Trial Outcomes & Findings for Vaccine Therapy for the Treatment of Newly Diagnosed Glioblastoma Multiforme (NCT NCT02465268)
NCT ID: NCT02465268
Last Updated: 2025-01-14
Results Overview
Kaplan-Meier survival curves and the log rank test will be used to characterize and compare OS in patients who received pp65-LAMP mRNA DC vaccine (Arms 1 and 2) and in control patients (Arm 3). OS will be defined as the time between first vaccination and death and will be censored at the last follow-up if death has not occurred.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
175 participants
Primary outcome timeframe
From date of first vaccine until the date of death, up to 48 months
Results posted on
2025-01-14
Participant Flow
175 participants were enrolled (consented) between 8/9/2016 and 10/5/2022.
Participants were evaluated for inclusion. 17 were determined not eligible and 4 participants withdrew. 154 participants were randomized with an allocation ratio of 1:1:1 into one of three arms: 1) Arm 1: pp65-shLAMP mRNA DCs with GM-CSF 150 µg (Td skin prep); 2) Arm 2: pp65-flLAMP mRNA DCs with GM-CSF 150 µg (Td skin prep); or 3) Arm 3: Unpulsed PBMCs (saline skin prep).
Participant milestones
| Measure |
pp65-shLAMP DC With GM-CSF and Td (Arm 1)
Prior to leukapheresis, patients will be randomized to receive one of three treatment regimens with dose-intensified TMZ treatment at 100 mg/m2/day for 21 days with an allocation ratio of 1:1:1 into one of three arms.
Experimental Arm 1 pp65-shLAMP DC with GM-CSF and Td
DC vaccines are given under the skin at day 22-24 after the first temozolomide cycle then at 2-week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.
Td: All subjects will receive a Td booster before study drug dose #1. Subjects in the experimental arms will receive Td skin prep before study drug doses #3, #6, and #9.
|
pp65-flLAMP DC With GM-CSF and Td (Arm 2)
Prior to leukapheresis, patients will be randomized to receive one of three treatment regimens with dose-intensified TMZ treatment at 100 mg/m2/day for 21 days with an allocation ratio of 1:1:1 into one of three arms.
Experimental Arm 2 pp65-flLAMP DC with GM-CSF and Td
DC vaccines are given under the skin at day 22-24 after the first temozolomide cycle then at 2-week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.
Td: All subjects will receive a Td booster before study drug dose #1. Subjects in the experimental arms will receive Td skin prep before study drug doses #3, #6, and #9.
|
Unpulsed PBMC and Saline (Arm 3)
The control group was Arm 3, Unpulsed PBMCs (saline skin prep)
Prior to leukapheresis, patients will be randomized to receive one of three treatment regimens with dose-intensified TMZ treatment at 100 mg/m2/day for 21 days with an allocation ratio of 1:1:1 into one of three arms.
|
|---|---|---|---|
|
Overall Study
STARTED
|
52
|
50
|
52
|
|
Overall Study
COMPLETED
|
36
|
34
|
41
|
|
Overall Study
NOT COMPLETED
|
16
|
16
|
11
|
Reasons for withdrawal
| Measure |
pp65-shLAMP DC With GM-CSF and Td (Arm 1)
Prior to leukapheresis, patients will be randomized to receive one of three treatment regimens with dose-intensified TMZ treatment at 100 mg/m2/day for 21 days with an allocation ratio of 1:1:1 into one of three arms.
Experimental Arm 1 pp65-shLAMP DC with GM-CSF and Td
DC vaccines are given under the skin at day 22-24 after the first temozolomide cycle then at 2-week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.
Td: All subjects will receive a Td booster before study drug dose #1. Subjects in the experimental arms will receive Td skin prep before study drug doses #3, #6, and #9.
|
pp65-flLAMP DC With GM-CSF and Td (Arm 2)
Prior to leukapheresis, patients will be randomized to receive one of three treatment regimens with dose-intensified TMZ treatment at 100 mg/m2/day for 21 days with an allocation ratio of 1:1:1 into one of three arms.
