Periodic Reporting for period 2 - PrIMAVeRa (Predicting the Impact of Monoclonal Antibodies & Vaccines on Antimicrobial Resistance)
Reporting period: 2022-11-01 to 2023-10-31
Predicting the Impact of Monoclonal Antibodies & Vaccines on Antimicrobial Resistance (PrIMAVeRA) seeks 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 by implementing vaccines and mAb. This well-known concept is difficult to operationalize due to the high number of infections, limited resources, and the impossibility of covering an entire population. PrIMAVeRa tries to fill this gap by modeling 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 vaccines and mAb strategies according to the local AMR burden.
In order 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 by implementing vaccines and mAb. This well-known concept is difficult to operationalize due to the high number of infections, limited resources, and the impossibility of covering an entire population. PrIMAVeRa tries to fill this gap by modeling 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 vaccines and mAb strategies according to the local AMR burden.
In order 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.
During the first project year, the Consortium focused on the literature search. Protocols for 4 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, and 4) existing mathematical models for AMR. In addition, a protocol for a systematic review of the grey literature was developed and registered in PROSPERO focused on obtaining individual level data. Potential databases were identified, and database owners were being contacted for exchange of their data. The Consortium also advanced discussions on how to make the data publicly available through the EPI-Net repository. The project management structure was established and set in operation, the project website was launched, and the Scientific Advisory Committee was established.
In the second year, work was completed on all 4 systematic reviews, and manuscripts were submitted for publication, of which 3 will become available before the end of 2023. Data was shared with the consortium directly, as well as with the general public through a public data repository on https://epi-net.eu/primavera/about/. Data gaps were identified and shared with the consortium for discussion on how to proceed. This has also informed work on a research prioritisation agenda, for which a Delphi has been performed and a manuscript has been drafted. Development of the theoretical framework of the models was advanced, with 3 case studies being selected for the population models to be developed, and data to populate the models is being identified, collected, and evaluated. More than 100 database owners have been contacted in the data search, and the infrastructure to gather the data and make it publicly available has been defined and implemented. The legal process to complete data sharing agreements is ongoing.
Since the project began, the consortium has held the first annual meeting as well as 2 teleconferences with the Scientific Advisory Committee, and 2 workshops to advance work on the models. Press releases and social media posts were also published alongside project advancements to increase project visibility.
In the second year, work was completed on all 4 systematic reviews, and manuscripts were submitted for publication, of which 3 will become available before the end of 2023. Data was shared with the consortium directly, as well as with the general public through a public data repository on https://epi-net.eu/primavera/about/. Data gaps were identified and shared with the consortium for discussion on how to proceed. This has also informed work on a research prioritisation agenda, for which a Delphi has been performed and a manuscript has been drafted. Development of the theoretical framework of the models was advanced, with 3 case studies being selected for the population models to be developed, and data to populate the models is being identified, collected, and evaluated. More than 100 database owners have been contacted in the data search, and the infrastructure to gather the data and make it publicly available has been defined and implemented. The legal process to complete data sharing agreements is ongoing.
Since the project began, the consortium has held the first annual meeting as well as 2 teleconferences with the Scientific Advisory Committee, and 2 workshops to advance work on the models. Press releases and social media posts were also 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.
rial field, making the development of novel, effective treatments more attainable and will help fight the emergence and spread of untreatable infections.
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.
rial field, making the development of novel, effective treatments more attainable and will help fight the emergence and spread of untreatable infections.