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 […]
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 […]
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 […]
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 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 […]
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 […]
Study OEV-128 – Phase IIB Study in children 6-18 months in The Gambia
Study OEV-124 – Phase I, Age-descending study in Zambia
Study OEV-123 – Phase IIb Safety, diagnostic methodology evaluation and estimated vaccine efficacy in travellers to Benin
Study OEV-122 – Phase I/II, Age descending safety and immunogenicity trial in Bangladesh (age ≥6 mo)
Study OEV-121A – Phase I, Booster dose memory study
Study OEV-121 – Phase I, Safety and immunogenicity of vaccine
Study OEV-120 – Phase I, Safety and immunogenicity of a prototype vaccine
Study DMID 09-066 – Phase I, dmLT adjuvant safety and immunogenicity
