVERVIEW OF VACCINE CANDIDATES IN PRECLINICAL DEVELOPMENT FOR UNIVERSAL, BROADLY PROTECTIVE, AND NEXT-GENERATION INFLUENZA VACCINES. SPECIFIC ACTIVITIES: 1. COLLECT AND CURATE INFORMATION ON UNIVERSAL, BROADLY PROTECTIVE, AND NEXT-GENERATION INFLUENZA VACCINES TECHNOLOGIES IN PRECLINICAL DEVELOPMENT FROM A WIDE RANGE OF PUBLICLY AVAILABLE SOURCES. CONTINUE RESEARCH ON UNIVERSAL, BROADLY PROTECTIVE, AND NEXT-GENERATION INFLUENZA VACCINE TECHNOLOGIES; MONITOR KEY SOURCES OF INFORMATION FROM THE SCIENTIFIC LITERATURE, PREPRINT SERVERS, AND INDUSTRY WEBSITES AND NEWS SOURCES; AND CROSSCHECK DATA ON VACCINE TECHNOLOGIES IN THE DATABASE. 2. UPLOAD NEW OR REVISED INFORMATION ON THE IVR LANDSCAPE WEBSITE ON A WEEKLY BASIS, FOR DISPLAY IN THE SNAPSHOT GRAPHIC AND DATABASE TABLE, AND MONITOR DATA FOR COMPLETENESS AND ACCURACY. 3. DISSEMINATE INFORMATION ON R&D OF INFLUENZA CANDIDATE VACCINES IN PRECLINICAL DEVELOPMENT VIA PRESENTATIONS AND PUBLICATIONS IN THE PEER-REVIEWED LITERATURE; ENCOURAGE FEEDBACK FROM DEVELOPERS, RESEARCHERS, AND FUNDING ORGANIZATIONS. 4. CONSULT WITH ADVISORY WORKING GROUP MEMBERS FOR GUIDANCE AND REVIEW. COMMUNICATE WITH DEVELOPERS TO VERIFY ACTIVITIES AND ACCURACY OF DATA. 5. MODIFY THE ONLINE DATABASE FORMAT AS NEEDED, WITH SUPPORT FROM CIDRAP€„¢S IT CONSULTANTS, AND IN COMMUNICATION WITH NIAID AND CIVICS-SEM. THE LANDSCAPE WILL PROVIDE A COMPREHENSIVE, UP-TO-DATE RESOURCE ON THE R&D PIPELINE FOR VACCINE CANDIDATES IN PRECLINICAL DEVELOPMENT FOR RESEARCHERS, DEVELOPERS, AND NIAID LEADERSHIP. THE LANDSCAPE SUPPORTS THE NIAID/CIVICS PROGRAM€„¢S GOAL OF ADVANCING INFLUENZA VACCINE SCIENCE AND IDENTIFYING POTENTIAL VACCINE CANDIDATES THAT MAY OFFER BROAD AND LONG-LASTING PROTECTION AGAINST SEASONAL AND PANDEMIC INFLUENZA.

THE UNIVERSITY OF MINNESOTA (UM) RESEARCHERS WILL BE THE CENTRAL LABORATORY FOR THE STUDY TITLED "HISPANIC COMMUNITY HEALTH STUDY-STUDY OF LATINOS (HCHS-SOL) COORDINATION CENTER". UM WILL COMPLETE THE FOLLOWING TASKS: A5. ESTABLISH AND MANAGE THE BIOLOGICAL SPECIMEN REPOSITORY; A5A. MAINTAIN THE HCHS/SOL BIOLOGIC SPECIMEN REPOSITORY IN ACCORDANCE WITH HCHS/SOL POLICIES AND PROCEDURES; A5B. INCORPORATE SURPLUS SPECIMENS FROM ANCILLARY STUDIES; A5C. TRACK SAMPLES; A5D. PROVIDE SPECIMENS TO APPROVED INVESTIGATORS IN ACCORDANCE WITH STUDY POLICIES AND PROCEDURES; A5E. CONDUCT QUALITY MANAGEMENT PROCEDURES; B2.3. PLAN AND CONDUCT THE RECEIPT AND PROCESSING OF COLLECTED BLOOD AND URINE SAMPLES; B2.5. TRAINING OF RELEVANT STAFF AT ALL FIELD CENTERS; C.3. PROVIDE SMOOTH TRANSFER OF ALL BIOLOGICAL SAMPLES; C.4. PREPARE AN APPLICATION FOR TRANSFER OF BIOLOGICAL SPECIMENS TO THE NHLBI BIOSPECIMEN REPOSITORY; C.5. SHIP ALL BIOLOGICAL SAMPLES TO THE NHLBI BIOSPECIMEN REPOSITORY AND/OR OTHER BIOREPOSITORIES.