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A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F +/- GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic Castrate-Resistant Prostate Cancer (Prospect)

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ClinicalTrials.gov Identifier: NCT01322490
Recruitment Status : Completed
First Posted : March 24, 2011
Results First Posted : August 8, 2019
Last Update Posted : September 4, 2019
Sponsor:
Information provided by (Responsible Party):
Bavarian Nordic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Prostate Cancer Metastatic
Interventions Biological: PROSTVAC-V
Biological: PROSTVAC-F
Drug: GM-CSF
Other: GM-CSF Placebo
Biological: Placebo
Enrollment 1297
Recruitment Details Phase 3, randomized, placebo-controlled, multicenter, multi-country efficacy trial of PROSTVAC administered SC to adult males with asymptomatic mCRPC, and was designed to enroll approximately 1200 men. Subjects were randomly assigned with equal probability (1:1:1) to one of three double-blind treatment arms.
Pre-assignment Details Screening activities were completed within 28 days prior to the first dose of any medication and were completed prior to dosing. Subjects who required anti-androgen wash-out specifically for this protocol were consented prior to beginning withdrawal of therapy, however, no other screening procedures were performed the subject was deemed eligible.
Arm/Group Title PROSTVAC-V/F-TRICOM + GM-CSF Placebo PROSTVAC-V/F-TRICOM + GM-CSF Placebo Control
Hide Arm/Group Description PROSTVAC V/F + Placebo GM-CSF, where PROSTVAC V is given SC at 2x10^8 Inf.U/0.5mL (Day 1) and PROSTVAC F is given SC at 1x10^9 Inf.U/0.5mL (Weeks 3, 5, 9, 13, 17, 21). Placebo GM-CSF was saline for injection (on days of PROSTVAC injection and three subsequent days). PROSTVAC V/F + GM-CSF, where PROSTVAC V is given SC at 2x10^8 Inf.U/0.5mL (Day 1) and PROSTVAC F is given SC at 1x10^9 Inf.U/0.5mL (Weeks 3, 5, 9, 13, 17, 21). GM-CSF is given SC at 100ug (on days of PROSTVAC injection and three subsequent days). Placebo PROSTVAC V/F + Placebo GM-CSF, where Placebo PROSTVAC V/F is an empty fowlpox vector (Day 1, Weeks 3, 5, 9, 13, 17, 21). Placebo GM-CSF was saline for injection (on days of PROSTVAC injection and three subsequent days).
Period Title: Treatment Period
Started 432 432 433
Treated 429 429 428
Completed 300 279 280
Not Completed 132 153 153
Reason Not Completed
Adverse Event             12             18             15
Death             5             7             3
Lack of Efficacy             89             100             112
Physician Decision             0             2             1
Protocol Violation             7             5             4
Withdrawal by Subject             14             16             11
Non-compliance with study drug             0             0             1
Other per report             2             2             1
Randomized but Not Treated             3             3             5
Period Title: Long Term Follow-up Period
Started 409 [1] 408 [1] 413 [1]
Completed 0 0 0
Not Completed 409 408 413
Reason Not Completed
Death             235             239             236
Lost to Follow-up             2             2             3
Withdrawal by Subject             9             6             6
Study Terminated by Sponsor             160             158             165
Other per report             3             2             2
Unknown/Missing             0             1             1
[1]
You did not have to complete treatment to enter follow up.
Arm/Group Title PROSTVAC-V/F-TRICOM + GM-CSF Placebo PROSTVAC-V/F-TRICOM + GM-CSF Placebo Control Total
Hide Arm/Group Description PROSTVAC V/F + Placebo GM-CSF, where PROSTVAC V is given SC at 2x10^8 Inf.U/0.5mL (Day 1) and PROSTVAC F is given SC at 1x10^9 Inf.U/0.5mL (Weeks 3, 5, 9, 13, 17, 21). Placebo GM-CSF was saline for injection (on days of PROSTVAC injection and three subsequent days). PROSTVAC V/F + GM-CSF, where PROSTVAC V is given SC at 2x10^8 Inf.U/0.5mL (Day 1) and PROSTVAC F is given SC at 1x10^9 Inf.U/0.5mL (Weeks 3, 5, 9, 13, 17, 21). GM-CSF is given SC at 100ug (on days of PROSTVAC injection and three subsequent days). Placebo PROSTVAC V/F + Placebo GM-CSF, where Placebo PROSTVAC V/F is an empty fowlpox vector (Day 1, Weeks 3, 5, 9, 13, 17, 21). Placebo GM-CSF was saline for injection (on days of PROSTVAC injection and three subsequent days). Total of all reporting groups