Experimental Arm 2 pp65-flLAMP DC with GM-CSF and Td
DC vaccines are given under the skin at day 22-24 after the first temozolomide cycle then at 2-week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.
Td: All subjects will receive a Td booster before study drug dose #1. Subjects in the experimental arms will receive Td skin prep before study drug doses #3, #6, and #9.
|
Unpulsed PBMC and Saline (Arm 3)
The control group was Arm 3, Unpulsed PBMCs (saline skin prep)
Prior to leukapheresis, patients will be randomized to receive one of three treatment regimens with dose-intensified TMZ treatment at 100 mg/m2/day for 21 days with an allocation ratio of 1:1:1 into one of three arms.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
3
|
1
|
|
Overall Study
Not evaluable per protocol criteria
|
3
|
2
|
1
|
|
Overall Study
did not meet eligibility prior to Cycle #1
|
8
|
9
|
9
|
|
Overall Study
Study drug did not pass QA/QC
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
Baseline Characteristics
Vaccine Therapy for the Treatment of Newly Diagnosed Glioblastoma Multiforme
Baseline characteristics by cohort
| Measure |
pp65-shLAMP DC With GM-CSF and Td (Arm 1)
n=36 Participants
The active treatment group were Arms 1 and 2
Arm 1: pp65-shLAMP mRNA DCs with GM-CSF 150 µg (Td skin prep)
Prior to leukapheresis, patients will be randomized to receive one of three treatment regimens with dose-intensified TMZ treatment at 100 mg/m2/day for 21 days with an allocation ratio of 1:1:1 into one of three arms.
|
pp65-flLAMP DC With GM-CSF and Td (Arm 2)
n=34 Participants
The active treatment group were Arms 1 and 2
Arm 2: pp65-flLAMP mRNA DCs with GM-CSF 150 µg (Td skin prep)
Prior to leukapheresis, patients will be randomized to receive one of three treatment regimens with dose-intensified TMZ treatment at 100 mg/m2/day for 21 days with an allocation ratio of 1:1:1 into one of three arms.
|
Unpulsed PBMC and Saline (Arm 3)
n=41 Participants
The control group was Arm 3, Unpulsed PBMCs (saline skin prep)
Prior to leukapheresis, patients will be randomized to receive one of three treatment regimens with dose-intensified TMZ treatment at 100 mg/m2/day for 21 days with an allocation ratio of 1:1:1 into one of three arms.
|
Total
n=111 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61.0 years
n=5 Participants
|
56.0 years
n=7 Participants
|
59.0 years
n=5 Participants
|
58.0 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
103 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
100 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=5 Participants
|
34 participants
n=7 Participants
|
41 participants
n=5 Participants
|
111 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From date of first vaccine until the date of death, up to 48 monthsPopulation: Survival in Patients receiving vaccine vs placebo.
Kaplan-Meier survival curves and the log rank test will be used to characterize and compare OS in patients who received pp65-LAMP mRNA DC vaccine (Arms 1 and 2) and in control patients (Arm 3). OS will be defined as the time between first vaccination and death and will be censored at the last follow-up if death has not occurred.
Outcome measures
| Measure |
pp65-shLAMP DC With GM-CSF and Td (Arm 1)
n=36 Participants
Given under the skin at day 22-24 after the first temozolomide cycle then at 2 week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.
pp65-shLAMP DC with GM-CSF (Arm 1) pp65-flLAMP DC with GM-CSF (Arm 2)
Td: All subjects will receive a Td booster before study drug dose #1. Subjects in the experimental arms will receive Td skin prep before study drug doses #3, #6, and #9.
|
pp65-flLAMP DC With GM-CSF and Td (Arm 2)
n=34 Participants
Given under the skin at day 22-24 after the first temozolomide cycle then at 2 week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.
pp65-shLAMP DC with GM-CSF (Arm 1) pp65-flLAMP DC with GM-CSF (Arm 2)
Td: All subjects will receive a Td booster before study drug dose #1. Subjects in the experimental arms will receive Td skin prep before study drug doses #3, #6, and #9.
