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DC Migration Study for Newly-Diagnosed GBM (ELEVATE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02366728
Recruitment Status : Completed
First Posted : February 19, 2015
Results First Posted : February 1, 2022
Last Update Posted : February 1, 2022
Sponsor:
Information provided by (Responsible Party):
Gary Archer Ph.D., Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Glioblastoma
Astrocytoma, Grade IV
Giant Cell Glioblastoma
Glioblastoma Multiforme
Interventions Biological: Unpulsed DCs
Biological: Td
Biological: Human CMV pp65-LAMP mRNA-pulsed autologous DCs
Biological: 111In-labeled DCs
Drug: Temozolomide
Drug: Saline
Drug: Basiliximab
Enrollment 64
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group I: Unpulsed DC Pre-conditioning Group II: Tetanus Pre-conditioning Group III: Basiliximab and Tetanus Pre-conditioning
Hide Arm/Group Description 0.4 mLs of 1 x 10^6 autologous unpulsed DCs in saline will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine. pp65 DC Vaccine #4 is 111In-labeled DCs for migration studies. Tetanus diptheria toxoid (Td) (1 flocculation unit) will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine. pp65 DC Vaccine #4 is 111In-labeled DCs for migration studies. Basiliximab infusions prior to human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccines #1 and #2 with Td pre-conditioning (1 flocculation unit) will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine.
Period Title: Overall Study
Started 27 28 9
Received at Least One ppp65 Vaccine 25 27 8
Completed 23 27 8
Not Completed 4 1 1
Reason Not Completed
Death             0             0             1
Adverse Event             1             0             0
Screen Failure             2             1             0
Only yielded 2 vaccines             1             0             0
Arm/Group Title Group I: Unpulsed DC Pre-conditioning Group II: Tetanus Pre-conditioning Group III: Basiliximab and Tetanus Pre-conditioning Total
Hide Arm/Group Description 0.4 mLs of 1 x 10^6 autologous unpulsed DCs in saline will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine. pp65 DC Vaccine #4 is 111In-labeled DCs for migration studies. Tetanus diptheria toxoid (Td) (1 flocculation unit) will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine. pp65 DC Vaccine #4 is 111In-labeled DCs for migration studies. Basiliximab infusions prior to human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccines #1 and #2 with Td pre-conditioning (1 flocculation unit) will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine. Total of all reporting groups
Overall Number of Baseline Participants 25 27 8 60
Hide Baseline Analysis Population Description
Participants who received at least one ppp65 vaccine.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 27 participants 8 participants 60 participants
55.7  (13.3) 53.7  (13.6) 50.4  (12.4) 54.1  (13.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 27 participants 8 participants 60 participants
Female
6
  24.0%
10
  37.0%
2
  25.0%
18
  30.0%
Male
19
  76.0%
17
  63.0%
6
  75.0%
42
  70.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 27 participants 8 participants 60 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
1
  12.5%
1
   1.7%
Not Hispanic or Latino
22
  88.0%
25
  92.6%
7
  87.5%
54
  90.0%
Unknown or Not Reported
3
  12.0%
2
   7.4%
0
   0.0%
5
   8.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 27 participants 8 participants 60 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   3.7%
0
   0.0%
1
   1.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   4.0%
0
   0.0%
0
   0.0%
1
   1.7%
White
23
  92.0%
25
  92.6%
8
 100.0%
56
  93.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   4.0%
1
   3.7%
0
   0.0%
2
   3.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 25 participants 27 participants 8 participants 60 participants
25
 100.0%
27
 100.0%
8
 100.0%
60
 100.0%
1.Primary Outcome
Title Median Overall Survival
Hide Description Overall survival will be defined as the time in months between randomization and death, or last follow-up if alive. Kaplan-Meier methods will be used to estimate overall survival.
Time Frame Up to 72 months (from the time of randomization of the first patient until approximately 31 months after randomization of the last patient)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group I: Unpulsed DC Pre-conditioning Group II: Tetanus Pre-conditioning Group III: Basiliximab and Tetanus Pre-conditioning
Hide Arm/Group Description:
0.4 mLs of 1 x 10^6 autologous unpulsed DCs in saline will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine. pp65 DC Vaccine #4 is 111In-labeled DCs for migration studies.
