Trial Outcomes & Findings for Safety, Tolerability, Immunogenicity and Efficacy of NDV-3A Vaccine in Preventing Recurrent Vulvovaginal Candidiasis (NCT NCT01926028)
NCT ID: NCT01926028
Last Updated: 2018-07-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
188 participants
Primary outcome timeframe
12-month
Results posted on
2018-07-18
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo: aluminum hydroxide and buffered saline
Placebo: 0.5 mL injection IM
|
NDV-3A
Experimental Vaccine: a purified, recombinant antigen (rAls3) formulated with aluminum hydroxide adjuvant
NDV-3A: 0.5mL injection IM
|
NDV-3
Experimental Vaccine: a purified, recombinant antigen (rAls3 with 6-His tag) formulated with aluminum hydroxide adjuvant
NDV-3: 0.5mL injection IM
|
|---|---|---|---|
|
Overall Study
STARTED
|
85
|
89
|
14
|
|
Overall Study
COMPLETED
|
64
|
67
|
12
|
|
Overall Study
NOT COMPLETED
|
21
|
22
|
2
|
Reasons for withdrawal
| Measure |
Placebo
Placebo: aluminum hydroxide and buffered saline
Placebo: 0.5 mL injection IM
|
NDV-3A
Experimental Vaccine: a purified, recombinant antigen (rAls3) formulated with aluminum hydroxide adjuvant
NDV-3A: 0.5mL injection IM
|
NDV-3
Experimental Vaccine: a purified, recombinant antigen (rAls3 with 6-His tag) formulated with aluminum hydroxide adjuvant
NDV-3: 0.5mL injection IM
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
6
|
0
|
|
Overall Study
Physician Decision
|
1
|
5
|
0
|
|
Overall Study
Withdrawal by Subject
|
9
|
9
|
2
|
|
Overall Study
Non compliance or other reasons
|
4
|
2
|
0
|
Baseline Characteristics
Safety, Tolerability, Immunogenicity and Efficacy of NDV-3A Vaccine in Preventing Recurrent Vulvovaginal Candidiasis
Baseline characteristics by cohort
| Measure |
Placebo
n=85 Participants
Placebo: aluminum hydroxide adjuvant
Placebo: 0.5 mL injection IM
|
NDV-3A
n=89 Participants
Experimental Vaccine: a purified, recombinant antigen (rAls3) formulated with aluminum hydroxide adjuvant
NDV-3A: 0.5mL injection IM
|
NDV-3
n=14 Participants
Experimental Vaccine: a purified, recombinant antigen (rAls3 with 6-His tag) formulated with aluminum hydroxide adjuvant
NDV-3: 0.5mL injection IM
|
Total
n=188 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
32.4 years
STANDARD_DEVIATION 8.80 • n=5 Participants
|
32.1 years
STANDARD_DEVIATION 8.82 • n=7 Participants
|
35.4 years
STANDARD_DEVIATION 10.70 • n=5 Participants
|
32.5 years
STANDARD_DEVIATION 8.95 • n=4 Participants
|
|
Sex: Female, Male
Female
|
85 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
188 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
27 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
58 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
122 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
64 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
144 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
85 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
188 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12-monthPopulation: All enrolled patients.
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.
