One and a half year ago a phase I/II randomized, double-blind, placebo-controlled trial was started in Dhaka, Bangladesh. All 450 participantshave now 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.
Vaccines to prevent diarrheal diseases are an essential and lifesaving part of diarrhoea-control strategies, and may even reduce malnutrition and developmental delays associated with severe diarrhoea in children.
The oral inactivated ETEC vaccine, ETVAX®, has in this trial been given to healthy adults, children (24-59month), toddlers (12-23month) and infants (6-11month) 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.
Thestudywasdesignedas4parts,oneforeachofthefouragegroups.AllparticipantsreceivedtwooraldosesofETVAX® or ETVAX®withoutdmLTorplacebo,withdifferentvaccine doselevelsassessedwithinall childrengroups.Beforemovingtohigherdoselevels,availablesafetydatawereevaluatedandreviewed.
Thisclinicaltrialisanessentialstudyalongthecriticalpathoftheoverallclinicaldevelopmentplanbeforethevaccinecanbetestedforprotectiveefficacyinchildrenindevelopingcountries. All samples are now being analysed and later this year data will be unblinded and presented.
For more information, please contact:
Björn Sjöstrand, CEO: +46 727-125 120, firstname.lastname@example.org
Scandinavian Biopharma is a Swedish research-based biotech company specialist in marketing and sales of vaccines, dental products and immunoglobulins to the Nordic market.
Research and development is mainly focused on development of a new oral traveler’s diarrhea vaccine in collaboration with PATH Vaccine Solutions and University of Gothenburg.