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Global Alignment of Immunisation safety Assessment in pregnancy (GAIA)

Project Overview

GAIA is a two-year project, coordinated by the Brighton Collaboration Foundation with core funding from the Bill & Melinda Gates Foundation for consortium partners. GAIA outputs will be developed in close interaction with a global network of volunteer experts to ensure global applicability and usefulness of the standards developed.

Aim

The aim of the GAIA consortium is to improve clinical outcome data of vaccine safety or effectiveness studies on immunization in pregnancy. There would be a specific focus on low and middle income countries (LMIC) where the incidence of infectious diseases is high.
The end results will be published on the GAIA website.

Context

Maternal Immunization has emerged as a new intervention to protect young infants from vaccine-preventable infections. By vaccinating pregnant women, there is protection provided against infectious diseases to the mother, her developing fetus and to the newborn infant. This is because post vaccination, a higher level of antibodies are generated in the mother against the particular infection, so that a protective level of antibody is transferred to the infant.

Outputs

Case definitions of key obstetric and neonatal outcomes
A set of about 20 standardised case definitions for key obstetric and neonatal events for global monitoring of immunisation in pregnancy
Accompanied by a glossary of well-defined enabling terms: terms of relevance to monitoring of many key events
Shared terminology and code mapping
A structured ontology of terms to demonstrate hierarchical and conceptual dependencies to promote a common understanding and shared language, synonyms of enabling terms and those describing key events
Case definitions with the glossary and ontology of terms will enable the creation of a map of disease codes used in healthcare databases, hospital discharge diagnoses and primary care claims registries
Standard blocks of case identification algorithms are developed for observational studies
Tools for harmonised data collection
Minimal guidance for collection, analysis and presentation of clinical safety outcome data of immunisation in pregnancy studies
A data collection matrix as a checklist informing protocol writing and the development of case report forms
An online tool for automated case classification (single case or batch classification) of events according to the standardised case definitions
Evaluation and implementation
Investigator and stakeholder meeting determining the needs and requirements of the various stakeholders and sharing experience with implementation of the interim standards and guidance documents.
Targeted stakeholder consultations and solicitation of feedback from investigators and parallel projects, partners from LMIC for the evaluation of applicability and usefulness of the standards and tools developed.
The finalised standards will be submitted for review and recommendation by pertinent technical, public health, and regulatory bodies

GAIA Consortium

The GAIA Consortium has 13 members:
Brighton Collaboration Foundation (BCF) Switzerland
World Health Organization (WHO) Switzerland
National Institutes of Health (NIH) USA
Public Health Agency of Canada Canada
International Alliance for Biological Standardization (IABS) Switzerland
Global Healthcare Consultants (GHC) India
University of Washington (UW) USA
Baylor College of Medicine (BCM) USA
Monash Institute of Medical Research Prince Henry’s Institute (MIMR-PHI) Australia
Erasmus University Medical Center (EMC) The Netherlands
Cincinnati Children’s Hospital, Global Health Center (CCH) USA
St George’s, University of London (SGUL) UK
Synapse Research Management Partners (SYNAPSE) Spain

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