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Global Alignment of Immunisation safety Assessment in pregnancy (GAIA)

STATUS OF GAIA

The GAIA project finalized the first set of outputs, which were presented at the Consensus Conference on harmonized safety monitoring of immunization in pregnancy on March 2016 at the National Institute of Health (NIH) in Bethesda, MD, U.S.A. Feedback received was key for establishing the next steps towards wider awareness, adoption and implementation of the tools in the field. A dissemination strategy was developed, including the publication of a GAIA Special Issue in the Journal Vaccine. At the same time, the project is working on developing the second set of case definitions and of the GAIA terminology (including the glossary of terms, the ontology of concepts, and the map of disease codes, and the terminology browser).

HARMONIZED SAFETY MONITORING OF IMMUNIZATION IN PREGNANCY INTERNATIONAL CONSENSUS CONFERENCE

March 29-30, 2016, National Institute of Health, Bethesda, Maryland, USA

The International Alliance for Biological Standardization (IABS) organized this meeting that was inspired by the work performed by GAIA project partners and volunteers worldwide. It brought together 142 registered participants coming from regulatory authorities, public health institutes, academia and industry to help resolve existing challenges of safety monitoring of immunization in pregnancy and to reach conclusions that will be valuable to a globally concerted approach.

The objectives of the meeting were to discuss new safety data from immunization in pregnancy studies, to identify converging stakeholder needs and requirements for high quality data, to review new standards and tools for safety monitoring, including terminology, and to build consensus on the best practice guidance for monitoring vaccine safety in pregnancy

As a result of 32 presentations and 7 panel discussions in 7 sessions, this meeting has enhanced a shared understanding of the challenges of monitoring immunization in pregnancy. It allowed for in depth discussion on solutions for a collaborative way forward and yielded consensus on the need for a globally concerted approach.

The need for systems for prompt identification and response to adverse events following immunization (AEFI) in pregnancy was generally agreed on. This primarily rests on moving from minimal to enhanced safety monitoring throughout the vaccine life cycle.

Specifically, it was highlighted that similar safety standards should apply to everyone exposed, no mater where they live in the world. This should be supported by standardized terminology case definitions, harmonized study protocols, a minimal core set of safety variables to be collected and a globally concerted effort to move towards enhanced surveillance. It was agreed that many efforts are ongoing around the globe towards this aim. However, these efforts are fragmented and would benefit from harmonization to increase data comparability, bring analytic power to the next level, and propel scientific progress.

One of the key outcomes was the agreement on the need and benefits of regulatory convergence on shared data collection requirements, harmonized use of terms, concepts and definitions of safety outcomes and assessment methods during the conduct of clinical trials, including follow-up times. It was further recommended to determine the applicability of GAIA outputs in other perinatal health arenas.

GAIA outputs were generally deemed relevant and useful in the different settings (high, middle and low income country settings (LMICs)). There was a clear call for an increased number of case definitions for key obstetric and neonatal terms to be developed, as well as for guidelines that are applicable to observational studies of immunization in pregnancy. The need of structured field testing and validation of GAIA outputs in different settings was highlighted as well as the need to promote their use and implementation by making available the guidelines, definitions, terminologies and tools in a resource center and via training and implementation modules for investigators, Data Safety Monitoring Board (DSMB) and National Immunization Technical Advisory Groups (NITAGs).

The GAIA platform was deemed useful and the growing global network of experts should be leveraged for next steps towards addressing practical challenges of monitoring, promoting learnings from the best approaches and improving data quality. There is a need for metrics of data quality in the emerging field of immunization in pregnancy.

Building capacity for observational studies is critical and should include a landscaping of available data sources beyond spontaneous reporting and the development of approaches to epidemiological study designs in LMICs. There is a series of unmet methodological challenges of high quality observational studies in LMICs, including the challenge of mother-child record linkage.

Dissemination strategies should include a published conference report, special issues in the Journal Vaccine, and targeted information to stakeholder groups, presentation at various scientific venues, and when feasible, implementation and validation of available key term definitions in new and ongoing clinical trials of vaccines in pregnancy.

INVESTIGATORS WORKSHOP

In order to stimulate and facilitate investigator feedback on the GAIA outputs, more than 15 investigators with experience in conducting clinical trials in LMIC came together in Bethesda on March 28th prior to the harmonized safety monitoring of immunization in pregnancy international consensus conference. A structured semi-quantitative feedback session was organized by WP 4 to ask about the ability to collect information as described in the GAIA data collection matrix for clinical trials. This feedback showed that most sites (across continents) would be able to collect most of the data-items. Subsequently each of the initial 10 maternal and neonatal case definitions was presented by Flor Munoz and Linda Eckert and a score for their applicability in the settings of reference was obtained. Investigator feedback will be disseminated as part of the series of GAIA outputs.

WHAT’S NEXT IN GAIA?

GAIA will be present at the following upcoming events:
EuroVaccine 2016 (Rome, Italy | 16-18 June 2016). Sonali Kochhar will present the GAIA project, the first set of outcomes, and the roadmap for further implementation.
2016 IDSOG Annual Meeting (Annapolis, MD, USA | 11-13 August 2016). Linda Eckert, Flor Muñoz and Alisa Kachikis will give a presentation about the process followed in GAIA for developing and reviewing the case definitions, including best practices and lessons learnt.
2016 ISV Annual Congress (Boston, USA | 2-4 October 2016). Flor Muñoz will present the GAIA project and will organize a specific session focused on maternal immunization.
A Special Issue comprising GAIA outputs will be published in the Journal Vaccine before summer. It will include the first set of ten case definitions, the guidelines for clinical trials on immunization in pregnancy and a data collection matrix, together with a GAIA baseline paper describing the GAIA process, structure and progress so far. The issue will be made available open access, to facilitate widest possible dissemination, specifically in Low and Middle Income Countries.
Working groups are working hard to have the first drafts of the second set of eleven case definitions available by late June so they can be made available to the stakeholder network for external review. Final consolidated manuscripts should be made available by September 2016.
The project is now in the process of engaging with key stakeholders that may support the implementation of GAIA’s outcomes in the field. As part of this strategy, various interactions with regulators, vaccine manufacturers, and relevant agencies are being organised.
As part of the efforts for leveraging the project results, work and dynamics, the consortium is already working on defining and developing a broader framework that allows the implementation and evaluation of the GAIA tools in the field. The scope and key players are still under discussion, with the objective of having this new framework up and running during the first quarter of 2017.

How to get involved?

Would you like to be a volunteer reviewer of codes and definitions for the GAIA project? If so, please send your details to info@gaia-consortium.net