Trial record 16 of 59 for:    Open Studies | "Vaginal Diseases"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by NovaDigm Therapeutics, Inc.
Sponsor:
Information provided by (Responsible Party):
NovaDigm Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01926028
First received: August 9, 2013
Last updated: August 16, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Vulvovaginal Candidiasis
Biological: NDV-3A
Biological: NDV-3
Biological: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phase 1b/2a, Multi-center, Double-blind, Randomized, Placebo-controlled Study of a Single Dose of NDV-3A or NDV-3 Vaccine to Evaluate Safety, Tolerability, Immunogenicity and Efficacy in Preventing Recurrent Vulvovaginal Candidiasis

Resource links provided by NLM:


Further study details as provided by NovaDigm Therapeutics, Inc.:

Primary Outcome Measures:
  • Safety and tolerability over the 12-months post vaccination period [ Time Frame: 12-month ] [ Designated as safety issue: Yes ]
    Number of vaccine-related adverse events over the 12-months post-vaccination period in the NDV-3A vaccine group, the NDV-3 vaccine group, and the placebo group.


Secondary Outcome Measures:
  • Recurrence of VVC over the 6-month post-vaccination period [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Recurrence of VVC due to Candida albicans in women with documented RVVC over the 6-month post-vaccination period in the NDV-3A vaccine group and the placebo group

  • Humoral immune response over the 12-month post-vaccination period [ Time Frame: 12-months ] [ Designated as safety issue: No ]
    Serum anti-Als3 antibody 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.

  • Cellular immune response over the 12-month post-vaccination period [ Time Frame: 12-months ] [ Designated as safety issue: No ]
    Als3-specific T-cell responses 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.


Other Outcome Measures:
  • Recurrence of VVC over the 12-month post-vaccination period [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Recurrence of VVC due to Candida albicans in women with documented RVVC over the 12-month post-vaccination period in the NDV-3A vaccine group and the placebo group.

  • Time to first VVC episode from Study Day 0 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Time-to-onset of first VVC episode from Study Day 0, the day of vaccination, for the NDV-3A vaccine group and the placebo group

  • Severity of VVC episodes over the 12-month post-vaccination period [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Severity of VVC episodes over the 12-month post-vaccination period based on the VVC Signs and Symptoms Questionnaire in the NDV-3A vaccine group and the placebo group


Estimated Enrollment: 189
Study Start Date: July 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NDV-3A
Experimental Vaccine: a purified, recombinant antigen (rAls3) formulated with aluminum hydroxide adjuvant
Biological: NDV-3A
0.5mL injection IM
Experimental: NDV-3
Experimental Vaccine: a purified, recombinant antigen (rAls3 with 6-His tag) formulated with aluminum hydroxide adjuvant
Biological: NDV-3
0.5mL injection IM
Placebo Comparator: Placebo
Placebo: aluminum hydroxide adjuvant
Biological: Placebo
aluminum hydroxide and buffered saline

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01926028

Contacts
Contact: John P. Hennessey, Jr., Ph.D. 701.757.5161 info@novadigm.net
Contact: Michael M Schwartz, BS 701-757-5161 info@novadigm.net

Locations
United States, Florida
Florida Clinical Research Group Recruiting
Clearwater, Florida, United States, 33759
Contact: Gayle Cameron    727-724-9730      
Principal Investigator: Edward Zbella, MD         
South Florida Wellness and Clinical Research Institute Recruiting
Margate, Florida, United States, 33063
Contact: Octavia Reed    954-582-7007      
Principal Investigator: Ivonne Reynolds, MD         
United States, Louisiana
MedPharmics Recruiting
Metarie, Louisiana, United States, 70006
Contact: Kristen Knight    504-265-9950      
Principal Investigator: Susan Jeanfreau, MD         
United States, Michigan
WSU Physician's Group Recruiting
Detroit, Michigan, United States, 48201
Contact: Deborah Leaman    313-993-7444      
Principal Investigator: Jack Sobel, MD         
United States, New Jersey
Lawrence OB/Gyn Clinical Research Recruiting
Lawrenceville, New Jersey, United States, 08648
Contact: Marianne Iavecchia    609-803-2378      
Principal Investigator: Steven Sussman, MD         
United States, New York
SUNY Downstate Medical Center Recruiting
Brooklyn, New York, United States, 11203
Contact: Lorraine DuBouchet    718-270-4123      
Principal Investigator: Michael Augenbraun, MD         
Suffolk Ob/Gyn Recruiting
Port Jefferson, New York, United States, 11777
Contact: Maureen Hurst, LPN, BS    631-656-4060      
Principal Investigator: Lance Edwards, MD         
United States, Oklahoma
OK State University Center for Health Sciences Recruiting
Tulsa, Oklahoma, United States, 74127
Contact: Angela Millington    918-586-4500      
Principal Investigator: Joseph Johnson, MD         
United States, Pennsylvania
Drexel College of Medicine Recruiting
Philadelphia, Pennsylvania, United States, 19102
Contact: Cheryl Tocci, BSN    215-762-4323      
Principal Investigator: Paul Nyirjesy, MD         
United States, Texas
Advanced Research Associates Recruiting
Corpus Christi, Texas, United States, 78414
Contact: Lisa Robertson, RN    361-906-1277      
Principal Investigator: Charles D Eubank, MD         
TMC Life Research Recruiting
Houston, Texas, United States, 77054
Contact: Debbie Goble    713-799-1635      
Principal Investigator: Mark Jacobs, MD         
United States, Utah
Jean Brown Research Recruiting
Salt Lake City, Utah, United States, 84124
Contact: Heather Kieffer    801-261-2000      
Principal Investigator: Alan T Rappleye, MD         
Sponsors and Collaborators
NovaDigm Therapeutics, Inc.
Investigators
Study Director: John P. Hennessey, Jr., Ph.D. NovaDigm Therapeutics, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: NovaDigm Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01926028     History of Changes
Other Study ID Numbers: NDV3A-003
Study First Received: August 9, 2013
Last Updated: August 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by NovaDigm Therapeutics, Inc.:
recurrent vulvovaginal candidiasis
candida
NDV3
vaginal thrush
chronic yeast infection

Additional relevant MeSH terms:
Vaginal Diseases
Candidiasis
Candidiasis, Vulvovaginal
Mycoses
Vulvovaginitis
Vaginitis
Genital Diseases, Female
Vulvitis
Vulvar Diseases
Aluminum Hydroxide
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antacids
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 28, 2014