Evaluation of the Efficacy and Safety of MV140
Research type
Research Study
Full title
A MULTICENTER, PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP PLACEBO-CONTROLLED CLINICAL STUDY FOR THE ASSESSMENT OF THE IMMUNOMODULATORY EFFICACY, SAFETY AND CLINICAL IMPACT AFTER THREE AND SIX MONTHS TREATMENT WITH A SUBLINGUAL POLYVALENT BACTERIAL VACCINE (IN ORAL MUCOSA) IN WOMEN WITH RECURRENT URINARY TRACT INFECTIONS (rUTIs).
IRAS ID
190370
Contact name
Khalil Ahmed
Contact email
Sponsor organisation
Syner-Med (PP) Ltd
Eudract number
2013-001838-17
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 31 days
Research summary
This is a double-blinded placebo controlled, randomised clinical study, which means that both the patients and researchers will not know which treatment group the patients are in as they will be assigned to each group randomly by a computer program. Some patient will get the active treatment, MV140, and some will get a dummy treatment (placebo). This study is designed to assess the clinical benefits and safety of the vaccine, MV140 in 18 – 75 years old women who are suffering from recurrent Urinary Tract Infections (rUTIs).
During the study the patients will receive either the active treatment, MV140 or an identical placebo in the form of sublingual (under the tongue) spray 2 puffs once daily. This study consists of two phases. In phase I, the patients will be divided into three groups and followed up for 12 months.
• The patients belonging to the first group will receive the MV140 for six months.
• The second group will receive the placebo for six months
• The third group will receive the MV140 for three months and the placebo for another three months.
In Phase II all patients who would have suffered from 2 or more UTIs in Phase I of the study will be given MV140 treatment for another 3 months. The patients who would have not suffered from further UTIs after using the vaccine will receive no further treatment. Both groups of patients will be followed for 12 months in Phase II of the study. In total the patients will be followed up to 24 months in both phases of the study.
The main objective of the study is to compare the average numbers of UTIs among different groups during the study time. Secondary endpoints will include healthcare cost, Quality of Life (QoL) and use of antibiotics to treat the UTI during the study. To evaluate the safety, all adverse events that occur during the course of the study will be recorded and assessed.
This study is funded by Inmunotek S.L. in Spain and by Syner-Med (PP) Ltd in the UK.REC name
South Central - Berkshire Research Ethics Committee
REC reference
16/SC/0075
Date of REC Opinion
6 May 2016
REC opinion
Further Information Favourable Opinion