The first cohort of 40 adults was enrolled in the company’s Phase I study in Zambia.
The study is part of a late phase development program in Africa funded by EDCTP with 7,4 million Euro. The program consists of two clinical trials and is initiated with a Phase I trial in Zambia to evaluate the optimal dose of ETVAX and the benefits of a booster dose in young children. This trial will immediately be followed by a Phase IIb study in The Gambia.
A sequel to the phase I/II trial in Bangladesh
The Phase I trial in Zambia is a sequel to the already successful phase I/II trial in a Bangladeshi study that encompassed 495 participants as young as 6 months old. This trial will include 246 participants and the objectives are to evaluate the safety and tolerability of ETVAX as well as to explore the potential benefits of a booster dose. The evaluation will begin in adults (18-45 years) and then proceed to younger age groups (children 6-23 months).
The company recently completed the enrolment of the first cohort, consisting of 40 adult participants including 10 placebos. The participants received ETVAX with 10ug dmLT or placebo in a double blinded manner. The children cohorts (60 children aged 10-23 months and 146 children 6-9 months) will receive two doses of placebo, 1/8 or 1/4 of the adult dose of ETVAX together with 2,5ug of dmLT followed by a booster dose.
The decision to move ETVAX forward into the proposed Phase IIb in The Gambia will be based on a favourable safety and immunogenicity profile. The trial will require the enrolment of approximately 5000 participants and the objectives are to establish the safety, immunogenicity and protective efficacy of ETVAX with dmLT against moderate-to-severe diarrhoea induced by ETEC.
Photo of Björn Sjöstrand, CEO of Scandinavian Biopharma