Periodic Reporting for period 3 - PrIMAVeRa (Predicting the Impact of Monoclonal Antibodies & Vaccines on Antimicrobial Resistance)
Berichtszeitraum: 2023-11-01 bis 2024-10-31
Predicting the Impact of Monoclonal Antibodies & Vaccines on Antimicrobial Resistance (PrIMAVeRA) aims to develop mathematical models and an epidemiological repository to assess the impact of vaccines and monoclonal antibodies (mAbs) on antimicrobial resistance (AMR).
AMR causes a high burden of disease that can be reduced by preventing infections through implemention of vaccines and mAb. These well-known strategies are challenging to put in practice due to limited knowledge about the most important target populations, or target pathogens, high development costs, and complex development process. PrIMAVeRa tries to fill this gap by modelling which pathogens, infections and populations result in the highest AMR burden, and through which healthcare services priority vaccines and mAb could be delivered. The final product will be a planning tool to identify the most cost-effective vaccine targets and mAb strategies according to the country-specific AMR burden.
To use limited resources most effectively, it is crucial to be able to rank potential interventions against AMR according to cost-effectiveness. The PrIMAVeRa project aims to provide policymakers with the comprehensive models necessary to provide this capability.
AMR causes a high burden of disease that can be reduced by preventing infections through implemention of vaccines and mAb. These well-known strategies are challenging to put in practice due to limited knowledge about the most important target populations, or target pathogens, high development costs, and complex development process. PrIMAVeRa tries to fill this gap by modelling which pathogens, infections and populations result in the highest AMR burden, and through which healthcare services priority vaccines and mAb could be delivered. The final product will be a planning tool to identify the most cost-effective vaccine targets and mAb strategies according to the country-specific AMR burden.
To use limited resources most effectively, it is crucial to be able to rank potential interventions against AMR according to cost-effectiveness. The PrIMAVeRa project aims to provide policymakers with the comprehensive models necessary to provide this capability.
In the first year, partners focused on the literature search. Protocols for 5 systematic reviews (SR) were developed and uploaded to the International Prospective Register of Systematic Reviews (PROSPERO): 1) frequency measures of healthcare-associated infections and antimicrobial resistance (AMR), 2) AMR-associated health outcomes, 3) AMR-associated economic outcomes, 4) existing mathematical models for AMR, and 5) obtaining individual-level data. Potential databases were identified, articles screened and extracted, and contact was initiated for data access.Discussions were advanced on making the aggregated and individual-level data publicly available through the EPI-Net repository. The project management structure was established and implemented, the project website launched, and the Scientific Advisory Committee established.
In year two, work concluded on all 4 systematic reviews, and manuscripts were submitted for publication. Aggregated data and visualisations of meta-analyses of the pathogen-specific impact of AMR were made publicly available through the EPI-Net platform: https://epi-net.eu/primavera/about/(öffnet in neuem Fenster). Data gaps were identified and discussed with partners to inform further action. These gaps also informed work on a research prioritisation agenda, for which a Delphi exercise was performed and a manuscript drafted. Atheoretical model framework was advanced, with 3 case studies selected for the population models to be developed, and data to populate the models was identified, collected, and evaluated. More than 100 database owners were contacted in the data search, and the infrastructure to gather the data and make it publicly available was defined and implemented, with the legal process to complete data sharing agreements ongoing.
Five papers were published in year three, based on the systematic reviews and research done for model development. Manuscripts were also prepared on future priorities for AMR research and challenges in data sharing. Work concluded on the case studies, of which two were chosen to be advanced in upcoming activities, a second search for additional patient-level data was performed, and 3rd parties can now apply for access to individual-level patient data on the ECRAID-Base EPI-Net platform (https://epi-net.eu/primavera/data-availability/(öffnet in neuem Fenster)). Work began on cost-effectiveness analysis and model evaluation and sustainability: the results of which will manifest in the next two years.
