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Effect of Adjuvant & Route of Administration on Safety & Immunogenicity of NDV-3 Vaccine

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ClinicalTrials.gov Identifier: NCT01447407
Recruitment Status : Completed
First Posted : October 6, 2011
Results First Posted : March 4, 2020
Last Update Posted : March 4, 2020
Sponsor:
Collaborator:
United States Department of Defense
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
Conditions Staphylococcal Infections
Yeast Infections
Candidiasis
Interventions Biological: NDV-3 vaccine with alum IM
Biological: NDV-3 vaccine without alum IM
Biological: Placebo with alum IM
Biological: NDV-3 vaccine without alum ID
Enrollment 164
Recruitment Details  
Pre-assignment Details Four subjects withdrew before completing Day 28 and were replaced. One subject withdrew before the last visit. While this subject is not considered to have completed the study, data from this subject are included in the immunogenicity and culture results.
Arm/Group Title NDV-3 Vaccine With Alum NDV-3 Vaccine Without Alum Placebo NDV-3 Vaccine ID
Hide Arm/Group Description NDV-3 (300 ug Als3) vaccine with alum administered IM: One dose administered IM NDV-3 (300 ug Als3) vaccine without alum administered IM: One dose administered IM Placebo administered ID: One dose saline placebo administered ID NDV-3 (30 ug Als3) vaccine without alum administered ID: One dose administered ID
Period Title: Overall Study
Started 41 40 41 42
Completed 39 40 40 40
Not Completed 2 0 1 2
Reason Not Completed
Withdrawal by Subject             2             0             0             1
Physician Decision             0             0             1             1
Arm/Group Title NDV-3 Vaccine With Alum NDV-3 Vaccine Without Alum Placebo NDV-3 Vaccine ID Total
Hide Arm/Group Description NDV-3 (300 ug Als3) vaccine with alum administered IM: One dose administered IM NDV-3 (300 ug Als3) vaccine without alum administered IM: One dose administered IM Placebo administered ID: One dose saline placebo administered ID NDV-3 (30 ug Als3) vaccine without alum administered ID: One dose administered ID Total of all reporting groups
Overall Number of Baseline Participants 41 40 41 42 164
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 41 participants 40 participants 41 participants 42 participants 164 participants
31.8
(18 to 47)
30.1
(18 to 49)
32.3
(19 to 50)
31.0
(18 to 50)
31.3
(18 to 50)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 40 participants 41 participants 42 participants 164 participants
Female
33
  80.5%
33
  82.5%
34
  82.9%
34
  81.0%
134
  81.7%
Male
8
  19.5%
7
  17.5%
7
  17.1%
8
  19.0%
30
  18.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 40 participants 41 participants 42 participants 164 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.4%
1
   0.6%
Not Hispanic or Latino
41
 100.0%
40
 100.0%
41
 100.0%
41
  97.6%
163
  99.4%
Unknown or Not Reported
0
   0.0%
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 41 participants 40 participants 41 participants 42 participants 164 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   2.5%
1
   2.4%
0
   0.0%
2
   1.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
   2.5%
1
   2.4%
2
   4.8%
4
   2.4%
White
38
  92.7%
37
  92.5%
36
  87.8%
38
  90.5%
149
  90.9%
More than one race
3
   7.3%
1
   2.5%
3
   7.3%
2
   4.8%
9
   5.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Participants With Treatment Emergent Adverse Events
Hide Description The primary objective of this study is to assess the safety of a single dose of NDV-3 vaccine, administered either IM with or without alum adjuvant at one dose level or ID at a lower dose level, compared to placebo. Clinical evaluations will be assessed on each subject at selected time points up to 90 days post-vaccination.
Time Frame Up to 90 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects completing study. Additionally, a subject in Group 4 withdrew from the study before the very last visit, so while this subject is not considered to have completed the study, immunogenicity and culture data for this subject were included.
