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Prostvac in Patients With Biochemically Recurrent Prostate Cancer

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: NCT02649439
Recruitment Status : Active, not recruiting
First Posted : January 7, 2016
Results First Posted : July 6, 2021
Last Update Posted : July 6, 2021
Sponsor:
Information provided by (Responsible Party):
Ravi A. Madan, M.D., National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Interventions Biological: PROSTVAC -V
Biological: PROSTVAC-F
Enrollment 97
Recruitment Details A total of 97 participants were enrolled and 17/97 were screen failures who were enrolled and not treated. They are not included in the table because "potential participants who are screened for the purpose of determining eligibility, but do not participate, are not considered enrolled unless otherwise specified by the protocol", and that is not otherwise specified in the protocol.
Pre-assignment Details  
Arm/Group Title A/PROSTVAC Treatment B/ Delayed PROSTVAC Treatment
Hide Arm/Group Description

PROSTVAC treatment for 6 months with an additional optional year of maintenance for eligible patients

PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus

PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus

Surveillance for 6 months followed by PROSTVAC treatment for 6 months with an additional year of maintenance for eligible patients

PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus

PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus

Period Title: Overall Study
Started 40 40
Completed 13 12
Not Completed 27 28
Reason Not Completed
Switched to alternative treatment             6             4
Patient decision             1             0
Patient going out of country             1             0
To start finasteride             1             0
Physician Decision             1             0
Disease progression on study             12             13
Refused further treatment             1             0
Refused further follow up             2             7
Completed treatment phase but refused the protocol specified follow up             1             0
No treatment, per protocol             1             0
PSA DT makes ineligible             0             1
Rising PSA No Mets             0             1
Rising PSA             0             1
Signed follow up protocol             0             1
Arm/Group Title A/PROSTVAC Treatment B/ Delayed PROSTVAC Treatment Total
Hide Arm/Group Description

PROSTVAC treatment for 6 months with an additional optional year of maintenance for eligible patients

PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus

PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus

Surveillance for 6 months followed by PROSTVAC treatment for 6 months with an additional year of maintenance for eligible patients

PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus

PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus

Total of all reporting groups
Overall Number of Baseline Participants 40 40 80
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
12
  30.0%
18
  45.0%
30
  37.5%
>=65 years
28
  70.0%
22
  55.0%
50
  62.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 40 participants 80 participants
67.06  (6.48) 67.02  (6.56) 67.04  (6.52)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
40
 100.0%
40
 100.0%
80
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 participants
Hispanic or Latino
1
   2.5%
2
   5.0%
3
   3.8%
Not Hispanic or Latino
32
  80.0%
31
  77.5%
63
  78.8%
Unknown or Not Reported
7
  17.5%
7
  17.5%
14
  17.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   2.5%
3
   7.5%
4
   5.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
  10.0%
4
  10.0%
8
  10.0%
White
33
  82.5%
32
  80.0%
65
  81.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   5.0%
1
   2.5%
3
   3.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 40 participants 40 participants 80 participants
40 40 80
Median Prostate Specific Antigen (PSA)   [1] 
Median (Full Range)
Unit of measure:  Ng/ml
Number Analyzed 40 participants 40 participants 80 participants
2.98
(0.83 to 28.15)
2.82
(0.95 to 19.39)
2.9
(0.89 to 23.77)
[1]
Measure Description: Normal PSA is zero.
1.Primary Outcome
Title Tumor Growth Rate as Measured by Prostate-specific Antigen (PSA) Rise After 6 Months When PROSTVAC is Initiated Compared to a Group on Surveillance for 6 Months
Hide Description Tumor growth rate was measured using the equation PSA (log growth rate) +/- SE (standard error).
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A/PROSTVAC Treatment B/ Delayed PROSTVAC Treatment
Hide Arm/Group Description:

PROSTVAC treatment for 6 months with an additional optional year of maintenance for eligible patients

PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus

PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus

Surveillance for 6 months followed by PROSTVAC treatment for 6 months with an additional year of maintenance for eligible patients

PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus

PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus

Overall Number of Participants Analyzed 40 40
Measure Type: Number
Unit of Measure: Unitless
-2.528 -2.449
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A/PROSTVAC Treatment, B/ Delayed PROSTVAC Treatment
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4852
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
2.Secondary Outcome
Title Effects of Vaccine on Prostate-specific Antigen (PSA) Growth Rate When PROSTVAC is Initiated After 6 Months on Surveillance
Hide Description Tumor growth rate was measured using the equation PSA (log growth rate) +/- SE (standard error).
Time Frame After the participants in the Arm/Group "B/ Delayed PROSTVAC Treatment" received treatment for 6 months after their 6 month surveillance (e.g., 12 months total).
Hide Outcome Measure Data
Hide Analysis Population Description
33/40 were evaluable in the first group.
Arm/Group Title A/PROSTVAC Treatment B/ Delayed PROSTVAC Treatment
Hide Arm/Group Description:

PROSTVAC treatment for 6 months with an additional optional year of maintenance for eligible patients

PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus

PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus

Surveillance for 6 months followed by PROSTVAC treatment for 6 months with an additional year of maintenance for eligible patients

PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus

PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus

Overall Number of Participants Analyzed 33 40
Measure Type: Number
Unit of Measure: Unitless
-2.513 -2.449
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A/PROSTVAC Treatment, B/ Delayed PROSTVAC Treatment
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3269
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With Prostate-specific Antigen (PSA) Specific T-Cells at Baseline and 6 Months
Hide Description Normal PSA is 0 nanograms per milliliter (ng/mL). Above 0 ng/mL is considered an increase in tumor growth.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
35/40 and 32/40 participants are reported because these are the numbers of participants with sufficient samples for analysis.
Arm/Group Title A/PROSTVAC Treatment B/ Delayed PROSTVAC Treatment
Hide Arm/Group Description:

PROSTVAC treatment for 6 months with an additional optional year of maintenance for eligible patients

PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus

PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus

Surveillance for 6 months followed by PROSTVAC treatment for 6 months with an additional year of maintenance for eligible patients

PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus

PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus

Overall Number of Participants Analyzed 35 32
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline
22
  62.9%
20
  62.5%
6 Months
14
  40.0%
11
  34.4%
4.Other Pre-specified Outcome
Title Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
Hide Description Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time Frame Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A/PROSTVAC Treatment B/ Delayed PROSTVAC Treatment
Hide Arm/Group Description:

PROSTVAC treatment for 6 months with an additional optional year of maintenance for eligible patients

PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus

PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus

Surveillance for 6 months followed by PROSTVAC treatment for 6 months with an additional year of maintenance for eligible patients

PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus

PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus

Overall Number of Participants Analyzed 40 40
Measure Type: Count of Participants
Unit of Measure: Participants
40
 100.0%
39
  97.5%
5.Other Pre-specified Outcome
Title Median Late Change in Peripheral Blood Mononuclear Cells (PBMCs) in Refined Subsets Monocyte Nonclassical, Monocyte Nonclassical Programmed Death Ligand 1 (PD-L1+), and Monocyte PD-1+ After PROSTVAC
Hide Description Blood samples collected were analyzed by multicolor flow cytometry in PBMCs for refined subsets of Monocytes. Changes in levels of PBMC subsets was a descriptive result with median percent change and interquartile range reported. P values were calculated using the Mann Whitney Test.
Time Frame Day 29 (Post vaccination) vs Pre (Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
7/40 and 29/40 participants were evaluable in the first and second group, respectively, based on availability of peripheral blood mononuclear cells (PBMCs) before and after vaccination.
Arm/Group Title A/PROSTVAC Treatment Responders B/ Delayed PROSTVAC Treatment Non-Responders
Hide Arm/Group Description:

PROSTVAC treatment for 6 months with an additional optional year of maintenance for eligible patients

PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus

PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus

PROSTVAC treatment for 6 months with an additional optional year of maintenance for eligible patients

PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus

PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus

Overall Number of Participants Analyzed 7 29
Median (Inter-Quartile Range)
Unit of Measure: Percent change
Monocyte Nonclassical Refined Subset
-29.8
(-70.8 to 10.0)
9.3
(-26.6 to 41.4)
Monocyte Nonclassical PD-L1+ Refined Subset
-57.5
(-73.7 to -2.8)
17.3
(-15.1 to 56.5)
Monocyte PD-1+ Refined Subset
-55.7
(-73.1 to -8.2)
-17.2
(-38.8 to 15.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A/PROSTVAC Treatment Responders, B/ Delayed PROSTVAC Treatment Non-Responders
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0255
Comments The reported p-value is representative of the PBMCs in monocyte nonclassical between responders and non-responders.
Method Mann Whitney Test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection A/PROSTVAC Treatment Responders, B/ Delayed PROSTVAC Treatment Non-Responders
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0021
Comments The reported p-value is representative of the PBMCs in monocyte nonclassical PD-L1+ between responders and non-responders.
Method Mann Whitney Test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection A/PROSTVAC Treatment Responders, B/ Delayed PROSTVAC Treatment Non-Responders
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0486
Comments The reported p-value is representative of the PBMCs in monocyte PD-1+ between responders and non-responders.
Method Mann Whitney Test
Comments [Not Specified]
6.Other Pre-specified Outcome
Title Median Late Change in Peripheral Blood Mononuclear Cells (PBMCs) in Cluster of Differentiation 4 (CD4), Cluster of Differentiation 8 (CD8), Regulatory T-cells (Treg), Natural Killer (NK), and Myeloid-derived Suppressor Cells (MDSC) After PROSTVAC
Hide Description Blood samples collected were analyzed by multicolor flow cytometry in PBMCs for cluster of differentiation 4 (CD4), cluster of differentiation 8 (CD8), Natural Killer (NK), myeloid-derived suppressor cell (MDSC) and Tregs. P values were calculated using the Mann Whitney Test.
Time Frame Day 29 (Post vaccination) vs Pre (Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
7/40 and 29/40 participants were evaluable in the first and second group, respectively, based on availability of peripheral blood mononuclear cells (PBMCs) before and after vaccination.
Arm/Group Title A/PROSTVAC Treatment Responders A/PROSTVAC Treatment Non-Responders
Hide Arm/Group Description:

PROSTVAC treatment for 6 months with an additional optional year of maintenance for eligible patients

PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus

PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus

PROSTVAC treatment for 6 months with an additional optional year of maintenance for eligible patients

PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus

PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus

Overall Number of Participants Analyzed 7 29
Median (Inter-Quartile Range)
Unit of Measure: Percent change
Classic Subset CD4
-7.1
(-51.7 to 13.0)
-3.3
(-13.4 to 11.2)
Classic Subset CD8
1.2
(-16.9 to 51.8)
2.8
(-12.0 to 15.2)
Classic Subset Treg
44.7
(-24.8 to 54.2)
0.7
(-23.7 to 46.2)
Classic Subset NK
26.2
(-8.7 to 72.0)
24.1
(-1.7 to 51.7)
Classic Subset MDSC
39.5
(-67.6 to 680.1)
20.9
(-12.6 to 118.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A/PROSTVAC Treatment Responders, A/PROSTVAC Treatment Non-Responders
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7317
Comments The reported p-value is representative of the PBMCs in CD4 between responders and non-responders.
Method Mann Whitney Test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection A/PROSTVAC Treatment Responders, A/PROSTVAC Treatment Non-Responders
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7545
Comments The reported p-value is representative of the PBMCs in CD8 between responders and non-responders.
Method Mann Whitney Test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection A/PROSTVAC Treatment Responders, A/PROSTVAC Treatment Non-Responders
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5310
Comments The reported p-value is representative of the PBMCs in Treg between responders and non-responders.
Method Mann Whitney Test
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection A/PROSTVAC Treatment Responders, A/PROSTVAC Treatment Non-Responders
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8451
Comments The reported p-value is representative of the PBMCs in NK between responders and non-responders.
Method Mann Whitney Test
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection A/PROSTVAC Treatment Responders, A/PROSTVAC Treatment Non-Responders
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9377
Comments The reported p-value is representative of the PBMCs in MDSC between responders and non-responders.
Method Mann Whitney Test
Comments [Not Specified]
7.Other Pre-specified Outcome
Title Peripheral Blood Mononuclear Cells (PBMCs) in Cluster of Differentiation 4 (CD4), Cluster of Differentiation 8 (CD8), Regulatory T-cells (Treg), Natural Killer (NK), and Myeloid-derived Suppressor Cells (MDSC), and naïve CD4 and CD8 T Cells After PROSTVAC
Hide Description Blood samples collected were analyzed by multicolor flow cytometry in PBMCs for cluster of differentiation 4 (CD4), cluster of differentiation 8 (CD8), Natural Killer (NK), myeloid-derived suppressor cell (MDSC), Tregs, and naïve CD4 and naïve CD8 T cells. P values were calculated using the Wilcoxon signed rank test.
Time Frame Baseline (Day 1) and one month (Day 29) after vaccine or surveillance (in the Delayed PROSTVAC group)
Hide Outcome Measure Data
Hide Analysis Population Description
36 and 12participants were evaluable in the first and second group, respectively, based on availability of peripheral blood mononuclear cells (PBMCs) before and after vaccination or surveillance (in the Delayed PROSTVAC group).
Arm/Group Title A/PROSTVAC Treatment Day 1 A/PROSTVAC Treatment Day 29 B/ Delayed PROSTVAC Treatment Day 1 B/ Delayed PROSTVAC Treatment Day 29
Hide Arm/Group Description:

PROSTVAC treatment for 6 months with an additional optional year of maintenance for eligible patients

PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus

PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus

PROSTVAC treatment for 6 months with an additional optional year of maintenance for eligible patients

PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus

PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus

Surveillance for 6 months followed by PROSTVAC treatment for 6 months with an additional year of maintenance for eligible patients

PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus

PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus

Surveillance for 6 months followed by PROSTVAC treatment for 6 months with an additional year of maintenance for eligible patients

PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus

PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus

Overall Number of Participants Analyzed 36 36 12 12
Median (Inter-Quartile Range)
Unit of Measure: Percentage of PBMC
CD4
29.83
(25.04 to 39.98)
29.16
(23.69 to 35.07)
32.44
(27.37 to 34.72)
29.07
(26.86 to 36.25)
CD8
8.87
(6.97 to 13.34)
9.98
(6.96 to 15.28)
12.71
(8.78 to 18.54)
13.00
(8.65 to 18.55)
Treg
0.58
(0.39 to 0.82)
0.59
(0.49 to 0.96)
1.03
(0.76 to 1.25)
0.99
(0.67 to 1.25)
NK
8.04
(5.64 to 9.08)
9.28
(5.79 to 14.39)
10.35
(5.82 to 16.03)
10.17
(6.18 to 15.93)
MDSC
4.60
(1.83 to 8.75)
6.02
(3.19 to 9.00)
5.74
(2.42 to 7.28)
5.52
(3.06 to 7.32)
Naive CD4
7.23
(3.11 to 10.13)
6.93
(2.77 to 12.07)
7.44
(2.93 to 11.27)
7.12
(3.58 to 9.09)
Naïve CD8
1.51
(0.81 to 2.72)
1.26
(0.83 to 2.71)
1.54
(0.60 to 3.84)
1.39
(0.77 to 3.39)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A/PROSTVAC Treatment Day 1, A/PROSTVAC Treatment Day 29
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2012
Comments The reported p-value is representative of the % of CD4 in PBMCs at Day 1 and Day 29.
Method Wilcoxon signed rank test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection A/PROSTVAC Treatment Day 1, A/PROSTVAC Treatment Day 29
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4891
Comments The reported p-value is representative of the % of CD8 in PBMCs at Day 1 and Day 29.
Method Wilcoxon signed rank test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection A/PROSTVAC Treatment Day 1, A/PROSTVAC Treatment Day 29
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4609
Comments The reported p-value is representative of the % of Tregs in PBMCs at Day 1 and Day 29.
Method Wilcoxon signed rank test
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection A/PROSTVAC Treatment Day 1, A/PROSTVAC Treatment Day 29
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0012
Comments The reported p-value is representative of the % of NK in PBMCs at Day 1 and Day 29.
Method Wilcoxon signed rank test
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection A/PROSTVAC Treatment Day 1, A/PROSTVAC Treatment Day 29
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0825
Comments The reported p-value is representative of the % of MDSC in PBMCs at Day 1 and Day 29.
Method Wilcoxon signed rank test
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection A/PROSTVAC Treatment Day 1, A/PROSTVAC Treatment Day 29
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5988
Comments The reported p-value is representative of the % of naïve CD4 in PBMCs at Day 1 and Day 29.
Method Wilcoxon signed rank test
Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection A/PROSTVAC Treatment Day 1, A/PROSTVAC Treatment Day 29
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5920
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments The reported p-value is representative of the % of naïve CD8 in PBMCs at Day 1 and Day 29.
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection B/ Delayed PROSTVAC Treatment Day 1, B/ Delayed PROSTVAC Treatment Day 29
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6221
Comments The reported p-value is representative of the % of CD4 in PBMCs at Day 1 and Day 29.
Method Wilcoxon signed rank test
Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection B/ Delayed PROSTVAC Treatment Day 1, B/ Delayed PROSTVAC Treatment Day 29
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7334
Comments The reported p-value is representative of the % of CD8 in PBMCs at Day 1 and Day 29.
Method Wilcoxon signed rank test
Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection B/ Delayed PROSTVAC Treatment Day 1, B/ Delayed PROSTVAC Treatment Day 29
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7910
Comments The reported p-value is representative of the % of Tregs in PBMCs at Day 1 and Day 29.
Method Wilcoxon signed rank test
Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection B/ Delayed PROSTVAC Treatment Day 1, B/ Delayed PROSTVAC Treatment Day 29
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5186
Comments The reported p-value is representative of the % of NK in PBMCs at Day 1 and Day 29.
Method Wilcoxon signed rank test
Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection B/ Delayed PROSTVAC Treatment Day 1, B/ Delayed PROSTVAC Treatment Day 29
Comments [Not Specified]
Type of Statistical Test Superiority
Comments The reported p-value is representative of the % of MDSC in PBMCs at Day 1 and Day 29.
Statistical Test of Hypothesis P-Value 0.5186
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection B/ Delayed PROSTVAC Treatment Day 1, B/ Delayed PROSTVAC Treatment Day 29
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9097
Comments The reported p-value is representative of the % of naïve CD4 in PBMCs at Day 1 and Day 29.
Method Wilcoxon signed rank test
Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection B/ Delayed PROSTVAC Treatment Day 1, B/ Delayed PROSTVAC Treatment Day 29
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7334
Comments The reported p-value is representative of the % of naïve CD8 in PBMCs at Day 1 and Day 29.
Method Wilcoxon signed rank test
Comments [Not Specified]
Time Frame Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title A/PROSTVAC Treatment B/ Delayed PROSTVAC Treatment
Hide Arm/Group Description

PROSTVAC treatment for 6 months with an additional optional year of maintenance for eligible patients

PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus

PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus

Surveillance for 6 months followed by PROSTVAC treatment for 6 months with an additional year of maintenance for eligible patients

