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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00736476 | Efficacy and Safety of an H.Pylori Vaccine in H.Pylori-Negative Adults | PHASE1 | COMPLETED | 63 | — | — | Oct 1, 2008 | Apr 1, 2010 | Feb 28, 2017 | 1 | Germany |
The efficacy of the investigational vaccine to prevent infection following H.pylori challenge in healthy adults was determined in terms of percentage of subjects with positive HP infections in the vaccinated and unvaccinated groups(Placebo). Infection rates was assessed by invasive Upper Gastrointestinal Endoscopy (UGE)tests that included HP histopathology, HP culture and rapid urease test (RUT), and non-invasive HP tests which included urea breath test (UBT) and fecal antigen test (FAT).
To assess the tolerability of an HP vaccine versus placebo in terms of number of subjects reporting solicited local\* and systemic adverse events.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| H.pylori vaccines | BIOLOGICAL | 1 dose of H.pylori vaccine at 0, 1, and 2 months |
| Placebo Vaccine | BIOLOGICAL | Placebo Vaccine at 0, 1, and 2 months |
Inclusion Criteria: * adults 18 - 40 years of age in good health * HP uninfected * not pregnant and agree to use birth control throughout the study (females who can become pregnant) Exclusion Criteria: * remote or current HP infection