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Trial record 2 of 2 for:    "Vulvovaginal Candidiasis" | "Immunologic Factors"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01926028
Recruitment Status : Completed
First Posted : August 20, 2013
Results First Posted : June 20, 2018
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
NovaDigm Therapeutics, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Vulvovaginal Candidiasis
Interventions Biological: NDV-3A
Biological: NDV-3
Biological: Placebo
Enrollment 188
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo NDV-3A NDV-3
Hide Arm/Group Description

Placebo: aluminum hydroxide and buffered saline

Placebo: 0.5 mL injection IM

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

NDV-3A: 0.5mL injection IM

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

NDV-3: 0.5mL injection IM

Period Title: Overall Study
Started 85 89 14
Completed 64 67 12
Not Completed 21 22 2
Reason Not Completed
Lost to Follow-up             7             6             0
Physician Decision             1             5             0
Withdrawal by Subject             9             9             2
Non compliance or other reasons             4             2             0
Arm/Group Title Placebo NDV-3A NDV-3 Total
Hide Arm/Group Description

Placebo: aluminum hydroxide adjuvant

Placebo: 0.5 mL injection IM

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

NDV-3A: 0.5mL injection IM

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

NDV-3: 0.5mL injection IM

Total of all reporting groups
Overall Number of Baseline Participants 85 89 14 188
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 85 participants 89 participants 14 participants 188 participants
32.4  (8.80) 32.1  (8.82) 35.4  (10.70) 32.5  (8.95)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 85 participants 89 participants 14 participants 188 participants
Female
85
 100.0%
89
 100.0%
14
 100.0%
188
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 85 participants 89 participants 14 participants 188 participants
Hispanic or Latino
27
  31.8%
36
  40.4%
3
  21.4%
66
  35.1%
Not Hispanic or Latino
58
  68.2%
53
  59.6%
11
  78.6%
122
  64.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 85 participants 89 participants 14 participants 188 participants
American Indian or Alaska Native
1
   1.2%
0
   0.0%
0
   0.0%
1
   0.5%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
2
   2.4%
0
   0.0%
0
   0.0%
2
   1.1%
Black or African American
17
  20.0%
19
  21.3%
2
  14.3%
38
  20.2%
White
64
  75.3%
68
  76.4%
12
  85.7%
144
  76.6%
More than one race
1
   1.2%
1
   1.1%
0
   0.0%
2
   1.1%
Unknown or Not Reported
0
   0.0%
1
   1.1%
0
   0.0%
1
   0.5%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 85 participants 89 participants 14 participants 188 participants
85
 100.0%
89
 100.0%
14
 100.0%
188
 100.0%
1.Primary Outcome
Title Summary of Injection Site Reactions for the Safety Population Over the 12-months Post Vaccination Period
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients.
Arm/Group Title Placebo NDV-3A NDV-3
Hide Arm/Group Description:

Placebo: aluminum hydroxide adjuvant

Placebo: 0.5 mL injection IM

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

NDV-3A: 0.5mL injection IM

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

NDV-3: 0.5mL injection IM

Overall Number of Participants Analyzed 85 89 14
Overall Number of Units Analyzed
Type of Units Analyzed: AEs
279 358 31
Count of Units
Unit of Measure: AEs
Patients with >= 1 injection site reaction
72
  25.8%
79
  22.1%
10
  32.3%
Induration
25
   9.0%
46
  12.8%
0
   0.0%
Pain
56
  20.1%
70
  19.6%
7
  22.6%
Redness
34
  12.2%
45
  12.6%
2
   6.5%
Swelling
28
  10.0%
47
  13.1%
2
   6.5%
Tenderness
64
  22.9%
71
  19.8%
10
  32.3%
2.Secondary Outcome
Title Number of Patients <40 Years Old Who Were Recurrence-free Over the 12-month Post-vaccination Period
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants <40 years old
Arm/Group Title Placebo NDV-3A
Hide Arm/Group Description:

Placebo: aluminum hydroxide adjuvant

Placebo: 0.5mL injection IM

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

NDV-3A: 0.5mL injection IM

Overall Number of Participants Analyzed 50 57
Measure Type: Count of Participants
Unit of Measure: Participants
11
  22.0%
24
  42.1%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, NDV-3A
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments The proportion of patients in each group was summarized with point estimates and their 95% confidence interval
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.39
Confidence Interval (2-Sided) 95%
0.17 to 0.91
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Patients Who Were Recurrence-free Over the 12-month Post-vaccination Period
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants
Arm/Group Title Placebo NDV-3A
Hide Arm/Group Description:

