Introduction: A subset of interstitial cystitis/bladder pain syndrome (IC/BPS) patients experience recurrent UTI (rUTI) associated with symptom flares. rUTI subjects with associated IC/BPS were enrolled in the First North American Early Clinical experience trial evaluating a new sublingual UTI preventative vaccine, MV140. Recent research shows that women with rUTI develop an imbalance in the T Helper 1 and 2 (Th2 over expression) in the bladder mucosa. Our study will suggest that this infection subcategory of IC/BPS patients develop a T Helper 2 (Th2)-type hypersensitivity (or allergy) to bacteria present in their urinary microbiome that responds to mucosal immune modulation. Methods: Female participants with =3 documented UTI/year underwent a 3 month vaccination treatment period with a 9 month efficacy period after completion of vaccine treatment (total 12 months). There was no exclusion criteria for subjects in relation to baseline urinary symptoms and/or discomfort/pain. Primary outcome was no UTI following vaccination. Secondary outcomes included change in UTI incidence, overall patient reported subjective global assessment (responder defined as moderately or markedly improved on 7-point SGA scale) and safety. Results: Sixteen subjects with IC/BPS related symptoms and rUTI (mean age 46.6; range 23-74 years; mean number of UTI in previous year 6.1 +/-4.2) were eligible to be included in the Health Canada approved MV140 vaccine study for prevention of rUTI. All subjects completed the 3 month vaccination period. One subject lost to followup after 6 month visit. Six subjects were UTI-free while all 16 subjects had a reduction in UTI compared to the year pre-vaccination. The total post-vaccination reduction in UTI compared to pre-vaccination was 80% (0.1 UTI/subject/month from 0.5 UTI/subject/month respectively) At 12 months, 13 subjects (81.3%) were SGA responders (moderately or markedly improved) and the responders reported a reduction in IC/BPS symptoms with 8 subjects reporting significant or almost complete resolution of their specific long-term bladder discomfort/pain and bothersome urinary frequency or urgency. Four subjects reported mild and self limited adverse events during vaccination period but none were related to MV140 vaccine. Conclusions: Sublingual MV140 vaccine in IC/BPS patients with rUTI not only report UTI-free or reduced UTI incidence status but also after approximately 9 months post vaccination, many have resolution of their-long term treatment refractory IC/BPS symptoms. This suggests some cases of IC/BPS may be etiologically based on a Th2 cell type hypersensitivity to bacteria within or entering the urinary microbiome that responds to a vaccine whose mechanism of action is to normalize or balance the bladder Th1/Th2 mucosal immune system. SOURCE OF Funding: Inmunotek provided MV140 vaccine