Tetanus diptheria toxoid (Td) (1 flocculation unit) will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine. pp65 DC Vaccine #4 is 111In-labeled DCs for migration studies.
Basiliximab infusions prior to human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccines #1 and #2 with Td pre-conditioning (1 flocculation unit) will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine.
Overall Number of Participants Analyzed 25 27 8
Median (95% Confidence Interval)
Unit of Measure: months
16
(12.8 to 25.5)
20
(16.7 to 25.6)
19 [1] 
(10.26 to NA)
[1]
An estimation was not possible due to an insufficient number of participants experiencing events.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group I: Unpulsed DC Pre-conditioning, Group II: Tetanus Pre-conditioning
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.072
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group I: Unpulsed DC Pre-conditioning, Group III: Basiliximab and Tetanus Pre-conditioning
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.089
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
2.Primary Outcome
Title Percentage of 111In-labeled Dendritic Cells Migrating to the Inguinal Lymph Nodes
Hide Description Within Groups I and II only, the percentage of 111In-labeled DCs migrating to the inguinal lymph nodes from the initial injection sites in the left and right groin at 48 hours post-vaccination #4 will be calculated.
Time Frame For each patient, migration studies will occur after vaccination #4 which occurs approximately 7 months after study consent.
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected on the Basiliximab and Tetanus pre-conditioning group.
Arm/Group Title Group I: Unpulsed DC Pre-conditioning Group II: Tetanus Pre-conditioning Group III: Basiliximab and Tetanus Pre-conditioning
Hide Arm/Group Description:
0.4 mLs of 1 x 10^6 autologous unpulsed DCs in saline will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine. pp65 DC Vaccine #4 is 111In-labeled DCs for migration studies.
Tetanus diptheria toxoid (Td) (1 flocculation unit) will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine. pp65 DC Vaccine #4 is 111In-labeled DCs for migration studies.
Basiliximab infusions prior to human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccines #1 and #2 with Td pre-conditioning (1 flocculation unit) will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine.
Overall Number of Participants Analyzed 25 27 0
Median (Inter-Quartile Range)
Unit of Measure: percentage of cells
6.0
(3.0 to 8.0)
9
(6.5 to 11.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group I: Unpulsed DC Pre-conditioning, Group II: Tetanus Pre-conditioning
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0195
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Primary Outcome
Title Median Overall Survival in CMV Positive Participants
Hide Description Median overall survival will be estimated in the subset of participants that are CMV positive. Overall survival will be defined as the time in months between randomization and death, or last follow-up if alive. Kaplan-Meier methods will be used to estimate overall survival.
Time Frame Up to 72 months (from the time of randomization of the first patient until approximately 31 months after randomization of the last patient)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who are CMV positive. Data not collected on the Basiliximab and Tetanus pre-conditioning group.
Arm/Group Title Group I: Unpulsed DC Pre-conditioning Group II: Tetanus Pre-conditioning Group III: Basiliximab and Tetanus Pre-conditioning
Hide Arm/Group Description:
0.4 mLs of 1 x 10^6 autologous unpulsed DCs in saline will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine. pp65 DC Vaccine #4 is 111In-labeled DCs for migration studies.
Tetanus diptheria toxoid (Td) (1 flocculation unit) will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine. pp65 DC Vaccine #4 is 111In-labeled DCs for migration studies.
Basiliximab infusions prior to human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccines #1 and #2 with Td pre-conditioning (1 flocculation unit) will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine.
Overall Number of Participants Analyzed 9 11 0
Median (95% Confidence Interval)
Unit of Measure: months
16.5
(12.8 to 44.1)
23.8 [1] 
(19.9 to NA)
[1]
An estimation was not possible due to an insufficient number of participants experiencing events.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group I: Unpulsed DC Pre-conditioning, Group II: Tetanus Pre-conditioning
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.40
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
4.Primary Outcome
Title Median Overall Survival in CMV Negative Participants
Hide Description Median overall survival will be estimated in the subset of participants that are CMV negative. Overall survival will be defined as the time in months between randomization and death, or last follow-up if alive. Kaplan-Meier methods will be used to estimate overall survival.
