Gambiaj.com – (BANJUL, The Gambia) – Scandinavian Biopharma has announced the successful completion of its Phase IIb pediatric trial for ETVAX®, a groundbreaking vaccine candidate aimed at combating enterotoxigenic Escherichia coli (ETEC), commonly referred to as traveler’s diarrhea. The trial, which was conducted in The Gambia, represents a significant step toward addressing the global health challenge posed by ETEC, particularly for children in low- and middle-income countries (LMICs) and for travelers.
In a press release, Scandinavian Biopharma explained that the Phase IIb trial, initiated in 2021, is part of a broader late-phase development program in Africa, co-financed by the European and Developing Countries Clinical Trials Partnership Association (EDCTP). A total of 4,936 children aged 6-18 months were enrolled in this randomized, placebo-controlled, and double-blind trial. The goal was to evaluate both the safety and efficacy of ETVAX® in young children.
The results of the trial are highly promising. ETVAX® demonstrated more than 80% efficacy against ETEC when excluding co-infections with parasites. Even when considering all co-infections, the vaccine’s efficacy remained strong, offering about 50% protection. Additionally, the vaccine showed a robust safety profile, with no significant safety concerns observed. Adverse events were evenly distributed between the vaccine and placebo groups.
Key highlights of the trial include:
High Efficacy: The vaccine offered over 80% protection against ETEC, the leading cause of moderate to severe diarrhea in The Gambia.
Safety: ETVAX® was proven safe for very young children, with no major side effects.
Broad Protection: The vaccine provided protection against over 90% of ETEC strains, with evidence suggesting broader protection against moderate to severe diarrhea (MSD) beyond ETEC itself.
These findings are crucial not only for children in LMICs, who face the risk of malnutrition, stunting, and cognitive impairment from diarrheal diseases, but also for travelers visiting ETEC-endemic regions.
Björn Sjöstrand, CEO of Scandinavian Biopharma, expressed optimism about the results, stating, “The outcomes of the Phase IIb trial highlight the potential of ETVAX® to address the pressing health challenges faced by children in LMICs. The vaccine’s broad protection, especially its high efficacy against ETEC, demonstrates its value in both LMIC settings and for travelers.”
The Phase IIb trial is a key milestone in the development of ETVAX® and paves the way for a pivotal Phase III trial. The ultimate goal is to make this vaccine available for children in LMICs, travelers, and other at-risk populations. Among those particularly at risk are members of the U.S. military. Despite modern sanitation measures, traveler’s diarrhea continues to affect service members, with an average attack rate of 29% per month worldwide. ETEC is the most common cause, responsible for approximately 80% of these cases.
Colonel Andy Nuce, commander of the U.S. Army Medical Materiel Development Activity (USAMMDA), emphasized the importance of an effective vaccine. “This study marks a promising milestone in the development and approval of an ETEC vaccine,” said Col. Nuce. “Having an effective vaccine would prevent illness, lessen the severity of symptoms, and help to avoid lost duty days among our troops deployed across the globe.”
Since 2020, USAMMDA has been providing funding and project management to support the manufacturing and development of ETVAX®, aiming for future evaluation and licensure by the U.S. Food and Drug Administration (FDA).
The successful completion of the Phase IIb trial is a promising step toward reducing the global burden of ETEC-related diarrhea, particularly in vulnerable populations. The next step in the journey is the Phase III trial, which will further validate the vaccine’s efficacy and safety before it can be made widely available. This development highlights a major advancement in global health, particularly for vulnerable populations who continue to face the risks of ETEC and other diarrheal diseases.
