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Scandinavian Biopharma Announces Successful Completion of Pediatric Phase IIb Trial for ETVAX® Vaccine in The Gambia
Scandinavian Biopharma is pleased to announce the successful completion of its large pediatric Phase IIb trial for ETVAX®, a promising vaccine candidate against enterotoxigenic Escherichia coli (ETEC), commonly called traveler’s diarrhea, conducted in The Gambia.
The promising findings from this study are a significant step forward in the mission to provide an essential ETEC vaccine for children in low- and middle-income countries (LMIC) and for travelers. The results from ETEC naïve children are also important supportive evidence for protection in travelers to ETEC endemic countries.
Initiated in 2021, the Phase IIb trial in The Gambia forms a crucial part of the late-phase development program for ETVAX® in Africa co-financed by the European and Developing Countries Clinical Trials Partnership Association (EDCTP). The randomized, placebo-controlled, and double-blinded trial enrolled a total of 4,936 children aged 6-18 months.
The objective of the study was to evaluate the safety and protective efficacy of ETVAX®. Administered in a three-dose schedule, with two doses given 14 days apart followed by a booster dose at day 90, ETVAX® demonstrated encouraging results.
Key highlights of the Phase IIb trial include:
- ETEC is a major cause of moderate to severe diarrhea in The Gambia.
- Promising Vaccine Efficacy: The protective efficacy was more than 80% against ETEC when allowing for any co-infections except parasites. The vaccine efficacy against a broader definition allowing for all co-infections reached approximately 50% protection.
- Strong Safety Profile: ETVAX® is safe in very young children, with no significant safety concerns observed. Adverse events were equally distributed between the vaccine and placebo groups.
- Great vaccine coverage: ETVAX® provides coverage against over 90% of ETEC strains.
- Broad protection: Data indicates that the vaccine may offer broader protection against MSD beyond ETEC, making it a valuable tool for public health initiatives.
- Similar results have also been observed in recent ETVAX® study in travelers.
Björn Sjöstrand, CEO at Scandinavian Biopharma, says: "We are thrilled by the outcomes of the Phase IIb trial, which indicate the potential ETVAX® has to address the pressing health challenges faced by children in LMIC. The broad protection offered by the vaccine, with high protection against ETEC when allowing for all co-infections, underscores its significance in both LMIC settings as well as for travelers to high-risk destinations."
For children in LMIC countries, infections can result in substantial mortality and morbidity impact due to malnutrition, stunting, and impairment of cognitive development. The outcome of this trial will pave the way for the pivotal Phase III trial and act as supportive data for travelers indication. The final goal is clear: to have a vaccine available for both children in LMIC and for travelers and other at-risk populations.
Among those at risk are members of the U.S. military. Despite sanitation and hygiene measures, the traveler’s diarrhea (TD) attack rate in service members still averages 29% per month worldwide. Approximately 80% of the TD is caused by bacterial agents and ETEC is by far the most common cause of TD.
The continuing risk that traveler’s diarrhea poses to unit readiness caused it to be ranked as the number one infectious disease threat by the military Infectious Diseases Threat Prioritization Panel.
“This study marks a promising milestone in the development and approval of an ETEC vaccine,” said Col. Andy Nuce, commander of the U.S. Army Medical Materiel Development Activity at Fort Detrick, Md. “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 (the United States Army Medical Materiel Development Activity) has supported the manufacturing and development effort, providing funding and project management to help facilitate evaluation and licensure of the product by the U.S. Food and Drug Administration.
More information
Please contact:
Björn Sjöstrand, CEO Scandinavian Biopharma
Email: bjorn@scandinavianbiopharma.se
Phone: +46 (0)72 712 51 20
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About Scandinavian Biopharma
Scandinavian Biopharma is a research-based specialty biopharma company determined to give people all over the world a longer and better life. Together with researchers at the University of Gothenburg and the international non-profit organization PATH, Scandinavian Biopharma is developing the first vaccine against ETEC which causes diarrhea in both travelers and endemic populations.
The development project is mainly funded by the EDCTP program, which is supported under Horizon 2020, the European Union’s (EU) Framework Program for Research and Innovation, as well as by PATH and the U.S. Army Medical Materiel Development Activity (USAMMDA).
Scandinavian Biopharma also acts as a distributor for a wide range of specialty biopharma products in Europe with a focus on vaccines, immunoglobulins and FSMP.
About ETEC
Enterotoxigenic Escherichia coli, or ETEC, is a major cause of bacterial diarrheal disease. ETEC infections are particularly common in low- and middle-income countries (LMIC). In children younger than 5 years, it has been estimated that 1.7 billion episodes of diarrhea occur annually. Diarrhea is also among the leading causes of death in children under five years of age in LMIC, with the majority of cases caused by ETEC. Repeated ETEC infections (even asymptomatic infection) can induce or exacerbate stunting and other forms of malnutrition. Stunting affects cognitive development which might determine a child’s ability to learn, their educational attainment, and future earnings, and it also puts children at risk due to other severe infectious diseases.
ETEC is the most common pathogen causing diarrhea in travelers and estimates have shown that approximately 35 million people are affected by traveler’s diarrhea (TD) every year. TD symptoms usually persist for up to 5 days but may last for 2 weeks or longer in up to 10% of cases. 10- 14% of TD cases associated with ETEC may also go on to develop persistent functional bowel disorders, like irritable bowel syndrome (IBS).
About ETVAX®
To date, no vaccine against ETEC exists and ETVAX® is the only ETEC vaccine candidate in late-stage development. The strong immunogenicity and safety data, as well as the promising field efficacy data, clearly distinguish ETVAX® as the lead vaccine candidate against ETEC. Successful development of this vaccine will address a huge unmet medical need for children in LMICs as well as for travelers and military personnel.
About USAMMDA
USAMMDA develops, delivers, and fields critical drugs, vaccines, biologics, devices, and medical support equipment to protect and preserve the lives of Warfighters across the globe. USAMMDA Project Managers guide the development of medical products for the U.S. Army Medical Department, other U.S. military services, the Joint Staff, the Defense Health Agency, and the U.S. Special Operations community. The process takes promising technology from the Department of Defense, industry, and academia to U.S. Forces, from the testing required for U.S. Food and Drug Administration approval or licensing to fielding and sustainment of the finished product. USAMMDA Project Management Offices will transition to a Program Executive Office under the Defense Health Agency, Deputy Assistant Director for Acquisition and Sustainment. No official endorsement of third parties or their products is made or inferred.
