---
title: "Performance and implementation challenges of Brighton Collaboration GAIA maternal immunisation cas"
id: "pubmed-42595590"
canonical_url: "https://medichelpline.com/clinical-feed/pubmed-42595590"
content_type: "clinical_feed_article"
specialty: "Pharmacology"
source_name: "PubMed / NCBI"
source_url: "https://pubmed.ncbi.nlm.nih.gov/42595590/"
doi: "10.1016/j.vaccine.2026.128899"
published_at: "2026-08-30T00:00:00.000Z"
evidence_level: "Journal Article"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Performance and implementation challenges of Brighton Collaboration GAIA maternal immunisation cas
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/pubmed-42595590
- **Specialty:** [Pharmacology](https://medichelpline.com/clinical-feed/pharmacology.md)
- **Primary Source:** PubMed / NCBI
- **Source URL:** [Original Journal Publication](https://pubmed.ncbi.nlm.nih.gov/42595590/)
- **DOI:** [10.1016/j.vaccine.2026.128899](https://doi.org/10.1016%2Fj.vaccine.2026.128899)
- **Published At:** 2026-08-30T00:00:00.000Z
- **Evidence Rating:** Journal Article
## Executive GIST (TL;DR)
- The Brighton Collaboration's **GAIA** initiative produced harmonised **case definitions** (CDs) to standardise safety monitoring for **maternal immunisation** studies worldwide, using **levels of diagnostic certainty (LOC)** to allow applicability across settings with different diagnostic capacity. - A prior 2023 review reported many GAIA CDs were unevaluated and several performed poorly, with many potential cases only classifying at LOC-4. - This systematic review searched Ovid MEDLINE, EMBASE and Web of Science for English-language studies from 2014 to May 5, 2025, and registered the protocol with PROSPERO (CRD42025620433). - Database searches returned 4,260 records; after deduplication and screening, 10 studies comprising 42,587 cases met inclusion criteria. - Three GAIA definitions—ectopic pregnancy, postpartum endometritis and neurodevelopmental delay—had not been evaluated in the included literature. - Several other definitions have only been assessed in high-income settings, limiting generalisability to lower-resource contexts. - Definitions for maternal death, neonatal death and preterm birth generally performed well and were classifiable at higher LOCs in many studies. - Other outcomes exhibited high proportions of unclassifiable cases, with large numbers limited to LOC-4; some studies classified 100% of potential cases while others classified as few as 50% at LOC 1–3. - Variability in performance likely reflects differences in setting-level resources, data availability and documentation quality, and possible limitations intrinsic to the definitions themselves. - The authors conclude that targeted refinement and broader validation across diverse settings and data sources are needed to support robust, standardised maternal immunisation safety surveillance globally.
## Clinical Analysis & Structured Key Points
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Epub 2026 Aug 13. # Updating the evidence on brighton collaboration's GAIA maternal immunisation case definitions: a systematic review of performance and implementation challenges [Robert Mboizi](https://pubmed.ncbi.nlm.nih.gov/?term=Mboizi+R&cauthor_id=42595590)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42595590/#full-view-affiliation-1 "Makerere University Johns Hopkins Research Collaboration \(MUJHU\), Kampala, Uganda; University of Antwerp, Antwerp, Belgium."), [Kirsten Maertens](https://pubmed.ncbi.nlm.nih.gov/?term=Maertens+K&cauthor_id=42595590)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42595590/#full-view-affiliation-2 "Centre for the Evaluation of Vaccination, Vaccine & Infectious Diseases Institute, University of Antwerp, Antwerp, Belgium."), [Kirsty