Scandinavian Biopharma has successfully completed the enrolment of their large Phase IIb trial in The Gambia
We are proud to announce that all participants have received the third and final vaccination dose in our large randomized, placebo-controlled, and double-blind phase IIb study in The Gambia.
The study started in 2021 and is part of the late phase development program in Africa for Scandinavian Biopharma’s vaccine candidate, ETVAX®, against Enterotoxigenic Escherichia coli (ETEC). The study, conducted at MRC – Medical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, includes 4 936 children aged 6-18 months. The overall goal of the study is to investigate the efficacy against moderate to severe diarrhea caused by ETEC.
Subject enrollment was completed in June 2022, and last vaccination dose was administered in October 2022. The passive surveillance follow-up period will be ended in October 2023.
Björn Sjöstrand, CEO at Scandinavian Biopharma, says: “The completion of the enrolment in the Gambia study is another important milestone towards making a vaccine available for children in low- and middle-income countries. An ETEC-vaccine is prioritized by World Health Organization (WHO) and has the potential to save hundred thousands of lives and reduce morbidity leading to poor physical and cognitive development among infants. The outcome of this pediatric trial will pave the way for the pivotal Phase 3 trial and generate evidence to support WHO prequalification of the vaccine.”
Part of the study team in Gambia.