Outcome measures
| Measure |
Placebo
n=279 AEs
Placebo: aluminum hydroxide adjuvant
Placebo: 0.5 mL injection IM
|
NDV-3A
n=358 AEs
Experimental Vaccine: a purified, recombinant antigen (rAls3) formulated with aluminum hydroxide adjuvant
NDV-3A: 0.5mL injection IM
|
NDV-3
n=31 AEs
Experimental Vaccine: a purified, recombinant antigen (rAls3 with 6-His tag) formulated with aluminum hydroxide adjuvant
NDV-3: 0.5mL injection IM
|
|---|---|---|---|
|
Summary of Injection Site Reactions for the Safety Population Over the 12-months Post Vaccination Period
Patients with >= 1 injection site reaction
|
72 AEs
|
79 AEs
|
10 AEs
|
|
Summary of Injection Site Reactions for the Safety Population Over the 12-months Post Vaccination Period
Pain
|
56 AEs
|
70 AEs
|
7 AEs
|
|
Summary of Injection Site Reactions for the Safety Population Over the 12-months Post Vaccination Period
Redness
|
34 AEs
|
45 AEs
|
2 AEs
|
|
Summary of Injection Site Reactions for the Safety Population Over the 12-months Post Vaccination Period
Swelling
|
28 AEs
|
47 AEs
|
2 AEs
|
|
Summary of Injection Site Reactions for the Safety Population Over the 12-months Post Vaccination Period
Induration
|
25 AEs
|
46 AEs
|
0 AEs
|
|
Summary of Injection Site Reactions for the Safety Population Over the 12-months Post Vaccination Period
Tenderness
|
64 AEs
|
71 AEs
|
10 AEs
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Participants \<40 years old
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
Outcome measures
| Measure |
Placebo
n=50 Participants
Placebo: aluminum hydroxide adjuvant
Placebo: 0.5 mL injection IM
|
NDV-3A
n=57 Participants
Experimental Vaccine: a purified, recombinant antigen (rAls3) formulated with aluminum hydroxide adjuvant
NDV-3A: 0.5mL injection IM
|
NDV-3
Experimental Vaccine: a purified, recombinant antigen (rAls3 with 6-His tag) formulated with aluminum hydroxide adjuvant
NDV-3: 0.5mL injection IM
|
|---|---|---|---|
|
Number of Patients <40 Years Old Who Were Recurrence-free Over the 12-month Post-vaccination Period
|
11 Participants
|
24 Participants
|
—
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: All participants
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
Outcome measures
| Measure |
Placebo
n=68 Participants
Placebo: aluminum hydroxide adjuvant
Placebo: 0.5 mL injection IM
|
NDV-3A
n=74 Participants
Experimental Vaccine: a purified, recombinant antigen (rAls3) formulated with aluminum hydroxide adjuvant
NDV-3A: 0.5mL injection IM
|
NDV-3
Experimental Vaccine: a purified, recombinant antigen (rAls3 with 6-His tag) formulated with aluminum hydroxide adjuvant
NDV-3: 0.5mL injection IM
|
|---|---|---|---|
|
Number of Patients Who Were Recurrence-free Over the 12-month Post-vaccination Period
|
17 Participants
|
28 Participants
|
—
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 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
Outcome measures
| Measure |
Placebo
n=50 Participants
Placebo: aluminum hydroxide adjuvant
Placebo: 0.5 mL injection IM
|
NDV-3A
n=57 Participants
Experimental Vaccine: a purified, recombinant antigen (rAls3) formulated with aluminum hydroxide adjuvant
NDV-3A: 0.5mL injection IM
|
NDV-3
Experimental Vaccine: a purified, recombinant antigen (rAls3 with 6-His tag) formulated with aluminum hydroxide adjuvant
NDV-3: 0.5mL injection IM
|
|---|---|---|---|
|
Time to First VVC Episode From Study Day 17 to 360 - Participants <40 Years Old
|
105 Days
Interval 45.0 to 325.0
|
210 Days
Interval 95.0 to 360.0
|
—
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: All participants
Time-to-onset of first VVC episode from Study Day 17 for the NDV-3A vaccine group and the placebo group
Outcome measures
| Measure |
Placebo
n=68 Participants
Placebo: aluminum hydroxide adjuvant
Placebo: 0.5 mL injection IM
|
NDV-3A
n=74 Participants
Experimental Vaccine: a purified, recombinant antigen (rAls3) formulated with aluminum hydroxide adjuvant
NDV-3A: 0.5mL injection IM
|
NDV-3
Experimental Vaccine: a purified, recombinant antigen (rAls3 with 6-His tag) formulated with aluminum hydroxide adjuvant
NDV-3: 0.5mL injection IM
|
|---|---|---|---|
|
Time to First VVC Episode From Study Day 17 to 360 - All Participants
|
135 Days
Interval 50.0 to 330.0
|
175 Days
Interval 70.0 to 350.0
|
—
|
SECONDARY outcome
Timeframe: 0, 14, 28, 90, 180 and 360 daysSerum 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.