Le Doare](https://pubmed.ncbi.nlm.nih.gov/?term=Le+Doare+K&cauthor_id=42595590)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42595590/#full-view-affiliation-3 "Makerere University Johns Hopkins Research Collaboration \(MUJHU\), Kampala, Uganda; Centre for Neonatal and Paediatric Infection, City St George's, University of London, London, United Kingdom."), [Clare L Cutland](https://pubmed.ncbi.nlm.nih.gov/?term=Cutland+CL&cauthor_id=42595590)[ 4 ](https://pubmed.ncbi.nlm.nih.gov/42595590/#full-view-affiliation-4 "University of the Witwatersrand, Johannesburg, South Africa."), [Flor M Muñoz](https://pubmed.ncbi.nlm.nih.gov/?term=Mu%C3%B1oz+FM&cauthor_id=42595590)[ 5 ](https://pubmed.ncbi.nlm.nih.gov/42595590/#full-view-affiliation-5 "Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX, United States of America."), [Hannah G Davies](https://pubmed.ncbi.nlm.nih.gov/?term=Davies+HG&cauthor_id=42595590)[ 6 ](https://pubmed.ncbi.nlm.nih.gov/42595590/#full-view-affiliation-6 "Centre for Neonatal and Paediatric Infection, City St George's, University of London, London, United Kingdom; London School of Hygiene & Tropical Medicine, London, United Kingdom; Department for Infection and Population Health, Institute for Global Health, University College London, United Kingdom. Electronic address: Hannah.g.davies@ucl.ac.uk.") Affiliations Expand ### Affiliations * 1 Makerere University Johns Hopkins Research Collaboration (MUJHU), Kampala, Uganda; University of Antwerp, Antwerp, Belgium. * 2 Centre for the Evaluation of Vaccination, Vaccine & Infectious Diseases Institute, University of Antwerp, Antwerp, Belgium. * 3 Makerere University Johns Hopkins Research Collaboration (MUJHU), Kampala, Uganda; Centre for Neonatal and Paediatric Infection, City St George's, University of London, London, United Kingdom. * 4 University of the Witwatersrand, Johannesburg, South Africa. * 5 Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX, United States of America. * 6 Centre for Neonatal and Paediatric Infection, City St George's, University of London, London, United Kingdom; London School of Hygiene & Tropical Medicine, London, United Kingdom; Department for Infection and Population Health, Institute for Global Health, University College London, United Kingdom. Electronic address: Hannah.g.davies@ucl.ac.uk. * PMID: **42595590** * DOI: [ 10.1016/j.vaccine.2026.128899 ](https://doi.org/10.1016/j.vaccine.2026.128899) Item in Clipboard # Updating the evidence on brighton collaboration's GAIA maternal immunisation case definitions: a systematic review of performance and implementation challenges Robert Mboizi et al. Vaccine. 2026. Show details Display options Display options Format Abstract PubMed PMID Vaccine Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Vaccine%22%5Bjour%5D&sort=date&sort_order=desc) * [ Search in NLM Catalog ](https://www.ncbi.nlm.nih.gov/nlmcatalog?term=%22Vaccine%22%5BTitle+Abbreviation%5D) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42595590/) . 2026 Aug 30:89:128899. doi: 10.1016/j.vaccine.2026.128899. Epub 2026 Aug 13. ### Authors [Robert Mboizi](https://pubmed.ncbi.nlm.nih.gov/?term=Mboizi+R&cauthor_id=42595590)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42595590/#short-view-affiliation-1 "Makerere University Johns Hopkins Research Collaboration \(MUJHU\), Kampala, Uganda; University of Antwerp, Antwerp, Belgium."), [Kirsten Maertens](https://pubmed.ncbi.nlm.nih.gov/?term=Maertens+K&cauthor_id=42595590)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42595590/#short-view-affiliation-2 "Centre for the Evaluation of Vaccination, Vaccine & Infectious Diseases Institute, University of Antwerp, Antwerp, Belgium."), [Kirsty Le