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Global Alignment of Immunisation safety Assessment in pregnancy (GAIA)

GAIA at peak productivity

The GAIA project started in January 2015 and work is at full capacity. In addition to the 23 professionals at the partnering organizations, GAIA counts on the active involvement of 129 volunteers worldwide actively contributing to the development of GAIA outputs. Almost 25% of the 430 members of from stakeholder organizations following up on GAIA’s activities come from Lower and Middle Income Countries as per the latest update of September 14th. An updated project overview, the list of involved partners and interested stakeholders, composition of working groups, news and other project related information can be found at our webite http://gaia-consortium.net.

First 10 case definitions available

All 10 case definitions WGs have developed draft case definitions for key events related to immunization in pregnancy. They will be made available for stakeholder consultation and review in October. You can expect to see draft definitions of:
OBSTETRIC: Maternal death in pregnancy, pathways to preterm birth, non-reassuring fetal status (initially Fetal Distress), pre-eclampsia/eclampsia, post partum hemorrhage
NEONATAL: Stillbirth, Neonatal death, Preterm birth, Neonatal Infection, Congenital anomalies

Next set of 10 case definitions prioritized

The second set of 10 terms has been prioritized for definition development:
OBSTETRIC: Abortion, Antenatal bleeding, Feat growth restriction, gestational diabetes, Dysfunctional labor.
NEONATAL: Low birth weight, Small for gestational age, Neonatal encephalopathy, respiratory distress. Failure to thrive or growth deficiency.

Guideline coming up

The guidance document for collection, analysis and presentation of safety data in clinical trials is in the final drafting stages and becoming available in November for stakeholder review. This is becoming the key document referencing the other GAIA standards and tools becoming available.

Data collection matrix drafted

To support, facilitate and standardize development of case report forms, a data collection matrix is now available and will be open for consultation by the stakeholder group in November.

Shared terminology available

A database of 3000 terms pertinent to maternal immunization was created based on existing NIH terminologies. A first structured database is available comprising the terms together with concept definitions, and a series of tags preparing a structured search possibilities. The terminology will be be made available for review with specific focus on applicability in LMIC. A user friendly format is expected to go online in Q2 2016.

Map of disease codes created

The disease codes in various key coding terminologies (e.g. MedDRA, ICD-9, ICD-10), were mapped to the 20 key disease concepts for which case definitions are being developed. This will support identification of cases in health care databases. For example, for estimating background rates of key events related to immunization in pregnancy.

WHAT’S NEXT IN GAIA?

Stakeholders will be invited in October to review the first set of case definitions. An email request with instructions will be sent soon to those already registered. There is still time to sign up for getting involved in the process by registering at www.gaia-consortium.net.
21st FIGO World Congress of Gynaecology and Obstetrics (Vancouver, 4-9 October 2015). Flor Muñoz-Rivas and Linda Eckert, together with WG leads, will have a 90-minute session on GAIA outputs focussing on the first 10 case definitions.
3rd International Neonatal & Maternal Immunisation Symposium (Gambia, 4-6 November 2015). Jan Bonhoeffer will give 30-minute presentation about GAIA, explaining the process, the roadmap, and the outcomes of the project pertinent to immunization in pregnancy research in Low and Medium Income Countries.
The call for participation in defining the next set of 10 Neonatal and Obstetric case definitions will start in November. Colleagues interested in becoming part of the groups please contact wp1@gaia-consortium.net.

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

SAVE THE DATE

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

Aim

The aim of this conference is to highlight progress in harmonizing safety monitoring of immunization in pregnancy and to develop consensus recommendations for a globally concerted approach.

Objectives

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
To build consensus on best practice guidance for monitoring vaccine safety in pregnancy

Outcomes

Shared understanding of the challenges of monitoring immunization in pregnancy
Shared understanding of potential solutions for a collaborative way forward
Consensus on the need for a globally concerted approach
Recommendations for a road map towards optimal safety data based on a globally harmonized approach

The conference is held in collaboration with the Eunice Kennedy Shriver National Institute of Child Health and Human Resources, the National Institute of Allergy and Infectious Diseases, the National Cancer Institute, the Bill and Melinda Gates Foundation, the World Health Organization, the International Alliance for Biological Standardization (IABS) and the Brighton Collaboration Foundation.
This meeting will bring together regulators, scientists, academia and industry experts 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.