Outcome measures
| Measure |
Placebo
n=85 Participants
Placebo: aluminum hydroxide adjuvant
Placebo: 0.5 mL injection IM
|
NDV-3A
n=89 Participants
Experimental Vaccine: a purified, recombinant antigen (rAls3) formulated with aluminum hydroxide adjuvant
NDV-3A: 0.5mL injection IM
|
NDV-3
n=14 Participants
Experimental Vaccine: a purified, recombinant antigen (rAls3 with 6-His tag) formulated with aluminum hydroxide adjuvant
NDV-3: 0.5mL injection IM
|
|---|---|---|---|
|
Serum Anti-Als3 IgG Titers Over the 12-month Post-vaccination Period
Day 0
|
465 Titer (dilution^-1)
Standard Deviation 3.3
|
434 Titer (dilution^-1)
Standard Deviation 3.5
|
305 Titer (dilution^-1)
Standard Deviation 3.1
|
|
Serum Anti-Als3 IgG Titers Over the 12-month Post-vaccination Period
Day 14
|
464 Titer (dilution^-1)
Standard Deviation 3.6
|
37381 Titer (dilution^-1)
Standard Deviation 3.9
|
18078 Titer (dilution^-1)
Standard Deviation 4.6
|
|
Serum Anti-Als3 IgG Titers Over the 12-month Post-vaccination Period
Day 28
|
419 Titer (dilution^-1)
Standard Deviation 3.3
|
31459 Titer (dilution^-1)
Standard Deviation 3.6
|
13674 Titer (dilution^-1)
Standard Deviation 4.6
|
|
Serum Anti-Als3 IgG Titers Over the 12-month Post-vaccination Period
Day 90
|
447 Titer (dilution^-1)
Standard Deviation 3.2
|
17818 Titer (dilution^-1)
Standard Deviation 3.5
|
10868 Titer (dilution^-1)
Standard Deviation 3.8
|
|
Serum Anti-Als3 IgG Titers Over the 12-month Post-vaccination Period
Day 180
|
523 Titer (dilution^-1)
Standard Deviation 3.5
|
10852 Titer (dilution^-1)
Standard Deviation 3.5
|
6297 Titer (dilution^-1)
Standard Deviation 3.9
|
|
Serum Anti-Als3 IgG Titers Over the 12-month Post-vaccination Period
Day 360
|
371 Titer (dilution^-1)
Standard Deviation 3.6
|
5349 Titer (dilution^-1)
Standard Deviation 3.2
|
4999 Titer (dilution^-1)
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: 0, 14, 28, 90, 180 and 360 daysPopulation: All participants
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.
Outcome measures
| Measure |
Placebo
n=85 Participants
Placebo: aluminum hydroxide adjuvant
Placebo: 0.5 mL injection IM
|
NDV-3A
n=89 Participants
Experimental Vaccine: a purified, recombinant antigen (rAls3) formulated with aluminum hydroxide adjuvant
NDV-3A: 0.5mL injection IM
|
NDV-3
n=14 Participants
Experimental Vaccine: a purified, recombinant antigen (rAls3 with 6-His tag) formulated with aluminum hydroxide adjuvant
NDV-3: 0.5mL injection IM
|
|---|---|---|---|
|
Serum Anti-Als3 IgA1 Titers Over the 12-month Post-vaccination Period
Day 360
|
563 Titer (dilution^-1)
Standard Deviation 7.3
|
8727 Titer (dilution^-1)
Standard Deviation 5.8
|
12357 Titer (dilution^-1)
Standard Deviation 3.1
|
|
Serum Anti-Als3 IgA1 Titers Over the 12-month Post-vaccination Period
Day 0
|
937 Titer (dilution^-1)
Standard Deviation 5.6
|
1011 Titer (dilution^-1)
Standard Deviation 5.5
|
657 Titer (dilution^-1)
Standard Deviation 3.1
|
|
Serum Anti-Als3 IgA1 Titers Over the 12-month Post-vaccination Period
Day 14
|
954 Titer (dilution^-1)
Standard Deviation 6.4
