R01AI187287

THE UPTAKE AND REAL-WORLD EFFECTIVENESS OF EMERGING RESPIRATORY SYNCYTIAL VIRUS MATERNAL VACCINES AND MONOCLONAL ANTIBODIES ON SHORT- AND LONG-TERM RESPIRATORY MORBIDITIES - PROJECT SUMMARY / ABSTRACT RESPIRATORY SYNCYTIAL VIRUS (RSV) IS ONE OF THE MOST COMMON RESPIRATORY VIRUSES RESULTING IN SIGNIFICANT MORBIDITY AND MORTALITY IN INFANTS AND YOUNG CHILDREN GLOBALLY. RECENT APPROVALS OF THE WORLD'S FIRST MATERNAL VACCINE AND INFANT EXTENDED HALF-LIFE MONOCLONAL ANTIBODY MEAN THAT FOR THE FIRST TIME, ALL INFANTS BORN IN THE US IN 2023 AND LATER WILL HAVE IMMUNIZATION OPTIONS FOR PROTECTION FROM RSV-ASSOCIATED SEVERE ILLNESS. THE TWO CURRENTLY AVAILABLE PREVENTION PRODUCTS DIFFER IN TARGET RECIPIENTS, TIMING OF ADMINISTRATION, BIOLOGIC MECHANISM OF ACTION, AND DURATION OF INFANT PROTECTION. AS THESE PRODUCTS HAVE BECOME PART OF RECOMMENDED MATERNAL AND INFANT VACCINE SCHEDULES, KEY QUESTIONS NEEDED TO INFORM POLICY INCLUDE DETERMINING: 1) THE REAL-WORLD COMPARATIVE EFFECTIVENESS, 2) THE COST-EFFECTIVENESS OF THESE PRODUCTS, 3) SAFETY OF MATERNAL VACCINE, AND 4) IMPACT ON OTHER ACUTE AND LONG-TERM RESPIRATORY OUTCOMES. TO ADDRESS THESE QUESTIONS, WE PROPOSE TO ASSEMBLE A POPULATION OF OVER 735,000 MOTHER-CHILD DYADS INCLUDING INFANTS BORN 2023-2029 UTILIZING THE DIVERSE POPULATIONS REPRESENTED BY THE TENNESSEE MEDICAID PROGRAM AND DEPARTMENT OF DEFENSE MILITARY HEALTH SYSTEM. THE OVERARCHING OBJECTIVES ARE TO DETERMINE OPTIMAL RSV PREVENTION STRATEGY(IES) TAKING INTO CONSIDERATION INFANT DATE OF BIRTH RELATIVE TO RSV CIRCULATION, INFANT RISK FOR RSV LRTI, MATERNAL- CHILD CHARACTERISTICS, AND THE EFFECTIVENESS AND COST-EFFECTIVENESS OF RSV PREVENTION PRODUCTS IN REDUCING THE RISK OF RSV LRTI, OTHER ACUTE RESPIRATORY ILLNESS, AND LATER CHILDHOOD ALL-CAUSE RESPIRATORY MORBIDITY. WE WILL DETERMINE THE UPTAKE, ADHERENCE TO POLICY RECOMMENDATIONS, AND CHARACTERISTICS OF THOSE WHO RECEIVE THE APPROVED RSV PREVENTION PRODUCTS (AIM 1), THE REAL-WORLD EFFECTIVENESS AND COMPARATIVE EFFECTIVENESS IN REDUCING THE RISK AND SEVERITY OF RSV LRTI AND OTHER ACUTE RESPIRATORY MORBIDITIES (AIM 2), THE EFFECTIVENESS ON REDUCING LATER CHILDHOOD ALL-CAUSE RESPIRATORY MORBIDITY (AIM 3), AND THE COST-EFFECTIVENESS IN REDUCING RSV LRTI AND CHILDHOOD ALL-CAUSE RESPIRATORY MORBIDITY (AIM 4) OF THESE RSV PREVENTION PRODUCTS. SOCIOECONOMIC ASSOCIATED HEALTH DISPARITIES AT THE INDIVIDUAL AND NEIGHBORHOOD LEVELS IN VACCINE UPTAKE (AIM 1) AND EFFECTIVENESS (AIMS 2 & 3) WILL BE DETERMINED. WITH SUPPLY CHAIN LIMITATIONS AFFECTING THE AVAILABILITY OF INFANT EXTENDED HALF-LIFE MONOCLONAL ANTIBODY, THE 2023-2024 RESPIRATORY SEASON PRESENTS A UNIQUE OPPORTUNITY TO EVALUATE THESE DISPARITIES IN THE SETTING OF THE INITIATION OF A LARGE NATIONWIDE MEDICAL INTERVENTION. RESULTS OF THE STUDY WILL INFORM PUBLIC HEALTH EXPECTATIONS AND POLICY RECOMMENDATIONS FOR RSV MATERNAL VACCINES AND EXTENDED HALF-LIFE MONOCLONAL ANTIBODIES, AND MORE IMPORTANTLY, IDENTIFY AND QUANTIFY ANY VALUE-ADDED LONG- TERM BENEFITS OF RSV LRTI PREVENTION DURING INFANCY ON LATER CHILDHOOD RESPIRATORY MORBIDITY. WE ANTICIPATE THAT THIS WILL IN TURN INCREASE PUBLIC ACCEPTABILITY, PROMOTE UPTAKE OF RSV PREVENTION PRODUCTS IN THE US, AND PROVIDE DATA TO SUPPORT THE ACUTE AND LONGER-TERM BENEFITS OF THESE PREVENTION PRODUCTS WORLDWIDE, PROMOTE UPTAKE OF THESE PRODUCTS WORLDWIDE AND PARTICULARLY IN LOW- AND MIDDLE-INCOME COUNTRIES.