Time Frame Up to 72 months (from the time of randomization of the first patient until approximately 31 months after randomization of the last patient)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who are CMV negative. Data not collected on the Basiliximab and Tetanus pre-conditioning group.
Arm/Group Title Group I: Unpulsed DC Pre-conditioning Group II: Tetanus Pre-conditioning Group III: Basiliximab and Tetanus Pre-conditioning
Hide Arm/Group Description:
0.4 mLs of 1 x 10^6 autologous unpulsed DCs in saline will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine. pp65 DC Vaccine #4 is 111In-labeled DCs for migration studies.
Tetanus diptheria toxoid (Td) (1 flocculation unit) will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine. pp65 DC Vaccine #4 is 111In-labeled DCs for migration studies.
Basiliximab infusions prior to human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccines #1 and #2 with Td pre-conditioning (1 flocculation unit) will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine.
Overall Number of Participants Analyzed 16 16 0
Median (95% Confidence Interval)
Unit of Measure: months
13.4
(9.5 to 26.1)
16.7
(13.6 to 45.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group I: Unpulsed DC Pre-conditioning, Group II: Tetanus Pre-conditioning
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.40
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
5.Secondary Outcome
Title Median Progression-free Survival
Hide Description Progression-free survival will be defined as the time in months between randomization and disease progression or death. Participants alive without disease progression will be censored at the time of their last follow-up. Kaplan-Meier methods will be used to estimate progression-free survival.
Time Frame Up to 72 months (from the time of randomization of the first patient until approximately 31 months after randomization of the last patient)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group I: Unpulsed DC Pre-conditioning Group II: Tetanus Pre-conditioning Group III: Basiliximab and Tetanus Pre-conditioning
Hide Arm/Group Description:
0.4 mLs of 1 x 10^6 autologous unpulsed DCs in saline will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine. pp65 DC Vaccine #4 is 111In-labeled DCs for migration studies.
Tetanus diptheria toxoid (Td) (1 flocculation unit) will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine. pp65 DC Vaccine #4 is 111In-labeled DCs for migration studies.
Basiliximab infusions prior to human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccines #1 and #2 with Td pre-conditioning (1 flocculation unit) will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine.
Overall Number of Participants Analyzed 25 27 8
Median (95% Confidence Interval)
Unit of Measure: months
6.5
(4.4 to 12.1)
6.7
(4.6 to 15.2)
7.1 [1] 
(6.0 to NA)
[1]
An estimation was not possible due to an insufficient number of participants experiencing events.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group I: Unpulsed DC Pre-conditioning, Group II: Tetanus Pre-conditioning
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group I: Unpulsed DC Pre-conditioning, Group III: Basiliximab and Tetanus Pre-conditioning
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.078
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
6.Secondary Outcome
Title Median Progression-free Survival in CMV Positive Participants
Hide Description Median progression-free survival will be estimated in the subset of participants that are CMV positive. Progression-free survival will be defined as the time in months between randomization and disease progression or death. Participants alive without disease progression will be censored at the time of their last follow-up. Kaplan-Meier methods will be used to estimate progression-free survival.
Time Frame Up to 72 months (from the time of randomization of the first patient until approximately 31 months after randomization of the last patient)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who are CMV positive. Data not collected on the Basiliximab and Tetanus pre-conditioning group.
Arm/Group Title Group I: Unpulsed DC Pre-conditioning Group II: Tetanus Pre-conditioning Group III: Basiliximab and Tetanus Pre-conditioning
Hide Arm/Group Description:
0.4 mLs of 1 x 10^6 autologous unpulsed DCs in saline will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine. pp65 DC Vaccine #4 is 111In-labeled DCs for migration studies.
Tetanus diptheria toxoid (Td) (1 flocculation unit) will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine. pp65 DC Vaccine #4 is 111In-labeled DCs for migration studies.
Basiliximab infusions prior to human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccines #1 and #2 with Td pre-conditioning (1 flocculation unit) will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine.