|
63834 Titer (dilution^-1)
Standard Deviation 5.1
|
44866 Titer (dilution^-1)
Standard Deviation 3.7
|
|
Serum Anti-Als3 IgA1 Titers Over the 12-month Post-vaccination Period
Day 28
|
850 Titer (dilution^-1)
Standard Deviation 5.5
|
43557 Titer (dilution^-1)
Standard Deviation 5.2
|
30118 Titer (dilution^-1)
Standard Deviation 3.2
|
|
Serum Anti-Als3 IgA1 Titers Over the 12-month Post-vaccination Period
Day 90
|
1062 Titer (dilution^-1)
Standard Deviation 6.0
|
23053 Titer (dilution^-1)
Standard Deviation 5.1
|
20349 Titer (dilution^-1)
Standard Deviation 3.1
|
|
Serum Anti-Als3 IgA1 Titers Over the 12-month Post-vaccination Period
Day 180
|
982 Titer (dilution^-1)
Standard Deviation 7.3
|
18215 Titer (dilution^-1)
Standard Deviation 5.9
|
14633 Titer (dilution^-1)
Standard Deviation 3.4
|
SECONDARY outcome
Timeframe: 0, 14, 28, 90, 180 and 360 daysPopulation: All participants
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.
Outcome measures
| Measure |
Placebo
n=85 Participants
Placebo: aluminum hydroxide adjuvant
Placebo: 0.5 mL injection IM
|
NDV-3A
n=89 Participants
Experimental Vaccine: a purified, recombinant antigen (rAls3) formulated with aluminum hydroxide adjuvant
NDV-3A: 0.5mL injection IM
|
NDV-3
n=14 Participants
Experimental Vaccine: a purified, recombinant antigen (rAls3 with 6-His tag) formulated with aluminum hydroxide adjuvant
NDV-3: 0.5mL injection IM
|
|---|---|---|---|
|
Cervicovaginal Wash Anti-Als3 IgG Titers Over the 12-month Post-vaccination Period
Day 0
|
2.03 Titer (dilution^-1)
Standard Deviation 5.27
|
1.93 Titer (dilution^-1)
Standard Deviation 4.19
|
1.47 Titer (dilution^-1)
Standard Deviation 4.69
|
|
Cervicovaginal Wash Anti-Als3 IgG Titers Over the 12-month Post-vaccination Period
Day 14
|
1.93 Titer (dilution^-1)
Standard Deviation 5.15
|
20.67 Titer (dilution^-1)
Standard Deviation 6.28
|
8.01 Titer (dilution^-1)
Standard Deviation 8.09
|
|
Cervicovaginal Wash Anti-Als3 IgG Titers Over the 12-month Post-vaccination Period
Day 28
|
1.44 Titer (dilution^-1)
Standard Deviation 3.63
|
24.98 Titer (dilution^-1)
Standard Deviation 6.97
|
9.88 Titer (dilution^-1)
Standard Deviation 14.49
|
|
Cervicovaginal Wash Anti-Als3 IgG Titers Over the 12-month Post-vaccination Period
Day 90
|
1.40 Titer (dilution^-1)
Standard Deviation 3.97
|
14.28 Titer (dilution^-1)
Standard Deviation 6.16
|
5.28 Titer (dilution^-1)
Standard Deviation 4.11
|
|
Cervicovaginal Wash Anti-Als3 IgG Titers Over the 12-month Post-vaccination Period
Day 180
|
1.66 Titer (dilution^-1)
Standard Deviation 4.55
|
7.68 Titer (dilution^-1)
Standard Deviation 6.73
|
2.72 Titer (dilution^-1)
Standard Deviation 6.42
|
|
Cervicovaginal Wash Anti-Als3 IgG Titers Over the 12-month Post-vaccination Period
Day 360
|
1.44 Titer (dilution^-1)
Standard Deviation 5.14
|
4.36 Titer (dilution^-1)
Standard Deviation 6.39
|
2.76 Titer (dilution^-1)
Standard Deviation 6.12
|
SECONDARY outcome
Timeframe: 0, 14, 28, 90, 180 and 360 daysPopulation: All participants
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.