Placebo: aluminum hydroxide adjuvant

Placebo: 0.5mL injection IM

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

NDV-3A: 0.5mL injection IM

Overall Number of Participants Analyzed 68 74
Measure Type: Count of Participants
Unit of Measure: Participants
17
  25.0%
28
  37.8%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, NDV-3A
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments The proportion of patients in each group was summarized with point estimates and their 95% confidence interval
Statistical Test of Hypothesis P-Value 0.10
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.55
Confidence Interval (2-Sided) 95%
0.27 to 1.13
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Time to First VVC Episode From Study Day 17 to 360 - Participants <40 Years Old
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants < 40 years old
Arm/Group Title Placebo NDV-3A
Hide Arm/Group Description:

Placebo: aluminum hydroxide adjuvant

Placebo: 0.5mL injection IM

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

NDV-3A: 0.5mL injection IM

Overall Number of Participants Analyzed 50 57
Median (Inter-Quartile Range)
Unit of Measure: Days
105
(45 to 325)
210
(95 to 360)
5.Secondary Outcome
Title Time to First VVC Episode From Study Day 17 to 360 - All Participants
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants
Arm/Group Title Placebo NDV-3A
Hide Arm/Group Description:

Placebo: aluminum hydroxide adjuvant

Placebo: 0.5mL injection IM

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

NDV-3A: 0.5mL injection IM

Overall Number of Participants Analyzed 68 74
Median (Inter-Quartile Range)
Unit of Measure: Days
135
(50 to 330)
175
(70 to 350)
6.Secondary Outcome
Title Serum Anti-Als3 IgG Titers Over the 12-month Post-vaccination Period
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo NDV-3A NDV-3
Hide Arm/Group Description:

Placebo: aluminum hydroxide adjuvant

Placebo: 0.5mL injection IM

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

NDV-3A: 0.5mL injection IM

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

NDV-3: 0.5mL injection IM

Overall Number of Participants Analyzed 85 89 14
Geometric Mean (Standard Deviation)
Unit of Measure: Titer (dilution^-1)
Day 0 465  (3.3) 434  (3.5) 305  (3.1)
Day 14 464  (3.6) 37381  (3.9) 18078  (4.6)
Day 28 419  (3.3) 31459  (3.6) 13674  (4.6)
Day 90 447  (3.2) 17818  (3.5) 10868  (3.8)
Day 180 523  (3.5) 10852  (3.5) 6297  (3.9)
Day 360 371  (3.6) 5349  (3.2) 4999  (3.9)
7.Secondary Outcome
Title Serum Anti-Als3 IgA1 Titers Over the 12-month Post-vaccination Period
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants
Arm/Group Title Placebo NDV-3A NDV-3
Hide Arm/Group Description:

Placebo: aluminum hydroxide adjuvant

Placebo: 0.5mL injection IM

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

NDV-3A: 0.5mL injection IM

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

NDV-3: 0.5mL injection IM

Overall Number of Participants Analyzed 85 89 14
Geometric Mean (Standard Deviation)
Unit of Measure: Titer (dilution^-1)
Day 0 937  (5.6) 1011  (5.5) 657  (3.1)
Day 14 954  (6.4) 63834  (5.1) 44866  (3.7)
Day 28 850  (5.5) 43557  (5.2) 30118  (3.2)
Day 90 1062  (6.0) 23053  (5.1) 20349  (3.1)
Day 180 982  (7.3) 18215  (5.9) 14633  (3.4)
Day 360 563  (7.3) 8727  (5.8) 12357  (3.1)
8.Secondary Outcome
Title Cervicovaginal Wash Anti-Als3 IgG Titers Over the 12-month Post-vaccination Period
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants
Arm/Group Title Placebo NDV-3A NDV-3
Hide Arm/Group Description:

Placebo: aluminum hydroxide adjuvant

Placebo: 0.5mL injection IM

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

NDV-3A: 0.5mL injection IM

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

NDV-3: 0.5mL injection IM

Overall Number of Participants Analyzed 85 89 14
Geometric Mean (Standard Deviation)
Unit of Measure: Titer (dilution^-1)
Day 0 2.03  (5.27) 1.93  (4.19) 1.47  (4.69)
Day 14 1.93  (5.15) 20.67  (6.28) 8.01  (8.09)
Day 28 1.44  (3.63) 24.98  (6.97) 9.88  (14.49)
Day 90 1.40  (3.97) 14.28  (6.16) 5.28  (4.11)
Day 180 1.66  (4.55) 7.68  (6.73) 2.72  (6.42)
Day 360 1.44  (5.14) 4.36  (6.39) 2.76  (6.12)
9.Secondary Outcome
Title Cervicovaginal Wash Anti-Als3 IgA1 Titers Over the 12-month Post-vaccination Period
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants
Arm/Group Title Placebo NDV-3A NDV-3
Hide Arm/Group Description:

