One and a half year ago a phase I/II randomized, double-blind, placebo-controlled trial was started by Scandinavian Biopharma in Dhaka, Bangladesh, and now, all 450 participants have been enrolled and the last child received the vaccine this February.
“This clinical trial is the first important step toward showing that our vaccine can protect children in the developing world against ETEC diarrhoea, that causes millions of diarrheal events and several hundred thousands of death’s every year says Björn Sjöstrand”, CEO at Scandinavian Biopharma.
The trial is a collaboration between the Enteric Vaccines Initiative at PATH, the University of Gothenburg, ICDDR, B Bangladesh and Scandinavian Biopharma.
The oral inactivated ETEC vaccine, ETVAX, has in this trial been given to healthy adults, children (24-59 month), toddlers (12-23 month) and infants (6-11 month) to test its safety and ability to stimulate immune responses against key ETEC antigens as well as to see the impact of the adjuvant, dmLT, on mucosal ETEC-specific immune responses. The study was designed as 4 parts, one for each of the four age groups. All participants received two oral doses of ETVAXor ETVAX without dmLT or placebo, with different vaccine dose levels assessed within all children groups. Before moving to higher dose levels, available safety data were evaluated and reviewed.
All samples are now being analysed and later this year data will be unblinded and presented.