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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 2 - I-MOVE-plus (I-MOVE+ Integrated Monitoring of Vaccines Effects in Europe: a platform to measure and compare effectiveness and impact of influenza and pneumococcal vaccines and vaccination strategies in the elderly)

Teaser

Summary

The I-MOVE+ (Integrated Monitoring of Vaccines in Europe) is a consortium of 26 European Union/European Economic Area (EU/EEA) partners (regional and national public health Institutes, SME, Universities). Its goal is to develop a sustainable platform of primary care, hospital and laboratory networks in the EU that can share and use validated standardised methods to serve the post marketing evaluation of existing and new vaccines programmes independently from commercial interests.
I-MOVE+ is based on a multi-country multidisciplinary network of clinicians, epidemiologists, laboratory specialists, statisticians, modellers and economists from a network of 15 EU/EEA Member States.

During the period covered by the project, I-MOVE+ will identify, pilot test, use, and disseminate in and beyond the European Union/European Economic Area the best study designs to measure,the effectiveness and impact of vaccines used in the elderly population to prevent influenza and pneumococcal infections. I-MOVE+ will produce evidence for informing decision making in the management of influenza and pneumococcal disease in the elderly population.

Influenza: We measure at primary care and hospital level, early and late in the season, the direct effect (effectiveness) and indirect effect of various brand and types of influenza vaccines against a core set of clinical (Influenza-like illness (ILI)/Acute Respiratory Infections (ARI), hospitalisation) and laboratory confirmed (PCR positive) outcomes in order to:
â€¢ understand the factors affecting vaccine effectiveness (VE), the duration of protection, the role of repeated seasonal vaccinations,
â€¢ identify key virus phenotypic or genotypic evolutions that could affect vaccine performances,
â€¢ identify vaccine types (adjuvanted vs not adjuvanted, live vs attenuated, trivalent vs quadrivalent) and brands with different effectiveness,
â€¢ understand the potential indirect effect of influenza vaccination in children on influenza incidence in the elderly in countries that have introduced universal influenza vaccination in children into their vaccination programme (Finland, United Kingdom).

Pneumococcal pneumonia: We measure the effectiveness (direct effect) of available vaccines and the impact of pneumococcal vaccination programmes (indirect and overall effect) against laboratory confirmed (serotype specific) cases of invasive pneumococcal disease (IPD) and a core set of clinically defined outcomes (pneumonia). In this way we will provide evidence on the occurrence and magnitude of serotype replacement following introduction of conjugate vaccination.

I-MOVE+ is structured in five Work Packages :
WP1 : Scientific Coordination and Management
WP2 : Influenza vaccines
WP3 : Pneumococcal vaccines
WP4: Electronic databases and registries
WP5: Cost-effectiveness analysis

Work performed

WP1 :
- Constitution of Steering-Scientific Committee and Executie board and organisation of face to face and webconferences meetings.
. Preparation of two Grant agreement amendments
. Organisation of 8 technical meetings and two annual meetings

WP2 :
- Generic protocols to measure influenza vaccine effectiveness (hospital and primary care level) and impact of vaccination programmmes finalised and available at the I-MOVE+ website
. Test-negative studies at primary care level (11 primary care studies) and hospital level (23 hospitals) finalised for the 2015/16, 2016/17 seasons. Influenza vaccine effectiveness resuts for the two seasons presented and published (list of publications available at the I-MOVE+ website). Studies for the 2017/18 season ongoing.
. Studies measuring the impact of influenza vaccination programmes ongoing.

WP3 :
- Generic protocols for effectiveness and impact of studies of pneumococcal vaccines finalised. Study sites protocols submitted and ethical approvals obtained
- Survey on data available for pneumococcal studies conducted
- Five sites have conducted feasibility studies on pneumonia using hospital discharge database: THL-Finland, DH-England and Wales, RIVM-The Netherlands, ISPLN-Navarra, INS Ricardo Jorge-Portugal
- Survey on data available for analyses relating to the role of influenza vaccination on IPD has been conducted; feasibility studies have been conducted by six sites

WP4 :
- Generic protocols to measure influenza vaccine effectiveness (hospital and primary care level) are available at the I-MOVE+ website.
- In 2015/16, vaccine effectiveness studies were performed using test-negative and screening methods at primary care level and test-negative, cohort and screening methods at secondary care level. In 2016/17, vaccine effectiveness studies were performed using cohort method at primary care level and test-negative and cohort methods at secondary care level.
- In both seasons, different partners published country specific vaccine effectiveness data.
- The impact of the three previous yearâ€™s vaccination history on current yearâ€™s vaccine effectiveness was estimated for both seasons.

WP5
- Survey of partners capacity and needs in the area of influenza and pneumococcal vaccination modelling and economic evaluation completed
. Cross-country comparison of pneumococcal disease burden and Generic cost-effectiveness model finalised
. Report on the potential indirectr effect of childhood infleunza vaccinaiton programme on the diseases burden among the elderly completed
- Ongoing data collection for the cost-effectiveness analysis of vaccination children and/or the elderly against influenza

Final results

The I-MOVE+ project assembles the largest ever network of study sites in the European Union (EU) and European Economic Area (15 countries, 26 beneficiaries) allowing to strengthen evaluation research in vaccinology between EU/EEA Member States.
Multicentre cohort and case control studies are used for the evaluation of the performances of influenza and pneumococcal vaccines in the 65+ years old.

The I-MOVE+ early influenza vaccine effectiveness have contributed to the decision of the WHO vaccine strain selection committee on strains to be included in the Southern and Northern Hemisphere influenza vaccines.

The WP2 laboratory component (protocol to randomly select influenza strains to be characterised) has contributed to increase the number of influenza viruses characterised and reported to the European virological surveillance system and WHO Global Flunet.

Two articles describing I-MOVE+ and the importance of public funding in studies evaluating vaccine performances have been published in the EU Parliament Magazine.
I-MOVE+ participated in the international meeting I-Rev to discuss the potential effect of repeated influenza vaccinations

We have developed an R-package to enable us to perform multiple cost-effectiveness analyses of influenza vaccination programmes using a standardised modelling and statistical tool. The R-package combines a dynamic transmission model and cost-effectiveness analysis template.
The fluEvidenceSynthesis R-package will eventually be made publically available to enable other research groups to conduct their own analyses using their own data.