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

NCT01926028 | Completed Phase 1 Results DMC

• 1 other identifier: NDV3A-003
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 20

Brief Summary

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.

Conditions

Vulvovaginal Candidiasis

Keywords

recurrent vulvovaginal candidiasis; candida; NDV3; vaginal thrush; chronic yeast infection

Outcome Measures

Primary Outcomes (1)

• 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.

  12-month

Secondary Outcomes (10)

• Number of Patients <40 Years Old Who Were Recurrence-free Over the 12-month Post-vaccination Period

  12 months

• Number of Patients Who Were Recurrence-free Over the 12-month Post-vaccination Period

  12 months

• Time to First VVC Episode From Study Day 17 to 360 - Participants <40 Years Old

  12 months

• Time to First VVC Episode From Study Day 17 to 360 - All Participants

  12 months

• Serum Anti-Als3 IgG Titers Over the 12-month Post-vaccination Period

  0, 14, 28, 90, 180 and 360 days

Study Arms (3)

NDV-3A

EXPERIMENTAL

Experimental Vaccine: a purified, recombinant antigen (rAls3) formulated with aluminum hydroxide adjuvant

Biological: NDV-3A

NDV-3

EXPERIMENTAL

Experimental Vaccine: a purified, recombinant antigen (rAls3 with 6-His tag) formulated with aluminum hydroxide adjuvant

Biological: NDV-3

Placebo

PLACEBO COMPARATOR

Placebo: aluminum hydroxide adjuvant

Biological: Placebo

Interventions

NDV-3A BIOLOGICAL

0.5mL injection IM

NDV-3A

NDV-3 BIOLOGICAL

0.5mL injection IM

NDV-3

Placebo BIOLOGICAL

aluminum hydroxide and buffered saline

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• NovaDigm Therapeutics, Inc.: lead

Study Sites (20)

Precision Trials LLC

Phoenix, Arizona, 85032, United States

Location

Arkansas Women's Center

Little Rock, Arkansas, 72205, United States

Location

Women's Health Care Research Corp

San Diego, California, 92123, United States

Location

McCann MD Research, Inc.

Torrance, California, 90505, United States

Location

Women's Medical Research Group, LLC

Clearwater, Florida, 33759, United States

Location

KO Clinical Research, LLC

Fort Lauderdale, Florida, 33316, United States

Location

Miami Clinical Research, LLC

Miami, Florida, 33155, United States

Location

Community Medical Research

Miami Beach, Florida, 33141, United States

Location

Community Medical Research LLC

North Miami, Florida, 33181, United States

Location

MedPharmics

Metairie, Louisiana, 70006, United States

Location

WSU Physician's Group

Detroit, Michigan, 48201, United States

Location

Saginaw Valley Medical Research Group, LLC

Saginaw, Michigan, 48604, United States

Location

Lawrence OB/Gyn Clinical Research

Lawrenceville, New Jersey, 08648, United States

Location

SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

Suffolk Ob/Gyn

Port Jefferson, New York, 11777, United States

Location

Drexel University College of Medicine

Philadelphia, Pennsylvania, 19102, United States

Location

Magnolia OB/GYN Research Center, LLC

Myrtle Beach, South Carolina, 29752, United States

Location

Advanced Research Associates

Corpus Christi, Texas, 78414, United States

Location

Discovery Clinical Trials- HCWC, LLC

Dallas, Texas, 75231, United States

Location

TMC Life Research

Houston, Texas, 77054, United States

Location

Related Publications (1)

• Edwards JE Jr, Schwartz MM, Schmidt CS, Sobel JD, Nyirjesy P, Schodel F, Marchus E, Lizakowski M, DeMontigny EA, Hoeg J, Holmberg T, Cooke MT, Hoover K, Edwards L, Jacobs M, Sussman S, Augenbraun M, Drusano M, Yeaman MR, Ibrahim AS, Filler SG, Hennessey JP Jr. A Fungal Immunotherapeutic Vaccine (NDV-3A) for Treatment of Recurrent Vulvovaginal Candidiasis-A Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial. Clin Infect Dis. 2018 Jun 1;66(12):1928-1936. doi: 10.1093/cid/ciy185.

  PMID: 29697768 DERIVED

MeSH Terms

Conditions

Candidiasis, Vulvovaginal; Torulopsis

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Vulvovaginitis; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vulvitis; Vulvar Diseases; Genital Diseases

Results Point of Contact

• Title: Chief Scientific Officer
• Organization: NovaDigm Therapeutics, Inc.

john_hennessey@novadigm.net

2676405189

Study Officials

• John P. Hennessey, Jr., Ph.D.

  NovaDigm Therapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2013
• First Posted: August 20, 2013
• Study Start: July 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2016
• Last Updated: July 18, 2018
• Results First Posted: June 20, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will share

Locations

US (20)