This is a multi-center, randomized, double-blind, placebo-controlled study intended to assess the safety, tolerability and humoral and cellular immune response over a 12-month period after receiving one dose of either the NDV-3A vaccine, NDV-3 vaccine, or placebo. In addition, the clinical efficacy of NDV-3A vaccine in lowering the recurrence rate of vulvovaginal candidiasis (VVC) in patients with recurrent VVC (RVVC) will be evaluated relative to placebo.
The purpose of the Phase 1b portion of this study is to compare the NDV-3A vaccine, the NDV-3 vaccine and the placebo head-to-head in the patient population of interest (women with RVVC) to evaluate safety and immunogenicity. The study size for comparing safety and immunogenicity (N=15 per group) is based on the dose comparison design used in study NDV3-001 (clinical trials.gov Identifier NCT01273922). The primary purpose of the Phase 2a portion of this study is to further evaluate safety, tolerability, and immunogenicity of the NDV-3A vaccine compared to placebo in a patient population of interest (women with RVVC). The secondary purpose is to determine whether the NDV-3A vaccine decreases the recurrence rate of VVC in 18-50 year old women with RVVC when compared to placebo. The study size for evaluating efficacy (N=87 per group) is based on assuming a 50% rate of VVC recurrences over the 6 month post-vaccination period in the placebo group and a 50% vaccine efficacy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
188
Precision Trials LLC
Phoenix, Arizona, United States
Arkansas Women's Center
Summary of Injection Site Reactions for the Safety Population Over the 12-months Post Vaccination Period
Summary of injection site reactions for the safety population over the 12-months post-vaccination period in the NDV-3A vaccine group, the NDV-3 vaccine group, and the placebo group.
Time frame: 12-month
Number of Patients <40 Years Old Who Were Recurrence-free Over the 12-month Post-vaccination Period
Number of patients \<40 years old with documented RVVC who were recurrence-free over the 12-month post-vaccination period in the NDV-3A vaccine group and the placebo group
Time frame: 12 months
Number of Patients Who Were Recurrence-free Over the 12-month Post-vaccination Period
Number of patients with documented RVVC who were recurrence-free over the 12-month post-vaccination period in the NDV-3A vaccine group and the placebo group
Time frame: 12 months
Time to First VVC Episode From Study Day 17 to 360 - Participants <40 Years Old
Time-to-onset of first VVC episode from Study Day 17 for the NDV-3A vaccine group and the placebo group
Time frame: 12 months
Time to First VVC Episode From Study Day 17 to 360 - All Participants
Time-to-onset of first VVC episode from Study Day 17 for the NDV-3A vaccine group and the placebo group
Time frame: 12 months
Serum Anti-Als3 IgG Titers Over the 12-month Post-vaccination Period
Serum anti-Als3 IgG titers will be measured by ELISA at pre-defined time points over the 12-month post-vaccination period in the NDV-3A vaccine group, the NDV-3 vaccine group, and the placebo group.
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Little Rock, Arkansas, United States
Women's Health Care Research Corp
San Diego, California, United States
McCann MD Research, Inc.
Torrance, California, United States
Women's Medical Research Group, LLC
Clearwater, Florida, United States
KO Clinical Research, LLC
Fort Lauderdale, Florida, United States
Miami Clinical Research, LLC
Miami, Florida, United States
Community Medical Research
Miami Beach, Florida, United States
Community Medical Research LLC
North Miami, Florida, United States
MedPharmics
Metairie, Louisiana, United States
...and 10 more locations
Time frame: 0, 14, 28, 90, 180 and 360 days
Serum Anti-Als3 IgA1 Titers Over the 12-month Post-vaccination Period
Serum anti-Als3 IgA1 titers will be measured by ELISA at pre-defined time points over the 12-month post-vaccination period in the NDV-3A vaccine group, the NDV-3 vaccine group, and the placebo group.
Time frame: 0, 14, 28, 90, 180 and 360 days
Cervicovaginal Wash Anti-Als3 IgG Titers Over the 12-month Post-vaccination Period
Cervicovaginal wash anti-Als3 IgG titers will be measured by ELISA at pre-defined time points over the 12-month post-vaccination period in the NDV-3A vaccine group, the NDV-3 vaccine group, and the placebo group.
Time frame: 0, 14, 28, 90, 180 and 360 days
Cervicovaginal Wash Anti-Als3 IgA1 Titers Over the 12-month Post-vaccination Period
Cervicovaginal wash anti-Als3 IgA1 titers will be measured by ELISA at pre-defined time points over the 12-month post-vaccination period in the NDV-3A vaccine group, the NDV-3 vaccine group, and the placebo group.
Time frame: 0, 14, 28, 90, 180 and 360 days
Als3-specific T-cell Production of Interferon Gamma Over the Post-vaccination Period
Als3-specific T-cell production of interferon gamma will be measured by enzyme-linked immunospot (ELISpot) at pre-defined time points over the 12-month post-vaccination period in the NDV-3A vaccine group, the NDV-3 vaccine group, and the placebo group.
Time frame: 0, 14, 90 days
Als3-specific T-cell Production of Interleukin-17A Over the Post-vaccination Period
Als3-specific T-cell production of interleukin-17A will be measured by enzyme-linked immunospot (ELISpot) at pre-defined time points over the 12-month post-vaccination period in the NDV-3A vaccine group, the NDV-3 vaccine group, and the placebo group.
Time frame: 0, 14, 90 days