|
Unpulsed PBMC and Saline (Arm 3)
n=41 Participants
Given under the skin at day 22-24 after the first temozolomide cycle then at 2 week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.
unpulsed PBMC and saline
Saline
|
|---|---|---|---|
|
Comparison of Overall Survival (OS) Between the Active Treatment Group (Arms 1 and 2) and the Control Group (Arm 3)
|
16.9 months
Interval 12.7 to 22.8
|
16.2 months
Interval 13.8 to 19.2
|
20.6 months
Interval 15.4 to 30.2
|
SECONDARY outcome
Timeframe: From date of first vaccine until time disease progression or death without prior progression/recurrence, up to 48 monthsPopulation: Progression free survival in patients receiving vaccine vs placebo.
Calculated as dated of first vaccine to date first progression/recurrence or death. Kaplan-Meier survival curves and the log rank test will be used to characterize and compare PFS in patients who received pp65-LAMP mRNA DC vaccine (Arms 1 and 2) and in control patients (Arm 3). PFS is defined as the time between first vaccination and first documentation of either disease progression/recurrence, or death without prior progression/recurrence.
Outcome measures
| Measure |
pp65-shLAMP DC With GM-CSF and Td (Arm 1)
n=36 Participants
Given under the skin at day 22-24 after the first temozolomide cycle then at 2 week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.
pp65-shLAMP DC with GM-CSF (Arm 1) pp65-flLAMP DC with GM-CSF (Arm 2)
Td: All subjects will receive a Td booster before study drug dose #1. Subjects in the experimental arms will receive Td skin prep before study drug doses #3, #6, and #9.
|
pp65-flLAMP DC With GM-CSF and Td (Arm 2)
n=34 Participants
Given under the skin at day 22-24 after the first temozolomide cycle then at 2 week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.
pp65-shLAMP DC with GM-CSF (Arm 1) pp65-flLAMP DC with GM-CSF (Arm 2)
Td: All subjects will receive a Td booster before study drug dose #1. Subjects in the experimental arms will receive Td skin prep before study drug doses #3, #6, and #9.
|
Unpulsed PBMC and Saline (Arm 3)
n=41 Participants
Given under the skin at day 22-24 after the first temozolomide cycle then at 2 week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.
unpulsed PBMC and saline
Saline
|
|---|---|---|---|
|
Comparison of Progression-free Survival Between the Active Treatment Group (Arms 1 and 2 Combined) and the Control Group (Arm 3)
|
6.1 months
Interval 3.9 to 11.0
|
6.4 months
Interval 4.2 to 10.8
|
7.1 months
Interval 3.9 to 14.8
|
SECONDARY outcome
Timeframe: baseline, post-vaccine #3Population: Participants in each arm who received at least 3 DC vaccines.
Within patient changes from baseline to vaccine 3.
Outcome measures
| Measure |
pp65-shLAMP DC With GM-CSF and Td (Arm 1)
n=20 Participants
Given under the skin at day 22-24 after the first temozolomide cycle then at 2 week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.
pp65-shLAMP DC with GM-CSF (Arm 1) pp65-flLAMP DC with GM-CSF (Arm 2)
Td: All subjects will receive a Td booster before study drug dose #1. Subjects in the experimental arms will receive Td skin prep before study drug doses #3, #6, and #9.
|
pp65-flLAMP DC With GM-CSF and Td (Arm 2)
n=26 Participants
Given under the skin at day 22-24 after the first temozolomide cycle then at 2 week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.
pp65-shLAMP DC with GM-CSF (Arm 1) pp65-flLAMP DC with GM-CSF (Arm 2)
Td: All subjects will receive a Td booster before study drug dose #1. Subjects in the experimental arms will receive Td skin prep before study drug doses #3, #6, and #9.
|
Unpulsed PBMC and Saline (Arm 3)
n=29 Participants
Given under the skin at day 22-24 after the first temozolomide cycle then at 2 week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.
unpulsed PBMC and saline
Saline
|
|---|---|---|---|
|
ELISPOT Assay (pp65)
|
126.3 spot forming units (SFU)
Standard Deviation 759.9
|
48.4 spot forming units (SFU)
Standard Deviation 377.5
|
-162.7 spot forming units (SFU)
Standard Deviation 1075.4
|
SECONDARY outcome
Timeframe: baseline, post-vaccine #3Population: Only participants who received at least 3 DC vaccines are included.