To ensure continuous progress, the consortium has held three annual meetings, three teleconferences with the Scientific Advisory Committee, and two workshops to advance work on the models. Press releases and social media posts were published alongside project advancements to increase project visibility.
In year two, work concluded on all 4 systematic reviews, and manuscripts were submitted for publication. Aggregated data and visualisations of meta-analyses of the pathogen-specific impact of AMR were made publicly available through the EPI-Net platform: https://epi-net.eu/primavera/about/(öffnet in neuem Fenster). Data gaps were identified and discussed with partners to inform further action. These gaps also informed work on a research prioritisation agenda, for which a Delphi exercise was performed and a manuscript drafted. Atheoretical model framework was advanced, with 3 case studies selected for the population models to be developed, and data to populate the models was identified, collected, and evaluated. More than 100 database owners were contacted in the data search, and the infrastructure to gather the data and make it publicly available was defined and implemented, with the legal process to complete data sharing agreements ongoing.
Five papers were published in year three, based on the systematic reviews and research done for model development. Manuscripts were also prepared on future priorities for AMR research and challenges in data sharing. Work concluded on the case studies, of which two were chosen to be advanced in upcoming activities, a second search for additional patient-level data was performed, and 3rd parties can now apply for access to individual-level patient data on the ECRAID-Base EPI-Net platform (https://epi-net.eu/primavera/data-availability/(öffnet in neuem Fenster)). Work began on cost-effectiveness analysis and model evaluation and sustainability: the results of which will manifest in the next two years.
To ensure continuous progress, the consortium has held three annual meetings, three teleconferences with the Scientific Advisory Committee, and two workshops to advance work on the models. Press releases and social media posts were published alongside project advancements to increase project visibility.
The outcomes of the PrIMAVeRa project are expected to generate several major impacts:
I. Faster and more effective access to relevant data: the epidemiological repository will allow access to a publicly available, searchable database on the epidemiology of a range of common bacterial infections, their associated health burden, and resource consumption for a wide range of drug-resistant as well as drug-susceptible pathogens;
II. Better capability for real-time, data-driven decision-making by policymakers and healthcare managers on vaccine and mAb strategies by utilizing well-designed mathematical models available through a user-friendly interface with country-specific information for parametrisation;
III. An innovative evidence-based approach to prioritize research and development strategies to reduce the burden of relevant AMR through vaccines and mAbs. The combination of innovative decision tools and access to real-world data may guide and thus improve the economic return of R&D in the antibacterial field, making the development of novel, effective treatments more attainable and will help fight the emergence and spread of untreatable infections.
What differentiates PrIMAVeRa from other initiatives is that the project focuses on pathogen-infection-specific impact of AMR within different patient strata, trying to distinguish the impact of gender, age, frailty, and other important risk profiles to provide actionable data for prioritization of implementation of preventive strategies, like vaccines and mAbs.
I. Faster and more effective access to relevant data: the epidemiological repository will allow access to a publicly available, searchable database on the epidemiology of a range of common bacterial infections, their associated health burden, and resource consumption for a wide range of drug-resistant as well as drug-susceptible pathogens;
II. Better capability for real-time, data-driven decision-making by policymakers and healthcare managers on vaccine and mAb strategies by utilizing well-designed mathematical models available through a user-friendly interface with country-specific information for parametrisation;
III. An innovative evidence-based approach to prioritize research and development strategies to reduce the burden of relevant AMR through vaccines and mAbs. The combination of innovative decision tools and access to real-world data may guide and thus improve the economic return of R&D in the antibacterial field, making the development of novel, effective treatments more attainable and will help fight the emergence and spread of untreatable infections.
What differentiates PrIMAVeRa from other initiatives is that the project focuses on pathogen-infection-specific impact of AMR within different patient strata, trying to distinguish the impact of gender, age, frailty, and other important risk profiles to provide actionable data for prioritization of implementation of preventive strategies, like vaccines and mAbs.