The objective of the planned study is to demonstrate if ETVAX®, given with two doses 14 days apart and a booster dose at day 90, is safe and provides protection against moderate-to-severe diarrhoea caused by ETEC. The study is a randomized, placebo-controlled, double-blind, field trial of the vaccine in approximately 5000 children residing in an ETEC-endemic area in The Gambia.

 

This study is co funded by  the EU Research and Innovation Framework Program, Horizon 2020 through the European and Developing Countries Clinical Trials Partnership (EDCTP) organization.

The OEV-124 study is a sequel to the already successful phase I/II trial in a Bangladeshi study encompassing 495 participants as young as 6 months old. The Zambian trial will further establish the exact safe and immunogenic dose of the vaccine in young children as well as to explore the potential benefits of a third booster dose.

The study was conducted in healthy adults (n = 40) and children (n = 206) 6-23 months old.

Nsofwa, Vaccine 2023. Safety, tolerability, and immunogenicity of an oral inactivated ETEC vaccine (ETVAX®) with dmLT adjuvant in healthy adults and children in Zambia: An age descending randomised, placebo-controlled trial

This study is co funded by  the EU Research and Innovation Framework Program, Horizon 2020 through the European and Developing Countries Clinical Trials Partnership (EDCTP) organization.

A randomised, placebo controlled, double blinded phase 2b study was conducted in 743 Finnish tourists, between the ages of 18 to 65 years of age, travelling to Benin. The objectives were to evaluate safety and tolerability, new diagnostical methodology and establish preliminary vaccine efficacy. The results were unblinded in 2020 and confirmed the excellent safety and overall positive immunogenicity of ETVAX^®. Read more here.

This study is co funded by SME Instrument, part of the EU’s Horizon 2020 research and Innovation programme.

The safety of the vaccine was documented in an age descending study in Bangladesh encompassing 475 subjects.

The study showed that two doses of ETVAX ® with dmLT were immunogenic for all vaccine antigens in all age groups and the study showed a strong immune response, exceeding our expectations, was demonstrated. The results further showed a correlation between age and immune responses. The strongest response against all antigens was observed in adults and moderately decreased by age.The immune responses did correlate with age such that responses were most pronounced against all antigens in adults and responses decreased moderately with age. Immune responses in those 6 to 11 months of age were lowest among all study age groups but still consistently above placebo responses. A significant dmLT driven early onset of immunity was shown in the youngest age. Overall, a significant faecal secretory IgA immune responses were recorded against all vaccine antigens in infants. Addition of dmLT enhanced the magnitude, breadth, and kinetics of immune responses in infants. The youngest age group the study showed that dmLT driven significant early onset of immunity.

F. Qadri, Lancet Infect Dis 2019. Safety and immunogenicity of the oral, inactivated, enterotoxigenic Escherichia coli vaccine ETVAX in Bangladeshi children and infants: a double-blind, randomised, placebo-controlled phase 1/2 trial

M.Akhtar, Vaccine 2018. Evaluation of the safety and immunogenicity of the oral inactivated multivalent enterotoxigenic Escherichia coli vaccine ETVAX in Bangladeshi adults in a double-blind, randomized, placebo-controlled Phase I trial using electrochemiluminescence and ELISA assays for immunogenicity analyses. 

A Booster study was conducted in a subset of the participants from the OEV121 study 18-24 months after the initial two doses. The immune responses in the participants that received the booster dose were comparable, or even higher, against the primary vaccine antigens than what was observed after only the initial two doses. The results also suggest that a single vaccine dose may be sufficient to boost mucosal immune responses several years after priming vaccination. The vaccine was safe and well tolerated.

A.Lundgren, Vaccine 2016. Induction of long term mucosal immunological memory in humans by an oral inactivated multivalent enterotoxigenic Escherichia coli vaccine

Enterotoxin (dmLT) to the vaccine was investigated in a placebo-controlled study. All primary endpoints were met and exceeded, yielding excellent safety and impressive frequency of responders. Both the vaccine formulation with and without the adjuvant were proven safe and well tolerated.

A. Lundgren, Vaccine 2014. Safety and immunogenicity of an improved oral inactivated multivalent enterotoxigenic Escherichia coli (ETEC) vaccine administered alone and together with dmLT adjuvant in a double-blind, randomized, placebo-controlled Phase I study