ClinicalTrials.gg
CompletedNCT01926028Updated Jul 18, 2018Results posted

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

A Phase 1/2 interventional study of NDV-3A and NDV-3 in Vulvovaginal Candidiasis, sponsored by NovaDigm Therapeutics, Inc.. Completed at 20 sites in United States. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2018-07-18.

Sponsored by NovaDigm Therapeutics, Inc. · Phase 1/2, Interventional, and Prevention

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Phase
Phase 1/2
Study type
Interventional
Enrollment
188
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 33 studies in Candidiasis, Vulvovaginal with a site in United States — 3 open to participants now, 4 under way, none of them phase 3. Candidiasis, Vulvovaginal · United States.

Enrollment
14th of 28
188 · median 187
Started
2013
with 3 others
Phase 1/2
Only one
of the 33
Registered
9th of 33
by date

Among the 33 studies in Candidiasis, Vulvovaginal with a site in United States, this one is the 14th largest by enrollment of the 28 interventional ones that give a count, is one of 4 that started in 2013, is the only one in phase 1/2, and was the 9th registered.

Candidiasis, Vulvovaginal

109 studies on the registry are indexed under Candidiasis, Vulvovaginal; 14 are open to participants now.

Browse Candidiasis, Vulvovaginal studies →

Open to participants now

3 of the 33 studies in Candidiasis, Vulvovaginal with a site in United States are open now. Recruiting first, the newest first:

All 3 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 11 Candidiasis, Vulvovaginal studies recruiting now, 4 (36%) set no upper age limit and 7 (64%) stop at 75 or younger; 3 take children under 18; 4 take healthy volunteers.

This study: 18 Years to 50 Years · female · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 33 studies in Candidiasis, Vulvovaginal with a site in United States, or all of them as a file.
02

Study 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.

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.

03

Conditions studied

  • Vulvovaginal Candidiasis

Keywords

  • recurrent vulvovaginal candidiasis
  • candida
  • NDV3
  • vaginal thrush
  • chronic yeast infection
04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Has been informed of the nature of the study and has agreed to and is able to read, review, and sign the document prior to Screening.
  • Is a female between 18-50 years of age, inclusive, at the time of vaccination on an acceptable form of .
  • 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 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

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 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 , , or (HIV).
  • Reports receiving or planning to receive any 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 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 drugs, including systemic or topical vaginal , 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.
Terms in these criteria, in plain language(10)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
188 participants (actual)

Study arms

  • Experimental
    NDV-3A

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

    Biological: NDV-3A

  • Experimental
    NDV-3

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

    Biological: NDV-3

  • Placebo comparator
    Placebo

    Placebo: aluminum hydroxide adjuvant

    Biological: Placebo

Interventions

  • BiologicalNDV-3A

    0.5mL injection IM

  • BiologicalNDV-3

    0.5mL injection IM

  • BiologicalPlacebo

    aluminum hydroxide and buffered saline

06

What researchers measure

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.

    Time frame: 12-month

Secondary outcomes

  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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 0, 14, 90 days

07

Results

Posted Jun 20, 2018

Participant flow

Participant flow — Overall Study
MilestonePlaceboNDV-3ANDV-3
Started858914
Completed646712
Not completed21222
Withdrew: Lost to follow-up760
Withdrew: Physician decision150
Withdrew: Withdrawal by subject992
Withdrew: Non compliance or other reasons420

Outcome measures

PrimarySummary 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.

Time frame:
12-month
Reported as:
Count of units · AEs
Summary of Injection Site Reactions for the Safety Population Over the 12-months Post Vaccination Period
AEsPlaceboNDV-3ANDV-3
Patients with >= 1 injection site reaction727910
Induration25460
Pain56707
Redness34452
Swelling28472
Tenderness647110
SecondaryNumber 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

Time frame:
12 months
Reported as:
Count of participants · Participants
Number of Patients <40 Years Old Who Were Recurrence-free Over the 12-month Post-vaccination Period
ParticipantsPlaceboNDV-3A
Number of Patients <40 Years Old Who Were Recurrence-free Over the 12-month Post-vaccination Period1124
Statistical analysis
  • Placebo vs NDV-3A · Wilcoxon (Mann-Whitney) · p = 0.03 · Cox proportional hazard: 0.39 · 95% CI 0.17 to 0.91
SecondaryNumber 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

Time frame:
12 months
Reported as:
Count of participants · Participants
Number of Patients Who Were Recurrence-free Over the 12-month Post-vaccination Period
ParticipantsPlaceboNDV-3A
Number of Patients Who Were Recurrence-free Over the 12-month Post-vaccination Period1728
Statistical analysis
  • Placebo vs NDV-3A · Wilcoxon (Mann-Whitney) · p = 0.10 · Cox proportional hazard: 0.55 · 95% CI 0.27 to 1.13
SecondaryTime 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

