We have successfully completed the enrolment of the first cohort including 40 adults in our study in Zambia
We are proud to announce that the first cohort of 40 adults was enrolled in our 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.
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).
We 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.
From left to right: Study co-ordinator Bupe Sichalwe and site co-principal investigator Dr Nsofwa Sukwa.
ETVAX® is the registered trademark of Scandinavian Biopharma’s vaccine candidate against diarrheal disease caused by ETEC. ETVAX® is currently in Phase IIb clinical trials to evaluate safety and estimate the protective efficacy in 743 Finnish travellers to Benin. The study will be unblinded Q1 2020.
ETVAX® is the only ETEC vaccine in late phase development and is judged as the most advanced ETEC vaccine project. The strong immunogenicity and safety clearly distinguish ETVAX® from other vaccine candidates that are under development against ETEC induced diarrhoea.
Successful development of this vaccine will address an unmet medical need of children in low-middle income countries as well as in travellers, since no licensed vaccine against this disease exists to date.