In short
Klebsiella pneumoniae, strain V113, inactivated is one of four inactivated bacterial strains in an investigational sublingual spray known as MV140, being studied for the prevention of recurrent non-complicated urinary tract infections (rUTIs) in women. A Phase 3 trial (2025-524377-16-00) is currently authorised to test whether this mucosal immunotherapy reduces new UTI episodes compared with placebo in 252 women over 15 months.
Key points
- Phase 3 trial authorised for recurrent non-complicated urinary tract infections
- 252 women planned to take part in the trial
- Given as a sublingual spray (under the tongue)
- Contains four inactivated bacterial strains, including Klebsiella pneumoniae V113
- Compared against placebo and standard antibiotic treatments
- Main measure: number of new UTI episodes over 15 months
What is Klebsiella pneumoniae, strain V113, inactivated?
Klebsiella pneumoniae, strain V113, inactivated is a bacterial component of an investigational mucosal immunotherapy product. The full registry name of the product is Klebsiella pneumoniae, strain V113, inactivated, Escherichia coli, strain V121, inactivated, Enterococcus faecalis, strain V125, inactivated, Proteus vulgaris, strain V127, inactivated. It is part of a fixed combination containing four inactivated bacterial strains, referred to in the trial as MV140. The substance has no marketing authorisation in the product records and remains an investigational substance. The product is supplied by INMUNOTEK S.L.
How does Klebsiella pneumoniae, strain V113, inactivated work?
The product is described in the trial record as a bacterial mucosal therapeutic vaccine. It is given under the tongue, where the mucosal immune system can encounter the inactivated bacterial components. The aim of this approach is to train the immune system to recognise and respond to bacteria that commonly cause urinary tract infections, thereby reducing the frequency of new infection episodes. The trial does not provide further detail on the exact molecular mechanism.
Which conditions is it used or studied for?
- Recurrent non-complicated urinary tract infections (rUTIs) — repeated urinary tract infections in women without underlying anatomical or functional risk factors. The trial studies whether the immunotherapy can reduce the number of new UTI episodes.
How is Klebsiella pneumoniae, strain V113, inactivated given?
The product is formulated as a sublingual spray, suspension, and is given by sublingual use, meaning it is sprayed under the tongue. The trial record lists a 0.2 millilitre dose for the sublingual spray. The trial also includes comparison arms with oral antibiotics: nitrofurantoin 100 mg, fosfomycin 3 g, and pivmecillinam 1200 mg.
What do the clinical trials show?
One trial is registered for this substance combination. The trial (2025-524377-16-00) is a Phase 3 study with a planned enrolment of 252 participants. Its status is Authorised, meaning it has received regulatory approval to proceed.
The trial enrols women with recurrent non-complicated urinary tract infections without risk factors. Participants receive either the MV140 sublingual spray or a placebo, and some comparison arms receive standard oral antibiotics.
The primary outcome measure is the number of new episodes of UTIs, confirmed both by the presence of symptoms (such as dysuria, overactive bladder, frequent and sudden urge to urinate, pelvic pain, pollakiuria, turbid white urine, haematuria, foul-smelling urine, polyuria, urinary itching, and urgency of urination) and a positive urine culture during 15 months after the beginning of the trial intervention. The trial also measures the percentage of patients who show new UTI episodes in this period.
What side effects are known?
No side effect information is available from the sources provided for this substance.