Overall Number of Participants Analyzed 9 11 0
Median (95% Confidence Interval)
Unit of Measure: months
6.5 [1] 
(4.4 to NA)
6.8 [1] 
(6.5 to NA)
[1]
An estimation was not possible due to an insufficient number of participants experiencing events.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group I: Unpulsed DC Pre-conditioning, Group II: Tetanus Pre-conditioning
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.64
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
7.Secondary Outcome
Title Median Progression-free Survival in CMV Negative Participants
Hide Description Median progression-free survival will be estimated in the subset of participants that are CMV negative. Progression-free survival will be defined as the time in months between randomization and disease progression or death. Participants alive without disease progression will be censored at the time of their last follow-up. Kaplan-Meier methods will be used to estimate progression-free survival.
Time Frame Up to 72 months (from the time of randomization of the first patient until approximately 31 months after randomization of the last patient)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who are CMV negative. Data not collected on the Basiliximab and Tetanus pre-conditioning group.
Arm/Group Title Group I: Unpulsed DC Pre-conditioning Group II: Tetanus Pre-conditioning Group III: Basiliximab and Tetanus Pre-conditioning
Hide Arm/Group Description:
0.4 mLs of 1 x 10^6 autologous unpulsed DCs in saline will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine. pp65 DC Vaccine #4 is 111In-labeled DCs for migration studies.
Tetanus diptheria toxoid (Td) (1 flocculation unit) will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine. pp65 DC Vaccine #4 is 111In-labeled DCs for migration studies.
Basiliximab infusions prior to human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccines #1 and #2 with Td pre-conditioning (1 flocculation unit) will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine.
Overall Number of Participants Analyzed 16 16 0
Median (95% Confidence Interval)
Unit of Measure: months
5.9
(4.1 to 14.7)
5.8
(4.1 to 24.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group I: Unpulsed DC Pre-conditioning, Group II: Tetanus Pre-conditioning
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.29
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Time Frame Approximately 72 months (from the time of randomization of the first patient until approximately 31 months after randomization of the last patient)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group I: Unpulsed DC Pre-conditioning Group II: Tetanus Pre-conditioning Group III: Basiliximab and Tetanus Pre-conditioning
Hide Arm/Group Description 0.4 mLs of 1 x 10^6 autologous unpulsed DCs in saline will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine. pp65 DC Vaccine #4 is 111In-labeled DCs for migration studies. Tetanus diptheria toxoid (Td) (1 flocculation unit) will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine. pp65 DC Vaccine #4 is 111In-labeled DCs for migration studies. Basiliximab infusions prior to human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccines #1 and #2 with Td pre-conditioning (1 flocculation unit) will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine.
