The Medical Research Council Unit, The Gambia, at the London School of Hygiene & Tropical Medicine (MRCG at LSHTM) has expressed optimism at the diarrhoea vaccine trial conducted in The Gambia describing it as “a major milestone for global diarrhoea disease prevention”.
A report on the vaccine trial was featured in The Lancet, one of the world’s highest-impact academic journals and one of the oldest medical journals published in the United Kingdom.
In a statement issued over the weekend, MRCG at LSHTM welcomed the publication of the Phase 2b clinical trial results of the oral ETVAX® vaccine in The Lancet confirming that the vaccine is safe with high immunogenicity and efficacy which supports progress to a pivotal Phase 3 trial.
The statement read: “The randomised, double-blind, placebo-controlled Phase 2b trial enrolled almost 5,000 children aged six to 18 months in The Gambia and was conducted in collaboration with Scandinavian Biopharma. It evaluated the safety and efficacy of the vaccine against enterotoxigenic Escherichia coli (ETEC), a leading cause of moderate-to-severe diarrhoeal disease in young children in low- and middle-income countries.
“Key findings published in The Lancet showed that the ETVAX vaccine can significantly reduce serious diarrhoea in young children. Overall, the vaccine cut cases of moderate-to-severe diarrhoea caused by ETEC by about half. Protection was even stronger when children were not affected by other intestinal infections. Children who received the vaccine before nine months of age benefited the most, highlighting the importance of early vaccination. Over two years of follow-up, vaccinated children also experienced fewer serious diarrhoea episodes from all causes, with a level of protection similar to that seen with rotavirus vaccines already used worldwide. The trial confirmed safety and strong immune responses, with ETVAX estimated to provide coverage against more than 90% of circulating ETEC strains in high-burden settings.”
Dr Jahangir Hossain, Principal Investigator of the ETVAX Study, said: “This study provides robust evidence that ETVAX is safe, well tolerated, and capable of significantly reducing the burden of diarrhoeal disease caused by ETEC in young children. The findings demonstrate particularly strong protection when vaccination occurs early in infancy. These results mark a critical step forward in the development of an effective ETEC vaccine with real public health impact.”
The research was implemented across multiple regions of The Gambia, supported by strong community engagement and collaboration with parents, traditional leaders, health care workers, and local authorities. Dissemination meetings held in Farafenni, Ngayen Sanjal, Kerewan, Noo Kunda, and Soma provided an opportunity to share preliminary findings directly with participating communities and stakeholders.
Professor Umberto D’Alessandro, Unit Director of MRCG at LSHTM, highlighted: “We are proud to register that the European Medicines Agency has concluded that the accumulated data support advancement to a pivotal Phase 3 trial. This represents a significant milestone and reflects the strength of long-standing research partnerships in The Gambia. We recognise the role played by The Gambia Government, communities, and rural health systems in generating evidence with global public health relevance.”
The planned Phase 3 study is expected to enrol more than 5,000 children aged six to nine months.
If implemented at scale through routine immunisation programmes, ETVAX has the potential to prevent millions of cases of moderate-to-severe diarrhoeal disease annually, improve child growth and cognitive development, reduce inappropriate antibiotic use, and contribute to our mission to save lives and improve health across the world.