PROSTVAC -V: Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus

PROSTVAC-F: Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus

All-Cause Mortality
A/PROSTVAC Treatment B/ Delayed PROSTVAC Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)      0/40 (0.00%)    
Hide Serious Adverse Events
A/PROSTVAC Treatment B/ Delayed PROSTVAC Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/40 (7.50%)      6/40 (15.00%)    
Cardiac disorders     
Chest pain - cardiac  1  3/40 (7.50%)  3 1/40 (2.50%)  1
Gastrointestinal disorders     
Colonic hemorrhage  1  1/40 (2.50%)  1 0/40 (0.00%)  0
General disorders     
Fever  1  0/40 (0.00%)  0 1/40 (2.50%)  1
Infections and infestations     
Infections and infestations - Other, Viral Myocarditis  1  0/40 (0.00%)  0 1/40 (2.50%)  1
Urinary tract infection  1  0/40 (0.00%)  0 0/40 (0.00%)  0
Investigations     
Creatinine increased  1  0/40 (0.00%)  0 1/40 (2.50%)  1
Metabolism and nutrition disorders     
Hypokalemia  1  0/40 (0.00%)  0 1/40 (2.50%)  1
Musculoskeletal and connective tissue disorders     
Non-cardiac chest pain  1  1/40 (2.50%)  1 0/40 (0.00%)  0
Nervous system disorders     
Stroke  1  0/40 (0.00%)  0 1/40 (2.50%)  1
Syncope  1  0/40 (0.00%)  0 1/40 (2.50%)  1
Renal and urinary disorders     
Acute kidney injury  1  1/40 (2.50%)  1 0/40 (0.00%)  0
Urinary tract obstruction  1  1/40 (2.50%)  1 0/40 (0.00%)  0
Renal calculi  1  0/40 (0.00%)  0 1/40 (2.50%)  1
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%
A/PROSTVAC Treatment B/ Delayed PROSTVAC Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   40/40 (100.00%)      39/40 (97.50%)    
Blood and lymphatic system disorders     
Anemia  1  2/40 (5.00%)  2 1/40 (2.50%)  1
Cardiac disorders     
Chest pain - cardiac  1  1/40 (2.50%)  1 0/40 (0.00%)  0
Sinus bradycardia  1  1/40 (2.50%)  1 0/40 (0.00%)  0
Sinus tachycardia  1  1/40 (2.50%)  1 0/40 (0.00%)  0
Supraventricular tachycardia  1  0/40 (0.00%)  0 1/40 (2.50%)  1
Ear and labyrinth disorders     
Hearing impaired  1  0/40 (0.00%)  0 1/40 (2.50%)  1
Endocrine disorders     
Endocrine disorders - Other, specify  1  1/40 (2.50%)  1 0/40 (0.00%)  0
Eye disorders     
Eye disorders - Other, specify  1  2/40 (5.00%)  2 0/40 (0.00%)  0
Flashing lights  1  1/40 (2.50%)  1 0/40 (0.00%)  0
Floaters  1  2/40 (5.00%)  2 1/40 (2.50%)  1
Hemorrhagic episode of left eye  1  0/40 (0.00%)  0 1/40 (2.50%)  1
Gastrointestinal disorders     
Abdominal pain  1  4/40 (10.00%)  5 0/40 (0.00%)  0
Constipation  1  1/40 (2.50%)  1 3/40 (7.50%)  3
Diarrhea  1  1/40 (2.50%)  2 4/40 (10.00%)  4
Gastroesophageal reflux disease  1  1/40 (2.50%)  1 0/40 (0.00%)  0
Nausea  1  5/40 (12.50%)  6 4/40 (10.00%)  4
Toothache  1  0/40 (0.00%)  0 1/40 (2.50%)  1
Vomiting  1  2/40 (5.00%)  2 4/40 (10.00%)  4
General disorders     
Chills  1  1/40 (2.50%)  1 3/40 (7.50%)  3
Edema face  1  1/40 (2.50%)  1 1/40 (2.50%)  1
