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Vulvovaginal CandidiasisPhase 1/2NCT01926028

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

A Phase 1/2 study testing NDV-3A and NDV-3 in people with Vulvovaginal Candidiasis, run by NovaDigm Therapeutics, Inc. at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years, women only
Conditions the study is for
Vulvovaginal Candidiasis
What is being tested?
NDV-3A and NDV-3
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
188 participants
Where
20 sitesUnited States
Study dates
Jul 2013to May 2016
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 16Show fewer
  • 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.

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

United States20 sites

  • SUNY Downstate Medical Center

    Brooklyn, New York, 11203

  • Women's Medical Research Group, LLC

    Clearwater, Florida, 33759

  • Advanced Research Associates

    Corpus Christi, Texas, 78414

  • Discovery Clinical Trials- HCWC, LLC

    Dallas, Texas, 75231

  • WSU Physician's Group

    Detroit, Michigan, 48201

  • KO Clinical Research, LLC

    Fort Lauderdale, Florida, 33316

  • TMC Life Research

    Houston, Texas, 77054

  • Lawrence OB/Gyn Clinical Research

    Lawrenceville, New Jersey, 08648

  • Arkansas Women's Center

    Little Rock, Arkansas, 72205

  • MedPharmics

    Metairie, Louisiana, 70006

  • Miami Clinical Research, LLC

    Miami, Florida, 33155

  • Community Medical Research

    Miami Beach, Florida, 33141

  • Magnolia OB/GYN Research Center, LLC

    Myrtle Beach, South Carolina, 29752

  • Community Medical Research LLC

    North Miami, Florida, 33181

  • Drexel University College of Medicine

    Philadelphia, Pennsylvania, 19102

  • Precision Trials LLC

    Phoenix, Arizona, 85032

  • Suffolk Ob/Gyn

    Port Jefferson, New York, 11777

  • Saginaw Valley Medical Research Group, LLC

    Saginaw, Michigan, 48604

  • Women's Health Care Research Corp

    San Diego, California, 92123

  • McCann MD Research, Inc.

    Torrance, California, 90505

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
NDV-3A, NDV-3, Placebo
Keywords
recurrent vulvovaginal candidiasis, candida, NDV3, vaginal thrush, chronic yeast infection
Medical subject headings
Candidiasis, Vulvovaginal, Torulopsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NDV-3ABiological

    0.5mL injection IM

  • NDV-3Biological

    0.5mL injection IM

  • PlaceboBiological

    aluminum hydroxide and buffered saline

Study groups in NCT01926028
Study groupRoleWhat they receive
NDV-3AExperimentalExperimental Vaccine: a purified, recombinant antigen (rAls3) formulated with aluminum hydroxide adjuvant
Receives: Biological: NDV-3A
NDV-3ExperimentalExperimental Vaccine: a purified, recombinant antigen (rAls3 with 6-His tag) formulated with aluminum hydroxide adjuvant
Receives: Biological: NDV-3
PlaceboPlacebo comparatorPlacebo: aluminum hydroxide adjuvant
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12-month

Secondary outcomes (10)

  1. 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

    Measured: 12 months

  2. 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

    Measured: 12 months

  3. 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

    Measured: 12 months

  4. 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

    Measured: 12 months

  5. 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.

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

  6. 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.

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

  7. 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.

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

  8. 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.

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

  9. 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.

    Measured: 0, 14, 90 days

  10. 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.

    Measured: 0, 14, 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2013 (estimated)
  2. Study startJul 2013
  3. Primary completionMay 2015
  4. Study completionMay 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
188 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01926028
Sponsor's protocol ID
NDV3A-003
Status last verified
Jun 2018
First submitted
9 Aug 2013
Last updated
18 Jul 2018
Data monitoring committee
Yes
Individual data sharing
Yes: Presentations at scientific meetings and publication

Publications

  • 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.

    PubMed 29697768

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing NDV-3A and NDV-3 in people with Vulvovaginal Candidiasis, run by NovaDigm Therapeutics, Inc. at 20 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Summary of Injection Site Reactions for the Safety Population Over the 12-months Post Vaccination Period (time frame: 12-month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01926028, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2018.

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