Placebo: aluminum hydroxide adjuvant

Placebo: 0.5mL injection IM

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

NDV-3A: 0.5mL injection IM

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

NDV-3: 0.5mL injection IM

Overall Number of Participants Analyzed 85 89 14
Geometric Mean (Standard Deviation)
Unit of Measure: Titer (dilution^-1)
Day 0 4.86  (6.37) 5.16  (5.38) 2.02  (6.81)
Day 14 4.99  (7.89) 53.65  (7.00) 28.24  (6.86)
Day 28 3.44  (4.51) 45.96  (8.56) 22.22  (9.61)
Day 90 2.87  (4.89) 22.52  (7.50) 5.75  (6.00)
Day 180 3.13  (5.60) 17.74  (5.76) 10.17  (4.83)
Day 360 3.39  (5.05) 9.32  (7.06) 5.02  (7.41)
10.Secondary Outcome
Title Als3-specific T-cell Production of Interferon Gamma Over the Post-vaccination Period
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants
Arm/Group Title Placebo NDV-3A NDV-3
Hide Arm/Group Description:

Placebo: aluminum hydroxide adjuvant

Placebo: 0.5mL injection IM

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

NDV-3A: 0.5mL injection IM

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

NDV-3: 0.5mL injection IM

Overall Number of Participants Analyzed 85 89 14
Geometric Mean (Standard Deviation)
Unit of Measure: Spot Forming Units
Day 0 2.7  (3.0) 3.6  (3.3) 2.6  (3.4)
Day 14 3.0  (3.2) 22.8  (5.3) 22.1  (7.7)
Day 90 3.2  (3.5) 16.6  (4.6) 15.1  (4.9)
11.Secondary Outcome
Title Als3-specific T-cell Production of Interleukin-17A Over the Post-vaccination Period
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All Participants
Arm/Group Title Placebo NDV-3A NDV-3
Hide Arm/Group Description:

Placebo: aluminum hydroxide adjuvant

Placebo: 0.5mL injection IM

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

NDV-3A: 0.5mL injection IM

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

NDV-3: 0.5mL injection IM

Overall Number of Participants Analyzed 85 89 14
Geometric Mean (Standard Deviation)
Unit of Measure: Spot Forming Units
Day 0 3.4  (4.1) 4.2  (4.4) 5.2  (4.1)
Day 14 2.6  (3.4) 9.6  (5.3) 11.1  (5.4)
Day 90 2.9  (3.5) 6.6  (3.9) 3.3  (3.7)
Time Frame 12-months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo NDV-3A NDV-3
Hide Arm/Group Description

Placebo: aluminum hydroxide adjuvant

Placebo: 0.5mL injection IM

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

NDV-3A: 0.5mL injection IM

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

NDV-3: 0.5mL injection IM

All-Cause Mortality
Placebo NDV-3A NDV-3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/85 (0.00%)   0/89 (0.00%)   0/14 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo NDV-3A NDV-3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/85 (0.00%)   0/89 (0.00%)   0/14 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Placebo NDV-3A NDV-3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   48/85 (56.47%)   35/89 (39.33%)   3/14 (21.43%) 
Blood and lymphatic system disorders       
Anemia  1  4/85 (4.71%)  0/89 (0.00%)  0/14 (0.00%) 
Infections and infestations       
Vaginitis bacterial  1  15/85 (17.65%)  13/89 (14.61%)  1/14 (7.14%) 
Urinary tract infection  1  16/85 (18.82%)  7/89 (7.87%)  1/14 (7.14%) 
Nasopharyngitis  1  6/85 (7.06%)  6/89 (6.74%)  1/14 (7.14%) 
Upper respiratory tract infection  1  3/85 (3.53%)  4/89 (4.49%)  0/14 (0.00%) 
Nervous system disorders       
Headache  1  4/85 (4.71%)  5/89 (5.62%)  0/14 (0.00%) 
1
Term from vocabulary, MedDRA (10.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Scientific Officer
Organization: NovaDigm Therapeutics, Inc.
Phone: 2676405189
EMail: john_hennessey@novadigm.net
Layout table for additonal information
Responsible Party: NovaDigm Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01926028     History of Changes
Other Study ID Numbers: NDV3A-003
First Submitted: August 9, 2013
First Posted: August 20, 2013
Results First Submitted: May 23, 2018
Results First Posted: June 20, 2018
Last Update Posted: July 18, 2018