Edema limbs  1  2/40 (5.00%)  2 0/40 (0.00%)  0
Fatigue  1  11/40 (27.50%)  13 16/40 (40.00%)  19
Fever  1  3/40 (7.50%)  3 2/40 (5.00%)  2
Flu like symptoms  1  6/40 (15.00%)  8 6/40 (15.00%)  10
General disorders and administration site conditions - Other, specify  1  0/40 (0.00%)  0 1/40 (2.50%)  1
Infusion related reaction  1  1/40 (2.50%)  1 0/40 (0.00%)  0
Injection site reaction  1  29/40 (72.50%)  119 33/40 (82.50%)  85
Malaise  1  4/40 (10.00%)  4 0/40 (0.00%)  0
Pain  1  9/40 (22.50%)  10 7/40 (17.50%)  8
Infections and infestations     
Gum infection  1  1/40 (2.50%)  1 0/40 (0.00%)  0
Headache  1  3/40 (7.50%)  5 5/40 (12.50%)  5
Infections and infestations - Other, specify  1  1/40 (2.50%)  1 0/40 (0.00%)  0
Infections and infestations - Other, specify  1  0/40 (0.00%)  0 1/40 (2.50%)  1
Lip infection  1  1/40 (2.50%)  1 0/40 (0.00%)  0
Sinusitis  1  1/40 (2.50%)  1 1/40 (2.50%)  1
Tooth infection  1  1/40 (2.50%)  1 1/40 (2.50%)  1
Upper respiratory infection  1  3/40 (7.50%)  3 2/40 (5.00%)  3
Urinary tract infection  1  0/40 (0.00%)  0 1/40 (2.50%)  1
Injury, poisoning and procedural complications     
Fall  1  1/40 (2.50%)  1 2/40 (5.00%)  3
Fracture  1  1/40 (2.50%)  1 0/40 (0.00%)  0
Investigations     
Alanine aminotransferase increased  1  2/40 (5.00%)  3 1/40 (2.50%)  1
Alkaline phosphatase increased  1  0/40 (0.00%)  0 1/40 (2.50%)  1
Blood bilirubin increased  1  1/40 (2.50%)  1 0/40 (0.00%)  0
CPK increased  1  2/40 (5.00%)  2 0/40 (0.00%)  0
Creatinine increased  1  2/40 (5.00%)  4 0/40 (0.00%)  0
Lymphocyte count decreased  1  2/40 (5.00%)  4 2/40 (5.00%)  5
Neutrophil count decreased  1  0/40 (0.00%)  0 2/40 (5.00%)  3
Platelet count decreased  1  1/40 (2.50%)  1 0/40 (0.00%)  0
Weight gain  1  1/40 (2.50%)  1 1/40 (2.50%)  2
Weight loss  1  2/40 (5.00%)  2 0/40 (0.00%)  0
White blood cell decreased  1  1/40 (2.50%)  1 2/40 (5.00%)  5
Metabolism and nutrition disorders     
Anorexia  1  1/40 (2.50%)  1 1/40 (2.50%)  1
Hyperglycemia  1  6/40 (15.00%)  9 2/40 (5.00%)  7
Hyperkalemia  1  1/40 (2.50%)  1 0/40 (0.00%)  0
Hyperuricemia  1  1/40 (2.50%)  1 1/40 (2.50%)  1
Hypocalcemia  1  0/40 (0.00%)  0 1/40 (2.50%)  1
Hypokalemia  1  1/40 (2.50%)  1 0/40 (0.00%)  0
Hypomagnesemia  1  1/40 (2.50%)  1 1/40 (2.50%)  1
Hyponatremia  1  0/40 (0.00%)  0 1/40 (2.50%)  3
Hypophosphatemia  1  8/40 (20.00%)  12 0/40 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia  1  2/40 (5.00%)  2 1/40 (2.50%)  2
Back pain  1  2/40 (5.00%)  3 1/40 (2.50%)  1
Musculoskeletal and connective tissue disorder - Other, specify  1  2/40 (5.00%)  2 0/40 (0.00%)  0
Myalgia  1  2/40 (5.00%)  2 2/40 (5.00%)  2
Neck pain  1  0/40 (0.00%)  0 1/40 (2.50%)  1
Pain in extremity  1  3/40 (7.50%)  3 0/40 (0.00%)  0
Pain in left heel  1  1/40 (2.50%)  1 0/40 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify  1  2/40 (5.00%)  2 1/40 (2.50%)  1
