Safety, Tolerability, Immunogenicity and Efficacy of NDV-3A Vaccine in Preventing Recurrent Vulvovaginal Candidiasis

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Vulvovaginal Candidiasis

In brief

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.

Key facts

Study ID

NCT01926028

Run by

NovaDigm Therapeutics, Inc.

People needed

188

Starts

2013-07-01

Expected to finish

2016-05-01

Last updated by the study team

2018-07-18

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Has been informed of the nature of the study and has agreed to and is able to read, review, and sign the informed consent document prior to Screening.
• Is a female between 18-50 years of age, inclusive, at the time of vaccination on an acceptable form of birth control.
• Has a current episode of VVC (at Screening/Day -14) that can be confirmed with acute signs and symptoms of VVC (Composite Questionnaire score of ≥3) and a positive vaginal mycological culture for C. albicans.
• Has a history of 2 or more documented episodes of VVC in the 12 months prior to Screening, including at least one of the previous episodes confirmed by positive results from a diagnostic lab test specific for the presence of Candida. Additional episodes may be self-reported.
• Has a normal Papanicolaou (Pap) smear from the previous 12 months, or has no clinically significant abnormalities on a Pap smear taken at study entry as judged and documented by the investigator(s).
• Is in general good health as judged and documented by the investigator(s)

You may not qualify if…

• Reports receiving any systemic or topical vaginal antifungal therapy for 4 weeks prior to study entry.
• Mycological results from Study Day -14 or earlier cultures taken within 4 weeks prior to vaccination that show other yeast species (e.g., C. glabrata, C. tropicalis, etc.) as the cause of vaginitis.
• Has other active infectious cause(s) of vulvovaginitis (e.g., bacterial vaginosis, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhea, symptomatic Herpes Simplex Virus-1 (HSV-1), symptomatic HSV-2, or symptomatic human papilloma virus) at Screening or other vaginal or vulvar conditions that would confound the interpretation of clinical response as judged by the investigator(s).
• Will be under treatment or surgery at the start of the study for cervical intraepithelial neoplasia (CIN) or cervical carcinoma.
• Reports any presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s), diagnosed diabetes mellitus (controlled or not) or psychiatric disease that would confound the interpretation of clinical response as judged by the investigator(s).
• Reports a history of allergic response(s) or other serious reactions to nickel, aluminum, or yeast products
• Reports a history of clinically significant allergies including food or drug allergies, anaphylaxis (or other serious reaction) to vaccines.
• Has a known history of or active infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
• Reports receiving or planning to receive any investigational drug, investigational vaccine, or investigational device within 4 weeks prior to vaccination, and at any other time during their participation in the study.
• Reports receiving or planning to receive any other live vaccine within 3 weeks prior to vaccination and for 3 weeks after vaccination.
• Reports having or shows evidence of a recent history of drug or alcohol abuse.
• Reports the use or planned use of any immunosuppressive drugs, including systemic or topical vaginal corticosteroids, within 4 weeks prior to vaccination, with the exception of topical steroids (e.g., Over-The-Counter hydrocortisone) used elsewhere on the body.
• Reports the use or planned use of any medications or treatments that may alter immune responses to the study vaccine within 3 weeks prior to vaccination
• Reports receiving any blood products within 3 months prior to vaccination and throughout the study.
• Reports donating blood/plasma within 4 weeks prior to vaccination.
• Is pregnant or intends to become pregnant over the course of the study, breastfeeding, or has any other medical and/or social (e.g., non-compliant) reason which, in the opinion of the investigator(s), would prevent participation in the study.

Where it is running

• Precision Trials LLC — Phoenix, Arizona, United States
• Arkansas Women's Center — 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
• WSU Physician's Group — Detroit, Michigan, United States
• Saginaw Valley Medical Research Group, LLC — Saginaw, Michigan, United States
• Lawrence OB/Gyn Clinical Research — Lawrenceville, New Jersey, United States
• SUNY Downstate Medical Center — Brooklyn, New York, United States
• Suffolk Ob/Gyn — Port Jefferson, New York, United States
• Drexel University College of Medicine — Philadelphia, Pennsylvania, United States
• Magnolia OB/GYN Research Center, LLC — Myrtle Beach, South Carolina, United States
• Advanced Research Associates — Corpus Christi, Texas, United States
• Discovery Clinical Trials- HCWC, LLC — Dallas, Texas, United States
• TMC Life Research — Houston, Texas, United States

Full record on ClinicalTrials.gov

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