Arm/Group Title NDV-3 Vaccine With Alum NDV-3 Vaccine Without Alum Placebo NDV-3 Vaccine ID
Hide Arm/Group Description:
NDV-3 (300 ug Als3) vaccine with alum administered IM: One dose administered IM
NDV-3 (300 ug Als3) vaccine without alum administered IM: One dose administered IM
Placebo administered ID: One dose saline placebo administered ID
NDV-3 (30 ug Als3) vaccine without alum administered ID: One dose administered ID
Overall Number of Participants Analyzed 39 40 40 40
Measure Type: Number
Unit of Measure: participants
>=1 TEAE 35 33 30 36
>=1 severe TEAE 2 0 4 2
>=1 severe drug-related TEAE 0 0 0 0
DIscontinued for >=1 TEAE 0 0 0 0
2.Secondary Outcome
Title Immunogenicity - Serum Anti-Als3 IgG
Hide Description A secondary objective is to compare the serum IgG immune response between the 2 dose levels, routes of administration, and effects of alum adjuvant, at selected time points up to 90 days post-vaccination. Serum IgG will be evaluated by ELISA on serial-diluted samples, resulting in titer values of reciprocal dilution at which the ELISA readout is three times greater than the assay background value.
Time Frame Baseline, Day 7, Day 14, Day 28, Day 90/Exit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NDV-3 Vaccine With Alum NDV-3 Vaccine Without Alum Placebo NDV-3 Vaccine ID
Hide Arm/Group Description:
NDV-3 (300 ug Als3) vaccine with alum administered IM: One dose administered IM
NDV-3 (300 ug Als3) vaccine without alum administered IM: One dose administered IM
Placebo administered ID: One dose saline placebo administered ID
NDV-3 (30 ug Als3) vaccine without alum administered ID: One dose administered ID
Overall Number of Participants Analyzed 39 40 40 40
Geometric Mean (Standard Deviation)
Unit of Measure: Titer
Baseline 372  (3.12) 320  (3.07) 363  (2.93) 375  (3.53)
Day 7 4447  (6.31) 3070  (6.71) 365  (2.81) 874  (5.25)
Day 14 44675  (3.04) 22675  (6.58) 370  (2.89) 5153  (6.97)
Day 28 38898  (2.83) 19220  (6.00) 377  (2.93) 4513  (6.60)
Day 90/Exit 20853  (3.24) 11771  (5.93) 347  (2.71) 3282  (5.55)
3.Secondary Outcome
Title Immunogenicity - Serum Anti-Als3 IgA1
Hide Description A secondary objective is to compare the serum IgA1 immune response between the 2 dose levels, routes of administration, and effects of alum adjuvant, at selected time points up to 90 days post-vaccination. Serum IgA1 will be evaluated by ELISA on serial-diluted samples, resulting in titer values of reciprocal dilution at which the ELISA readout is three times greater than the assay background value.
Time Frame Baseline, Day 7, Day 14, Day 28, Day 90/Exit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NDV-3 Vaccine With Alum NDV-3 Vaccine Without Alum Placebo NDV-3 Vaccine ID
Hide Arm/Group Description:
NDV-3 (300 ug Als3) vaccine with alum administered IM: One dose administered IM
NDV-3 (300 ug Als3) vaccine without alum administered IM: One dose administered IM
Placebo administered ID: One dose saline placebo administered ID
NDV-3 (30 ug Als3) vaccine without alum administered ID: One dose administered ID
Overall Number of Participants Analyzed 39 40 40 40
Geometric Mean (Standard Deviation)
Unit of Measure: Titer
Baseline 573  (4.07) 480  (3.44) 418  (3.72) 550  (4.93)
Day 7 7643  (6.61) 5497  (7.01) 431  (3.69) 1640  (6.56)
Day 14 69616  (3.1) 34946  (6.77) 429  (3.93) 9356  (6014)
Day 28 43790  (2.59) 19999  (5.36) 412  (3.86) 7400  (6.33)
Day 90/Exit 20656  (2.51) 10698  (4.61) 404  (3.78) 3641  (5.18)
4.Secondary Outcome
Title Immunogenicity - Cervicovaginal Wash Anti-Als3 IgG
Hide Description A secondary objective is to compare the cervicovaginal wash IgG immune response between the 2 dose levels, routes of administration, and effects of alum adjuvant, at selected time points up to 90 days post-vaccination. Cervicovaginal wash IgG will be evaluated by ELISA on serial-diluted samples, resulting in titer values of reciprocal dilution at which the ELISA readout is three times greater than the assay background value.
