Evaluation of the Efficacy and Safety of MV140

Inmunotek

Status and phase: Completed; Phase 3

Conditions: Urinary Tract Infection Bacterial

Treatments: Biological: MV140; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02543827

MV140-SLG-003

2013-001838-17 (EudraCT Number)

Details and patient eligibility

About

The purpose of the study is to evaluate the efficacy and safety of a biological vaccine (MV140) in women with Recurrent Urinary Tract Infections (RUTI) compared with a placebo group.

Full description

Double blind parallel placebo controlled study. The subjects will receive medication during three or six months and will be followed up during another twelve months.

Enrollment: 240 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women who gave their informed consent.
• Age between 18 and 75 years.
• Must be able to meet the dosage regimen.
• Subjects who had had at least 5 episodes of cystitis in the last 12 months.
• Subjects who had not responded to hygienic-sanitary measures and / or suppressive treatment and / or postcoital prophylaxis.
• Subjects who were free of urinary tract infections at the time of inclusion in the study.

Exclusion criteria

• Had not given their informed consent.
• Age was not within the established age range.
• Could not offer cooperation and/or had severe psychiatric disorders.
• Presented a pathologic post-micturition residue.
• Presented moderate to severe incontinence.
• Presented genital tumours.
• Presented Urinary tract tumours.
• Presented lithiasis.
• Presented alterations in the immune system.
• Presented complicated UTIs.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 3 patient groups, including a placebo group

MV140 I

Experimental group

Description:

The subjects will receive daily dose of MV140 during 6 months

Treatment:

Biological: MV140

MV140 II

Experimental group

Description:

The subjects will receive daily dose of MV140 during 3 months and placebo during 3 months

Treatment:

Biological: MV140

Biological: Placebo

Placebo

Placebo Comparator group

Description:

The subjects will receive daily dose of placebo during 6 month

Treatment:

Biological: Placebo