Percentage of circulating cellular subsets of T cells within PBMCs.
Outcome measures
| Measure |
pp65-shLAMP DC With GM-CSF and Td (Arm 1)
n=15 Participants
Given under the skin at day 22-24 after the first temozolomide cycle then at 2 week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.
pp65-shLAMP DC with GM-CSF (Arm 1) pp65-flLAMP DC with GM-CSF (Arm 2)
Td: All subjects will receive a Td booster before study drug dose #1. Subjects in the experimental arms will receive Td skin prep before study drug doses #3, #6, and #9.
|
pp65-flLAMP DC With GM-CSF and Td (Arm 2)
n=19 Participants
Given under the skin at day 22-24 after the first temozolomide cycle then at 2 week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.
pp65-shLAMP DC with GM-CSF (Arm 1) pp65-flLAMP DC with GM-CSF (Arm 2)
Td: All subjects will receive a Td booster before study drug dose #1. Subjects in the experimental arms will receive Td skin prep before study drug doses #3, #6, and #9.
|
Unpulsed PBMC and Saline (Arm 3)
n=17 Participants
Given under the skin at day 22-24 after the first temozolomide cycle then at 2 week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.
unpulsed PBMC and saline
Saline
|
|---|---|---|---|
|
Flow Cytometric Analysis (T Cell)
|
-0.1 percentage of PBMC
Standard Deviation 11.1
|
5.9 percentage of PBMC
Standard Deviation 16.6
|
1.7 percentage of PBMC
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: baseline, post-vaccine #3Population: Only participants who received at least 3 DC vaccines are included in the analysis
Change in concentration (pg/mL) of IFN-g as measured by multiplex array from Baseline (V1) to post-Vaccine #3.
Outcome measures
| Measure |
pp65-shLAMP DC With GM-CSF and Td (Arm 1)
n=25 Participants
Given under the skin at day 22-24 after the first temozolomide cycle then at 2 week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.
pp65-shLAMP DC with GM-CSF (Arm 1) pp65-flLAMP DC with GM-CSF (Arm 2)
Td: All subjects will receive a Td booster before study drug dose #1. Subjects in the experimental arms will receive Td skin prep before study drug doses #3, #6, and #9.
|
pp65-flLAMP DC With GM-CSF and Td (Arm 2)
n=30 Participants
Given under the skin at day 22-24 after the first temozolomide cycle then at 2 week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.
pp65-shLAMP DC with GM-CSF (Arm 1) pp65-flLAMP DC with GM-CSF (Arm 2)
Td: All subjects will receive a Td booster before study drug dose #1. Subjects in the experimental arms will receive Td skin prep before study drug doses #3, #6, and #9.
|
Unpulsed PBMC and Saline (Arm 3)
n=33 Participants
Given under the skin at day 22-24 after the first temozolomide cycle then at 2 week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.
unpulsed PBMC and saline
Saline
|
|---|---|---|---|
|
Cytokine Array Analysis (IFN-g)
|
-3.5 pg/mL
Standard Deviation 5.0
|
3.3 pg/mL
Standard Deviation 17.7
|
-1.7 pg/mL
Standard Deviation 10.0
|
SECONDARY outcome
Timeframe: baseline, post-vaccine #3Population: Participants in each arm who received at least 3 DC vaccines.
Within patient changes from baseline to vaccine 3.