Time Frame Baseline, Day 7, Day 14, Day 28, Day 90/Exit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NDV-3 Vaccine With Alum NDV-3 Vaccine Without Alum Placebo NDV-3 Vaccine ID
Hide Arm/Group Description:
NDV-3 (300 ug Als3) vaccine with alum administered IM: One dose administered IM
NDV-3 (300 ug Als3) vaccine without alum administered IM: One dose administered IM
Placebo administered ID: One dose saline placebo administered ID
NDV-3 (30 ug Als3) vaccine without alum administered ID: One dose administered ID
Overall Number of Participants Analyzed 39 40 40 40
Geometric Mean (Standard Deviation)
Unit of Measure: Titer
Baseline 2  (1.5) 2  (1.55) 3  (2.12) 3  (1.98)
Day 7 4  (3.98) 6  (5.84) 2  (1.61) 3  (2.45)
Day 14 78  (7.12) 26  (7.50) 3  (1.99) 8  (4.27)
Day 28 44  (5.85) 26  (7.09) 3  (2.20) 8  (4.63)
Day 90/Exit 20  (4.93) 13  (4.65) 3  (2.11) 6  (4.35)
5.Secondary Outcome
Title Immunogenicity - Cervicovaginal Wash Anti-Als3 IgA1
Hide Description A secondary objective is to compare the cervicovaginal wash IgA1 immune response between the 2 dose levels, routes of administration, and effects of alum adjuvant, at selected time points up to 90 days post-vaccination. Cervicovaginal wash IgA1 will be evaluated by ELISA on serial-diluted samples, resulting in titer values of reciprocal dilution at which the ELISA readout is three times greater than the assay background value.
Time Frame Baseline, Day 7, Day 14, Day 28, Day 90/Exit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NDV-3 Vaccine With Alum NDV-3 Vaccine Without Alum Placebo NDV-3 Vaccine ID
Hide Arm/Group Description:
NDV-3 (300 ug Als3) vaccine with alum administered IM: One dose administered IM
NDV-3 (300 ug Als3) vaccine without alum administered IM: One dose administered IM
Placebo administered ID: One dose saline placebo administered ID
NDV-3 (30 ug Als3) vaccine without alum administered ID: One dose administered ID
Overall Number of Participants Analyzed 39 40 40 40
Geometric Mean (Standard Deviation)
Unit of Measure: Titer
Baseline 3  (2.03) 3  (2.08) 3  (2.24) 3  (2.5)
Day 7 5  (2.87) 7  (6.64) 3  (1.45) 4  (2.71)
Day 14 83  (4.50) 29  (6.48) 3  (1.64) 12  (4.23)
Day 28 36  (3.82) 25  (6.72) 3  (2.40) 8  (4.56)
Day 90/Exit 15  (3.18) 8  (3.27) 3  (1.98) 5  (3.40)
6.Secondary Outcome
Title Immunogenicity - Number of Participants Positive for Peripheral Blood Mononuclear Cells (PBMCs) Producing Als3-specific Interferon-gamma (IFN-g)
Hide Description A secondary objective is to compare the cellular immune response for Als3-specific production of IFN-g from PBMCs between the 2 dose levels, routes of administration, and effects of alum adjuvant, at selected time points up to 90 days post-vaccination. The IFN-g cellular immune responses will be evaluated by ELISpot using approximately 200,000 PBMCs per well. A positive response was defined as a sample with greater than 20 spot forming units per 10^6 PBMCs.
