Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07122986 | A Study to Learn About a Vaccine Against E Coli in Healthy Adults | PHASE1 | RECRUITING | 310 | — | — | Aug 11, 2025 | May 26, 2028 | Apr 30, 2026 | 11 | United States |
Prespecified local reactions (redness, swelling, and pain at the injection site) following each vaccination
Prespecified systemic events (fever, fatigue, headache, chills, vomiting, diarrhea, joint pain, and muscle pain) following each vaccination
Adverse events occurring up to 1 month after the last dose of study intervention
MAEs occurring up to 12 months after the last dose of study intervention
SAEs occurring up to 12 months after the last dose of study intervention
| Arm | Type | Description |
|---|---|---|
| E coli vaccine 1 Dose A | EXPERIMENTAL | Candidate E coli vaccine on day 1 and day 180 |
| E coli vaccine 1 Dose B | EXPERIMENTAL | Candidate E coli vaccine on day 1 and day 180 |
| E coli vaccine 2 | EXPERIMENTAL | Candidate E coli vaccine on day 1 and day 180 |
| E coli vaccine 3 | EXPERIMENTAL | Candidate E coli vaccine on day 1 and day 180 |
| E coli Vaccine 4 Dose A | EXPERIMENTAL | Candidate E coli vaccine on day 1 and day 180 |
| E coli Vaccine 4 Dose B | EXPERIMENTAL | Candidate E coli vaccine on day 1 and day 180 |
| E coli Vaccine 4 Dose C | EXPERIMENTAL | Candidate E coli vaccine on day 1 and day 180 |
| E coli Vaccine 5 Dose A | EXPERIMENTAL | - |
| E coli Vaccine 5 Dose B | EXPERIMENTAL | - |
| Placebo | EXPERIMENTAL | Placebo received on day 1 and day 180 |
| Name | Type | Description |
|---|---|---|
| E coli vaccine 1 Dose A | DRUG | Candidate E coli vaccine 1 Dose A, administered according to a 0, 6-month interval |
| E coli vaccine 1 Dose B | DRUG | Candidate E coli vaccine 1 Dose B, administered according to a 0, 6-month interval |
| E coli vaccine 2 | DRUG | Candidate E coli vaccine 2, administered according to a 0, 6-month interval |
| E coli vaccine 3 | DRUG | Candidate E coli vaccine 3, administered according to a 0, 6-month interval |
| E coli Vaccine 4 Dose A | DRUG | Candidate E coli vaccine 4 Dose A, administered according to a 0, 6-month interval |
| E coli Vaccine 4 Dose B | DRUG | Candidate E coli vaccine 4 Dose B, administered according to a 0, 6-month interval |
| E coli Vaccine 4 Dose C | DRUG | Candidate E coli vaccine 4 Dose C, administered according to a 0, 6-month interval |
| E coli Vaccine 5 Dose A | DRUG | Candidate E coli vaccine 5 Dose A, administered according to a 0, 6-month interval |
| E coli Vaccine 5 Dose B | DRUG | Candidate E coli vaccine 5 Dose B, administered according to a 0, 6-month interval |
| Placebo | DRUG | Placebo administered according to a 0, 6-month interval |
Ages Eligible for Study: 18 to 64 Years (Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: Yes Key Inclusion Criteria 1. Adult Participants \>= 18 through \< 64 years of age at the time of enrollment. 2. Healthy participants as determined by medical history, physical examination, an...