All-Cause Mortality
Group I: Unpulsed DC Pre-conditioning Group II: Tetanus Pre-conditioning Group III: Basiliximab and Tetanus Pre-conditioning
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   24/27 (88.89%)   22/28 (78.57%)   6/9 (66.67%) 
Hide Serious Adverse Events
Group I: Unpulsed DC Pre-conditioning Group II: Tetanus Pre-conditioning Group III: Basiliximab and Tetanus Pre-conditioning
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/27 (3.70%)   4/28 (14.29%)   2/9 (22.22%) 
Gastrointestinal disorders       
Colonic perforation † 1  0/27 (0.00%)  0/28 (0.00%)  1/9 (11.11%) 
Infections and infestations       
Lung infection † 1  1/27 (3.70%)  0/28 (0.00%)  0/9 (0.00%) 
Urinary tract infection † 1  0/27 (0.00%)  1/28 (3.57%)  0/9 (0.00%) 
Musculoskeletal and connective tissue disorders       
Generalized muscle weakness † 1  0/27 (0.00%)  1/28 (3.57%)  1/9 (11.11%) 
Muscle weakness left-sided † 1  0/27 (0.00%)  0/28 (0.00%)  1/9 (11.11%) 
Nervous system disorders       
Dysphasia † 1  0/27 (0.00%)  1/28 (3.57%)  0/9 (0.00%) 
Headache † 1  0/27 (0.00%)  1/28 (3.57%)  0/9 (0.00%) 
Pyramidal tract syndrome † 1  0/27 (0.00%)  1/28 (3.57%)  1/9 (11.11%) 
Seizure † 1  0/27 (0.00%)  2/28 (7.14%)  0/9 (0.00%) 
Psychiatric disorders       
Delirium † 1  0/27 (0.00%)  1/28 (3.57%)  0/9 (0.00%) 
1
Term from vocabulary, CTCAE (4.0)
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group I: Unpulsed DC Pre-conditioning Group II: Tetanus Pre-conditioning Group III: Basiliximab and Tetanus Pre-conditioning
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   25/27 (92.59%)   27/28 (96.43%)   9/9 (100.00%) 
Blood and lymphatic system disorders       
Anemia † 1  13/27 (48.15%)  15/28 (53.57%)  6/9 (66.67%) 
Blood and lymphatic system disorders - Other, Specify (SWOLLEN LYMPH NODES BILATERAL NECK) † 1  0/27 (0.00%)  0/28 (0.00%)  1/9 (11.11%) 
Cardiac disorders       
Chest pain - cardiac † 1  1/27 (3.70%)  0/28 (0.00%)  0/9 (0.00%) 
Sinus tachycardia † 1  1/27 (3.70%)  0/28 (0.00%)  1/9 (11.11%) 
Ear and labyrinth disorders       
Ear pain † 1  0/27 (0.00%)  1/28 (3.57%)  1/9 (11.11%) 
Tinnitus † 1  1/27 (3.70%)  0/28 (0.00%)  0/9 (0.00%) 
Eye disorders       
Blurred vision † 1  0/27 (0.00%)  1/28 (3.57%)  0/9 (0.00%) 
Dry eye † 1  0/27 (0.00%)  2/28 (7.14%)  0/9 (0.00%) 
Eye disorders - Other, Specify (DIFFICULTY WITH DEPTH PERCEPTION) † 1  0/27 (0.00%)  0/28 (0.00%)  1/9 (11.11%) 
Eye disorders - Other, Specify (L EYE REDNESS, INFLAMMATION) † 1  0/27 (0.00%)  1/28 (3.57%)  0/9 (0.00%) 
Eye disorders - Other, Specify (PERIPHERAL VISION LOSS) † 1  0/27 (0.00%)  1/28 (3.57%)  0/9 (0.00%) 
Floaters † 1  0/27 (0.00%)  1/28 (3.57%)  0/9 (0.00%) 
Gastrointestinal disorders       
Abdominal pain † 1  0/27 (0.00%)  1/28 (3.57%)  0/9 (0.00%) 
Constipation † 1  4/27 (14.81%)  2/28 (7.14%)  1/9 (11.11%) 