Doare](https://pubmed.ncbi.nlm.nih.gov/?term=Le+Doare+K&cauthor_id=42595590)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42595590/#short-view-affiliation-3 "Makerere University Johns Hopkins Research Collaboration \(MUJHU\), Kampala, Uganda; Centre for Neonatal and Paediatric Infection, City St George's, University of London, London, United Kingdom."), [Clare L Cutland](https://pubmed.ncbi.nlm.nih.gov/?term=Cutland+CL&cauthor_id=42595590)[ 4 ](https://pubmed.ncbi.nlm.nih.gov/42595590/#short-view-affiliation-4 "University of the Witwatersrand, Johannesburg, South Africa."), [Flor M Muñoz](https://pubmed.ncbi.nlm.nih.gov/?term=Mu%C3%B1oz+FM&cauthor_id=42595590)[ 5 ](https://pubmed.ncbi.nlm.nih.gov/42595590/#short-view-affiliation-5 "Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX, United States of America."), [Hannah G Davies](https://pubmed.ncbi.nlm.nih.gov/?term=Davies+HG&cauthor_id=42595590)[ 6 ](https://pubmed.ncbi.nlm.nih.gov/42595590/#short-view-affiliation-6 "Centre for Neonatal and Paediatric Infection, City St George's, University of London, London, United Kingdom; London School of Hygiene & Tropical Medicine, London, United Kingdom; Department for Infection and Population Health, Institute for Global Health, University College London, United Kingdom. Electronic address: Hannah.g.davies@ucl.ac.uk.") ### Affiliations * 1 Makerere University Johns Hopkins Research Collaboration (MUJHU), Kampala, Uganda; University of Antwerp, Antwerp, Belgium. * 2 Centre for the Evaluation of Vaccination, Vaccine & Infectious Diseases Institute, University of Antwerp, Antwerp, Belgium. * 3 Makerere University Johns Hopkins Research Collaboration (MUJHU), Kampala, Uganda; Centre for Neonatal and Paediatric Infection, City St George's, University of London, London, United Kingdom. * 4 University of the Witwatersrand, Johannesburg, South Africa. * 5 Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX, United States of America. * 6 Centre for Neonatal and Paediatric Infection, City St George's, University of London, London, United Kingdom; London School of Hygiene & Tropical Medicine, London, United Kingdom; Department for Infection and Population Health, Institute for Global Health, University College London, United Kingdom. Electronic address: Hannah.g.davies@ucl.ac.uk. * PMID: **42595590** * DOI: [ 10.1016/j.vaccine.2026.128899 ](https://doi.org/10.1016/j.vaccine.2026.128899) Item in Clipboard Full text links Cite Display options Display options Format Abstract PubMed PMID ## Abstract **Background:** The Brighton Collaboration's GAIA initiative developed harmonised case definitions (CDs) to standardise safety monitoring for maternal immunisation studies globally. These definitions use levels of diagnostic certainty (LOC) to support use across settings with differing diagnostic capacity, but their real-world performance and applicability have remained uncertain. A 2023 review found that around half of GAIA CDs had not been evaluated and that several key outcomes performed poorly with high rates of cases that could not be classified at LOC 1-3 (achieving only LOC-4). **Methods:** Ovid MEDLINE, EMBASE, and Web of Science databases were searched for research studies in English-language publications from 2014 to May 5th, 2025, that assessed the performance of the GAIA case definitions in routine care or research. Two reviewers independently screened studies and extracted data, resolving any discrepancies through consensus. The review protocol was registered with PROSPERO (CRD42025620433). **Results:** Database searches identified 4260 records; after deduplication and two-stage screening, 10 studies including 42,587 cases were eligible. Three definitions had not been evaluated (ectopic pregnancy, postpartum endometritis, neurodevelopmental delay), and several others