Sublingual vaccination with Uromune (MV140) prevents recurrent urinary tract infections in women.
Preliminary results from a multicentre, Spanish-UK randomized, double-blind, placebo-controlled phase III trial
BAUS ePoster online library. Yang B. 06/21/21; 319088; p5-1
Disclosure(s): The RCT was funded by Inmunotek (Spain)
Preliminary results from a multicentre, Spanish-UK randomized, double-blind, placebo-controlled phase III trial
Mr. Bob Yang
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Abstract
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Introduction:
Antibiotic prophylaxis for recurrent urinary tract infections (rUTI) in women and the rise in antibiotic resistance has resulted in tremendous costs, treatment failure and patient morbidity. MV140 (Uromune) is a polybacterial sublingual vaccine consisting of whole-cell inactivated bacteria (E. coli, K. pneumoniae, E. faecalis and P. vulgaris) that has shown clinical benefit in previous observational studies. Results from a randomized placebo-controlled trial (RCT) were awaited to confirm its clinical efficacy.
Patients and Methods:
A phase III multicentre, double-blind, parallel‐group RCT, enrolled 240 women aged 18-75 with rUTI from Spain and UK. They were randomly allocated to receive placebo for 6 months or MV140 (active) for 3 or 6 months, in a 1:1:1 ratio. Primary and major secondary endpoints were the number of UTIs and UTI-free rate in the 9-month efficacy period, respectively.
Results:
The median number of UTI episodes was 3.0 [interquartile range, IQR, 0.5-6.0] for placebo group compared to 0.0 [IQR, 0.0-1.0] in both groups receiving MV140 (P≤0.001). A significant increase (over 2-fold) in the UTI-free rate was observed in the treatment groups (P≤0.001) compared to the placebo group (25.0%). Only 5 subjects reported non-serious adverse reactions, 2 in the placebo group and 3 in the MV140 3-month group.
Conclusions:
The preliminary late-breaking analysis of this first MV140 RCT shows clinical efficacy and safety in reducing the incidence and preventing recurrence of UTIs. Clinical utilisation of this novel sublingual bacterial vaccine may offer women an effective evidence-based alternative to antibiotic prophylaxis in the management of rUTI.
Antibiotic prophylaxis for recurrent urinary tract infections (rUTI) in women and the rise in antibiotic resistance has resulted in tremendous costs, treatment failure and patient morbidity. MV140 (Uromune) is a polybacterial sublingual vaccine consisting of whole-cell inactivated bacteria (E. coli, K. pneumoniae, E. faecalis and P. vulgaris) that has shown clinical benefit in previous observational studies. Results from a randomized placebo-controlled trial (RCT) were awaited to confirm its clinical efficacy.
Patients and Methods:
A phase III multicentre, double-blind, parallel‐group RCT, enrolled 240 women aged 18-75 with rUTI from Spain and UK. They were randomly allocated to receive placebo for 6 months or MV140 (active) for 3 or 6 months, in a 1:1:1 ratio. Primary and major secondary endpoints were the number of UTIs and UTI-free rate in the 9-month efficacy period, respectively.
Results:
The median number of UTI episodes was 3.0 [interquartile range, IQR, 0.5-6.0] for placebo group compared to 0.0 [IQR, 0.0-1.0] in both groups receiving MV140 (P≤0.001). A significant increase (over 2-fold) in the UTI-free rate was observed in the treatment groups (P≤0.001) compared to the placebo group (25.0%). Only 5 subjects reported non-serious adverse reactions, 2 in the placebo group and 3 in the MV140 3-month group.
Conclusions:
The preliminary late-breaking analysis of this first MV140 RCT shows clinical efficacy and safety in reducing the incidence and preventing recurrence of UTIs. Clinical utilisation of this novel sublingual bacterial vaccine may offer women an effective evidence-based alternative to antibiotic prophylaxis in the management of rUTI.
Introduction:
Antibiotic prophylaxis for recurrent urinary tract infections (rUTI) in women and the rise in antibiotic resistance has resulted in tremendous costs, treatment failure and patient morbidity. MV140 (Uromune) is a polybacterial sublingual vaccine consisting of whole-cell inactivated bacteria (E. coli, K. pneumoniae, E. faecalis and P. vulgaris) that has shown clinical benefit in previous observational studies. Results from a randomized placebo-controlled trial (RCT) were awaited to confirm its clinical efficacy.
Patients and Methods:
A phase III multicentre, double-blind, parallel‐group RCT, enrolled 240 women aged 18-75 with rUTI from Spain and UK. They were randomly allocated to receive placebo for 6 months or MV140 (active) for 3 or 6 months, in a 1:1:1 ratio. Primary and major secondary endpoints were the number of UTIs and UTI-free rate in the 9-month efficacy period, respectively.
Results:
The median number of UTI episodes was 3.0 [interquartile range, IQR, 0.5-6.0] for placebo group compared to 0.0 [IQR, 0.0-1.0] in both groups receiving MV140 (P≤0.001). A significant increase (over 2-fold) in the UTI-free rate was observed in the treatment groups (P≤0.001) compared to the placebo group (25.0%). Only 5 subjects reported non-serious adverse reactions, 2 in the placebo group and 3 in the MV140 3-month group.
Conclusions:
The preliminary late-breaking analysis of this first MV140 RCT shows clinical efficacy and safety in reducing the incidence and preventing recurrence of UTIs. Clinical utilisation of this novel sublingual bacterial vaccine may offer women an effective evidence-based alternative to antibiotic prophylaxis in the management of rUTI.
Antibiotic prophylaxis for recurrent urinary tract infections (rUTI) in women and the rise in antibiotic resistance has resulted in tremendous costs, treatment failure and patient morbidity. MV140 (Uromune) is a polybacterial sublingual vaccine consisting of whole-cell inactivated bacteria (E. coli, K. pneumoniae, E. faecalis and P. vulgaris) that has shown clinical benefit in previous observational studies. Results from a randomized placebo-controlled trial (RCT) were awaited to confirm its clinical efficacy.
Patients and Methods:
A phase III multicentre, double-blind, parallel‐group RCT, enrolled 240 women aged 18-75 with rUTI from Spain and UK. They were randomly allocated to receive placebo for 6 months or MV140 (active) for 3 or 6 months, in a 1:1:1 ratio. Primary and major secondary endpoints were the number of UTIs and UTI-free rate in the 9-month efficacy period, respectively.
Results:
The median number of UTI episodes was 3.0 [interquartile range, IQR, 0.5-6.0] for placebo group compared to 0.0 [IQR, 0.0-1.0] in both groups receiving MV140 (P≤0.001). A significant increase (over 2-fold) in the UTI-free rate was observed in the treatment groups (P≤0.001) compared to the placebo group (25.0%). Only 5 subjects reported non-serious adverse reactions, 2 in the placebo group and 3 in the MV140 3-month group.
Conclusions:
The preliminary late-breaking analysis of this first MV140 RCT shows clinical efficacy and safety in reducing the incidence and preventing recurrence of UTIs. Clinical utilisation of this novel sublingual bacterial vaccine may offer women an effective evidence-based alternative to antibiotic prophylaxis in the management of rUTI.
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