Diarrhea † 1  1/27 (3.70%)  1/28 (3.57%)  0/9 (0.00%) 
Dry mouth † 1  1/27 (3.70%)  0/28 (0.00%)  0/9 (0.00%) 
Dyspepsia † 1  1/27 (3.70%)  0/28 (0.00%)  1/9 (11.11%) 
Fecal incontinence † 1  0/27 (0.00%)  2/28 (7.14%)  0/9 (0.00%) 
Nausea † 1  4/27 (14.81%)  5/28 (17.86%)  2/9 (22.22%) 
Vomiting † 1  3/27 (11.11%)  2/28 (7.14%)  1/9 (11.11%) 
General disorders       
Edema face † 1  1/27 (3.70%)  0/28 (0.00%)  0/9 (0.00%) 
Edema limbs † 1  0/27 (0.00%)  2/28 (7.14%)  1/9 (11.11%) 
Fatigue † 1  2/27 (7.41%)  4/28 (14.29%)  2/9 (22.22%) 
Fever † 1  0/27 (0.00%)  1/28 (3.57%)  0/9 (0.00%) 
Flu like symptoms † 1  0/27 (0.00%)  1/28 (3.57%)  0/9 (0.00%) 
Gait disturbance † 1  1/27 (3.70%)  1/28 (3.57%)  0/9 (0.00%) 
Other, Specify (36 HOURS POST VACCINES, INCREASED CONFUSION, INCREASED FATIGUE, INCREASED APHASIA) † 1  0/27 (0.00%)  1/28 (3.57%)  0/9 (0.00%) 
Other, Specify (INTERMITTENT PULSATING IN EARS; POSSIBLE TINNITUS) † 1  0/27 (0.00%)  1/28 (3.57%)  0/9 (0.00%) 
Infusion related reaction † 1  0/27 (0.00%)  1/28 (3.57%)  1/9 (11.11%) 
Injection site reaction † 1  0/27 (0.00%)  4/28 (14.29%)  2/9 (22.22%) 
Localized edema † 1  0/27 (0.00%)  0/28 (0.00%)  1/9 (11.11%) 
Pain † 1  2/27 (7.41%)  3/28 (10.71%)  1/9 (11.11%) 
Immune system disorders       
Allergic reaction † 1  1/27 (3.70%)  1/28 (3.57%)  0/9 (0.00%) 
Infections and infestations       
Bronchial infection † 1  1/27 (3.70%)  1/28 (3.57%)  0/9 (0.00%) 
Infections and infestations - Other, Specify (BLEPHARITIS) † 1  1/27 (3.70%)  0/28 (0.00%)  0/9 (0.00%) 
Infections and infestations - Other, Specify (ENLARGED AREAS UNDER ARMPITS) † 1  1/27 (3.70%)  0/28 (0.00%)  0/9 (0.00%) 
Infections and infestations - Other, Specify (ORAL THRUSH) † 1  0/27 (0.00%)  1/28 (3.57%)  0/9 (0.00%) 
Infections and infestations - Other, Specify (SHINGLES) † 1  1/27 (3.70%)  0/28 (0.00%)  0/9 (0.00%) 
Infections and infestations - Other, Specify (TICK BITES) † 1  1/27 (3.70%)  0/28 (0.00%)  0/9 (0.00%) 
Infections and infestations - Other, Specify (YEAST INFECTION) † 1  0/27 (0.00%)  1/28 (3.57%)  0/9 (0.00%) 
Mucosal infection † 1  0/27 (0.00%)  0/28 (0.00%)  1/9 (11.11%) 
Otitis media † 1  0/27 (0.00%)  0/28 (0.00%)  1/9 (11.11%) 
Sinusitis † 1  0/27 (0.00%)  3/28 (10.71%)  3/9 (33.33%) 
Upper respiratory infection † 1  3/27 (11.11%)  6/28 (21.43%)  3/9 (33.33%) 
Urinary tract infection † 1  1/27 (3.70%)  2/28 (7.14%)  0/9 (0.00%) 
Injury, poisoning and procedural complications       
Bruising † 1  1/27 (3.70%)  1/28 (3.57%)  0/9 (0.00%) 
Fall † 1  1/27 (3.70%)  3/28 (10.71%)  0/9 (0.00%) 
Injury, poisoning and procedural complications - Other, Specify (CHIPPED TOOTH) † 1  0/27 (0.00%)  1/28 (3.57%)  0/9 (0.00%) 
Injury, poisoning and procedural complications - Other, Specify (DOG BITE) † 1  0/27 (0.00%)  1/28 (3.57%)  0/9 (0.00%) 
Injury, poisoning and procedural complications - Other, Specify (HEAD INJURY) † 1  0/27 (0.00%)  1/28 (3.57%)  0/9 (0.00%) 
Injury, poisoning and procedural complications - Other, Specify (L ELBOW INJURY FALLING OUT OF BED) † 1  0/27 (0.00%)  0/28 (0.00%)  1/9 (11.11%) 