Time Frame Baseline, Day 7, Day 14, Day 28, Day 90/Exit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NDV-3 Vaccine With Alum NDV-3 Vaccine Without Alum Placebo NDV-3 Vaccine ID
Hide Arm/Group Description:
NDV-3 (300 ug Als3) vaccine with alum administered IM: One dose administered IM
NDV-3 (300 ug Als3) vaccine without alum administered IM: One dose administered IM
Placebo administered ID: One dose saline placebo administered ID
NDV-3 (30 ug Als3) vaccine without alum administered ID: One dose administered ID
Overall Number of Participants Analyzed 39 40 40 40
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline
7
  17.9%
9
  22.5%
7
  17.5%
5
  12.5%
Day 7
27
  69.2%
25
  62.5%
10
  25.0%
20
  50.0%
Day 14
19
  48.7%
21
  52.5%
5
  12.5%
20
  50.0%
Day 90/Exit
25
  64.1%
18
  45.0%
9
  22.5%
14
  35.0%
7.Secondary Outcome
Title Immunogenicity - Number of Participants Positive for Peripheral Blood Mononuclear Cells (PBMCs) Producing Als3-specific Interleukin-17A (IL-17A)
Hide Description A secondary objective is to compare the cellular immune response for Als3-specific production of IL-17A from PBMCs between the 2 dose levels, routes of administration, and effects of alum adjuvant, at selected time points up to 90 days post-vaccination. The IL-17A cellular immune responses will be evaluated by ELISpot using approximately 200,000 PBMCs per well. A positive response was defined as a sample with greater than 20 spot forming units per 10^6 PBMCs.
Time Frame Baseline, Day 7, Day 14, Day 28, Day 90/Exit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NDV-3 Vaccine With Alum NDV-3 Vaccine Without Alum Placebo NDV-3 Vaccine ID
Hide Arm/Group Description:
NDV-3 (300 ug Als3) vaccine with alum administered IM: One dose administered IM
NDV-3 (300 ug Als3) vaccine without alum administered IM: One dose administered IM
Placebo administered ID: One dose saline placebo administered ID
NDV-3 (30 ug Als3) vaccine without alum administered ID: One dose administered ID
Overall Number of Participants Analyzed 39 40 40 40
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline
6
  15.4%
10
  25.0%
12
  30.0%
9
  22.5%
Day 7
22
  56.4%
19
  47.5%
8
  20.0%
13
  32.5%
Day 14
15
  38.5%
17
  42.5%
7
  17.5%
16
  40.0%
Day 90/Exit
17
  43.6%
15
  37.5%
18
  45.0%
23
  57.5%
Time Frame 90 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title NDV-3 Vaccine With Alum NDV-3 Vaccine Without Alum Placebo NDV-3 Vaccine ID
Hide Arm/Group Description NDV-3 (300 ug Als3) vaccine with alum administered IM: One dose administered IM NDV-3 (300 ug Als3) vaccine without alum administered IM: One dose administered IM Placebo administered ID: One dose saline placebo administered ID NDV-3 (30 ug Als3) vaccine without alum administered ID: One dose administered ID
All-Cause Mortality
NDV-3 Vaccine With Alum NDV-3 Vaccine Without Alum Placebo NDV-3 Vaccine ID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/41 (0.00%)      0/40 (0.00%)      0/41 (0.00%)      0/42 (0.00%)    
Hide Serious Adverse Events
NDV-3 Vaccine With Alum NDV-3 Vaccine Without Alum Placebo NDV-3 Vaccine ID