have only been assessed in high-income settings. While CDs for maternal death, neonatal death, and preterm birth performed well, others had high proportions of unclassifiable cases, achieving only LOC-4. Variability was seen with some studies able to classify 100% of potential cases, whilst others were only able to classify 50% at LOC 1-3. **Conclusions:** Although progress has been made in evaluating GAIA case definitions, challenges remain in understanding their applicability across settings and data sources. Variability likely reflects differences in setting-level resources, data availability and documentation quality, as well as limitations inherent to the definitions themselves, highlighting the need for targeted refinement and broader validation to support robust, standardised, and comparable maternal immunisation safety surveillance globally. **Keywords:** Brighton collaboration; GAIA; Maternal immunisation; Neonatal infections; Vaccine safety. Copyright © 2026. Published by Elsevier Ltd. [PubMed Disclaimer](https://pubmed.ncbi.nlm.nih.gov/disclaimer/) ## Conflict of interest statement Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. ## Similar articles * [ Folic acid supplementation and malaria susceptibility and severity among people taking antifolate antimalarial drugs in endemic areas. ](https://pubmed.ncbi.nlm.nih.gov/36321557/) Crider K, Williams J, Qi YP, Gutman J, Yeung L, Mai C, Finkelstain J, Mehta S, Pons-Duran C, Menéndez C, Moraleda C, Rogers L, Daniels K, Green P.Crider K, et al.Cochrane Database Syst Rev. 2022 Feb 1;2(2022):CD014217. doi: 10.1002/14651858.CD014217.Cochrane Database Syst Rev. 2022.Update in: [Cochrane Database Syst Rev. 2026 Feb 18;2:CD014217. doi: 10.1002/14651858.CD014217.pub2.](https://pubmed.ncbi.nlm.nih.gov/41705996/)PMID: 36321557Free PMC article.Updated. * [ Immunization in pregnancy safety surveillance in low and middle-income countries- field performance and validation of novel case definitions. ](https://pubmed.ncbi.nlm.nih.gov/31014963/) Kochhar S, Clarke E, Izu A, Emmanuel Kekane-Mochwari K, Cutland CL.Kochhar S, et al.Vaccine. 2019 May 16;37(22):2967-2974. doi: 10.1016/j.vaccine.2019.03.074. Epub 2019 Apr 20.Vaccine. 2019.PMID: 31014963 * [ WHO global vaccine safety multi-country collaboration project on safety in pregnancy: Assessing the level of diagnostic certainty using standardized case definitions for perinatal and neonatal outcomes and maternal immunization. ](https://pubmed.ncbi.nlm.nih.gov/34825164/) Stuurman AL, Sharan A, Jahagirdar S, Elango V, Riera-Montes M, Kashyap N, Biccler J, Poluru R, Arora N, Mathai M, Mangtani P, DeVlieger H, Anderson S, Whitaker B, Wong HL, Cutland C, Guillard Maure C; WHO GVS MCC Sites.Stuurman AL, et al.Vaccine X. 2021 Nov 3;9:100123. doi: 10.1016/j.jvacx.2021.100123. eCollection 2021 Dec.Vaccine X. 2021.PMID: 34825164Free PMC article. * [ Baseline adverse birth outcomes in a prospective pregnancy cohort in Uganda: Evidence to inform maternal vaccine readiness. ](https://pubmed.ncbi.nlm.nih.gov/42570461/) Davies HG, Rukundo G, Komugisha C, Kipyeko S, Young A, Kisakye J, Voysey M, Mboizi R, Heath PT, Sekikubo M, Le Doare K.Davies HG, et al.Vaccine. 2026 Sep 17;90:128952. doi: 10.1016/j.vaccine.2026.128952. Epub 2026 Aug 8.Vaccine. 2026.PMID: 42570461 * [ Standardizing case definitions for monitoring the safety of maternal vaccines globally: GAIA definitions, a review of progress to date. ](https://pubmed.ncbi.nlm.nih.gov/37194339/) Davies HG, Bowman C, Watson G, Dodd C, Jones CE, Munoz FM, Heath PT, Cutland CL, Le Doare K.Davies HG, et al.Int J Gynaecol Obstet. 2023 Jul;162(1):29-38. doi: 10.1002/ijgo.14843. Epub 2023 May 16.Int J Gynaecol Obstet. 2023.PMID: 37194339Review. 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