Injury, poisoning and procedural complications - Other, Specify (LEFT SHIN WOUND) † 1  0/27 (0.00%)  0/28 (0.00%)  1/9 (11.11%) 
Wound complication † 1  0/27 (0.00%)  0/28 (0.00%)  1/9 (11.11%) 
Investigations       
Alanine aminotransferase increased † 1  1/27 (3.70%)  4/28 (14.29%)  2/9 (22.22%) 
Alkaline phosphatase increased † 1  0/27 (0.00%)  1/28 (3.57%)  0/9 (0.00%) 
Aspartate aminotransferase increased † 1  0/27 (0.00%)  3/28 (10.71%)  3/9 (33.33%) 
Blood bilirubin increased † 1  1/27 (3.70%)  3/28 (10.71%)  0/9 (0.00%) 
CD4 lymphocytes decreased † 1  3/27 (11.11%)  2/28 (7.14%)  5/9 (55.56%) 
Creatinine increased † 1  4/27 (14.81%)  3/28 (10.71%)  2/9 (22.22%) 
Lymphocyte count decreased † 1  15/27 (55.56%)  16/28 (57.14%)  6/9 (66.67%) 
Neutrophil count decreased † 1  10/27 (37.04%)  10/28 (35.71%)  4/9 (44.44%) 
Platelet count decreased † 1  14/27 (51.85%)  15/28 (53.57%)  6/9 (66.67%) 
Weight loss † 1  0/27 (0.00%)  1/28 (3.57%)  0/9 (0.00%) 
White blood cell decreased † 1  11/27 (40.74%)  12/28 (42.86%)  4/9 (44.44%) 
Metabolism and nutrition disorders       
Anorexia † 1  2/27 (7.41%)  3/28 (10.71%)  0/9 (0.00%) 
Dehydration † 1  1/27 (3.70%)  1/28 (3.57%)  1/9 (11.11%) 
Glucose intolerance † 1  0/27 (0.00%)  0/28 (0.00%)  1/9 (11.11%) 
Hypercalcemia † 1  0/27 (0.00%)  0/28 (0.00%)  1/9 (11.11%) 
Hyperglycemia † 1  14/27 (51.85%)  14/28 (50.00%)  6/9 (66.67%) 
Hyperkalemia † 1  2/27 (7.41%)  2/28 (7.14%)  0/9 (0.00%) 
Hypermagnesemia † 1  0/27 (0.00%)  0/28 (0.00%)  1/9 (11.11%) 
Hypernatremia † 1  1/27 (3.70%)  3/28 (10.71%)  0/9 (0.00%) 
Hypoalbuminemia † 1  3/27 (11.11%)  1/28 (3.57%)  2/9 (22.22%) 
Hypocalcemia † 1  2/27 (7.41%)  8/28 (28.57%)  4/9 (44.44%) 
Hypoglycemia † 1  2/27 (7.41%)  6/28 (21.43%)  2/9 (22.22%) 
Hypokalemia † 1  4/27 (14.81%)  4/28 (14.29%)  2/9 (22.22%) 
Hyponatremia † 1  2/27 (7.41%)  5/28 (17.86%)  3/9 (33.33%) 
Hypophosphatemia † 1  0/27 (0.00%)  1/28 (3.57%)  0/9 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia † 1  1/27 (3.70%)  0/28 (0.00%)  2/9 (22.22%) 
Muscle weakness left-sided † 1  1/27 (3.70%)  0/28 (0.00%)  1/9 (11.11%) 
Muscle weakness right-sided † 1  1/27 (3.70%)  1/28 (3.57%)  0/9 (0.00%) 
Musculoskeletal and connective tissue disorder - Other, Specify † 1  1/27 (3.70%)  1/28 (3.57%)  0/9 (0.00%) 
Myalgia † 1  1/27 (3.70%)  1/28 (3.57%)  0/9 (0.00%) 
Pain in extremity † 1  0/27 (0.00%)  1/28 (3.57%)  0/9 (0.00%) 
Nervous system disorders       
Dizziness † 1  3/27 (11.11%)  3/28 (10.71%)  1/9 (11.11%) 
Dysgeusia † 1  0/27 (0.00%)  2/28 (7.14%)  0/9 (0.00%) 
Dysphasia † 1  6/27 (22.22%)  5/28 (17.86%)  0/9 (0.00%) 
Facial muscle weakness † 1  0/27 (0.00%)  1/28 (3.57%)  1/9 (11.11%) 
Facial nerve disorder † 1  1/27 (3.70%)  0/28 (0.00%)  0/9 (0.00%) 
Headache † 1  2/27 (7.41%)  4/28 (14.29%)  1/9 (11.11%) 
Hydrocephalus † 1  0/27 (0.00%)  0/28 (0.00%)  1/9 (11.11%) 
Memory impairment † 1  1/27 (3.70%)  5/28 (17.86%)  2/9 (22.22%) 
Movements involuntary † 1  0/27 (0.00%)  0/28 (0.00%)  2/9 (22.22%) 
