Completed Infection & Immunity Digestion, Kidneys & Other Organs

GMMA-based Shigella vaccine serology and schedule finding trial

Funder Wellcome Charity-funded
Associated organisations GlaxoSmithKline Biologicals SA · GSK Vaccines Institute for Global Health Europe PMC affiliations are not treated as award recipients or mapped locations.
Funding £1.6M
Period Aug 2021 — Mar 2026

In plain English

AI plain-English summary

A single vaccine could eventually protect against the four most common strains of *Shigella* bacteria, which cause severe diarrhoea and kill hundreds of thousands of children each year in low- and middle-income countries. The problem is that conventional *Shigella* vaccines are expensive and difficult to manufacture at scale. This project uses a technology called GMMA—essentially, tiny blebs of bacterial outer membrane that present key surface sugars to the immune system. GMMA vaccines can be produced cheaply and in high yield, making them practical for widespread use in the places that need them most. If the trial succeeds, the four-component GMMA *Shigella* vaccine could be given during routine childhood immunisation visits, slotting into existing health infrastructure without requiring extra cold chain or delivery logistics. That would dramatically simplify getting the vaccine to children in remote or resource-poor settings. The project is designed to generate the human proof-of-concept data that pharmaceutical companies and investors need to justify the large-scale manufacturing and distribution required for licensure. Without this step, the vaccine would likely stall in what developers call the “second valley of death”—the gap between promising early results and a product that actually reaches patients.

View original technical description
This proposal builds on prior investments from GSK BIO, Bill & Melinda Gates Foundation and the EU Framework Programme 7 for the preclinical development of GMMA technology, preclinical and early clinical evaluations of S. sonnei GMMA vaccine, 1790GAHB, as well as the 4-component Shigella vaccine including GMMA from S. sonnei and the most epidemiologically important serotypes of S. flexneri (Sonflex1-2-3). GMMA are highly immunogenic bacterial outer membrane exosomes used as O antigen delivery system that can be manufactured at high yield and low cost, address the strategic goal of affordable vaccines for low- and middle-income countries. GSK is developing the innovative GMMA platform for making vaccines for neglected diseases that may not be developed through normal market forces. Funding from the Wellcome Trust ensures demonstration of human proof-of-concept needed to reduce development risk and prompt capital investment for sustainable vaccine manufacture through the “second vaccine development valley of death”. Positive outcomes could support administration of the 4-component GMMA Shigella vaccine during established Extended Programme of Immunization (EPI) visits facilitating vaccine delivery. GSK BIO will be looking to partner with external organizations to take this candidate vaccine through to licensure and distribution to regions where it is most needed.

View the original record at the funder ↗

Researchers

Francesca Micoli (EPMC Awardee)Laura Martin (EPMC Awardee)

Related Research

Grants with similar aims, by meaning.

The production of “Shigella plus” low-cost recombinant Shigella glycoconjugate vaccines
Advancing a GMMA-based vaccine against invasive non-typhoidal salmonellosis through Phase 1 trial in Europe and sub-Saharan Africa
A Phase 1 Clinical Study to Determine the Safety and Immunogenicity of a Novel GMMA Vaccine Against Invasive Non-Typhoid Salmonella
Development of a multivalent Shigella bioconjugate vaccine
Development of a Generalized Modules for Membrane Antigens vaccine against gonococcus

Original classification

Innovations Priority Project

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