Outcome measures
| Measure |
Placebo
n=85 Participants
Placebo: aluminum hydroxide adjuvant
Placebo: 0.5 mL injection IM
|
NDV-3A
n=89 Participants
Experimental Vaccine: a purified, recombinant antigen (rAls3) formulated with aluminum hydroxide adjuvant
NDV-3A: 0.5mL injection IM
|
NDV-3
n=14 Participants
Experimental Vaccine: a purified, recombinant antigen (rAls3 with 6-His tag) formulated with aluminum hydroxide adjuvant
NDV-3: 0.5mL injection IM
|
|---|---|---|---|
|
Cervicovaginal Wash Anti-Als3 IgA1 Titers Over the 12-month Post-vaccination Period
Day 0
|
4.86 Titer (dilution^-1)
Standard Deviation 6.37
|
5.16 Titer (dilution^-1)
Standard Deviation 5.38
|
2.02 Titer (dilution^-1)
Standard Deviation 6.81
|
|
Cervicovaginal Wash Anti-Als3 IgA1 Titers Over the 12-month Post-vaccination Period
Day 360
|
3.39 Titer (dilution^-1)
Standard Deviation 5.05
|
9.32 Titer (dilution^-1)
Standard Deviation 7.06
|
5.02 Titer (dilution^-1)
Standard Deviation 7.41
|
|
Cervicovaginal Wash Anti-Als3 IgA1 Titers Over the 12-month Post-vaccination Period
Day 14
|
4.99 Titer (dilution^-1)
Standard Deviation 7.89
|
53.65 Titer (dilution^-1)
Standard Deviation 7.00
|
28.24 Titer (dilution^-1)
Standard Deviation 6.86
|
|
Cervicovaginal Wash Anti-Als3 IgA1 Titers Over the 12-month Post-vaccination Period
Day 28
|
3.44 Titer (dilution^-1)
Standard Deviation 4.51
|
45.96 Titer (dilution^-1)
Standard Deviation 8.56
|
22.22 Titer (dilution^-1)
Standard Deviation 9.61
|
|
Cervicovaginal Wash Anti-Als3 IgA1 Titers Over the 12-month Post-vaccination Period
Day 90
|
2.87 Titer (dilution^-1)
Standard Deviation 4.89
|
22.52 Titer (dilution^-1)
Standard Deviation 7.50
|
5.75 Titer (dilution^-1)
Standard Deviation 6.00
|
|
Cervicovaginal Wash Anti-Als3 IgA1 Titers Over the 12-month Post-vaccination Period
Day 180
|
3.13 Titer (dilution^-1)
Standard Deviation 5.60
|
17.74 Titer (dilution^-1)
Standard Deviation 5.76
|
10.17 Titer (dilution^-1)
Standard Deviation 4.83
|
SECONDARY outcome
Timeframe: 0, 14, 90 daysPopulation: All participants
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.
Outcome measures
| Measure |
Placebo
n=85 Participants
Placebo: aluminum hydroxide adjuvant
Placebo: 0.5 mL injection IM
|
NDV-3A
n=89 Participants
Experimental Vaccine: a purified, recombinant antigen (rAls3) formulated with aluminum hydroxide adjuvant
NDV-3A: 0.5mL injection IM
|
NDV-3
n=14 Participants
Experimental Vaccine: a purified, recombinant antigen (rAls3 with 6-His tag) formulated with aluminum hydroxide adjuvant
NDV-3: 0.5mL injection IM
|
|---|---|---|---|
|
Als3-specific T-cell Production of Interferon Gamma Over the Post-vaccination Period
Day 0
|
2.7 Spot Forming Units
Standard Deviation 3.0
|
3.6 Spot Forming Units
Standard Deviation 3.3
|
2.6 Spot Forming Units
Standard Deviation 3.4
|
|
Als3-specific T-cell Production of Interferon Gamma Over the Post-vaccination Period
Day 14
|
3.0 Spot Forming Units
Standard Deviation 3.2
|
22.8 Spot Forming Units
Standard Deviation 5.3
|
22.1 Spot Forming Units
Standard Deviation 7.7
|
|
Als3-specific T-cell Production of Interferon Gamma Over the Post-vaccination Period
Day 90
|
3.2 Spot Forming Units
Standard Deviation 3.5
|
16.6 Spot Forming Units
Standard Deviation 4.6
|
15.1 Spot Forming Units
Standard Deviation 4.9
|
SECONDARY outcome
Timeframe: 0, 14, 90 daysPopulation: All Participants
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.