Nervous system disorders - Other, Specify (FEELING OF HEAD SPINNING) † 1  1/27 (3.70%)  0/28 (0.00%)  0/9 (0.00%) 
Nervous system disorders - Other, Specify (LEFT HAND LIMP) † 1  1/27 (3.70%)  0/28 (0.00%)  0/9 (0.00%) 
Nervous system disorders - Other, Specify (RESTLESSNESS) † 1  0/27 (0.00%)  1/28 (3.57%)  0/9 (0.00%) 
Nervous system disorders - Other, Specify (RIGHT ARM SENSATION) † 1  0/27 (0.00%)  1/28 (3.57%)  0/9 (0.00%) 
Nervous system disorders - Other, Specify (VISUAL FIELD CUT - HEMIANOPSIA) † 1  0/27 (0.00%)  1/28 (3.57%)  0/9 (0.00%) 
Paresthesia † 1  1/27 (3.70%)  1/28 (3.57%)  2/9 (22.22%) 
Presyncope † 1  0/27 (0.00%)  1/28 (3.57%)  0/9 (0.00%) 
Pyramidal tract syndrome † 1  0/27 (0.00%)  1/28 (3.57%)  1/9 (11.11%) 
Seizure † 1  7/27 (25.93%)  8/28 (28.57%)  2/9 (22.22%) 
Spasticity † 1  1/27 (3.70%)  0/28 (0.00%)  0/9 (0.00%) 
Tremor † 1  0/27 (0.00%)  1/28 (3.57%)  1/9 (11.11%) 
Psychiatric disorders       
Anxiety † 1  1/27 (3.70%)  2/28 (7.14%)  0/9 (0.00%) 
Confusion † 1  0/27 (0.00%)  2/28 (7.14%)  1/9 (11.11%) 
Insomnia † 1  1/27 (3.70%)  2/28 (7.14%)  1/9 (11.11%) 
Renal and urinary disorders       
Hematuria † 1  1/27 (3.70%)  1/28 (3.57%)  1/9 (11.11%) 
Proteinuria † 1  0/27 (0.00%)  1/28 (3.57%)  0/9 (0.00%) 
Urinary incontinence † 1  0/27 (0.00%)  3/28 (10.71%)  2/9 (22.22%) 
Urinary retention † 1  0/27 (0.00%)  0/28 (0.00%)  1/9 (11.11%) 
Respiratory, thoracic and mediastinal disorders       
Allergic rhinitis † 1  1/27 (3.70%)  1/28 (3.57%)  1/9 (11.11%) 
Dyspnea † 1  3/27 (11.11%)  0/28 (0.00%)  0/9 (0.00%) 
Epistaxis † 1  1/27 (3.70%)  0/28 (0.00%)  0/9 (0.00%) 
Productive cough † 1  1/27 (3.70%)  0/28 (0.00%)  0/9 (0.00%) 
Sore throat † 1  0/27 (0.00%)  1/28 (3.57%)  0/9 (0.00%) 
Skin and subcutaneous tissue disorders       
Dry skin † 1  2/27 (7.41%)  0/28 (0.00%)  1/9 (11.11%) 
Pruritus † 1  1/27 (3.70%)  1/28 (3.57%)  0/9 (0.00%) 
Rash maculo-papular † 1  1/27 (3.70%)  1/28 (3.57%)  0/9 (0.00%) 
Skin and subcutaneous tissue disorders - Other, Specify (NIGHT SWEATS) † 1  1/27 (3.70%)  0/28 (0.00%)  0/9 (0.00%) 
Skin and subcutaneous tissue disorders - Other, Specify (PIMPLE LIKE AREA NEAR SITE OF INJECTION) † 1  0/27 (0.00%)  0/28 (0.00%)  1/9 (11.11%) 
Skin and subcutaneous tissue disorders - Other, Specify (RASH) † 1  2/27 (7.41%)  3/28 (10.71%)  4/9 (44.44%) 
Skin and subcutaneous tissue disorders - Other, Specify (SKIN "SORENESS" AROUND L EYE) † 1  0/27 (0.00%)  0/28 (0.00%)  1/9 (11.11%) 
Vascular disorders       
Hypertension † 1  22/27 (81.48%)  24/28 (85.71%)  9/9 (100.00%) 
1
Term from vocabulary, CTCAE (4.0)
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mustafa Khasraw, M.D.
Organization: Duke University
Phone: 919-668-6688
EMail: mustafa.khasraw@duke.edu
Layout table for additonal information
Responsible Party: Gary Archer Ph.D., Duke University
ClinicalTrials.gov Identifier: NCT02366728    
Other Study ID Numbers: Pro00054740
First Submitted: October 28, 2014
First Posted: February 19, 2015
Results First Submitted: October 20, 2021
Results First Posted: February 1, 2022
Last Update Posted: February 1, 2022