Nervous system disorders     
Ataxia  1  0/40 (0.00%)  0 1/40 (2.50%)  1
Dizziness  1  2/40 (5.00%)  2 1/40 (2.50%)  1
Movements involuntary  1  0/40 (0.00%)  0 1/40 (2.50%)  1
Paresthesia  1  1/40 (2.50%)  3 1/40 (2.50%)  1
Peripheral sensory neuropathy  1  1/40 (2.50%)  1 0/40 (0.00%)  0
Psychiatric disorders     
Anxiety  1  1/40 (2.50%)  1 0/40 (0.00%)  0
Aspartate aminotransferase increased  1  2/40 (5.00%)  2 0/40 (0.00%)  0
Depression  1  0/40 (0.00%)  0 1/40 (2.50%)  1
Insomnia  1  1/40 (2.50%)  1 0/40 (0.00%)  0
Renal and urinary disorders     
Acute kidney injury  1  1/40 (2.50%)  2 0/40 (0.00%)  0
Cystitis noninfective  1  2/40 (5.00%)  2 0/40 (0.00%)  0
Dysuria  1  1/40 (2.50%)  1 0/40 (0.00%)  0
Hematuria  1  3/40 (7.50%)  3 4/40 (10.00%)  5
Urinary frequency  1  2/40 (5.00%)  4 2/40 (5.00%)  2
Urinary incontinence  1  1/40 (2.50%)  1 0/40 (0.00%)  0
Urinary retention  1  2/40 (5.00%)  2 0/40 (0.00%)  0
Urinary tract obstruction  1  1/40 (2.50%)  1 0/40 (0.00%)  0
Urinary tract pain  1  3/40 (7.50%)  3 1/40 (2.50%)  1
Urinary urgency  1  1/40 (2.50%)  2 0/40 (0.00%)  0
Reproductive system and breast disorders     
Testicular disorder  1  1/40 (2.50%)  1 0/40 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough  1  3/40 (7.50%)  3 3/40 (7.50%)  4
Dyspnea  1  2/40 (5.00%)  4 1/40 (2.50%)  2
Epistaxis  1  0/40 (0.00%)  0 1/40 (2.50%)  1
Nasal congestion  1  4/40 (10.00%)  5 3/40 (7.50%)  3
Respiratory, thoracic and mediastinal disorders - Other, specify  1  0/40 (0.00%)  0 1/40 (2.50%)  1
Respiratory, thoracic and mediastinal disorders - Other, specify  1  3/40 (7.50%)  3 0/40 (0.00%)  0
Sore throat  1  0/40 (0.00%)  0 1/40 (2.50%)  1
Skin and subcutaneous tissue disorders     
Dry skin  1  2/40 (5.00%)  2 0/40 (0.00%)  0
Pruritus  1  2/40 (5.00%)  2 3/40 (7.50%)  3
Rash acneiform  1  0/40 (0.00%)  0 1/40 (2.50%)  1
Rash maculo-papular  1  4/40 (10.00%)  4 4/40 (10.00%)  6
Skin and subcutaneous tissue disorders - Other, specify  1  4/40 (10.00%)  4 0/40 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, specify  1  0/40 (0.00%)  0 3/40 (7.50%)  4
Skin ulceration  1  1/40 (2.50%)  1 0/40 (0.00%)  0
Surgical and medical procedures     
Surgical and medical procedures - Other, specify  1  0/40 (0.00%)  0 1/40 (2.50%)  1
Vascular disorders     
Hypertension  1  11/40 (27.50%)  12 9/40 (22.50%)  18
Hypotension  1  1/40 (2.50%)  1 0/40 (0.00%)  0
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Ravi Madan
Organization: National Cancer Institute
Phone: 301-480-7168
EMail: rm480i@nih.gov
Layout table for additonal information
Responsible Party: Ravi A. Madan, M.D., National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT02649439    
Other Study ID Numbers: 160035
16-C-0035
First Submitted: January 6, 2016
First Posted: January 7, 2016
Results First Submitted: March 24, 2021
Results First Posted: July 6, 2021
Last Update Posted: July 6, 2021