Trial record 1 of 1 for:
NCT01926028
Safety, Tolerability, Immunogenicity and Efficacy of NDV-3A Vaccine in Preventing Recurrent Vulvovaginal Candidiasis
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| ClinicalTrials.gov Identifier: NCT01926028 |
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Recruitment Status :
Completed
First Posted : August 20, 2013
Results First Posted : June 20, 2018
Last Update Posted : July 18, 2018
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Sponsor:
NovaDigm Therapeutics, Inc.
Information provided by (Responsible Party):
NovaDigm Therapeutics, Inc.
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Vulvovaginal Candidiasis | Biological: NDV-3A Biological: NDV-3 Biological: Placebo | Phase 1 Phase 2 |
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 (Clinical Trial) |
| Actual Enrollment : | 188 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, 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 |
| Study Start Date : | July 2013 |
| Actual Primary Completion Date : | May 2015 |
| Actual Study Completion Date : | May 2016 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: NDV-3A
Experimental Vaccine: a purified, recombinant antigen (rAls3) formulated with aluminum hydroxide adjuvant
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Biological: NDV-3A
0.5mL injection IM |
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Experimental: NDV-3
Experimental Vaccine: a purified, recombinant antigen (rAls3 with 6-His tag) formulated with aluminum hydroxide adjuvant
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Biological: NDV-3
0.5mL injection IM |
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Placebo Comparator: Placebo
Placebo: aluminum hydroxide adjuvant
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Biological: Placebo
aluminum hydroxide and buffered saline |
Primary Outcome Measures :
- Summary of Injection Site Reactions for the Safety Population Over the 12-months Post Vaccination Period [ Time Frame: 12-month ]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.
Secondary Outcome Measures :
- Number of Patients <40 Years Old Who Were Recurrence-free Over the 12-month Post-vaccination Period [ Time Frame: 12 months ]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
- Number of Patients Who Were Recurrence-free Over the 12-month Post-vaccination Period [ Time Frame: 12 months ]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 to First VVC Episode From Study Day 17 to 360 - Participants <40 Years Old [ Time Frame: 12 months ]Time-to-onset of first VVC episode from Study Day 17 for the NDV-3A vaccine group and the placebo group
- Time to First VVC Episode From Study Day 17 to 360 - All Participants [ Time Frame: 12 months ]Time-to-onset of first VVC episode from Study Day 17 for the NDV-3A vaccine group and the placebo group
- Serum Anti-Als3 IgG Titers Over the 12-month Post-vaccination Period [ Time Frame: 0, 14, 28, 90, 180 and 360 days ]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.
- Serum Anti-Als3 IgA1 Titers Over the 12-month Post-vaccination Period [ Time Frame: 0, 14, 28, 90, 180 and 360 days ]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.
- Cervicovaginal Wash Anti-Als3 IgG Titers Over the 12-month Post-vaccination Period [ Time Frame: 0, 14, 28, 90, 180 and 360 days ]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.
- Cervicovaginal Wash Anti-Als3 IgA1 Titers Over the 12-month Post-vaccination Period [ Time Frame: 0, 14, 28, 90, 180 and 360 days ]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.
- Als3-specific T-cell Production of Interferon Gamma Over the Post-vaccination Period [ Time Frame: 0, 14, 90 days ]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.
- Als3-specific T-cell Production of Interleukin-17A Over the Post-vaccination Period [ Time Frame: 0, 14, 90 days ]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.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
| Sexes 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01926028
Locations
Show 20 study locations
Sponsors and Collaborators
NovaDigm Therapeutics, Inc.
Investigators
| Study Director: | John P. Hennessey, Jr., Ph.D. | NovaDigm Therapeutics, Inc. |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | NovaDigm Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT01926028 |
| Other Study ID Numbers: |
NDV3A-003 |
| First Posted: | August 20, 2013 Key Record Dates |
| Results First Posted: | June 20, 2018 |
| Last Update Posted: | July 18, 2018 |
| Last Verified: | June 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Presentations at scientific meetings and publication |
Keywords provided by NovaDigm Therapeutics, Inc.:
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recurrent vulvovaginal candidiasis candida NDV3 vaginal thrush chronic yeast infection |
Additional relevant MeSH terms:
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Candidiasis Candidiasis, Vulvovaginal 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 |