Outcome measures
| Measure |
Placebo
n=85 Participants
Placebo: aluminum hydroxide adjuvant
Placebo: 0.5 mL injection IM
|
NDV-3A
n=89 Participants
Experimental Vaccine: a purified, recombinant antigen (rAls3) formulated with aluminum hydroxide adjuvant
NDV-3A: 0.5mL injection IM
|
NDV-3
n=14 Participants
Experimental Vaccine: a purified, recombinant antigen (rAls3 with 6-His tag) formulated with aluminum hydroxide adjuvant
NDV-3: 0.5mL injection IM
|
|---|---|---|---|
|
Als3-specific T-cell Production of Interleukin-17A Over the Post-vaccination Period
Day 14
|
2.6 Spot Forming Units
Standard Deviation 3.4
|
9.6 Spot Forming Units
Standard Deviation 5.3
|
11.1 Spot Forming Units
Standard Deviation 5.4
|
|
Als3-specific T-cell Production of Interleukin-17A Over the Post-vaccination Period
Day 90
|
2.9 Spot Forming Units
Standard Deviation 3.5
|
6.6 Spot Forming Units
Standard Deviation 3.9
|
3.3 Spot Forming Units
Standard Deviation 3.7
|
|
Als3-specific T-cell Production of Interleukin-17A Over the Post-vaccination Period
Day 0
|
3.4 Spot Forming Units
Standard Deviation 4.1
|
4.2 Spot Forming Units
Standard Deviation 4.4
|
5.2 Spot Forming Units
Standard Deviation 4.1
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 48 other events
Deaths: 0 deaths
NDV-3A
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
NDV-3
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=85 participants at risk
Placebo: aluminum hydroxide adjuvant
Placebo: 0.5mL injection IM
|
NDV-3A
n=89 participants at risk
Experimental Vaccine: a purified, recombinant antigen (rAls3) formulated with aluminum hydroxide adjuvant
NDV-3A: 0.5mL injection IM
|
NDV-3
n=14 participants at risk
Experimental Vaccine: a purified, recombinant antigen (rAls3 with 6-His tag) formulated with aluminum hydroxide adjuvant
NDV-3: 0.5mL injection IM
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
4.7%
4/85 • 12-months
|
0.00%
0/89 • 12-months
|
0.00%
0/14 • 12-months
|
|
Infections and infestations
Vaginitis bacterial
|
17.6%
15/85 • 12-months
|
14.6%
13/89 • 12-months
|
7.1%
1/14 • 12-months
|
|
Infections and infestations
Urinary tract infection
|
18.8%
16/85 • 12-months
|
7.9%
7/89 • 12-months
|
7.1%
1/14 • 12-months
|
|
Infections and infestations
Nasopharyngitis
|
7.1%
6/85 • 12-months
|
6.7%
6/89 • 12-months
|
7.1%
1/14 • 12-months
|
|
Infections and infestations
Upper respiratory tract infection
|
3.5%
3/85 • 12-months
|
4.5%
4/89 • 12-months
|
0.00%
0/14 • 12-months
|
|
Nervous system disorders
Headache
|
4.7%
4/85 • 12-months
|
5.6%
5/89 • 12-months
|
0.00%
0/14 • 12-months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60