Methods
NDV-3A is a vaccine comprised of a recombinant N-terminal portion of the agglutinin-like sequence 3 (rAls3) protein from Candida albicans. In two Phase 1 clinical studies of 200 adult subjects, it was safe and immunogenic. An exploratory double-blind, placebo controlled Phase 2a proof-of-concept clinical study was conducted in women (18-50 years old) with a documented history of RVVC. The last patient exited the study in May 2016. We performed a preliminary analysis of final data for observations up to 12-months post-vaccination. All participants had >3 episodes of VVC in the past year, including an acute episode of VVC and a positive C. albicans culture at the time of screening and confirmation that the episode was resolved with fluconazole by the day of vaccination. A VVC score card was used to obtain severity ratings of patient-assessed symptoms and physician-assessed signs of VVC. All patients who met the inclusion/exclusion criteria received one dose of either NDV-3A or placebo. Patient follow-up included scheduled and patient-initiated visits and scheduled phone calls for one year post-vaccination.
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