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/41 (0.00%)      0/40 (0.00%)      0/41 (0.00%)      0/42 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
NDV-3 Vaccine With Alum NDV-3 Vaccine Without Alum Placebo NDV-3 Vaccine ID
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   35/41 (85.37%)      33/40 (82.50%)      30/41 (73.17%)      36/42 (85.71%)    
Gastrointestinal disorders         
Diarrhoea  1  2/41 (4.88%)  2 2/40 (5.00%)  2 3/41 (7.32%)  3 3/42 (7.14%)  3
Nausea  1  5/41 (12.20%)  5 2/40 (5.00%)  2 1/41 (2.44%)  1 7/42 (16.67%)  7
General disorders         
Fatigue  1  4/41 (9.76%)  4 4/40 (10.00%)  4 4/41 (9.76%)  4 13/42 (30.95%)  13
Injection site erythema  1  1/41 (2.44%)  1 1/40 (2.50%)  1 0/41 (0.00%)  0 8/42 (19.05%)  8
Injection site pain  1  32/41 (78.05%)  32 18/40 (45.00%)  18 3/41 (7.32%)  3 15/42 (35.71%)  15
Injection site pruritus  1  1/41 (2.44%)  1 1/40 (2.50%)  1 0/41 (0.00%)  0 8/42 (19.05%)  8
Injection site swelling  1  1/41 (2.44%)  1 2/40 (5.00%)  2 0/41 (0.00%)  0 1/42 (2.38%)  1
Infections and infestations         
Nasopharyngitis  1  3/41 (7.32%)  3 4/40 (10.00%)  4 1/41 (2.44%)  1 0/42 (0.00%)  0
Injury, poisoning and procedural complications         
Procedural dizziness  1  0/41 (0.00%)  0 1/40 (2.50%)  1 1/41 (2.44%)  1 3/42 (7.14%)  3
Investigations         
Alanine aminotransferase increased  1  1/41 (2.44%)  1 2/40 (5.00%)  2 3/41 (7.32%)  3 1/42 (2.38%)  1
Blood albumin decreased  1  0/41 (0.00%)  0 2/40 (5.00%)  2 1/41 (2.44%)  1 0/42 (0.00%)  0
Blood glucose increased  1  3/41 (7.32%)  3 1/40 (2.50%)  1 5/41 (12.20%)  5 6/42 (14.29%)  6
Protein total decreased  1  2/41 (4.88%)  2 8/40 (20.00%)  8 3/41 (7.32%)  3 7/42 (16.67%)  7
Protein urine present  1  4/41 (9.76%)  4 0/40 (0.00%)  0 4/41 (9.76%)  4 4/42 (9.52%)  4
Red blood cells urine positive  1  5/41 (12.20%)  5 7/40 (17.50%)  7 9/41 (21.95%)  9 7/42 (16.67%)  7
Musculoskeletal and connective tissue disorders         
Myalgia  1  1/41 (2.44%)  1 1/40 (2.50%)  1 1/41 (2.44%)  1 8/42 (19.05%)  8
Nervous system disorders         
Headache  1  10/41 (24.39%)  10 7/40 (17.50%)  7 9/41 (21.95%)  9 19/42 (45.24%)  19
Respiratory, thoracic and mediastinal disorders         
Nasal congestion  1  1/41 (2.44%)  1 1/40 (2.50%)  1 3/41 (7.32%)  3 3/42 (7.14%)  3
Oropharyngeal pain  1  2/41 (4.88%)  2 4/40 (10.00%)  4 2/41 (4.88%)  2 2/42 (4.76%)  2
Rhinorrhoea  1  2/41 (4.88%)  2 2/40 (5.00%)  2 1/41 (2.44%)  1 3/42 (7.14%)  3
Sinus congestion  1  1/41 (2.44%)  1 2/40 (5.00%)  2 1/41 (2.44%)  1 3/42 (7.14%)  3
1
Term from vocabulary, MedDRA (14.1)
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: John P. Hennessey, Jr.
Organization: NovaDigm Therapeutics, Inc.
Phone: 12676405189
EMail: john_hennessey@novadigm.net
Layout table for additonal information
Responsible Party: NovaDigm Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01447407    
Other Study ID Numbers: NDV3-002
First Submitted: October 3, 2011
First Posted: October 6, 2011
Results First Submitted: January 28, 2020
Results First Posted: March 4, 2020
Last Update Posted: March 4, 2020