Outcome measures
| Measure |
pp65-shLAMP DC With GM-CSF and Td (Arm 1)
n=20 Participants
Given under the skin at day 22-24 after the first temozolomide cycle then at 2 week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.
pp65-shLAMP DC with GM-CSF (Arm 1) pp65-flLAMP DC with GM-CSF (Arm 2)
Td: All subjects will receive a Td booster before study drug dose #1. Subjects in the experimental arms will receive Td skin prep before study drug doses #3, #6, and #9.
|
pp65-flLAMP DC With GM-CSF and Td (Arm 2)
n=26 Participants
Given under the skin at day 22-24 after the first temozolomide cycle then at 2 week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.
pp65-shLAMP DC with GM-CSF (Arm 1) pp65-flLAMP DC with GM-CSF (Arm 2)
Td: All subjects will receive a Td booster before study drug dose #1. Subjects in the experimental arms will receive Td skin prep before study drug doses #3, #6, and #9.
|
Unpulsed PBMC and Saline (Arm 3)
n=29 Participants
Given under the skin at day 22-24 after the first temozolomide cycle then at 2 week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.
unpulsed PBMC and saline
Saline
|
|---|---|---|---|
|
ELISPOT Assay (Actin)
|
0.4 spot forming units (SFU)
Standard Deviation 6.0
|
-0.2 spot forming units (SFU)
Standard Deviation 26.1
|
-0.4 spot forming units (SFU)
Standard Deviation 9.4
|
SECONDARY outcome
Timeframe: baseline, post-vaccine #3Population: Only participants who received at least 3 DC vaccines are included.
Percentage of circulating cellular subsets of NK cells within PBMCs.
Outcome measures
| Measure |
pp65-shLAMP DC With GM-CSF and Td (Arm 1)
n=15 Participants
Given under the skin at day 22-24 after the first temozolomide cycle then at 2 week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.
pp65-shLAMP DC with GM-CSF (Arm 1) pp65-flLAMP DC with GM-CSF (Arm 2)
Td: All subjects will receive a Td booster before study drug dose #1. Subjects in the experimental arms will receive Td skin prep before study drug doses #3, #6, and #9.
|
pp65-flLAMP DC With GM-CSF and Td (Arm 2)
n=19 Participants
Given under the skin at day 22-24 after the first temozolomide cycle then at 2 week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.
pp65-shLAMP DC with GM-CSF (Arm 1) pp65-flLAMP DC with GM-CSF (Arm 2)
Td: All subjects will receive a Td booster before study drug dose #1. Subjects in the experimental arms will receive Td skin prep before study drug doses #3, #6, and #9.
|
Unpulsed PBMC and Saline (Arm 3)
n=17 Participants
Given under the skin at day 22-24 after the first temozolomide cycle then at 2 week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.
unpulsed PBMC and saline
Saline
|
|---|---|---|---|
|
Flow Cytometric Analysis (NK Cell)
|
-1.3 percentage of PBMC
Standard Deviation 11.1
|
5.9 percentage of PBMC
Standard Deviation 16.6
|
1.7 percentage of PBMC
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: baseline, post-vaccine #3Population: Only participants who received at least 3 DC vaccines are included.
Percentage of circulating cellular subsets of CD4.CD25 T Reg within PBMCs.
Outcome measures
| Measure |
pp65-shLAMP DC With GM-CSF and Td (Arm 1)
n=15 Participants
Given under the skin at day 22-24 after the first temozolomide cycle then at 2 week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.
pp65-shLAMP DC with GM-CSF (Arm 1) pp65-flLAMP DC with GM-CSF (Arm 2)
Td: All subjects will receive a Td booster before study drug dose #1. Subjects in the experimental arms will receive Td skin prep before study drug doses #3, #6, and #9.
|
pp65-flLAMP DC With GM-CSF and Td (Arm 2)
n=19 Participants
Given under the skin at day 22-24 after the first temozolomide cycle then at 2 week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.
pp65-shLAMP DC with GM-CSF (Arm 1) pp65-flLAMP DC with GM-CSF (Arm 2)
Td: All subjects will receive a Td booster before study drug dose #1. Subjects in the experimental arms will receive Td skin prep before study drug doses #3, #6, and #9.
|
Unpulsed PBMC and Saline (Arm 3)
n=17 Participants
Given under the skin at day 22-24 after the first temozolomide cycle then at 2 week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.
