Table 2.
Description of trials evaluating the efficacy of MV140 in women with rUTIs. All included trials must have included a UTI-free outcome (percentage of subjects with no UTI after vaccination).
| Study Design (Reference) |
Subjects (rUTI in Women) |
Treatment | Efficacy Findings |
|---|---|---|---|
| Randomized placebo-controlled Lorenzo-Gomez et al [32] |
78 | Placebo 6 months | 9-month UTI reduction (after 3-month treatment): median 3.0 placebo vs. 0.0 MV140 groups (p < 0.001) 9-month UTI-free rate 55.7–58.0% MV140 vs. 25.0% placebo groups (p < 0.001) |
| 77 | MV140 3 months (+Placebo 3 months) | ||
| 75 | MV140 6 months | ||
| Retrospective antibiotic-comparator Lorenzo-Gomez et al [27] |
159 | MV140 3 months | 15-month UTI-free rate: 34.6% MV140 vs. 0% Antibiotic group (p < 0.001) 15-month UTI reduction: mean 5.75 Antibiotics vs. 1.35 MV140 (p < 0.001) |
| 160 | TMP/SMX 6 months |
||
| Retrospective antibiotic-comparator Lorenzo-Gomez et al. [28] |
360 | MV140 3 months | 12-month UTI-free rate: 90.3% MV140 vs. 0% antibiotic group (p < 0.001) Delayed UTI onset postvaccination: median 180 days MV140 vs. 19 days ATB group (p < 0.001) |
| 339 | TMP/SMX or nitrofurantoin 6 months |
||
| Prospective observational descriptive noncomparative Yang et al [29] |
75 | MV140 3 months | 12-month UTI-free rate: 78.7% |
| Prospective observational descriptive noncomparative Ramirez-Sevilla et al [30] |
648 | MV140 3 months | 6-month UTI-free rate (postvaccination): 32.3% Rate of 0–1 UTI (6 months postvaccination): 65.9% |
| Prospective observational longitudinal Carrion-Lopez et al [31] |
166 | MV140 3 months | 12-month/24-month UTI-free rate: 52.4%/44.5% UTI reduction/year: 54.6% (p < 0.001 compared to prevaccination) |
| Prospective observational real-world early clinical experience—preliminary report Nickel et al [33] |
25 (pre-COVID-19 cohort) | MV140 3 months | 9-month UTI-free rate (postvaccination): 48% UTI/month reduction: 82% (compared to the year prevaccination) Self-reported moderate/marked improvement: 80% of subjects |
| Prospective observational real-world early clinical experience—Final report Nickel et al. (this work) |
64 | MV140 3 months | 9-month UTI-free rate (postvaccination): Pending 2023 UTI/month reduction: Pending 2023 Self-reported moderate/marked improvement: Pending 2023 |