Vanderbilt University Medical Center

TO ASSIST PUBLIC AND PRIVATE NONPROFIT INSTITUTIONS AND INDIVIDUALS TO ESTABLISH, EXPAND AND IMPROVE BIOMEDICAL RESEARCH AND RESEARCH TRAINING IN INFECTIOUS DISEASES AND RELATED AREAS, TO CONDUCT DEVELOPMENTAL RESEARCH, TO PRODUCE AND TEST RESEARCH MATERIALS. TO ASSIST PUBLIC, PRIVATE AND COMMERCIAL INSTITUTIONS TO CONDUCT DEVELOPMENTAL RESEARCH, TO PRODUCE AND TEST RESEARCH MATERIALS, TO PROVIDE RESEARCH SERVICES AS REQUIRED BY THE AGENCY FOR PROGRAMS IN INFECTIOUS DISEASES, AND CONTROLLING DISEASE CAUSED BY INFECTIOUS OR PARASITIC AGENTS, ALLERGIC AND IMMUNOLOGIC DISEASES AND RELATED AREAS. PROJECTS RANGE FROM STUDIES OF MICROBIAL PHYSIOLOGY AND ANTIGENIC STRUCTURE TO COLLABORATIVE TRIALS OF EXPERIMENTAL DRUGS AND VACCINES, MECHANISMS OF RESISTANCE TO ANTIBIOTICS AS WELL AS RESEARCH DEALING WITH EPIDEMIOLOGICAL OBSERVATIONS IN HOSPITALIZED PATIENTS OR COMMUNITY POPULATIONS AND PROGRESS IN ALLERGIC AND IMMUNOLOGIC DISEASES. BECAUSE OF THIS DUAL FOCUS, THE PROGRAM ENCOMPASSES BOTH BASIC RESEARCH AND CLINICAL RESEARCH. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM EXPANDS AND IMPROVES PRIVATE SECTOR PARTICIPATION IN BIOMEDICAL RESEARCH. THE SBIR PROGRAM INTENDS TO INCREASE AND FACILITATE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. THE SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM STIMULATES AND FOSTERS SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. RESEARCH CAREER DEVELOPMENT AWARDS SUPPORT THE DEVELOPMENT OF SCIENTISTS DURING THE FORMATIVE STAGES OF THEIR CAREERS. INDIVIDUAL NATIONAL RESEARCH SERVICE AWARDS (NRSAS) ARE MADE DIRECTLY TO APPROVE APPLICANTS FOR RESEARCH TRAINING IN SPECIFIED BIOMEDICAL SHORTAGE AREAS. IN ADDITION, INSTITUTIONAL NATIONAL RESEARCH SERVICE AWARDS ARE MADE TO ENABLE INSTITUTIONS TO SELECT AND MAKE AWARDS TO INDIVIDUALS TO RECEIVE TRAINING UNDER THE AEGIS OF THEIR INSTITUTIONAL PROGRAM.

93.855 - Allergy and Infectious Diseases Research

National Institute of Allergy and Infectious Diseases (NIAID) [HHS - NIH]

Nashville, Tennessee 37203 United States

Single Zip Code

NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed) (PA-20-185)