unpulsed PBMC and saline
Saline
|
|---|---|---|---|
|
Flow Cytometric Analysis (CD4.CD25 T Reg)
|
-0.1 percentage of PBMC
Standard Deviation 4.3
|
1.4 percentage of PBMC
Standard Deviation 2.2
|
-0.1 percentage of PBMC
Standard Deviation 2.0
|
Adverse Events
pp65-shLAMP DC With GM-CSF and Td (Arm 1)
Serious events: 8 serious events
Other events: 16 other events
Deaths: 28 deaths
pp65-flLAMP DC With GM-CSF and Td (Arm 2)
Serious events: 6 serious events
Other events: 11 other events
Deaths: 31 deaths
Unpulsed PBMC and Saline (Arm 3)
Serious events: 5 serious events
Other events: 13 other events
Deaths: 31 deaths
Serious adverse events
| Measure |
pp65-shLAMP DC With GM-CSF and Td (Arm 1)
n=36 participants at risk
The active treatment group was arms 1 and 2 combined.
Arm 1: pp65-shLAMP mRNA DCs with GM-CSF 150 µg (Td skin prep) Arm 2: pp65-flLAMP mRNA DCs with GM-CSF 150 µg (Td skin prep)
|
pp65-flLAMP DC With GM-CSF and Td (Arm 2)
n=34 participants at risk
The active treatment group was arms 1 and 2 combined.
Arm 1: pp65-shLAMP mRNA DCs with GM-CSF 150 µg (Td skin prep) Arm 2: pp65-flLAMP mRNA DCs with GM-CSF 150 µg (Td skin prep)
|
Unpulsed PBMC and Saline (Arm 3)
n=41 participants at risk
The control group was Arm 3, Unpulsed PBMCs (saline skin prep)
Prior to leukapheresis, patients will be randomized to receive one of three treatment regimens with dose-intensified TMZ treatment at 100 mg/m2/day for 21 days with an allocation ratio of 1:1:1 into one of three arms.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Bruising
|
0.00%
0/36 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
0.00%
0/34 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
2.4%
1/41 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Specify, appendicitis)
|
0.00%
0/36 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
2.9%
1/34 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
0.00%
0/41 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
|
Blood and lymphatic system disorders
Hematoma
|
0.00%
0/36 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
2.9%
1/34 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
0.00%
0/41 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
|
Infections and infestations
Infection
|
5.6%
2/36 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
2.9%
1/34 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
2.4%
1/41 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
2.8%
1/36 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
0.00%
0/34 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
0.00%
0/41 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.00%
0/36 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
0.00%
0/34 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
2.4%
1/41 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Left-sided
|
2.8%
1/36 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
0.00%
0/34 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
0.00%
0/41 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
0.00%
0/36 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
0.00%
0/34 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
2.4%
1/41 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
|
Nervous system disorders
Hydrocephalus
|
2.8%
1/36 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
0.00%
0/34 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
0.00%
0/41 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
|
Nervous system disorders
Neurology - Other (Specify, cerebral edema)
|
8.3%
3/36 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
5.9%
2/34 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
2.4%
1/41 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
|
Nervous system disorders
Seizure
|
11.1%
4/36 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
2.9%
1/34 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
0.00%
0/41 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
|
Nervous system disorders
Syncope (fainting)
|
0.00%
0/36 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
2.9%
1/34 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
0.00%
0/41 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
2.8%
1/36 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
0.00%
0/34 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
0.00%
0/41 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
0.00%
0/36 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
2.9%
1/34 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
0.00%
0/41 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
Other adverse events
| Measure |
pp65-shLAMP DC With GM-CSF and Td (Arm 1)
n=36 participants at risk
The active treatment group was arms 1 and 2 combined.
Arm 1: pp65-shLAMP mRNA DCs with GM-CSF 150 µg (Td skin prep) Arm 2: pp65-flLAMP mRNA DCs with GM-CSF 150 µg (Td skin prep)
|
pp65-flLAMP DC With GM-CSF and Td (Arm 2)
n=34 participants at risk
The active treatment group was arms 1 and 2 combined.
