TABLE 2 

Completed and ongoing clinical trials with dmLT adjuvanta

Pathogen:
antigen
RouteStudy design (Clinicaltrials.gov ID
[reference {if available}])
Population; status: results
None: nonep.o.Phase 1, escalating dose safety study (NCT01147445 [70])U.S. adults; completed: no detectable SAE
ETEC: whole-killed (ETVAX)p.o.Phase 1, whole cells ± 10 or 25 µg dmLT (EudraCT no. 2011-003228-11 [71])Swedish adults; completed: 10 µg dmLT enhanced responses to less immunogenic antigens
ETEC: live-attenuated (ACE527)p.o.Phase 1 and 2b, 25 µg dmLT with live-attenuated ETEC (NCT01739231 [72])U.S. adults; completed: dmLT enhanced protective efficacy from oral challenge 6–7 mo postimmunization
None: nones.l.Phase 1, escalating dose safety study (NCT02052934)U.S. adults; completed
None: nonei.d.Phase 1, escalating dose of 0.1, 0.3, 1, or 2 µg dmLT (NCT02531685)U.S. adults; recruiting
ETEC: whole-killed (ETVAX)p.o.Phase 1 and 2 escalating dose of ETVAX ± 2.5, 5, or 10 µg dmLT (NCT02531802)Bangladesh infants, toddlers, children, adults; completed
ETEC: subunit (CS6)i.m.Phase 1, escalating dose safety study (NCT03404674)U.S. adults; recruiting
ETEC: whole-killed (ETVAX)p.o.Phase 2b, ETVAX plus 10 µg dmLT (EudraCT no. 2016-002690-35)Finnish adult travelers to Benin; ongoing
  • a Abbreviations: SAE, severe adverse events; ID, identifier.