Time frame:
12 months
Reported as:
Median · Days
Time to First VVC Episode From Study Day 17 to 360 - Participants <40 Years Old
DaysPlaceboNDV-3A
Time to First VVC Episode From Study Day 17 to 360 - Participants <40 Years Old105 (45 to 325)210 (95 to 360)
SecondaryTime 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

Time frame:
12 months
Reported as:
Median · Days
Time to First VVC Episode From Study Day 17 to 360 - All Participants
DaysPlaceboNDV-3A
Time to First VVC Episode From Study Day 17 to 360 - All Participants135 (50 to 330)175 (70 to 350)
SecondarySerum 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.

Time frame:
0, 14, 28, 90, 180 and 360 days
Reported as:
Geometric mean · Titer (dilution^-1)
Serum Anti-Als3 IgG Titers Over the 12-month Post-vaccination Period
Titer (dilution^-1)PlaceboNDV-3ANDV-3
Day 0465 ± 3.3434 ± 3.5305 ± 3.1
Day 14464 ± 3.637381 ± 3.918078 ± 4.6
Day 28419 ± 3.331459 ± 3.613674 ± 4.6
Day 90447 ± 3.217818 ± 3.510868 ± 3.8
Day 180523 ± 3.510852 ± 3.56297 ± 3.9
Day 360371 ± 3.65349 ± 3.24999 ± 3.9
SecondarySerum 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.

Time frame:
0, 14, 28, 90, 180 and 360 days
Reported as:
Geometric mean · Titer (dilution^-1)
Serum Anti-Als3 IgA1 Titers Over the 12-month Post-vaccination Period
Titer (dilution^-1)PlaceboNDV-3ANDV-3
Day 0937 ± 5.61011 ± 5.5657 ± 3.1
Day 14954 ± 6.463834 ± 5.144866 ± 3.7
Day 28850 ± 5.543557 ± 5.230118 ± 3.2
Day 901062 ± 6.023053 ± 5.120349 ± 3.1
Day 180982 ± 7.318215 ± 5.914633 ± 3.4
Day 360563 ± 7.38727 ± 5.812357 ± 3.1
SecondaryCervicovaginal 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.

Time frame:
0, 14, 28, 90, 180 and 360 days
Reported as:
Geometric mean · Titer (dilution^-1)
Cervicovaginal Wash Anti-Als3 IgG Titers Over the 12-month Post-vaccination Period
Titer (dilution^-1)PlaceboNDV-3ANDV-3
Day 02.03 ± 5.271.93 ± 4.191.47 ± 4.69
Day 141.93 ± 5.1520.67 ± 6.288.01 ± 8.09
Day 281.44 ± 3.6324.98 ± 6.979.88 ± 14.49
Day 901.40 ± 3.9714.28 ± 6.165.28 ± 4.11
Day 1801.66 ± 4.557.68 ± 6.732.72 ± 6.42
Day 3601.44 ± 5.144.36 ± 6.392.76 ± 6.12
SecondaryCervicovaginal 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.

Time frame:
0, 14, 28, 90, 180 and 360 days
Reported as:
Geometric mean · Titer (dilution^-1)
Cervicovaginal Wash Anti-Als3 IgA1 Titers Over the 12-month Post-vaccination Period
Titer (dilution^-1)PlaceboNDV-3ANDV-3
Day 04.86 ± 6.375.16 ± 5.382.02 ± 6.81
Day 144.99 ± 7.8953.65 ± 7.0028.24 ± 6.86
Day 283.44 ± 4.5145.96 ± 8.5622.22 ± 9.61
Day 902.87 ± 4.8922.52 ± 7.505.75 ± 6.00
Day 1803.13 ± 5.6017.74 ± 5.7610.17 ± 4.83
Day 3603.39 ± 5.059.32 ± 7.065.02 ± 7.41
SecondaryAls3-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.

Time frame:
0, 14, 90 days
Reported as:
Geometric mean · Spot Forming Units
Als3-specific T-cell Production of Interferon Gamma Over the Post-vaccination Period
Spot Forming UnitsPlaceboNDV-3ANDV-3
Day 02.7 ± 3.03.6 ± 3.32.6 ± 3.4
Day 143.0 ± 3.222.8 ± 5.322.1 ± 7.7
Day 903.2 ± 3.516.6 ± 4.615.1 ± 4.9
SecondaryAls3-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.