Arm 1: pp65-shLAMP mRNA DCs with GM-CSF 150 µg (Td skin prep) Arm 2: pp65-flLAMP mRNA DCs with GM-CSF 150 µg (Td skin prep)
|
Unpulsed PBMC and Saline (Arm 3)
n=41 participants at risk
The control group was Arm 3, Unpulsed PBMCs (saline skin prep)
Prior to leukapheresis, patients will be randomized to receive one of three treatment regimens with dose-intensified TMZ treatment at 100 mg/m2/day for 21 days with an allocation ratio of 1:1:1 into one of three arms.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
CD4 Count
|
2.8%
1/36 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
0.00%
0/34 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
0.00%
0/41 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
11.1%
4/36 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
17.6%
6/34 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
12.2%
5/41 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes
|
2.8%
1/36 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
0.00%
0/34 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
0.00%
0/41 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
|
Blood and lymphatic system disorders
Platelets
|
2.8%
1/36 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
5.9%
2/34 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
4.9%
2/41 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
|
Cardiac disorders
Hypertension
|
5.6%
2/36 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
0.00%
0/34 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
9.8%
4/41 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
0.00%
0/36 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
2.9%
1/34 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
0.00%
0/41 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
|
Skin and subcutaneous tissue disorders
Bruising
|
0.00%
0/36 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
0.00%
0/34 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
2.4%
1/41 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/36 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
0.00%
0/34 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
2.4%
1/41 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
|
Gastrointestinal disorders
Diarrhea
|
5.6%
2/36 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
0.00%
0/34 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
0.00%
0/41 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
|
Gastrointestinal disorders
Gastrointestinal - Other
|
0.00%
0/36 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
2.9%
1/34 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
0.00%
0/41 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
|
Blood and lymphatic system disorders
Hematoma
|
0.00%
0/36 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
2.9%
1/34 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
0.00%
0/41 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils
|
2.8%
1/36 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
0.00%
0/34 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
0.00%
0/41 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
|
Infections and infestations
Infection - Other
|
2.8%
1/36 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
0.00%
0/34 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
0.00%
0/41 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Kidney
|
0.00%
0/36 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
0.00%
0/34 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
2.4%
1/41 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
|
Infections and infestations
Opportunistic infection associated with >=Grade 2 Lymphopenia
|
2.8%
1/36 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
2.9%
1/34 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
0.00%
0/41 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
0.00%
0/36 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
2.9%
1/34 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
2.4%
1/41 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
2.8%
1/36 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
0.00%
0/34 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
2.4%
1/41 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.00%
0/36 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
0.00%
0/34 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
2.4%
1/41 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Left-sided
|
2.8%
1/36 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
0.00%
0/34 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
0.00%
0/41 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
0.00%
0/36 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
0.00%
0/34 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
2.4%
1/41 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
|
Nervous system disorders
Hydrocephalus
|
2.8%
1/36 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
0.00%
0/34 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
0.00%
0/41 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
|
Nervous system disorders
Mood alteration - Depression
|
2.8%
1/36 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
0.00%
0/34 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
0.00%
0/41 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
|
Nervous system disorders
Neurology - Other
|
11.1%
4/36 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
5.9%
2/34 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
7.3%
3/41 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
|
Nervous system disorders
Pyramidal tract dysfunction
|
0.00%
0/36 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
2.9%
1/34 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
0.00%
0/41 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
|
Nervous system disorders
Seizure
|
13.9%
5/36 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
8.8%
3/34 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
2.4%
1/41 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
|
Nervous system disorders
Syncope (fainting)
|
0.00%
0/36 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
2.9%
1/34 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
0.00%
0/41 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
|
General disorders
Pain - Head/headache
|
0.00%
0/36 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
2.9%
1/34 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
0.00%
0/41 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
2.8%
1/36 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
0.00%
0/34 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
0.00%
0/41 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
0.00%
0/36 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
2.9%
1/34 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
0.00%
0/41 • AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place