drugset / Trial / NCT03404674
Dose Escalating Study of a Prototype CS6 Subunit Vaccine With a Modified Heat-labile Enterotoxin From Enterotoxigenic Escherichia Coli (ETEC)
Phase 1
Completed
50 enrolled
PATH
Naval Medical Research Center · collabWalter Reed Army Institute of Research (WRAIR) · collab
Non-randomizedSequentialOpen-labelPrevention
Summary
This study will evaluate the safety of a prototype Coli surface antigen 6 (CS6) subunit vaccine (CssBA) alone or in combination with Escherichia coli double mutant heat labile toxin (dmLT) given by intramuscular (IM) injection.
Timeline
- Start
- 2018-01-16
- Primary completion
- 2019-03-26
- Completion
- 2019-03-26
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CssBA | Vaccine | 5 ug | Intramuscular |
| Subject | CssBA | Vaccine | 15 ug | Intramuscular |
| Subject | CssBA | Vaccine | 45 ug | Intramuscular |
| Subject | LTR192G | Protein / enzyme biologic | 100 ng | Intramuscular |
| Subject | LTR192G | Protein / enzyme biologic | 500 ng | Intramuscular |