Time frame:
0, 14, 90 days
Reported as:
Geometric mean · Spot Forming Units
Als3-specific T-cell Production of Interleukin-17A Over the Post-vaccination Period
Spot Forming UnitsPlaceboNDV-3ANDV-3
Day 03.4 ± 4.14.2 ± 4.45.2 ± 4.1
Day 142.6 ± 3.49.6 ± 5.311.1 ± 5.4
Day 902.9 ± 3.56.6 ± 3.93.3 ± 3.7

Adverse events

Collected over 12-months. Non-serious events are listed at a 4% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo0/85 (0%)0/85 (0%)48/85 (56.5%)
NDV-3A0/89 (0%)0/89 (0%)35/89 (39.3%)
NDV-30/14 (0%)0/14 (0%)3/14 (21.4%)
Most frequent other events
Most frequent other events
EventPlaceboNDV-3ANDV-3
Urinary tract infectionInfections and infestations16/857/891/14
Vaginitis bacterialInfections and infestations15/8513/891/14
NasopharyngitisInfections and infestations6/856/891/14
HeadacheNervous system disorders4/855/890/14
AnemiaBlood and lymphatic system disorders4/850/890/14
Upper respiratory tract infectionInfections and infestations3/854/890/14

Baseline characteristics

Age, Continuous
Age, Continuous(years)PlaceboNDV-3ANDV-3Total
Mean32.4 ± 8.8032.1 ± 8.8235.4 ± 10.7032.5 ± 8.95
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboNDV-3ANDV-3Total
Female858914188
Male0000
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)PlaceboNDV-3ANDV-3Total
Hispanic or Latino2736366
Not Hispanic or Latino585311122
Unknown or Not Reported0000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)PlaceboNDV-3ANDV-3Total
American Indian or Alaska Native1001
Asian0000
Native Hawaiian or Other Pacific Islander2002
Black or African American1719238
White646812144
More than one race1102
Unknown or Not Reported0101
Region of Enrollment
Region of Enrollment(Participants)PlaceboNDV-3ANDV-3Total
United States858914188
08

Study locations

20 sites
  • Precision Trials LLC
    Phoenix, Arizona 85032, United States
  • Arkansas Women's Center
    Little Rock, Arkansas 72205, United States
  • Women's Health Care Research Corp
    San Diego, California 92123, United States
  • McCann MD Research, Inc.
    Torrance, California 90505, United States
  • Women's Medical Research Group, LLC
    Clearwater, Florida 33759, United States
  • KO Clinical Research, LLC
    Fort Lauderdale, Florida 33316, United States
  • Community Medical Research
    Miami Beach, Florida 33141, United States
  • Miami Clinical Research, LLC
    Miami, Florida 33155, United States
  • Community Medical Research LLC
    North Miami, Florida 33181, United States
  • MedPharmics
    Metairie, Louisiana 70006, United States
  • WSU Physician's Group
    Detroit, Michigan 48201, United States
  • Saginaw Valley Medical Research Group, LLC
    Saginaw, Michigan 48604, United States
  • Lawrence OB/Gyn Clinical Research
    Lawrenceville, New Jersey 08648, United States
  • SUNY Downstate Medical Center
    Brooklyn, New York 11203, United States
  • Suffolk Ob/Gyn
    Port Jefferson, New York 11777, United States
  • Drexel University College of Medicine
    Philadelphia, Pennsylvania 19102, United States
  • Magnolia OB/GYN Research Center, LLC
    Myrtle Beach, South Carolina 29752, United States
  • Advanced Research Associates
    Corpus Christi, Texas 78414, United States
  • Discovery Clinical Trials- HCWC, LLC
    Dallas, Texas 75231, United States
  • TMC Life Research
    Houston, Texas 77054, United States
09

References and documents

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 ↗

Individual participant data

Plan to share: Yes — Presentations at scientific meetings and publication

10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2013, a primary completion of May 2015 and a completion of May 2016. It does not say whether these dates are actual or estimated.

Results were first posted in Jun 2018, 3 years 1 month after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 9, 2013
First posted
Aug 20, 2013
Start
Jul 2013
Primary completionActual
May 2015
CompletionActual
May 2016
Results first posted
Jun 20, 2018
Last update
Jul 18, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 18, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01926028
Lead sponsor
NovaDigm Therapeutics, Inc.
Responsible party
Sponsor
First posted
Aug 20, 2013
Start date
Jul 2013
Primary completion
May 2015
Completion
May 2016
Results posted
Jun 20, 2018
Last update
Jul 18, 2018

Study contacts

John P. Hennessey, Jr., Ph.D.
study director · NovaDigm Therapeutics, Inc.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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