Overall Number of Baseline Participants 432 432 433 1297
Hide Baseline Analysis Population Description
Intent to treat, including all randomized subjects.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 432 participants 432 participants 433 participants 1297 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
104
  24.1%
121
  28.0%
109
  25.2%
334
  25.8%
>=65 years
328
  75.9%
311
  72.0%
324
  74.8%
963
  74.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 432 participants 432 participants 433 participants 1297 participants
71.3  (8.00) 70.6  (8.42) 71.4  (8.33) 71.1  (8.25)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 432 participants 432 participants 433 participants 1297 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
432
 100.0%
432
 100.0%
433
 100.0%
1297
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 432 participants 432 participants 433 participants 1297 participants
Hispanic or Latino
11
   2.5%
11
   2.5%
18
   4.2%
40
   3.1%
Not Hispanic or Latino
418
  96.8%
421
  97.5%
415
  95.8%
1254
  96.7%
Unknown or Not Reported
3
   0.7%
0
   0.0%
0
   0.0%
3
   0.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 432 participants 432 participants 433 participants 1297 participants
American Indian or Alaska Native
1
   0.2%
0
   0.0%
0
   0.0%
1
   0.1%
Asian
7
   1.6%
6
   1.4%
7
   1.6%
20
   1.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   0.2%
0
   0.0%
1
   0.1%
Black or African American
17
   3.9%
25
   5.8%
23
   5.3%
65
   5.0%
White
404
  93.5%
400
  92.6%
403
  93.1%
1207
  93.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
   0.7%
0
   0.0%
0
   0.0%
3
   0.2%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 432 participants 432 participants 433 participants 1297 participants
Puerto Rico
2
   0.5%
1
   0.2%
2
   0.5%
5
   0.4%
United States
124
  28.7%
141
  32.6%
129
  29.8%
394
  30.4%
United Kingdom
31
   7.2%
29
   6.7%
39
   9.0%
99
   7.6%
Iceland
4
   0.9%
3
   0.7%
3
   0.7%
10
   0.8%
Russia
50
  11.6%
52
  12.0%
61
  14.1%
163
  12.6%
Spain
45
  10.4%
33
   7.6%
48
  11.1%
126
   9.7%
Canada
30
   6.9%
13
   3.0%
26
   6.0%
69
   5.3%
Netherlands
6
   1.4%
4
   0.9%
6
   1.4%
16
   1.2%
Belgium
12
   2.8%
8
   1.9%
10
   2.3%
30
   2.3%
Denmark
34
   7.9%
42
   9.7%
32
   7.4%
108
   8.3%
Poland
6
   1.4%
9
   2.1%
5
   1.2%
20
   1.5%
Israel
13
   3.0%
11
   2.5%
5
   1.2%
29
   2.2%
Australia
36
   8.3%
38
   8.8%
27
   6.2%
101
   7.8%
France
29
   6.7%
28
   6.5%
28
   6.5%
85
   6.6%
Germany
3
   0.7%
13
   3.0%
6
   1.4%
22
   1.7%
Estonia
7
   1.6%
7
   1.6%
6
   1.4%
20
   1.5%
Randomization Stratum   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 432 participants 432 participants 433 participants 1297 participants
PSA < 50 ng/mL and LDH < 200 U/L
168
  38.9%
168
  38.9%
168
  38.8%
504
  38.9%
PSA < 50 ng/mL and LDH >= 200 U/L
135
  31.3%
135
  31.3%
135
  31.2%
405
  31.2%
PSA >= 50 ng/mL and LDH < 200 U/L
65
  15.0%
64
  14.8%
64
  14.8%
193
  14.9%
PSA >= 50 ng/mL and LDH >= 200 U/L
64
  14.8%
65
  15.0%
66
  15.2%
195
  15.0%
[1]
Measure Description: Randomization stratum based on PSA 50ng/mL cut and LDH 200 U/L cut at baseline.
1.Primary Outcome
Title Overall Survival
Hide Description The time between the date of randomization and the date of death due to any cause. Subjects who did not experience death or the competing events of “definite” loss to follow-up or withdrawal of consent were right censored at the date of last contact. OS was calculated using the formula: OS = Date of death/competing event/censoring - date of randomization + 1.
Time Frame Randomization through the date of death due to any cause. Subjects were followed up for approximately 6 years from the first subject randomized to the completion of the study.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat, including all randomized subjects.
Arm/Group Title PROSTVAC-V/F-TRICOM + GM-CSF Placebo PROSTVAC-V/F-TRICOM + GM-CSF Placebo Control
Hide Arm/Group Description:
PROSTVAC V/F + Placebo GM-CSF, where PROSTVAC V is given SC at 2x10^8 Inf.U/0.5mL (Day 1) and PROSTVAC F is given SC at 1x10^9 Inf.U/0.5mL (Weeks 3, 5, 9, 13, 17, 21). Placebo GM-CSF was saline for injection (on days of PROSTVAC injection and three subsequent days).
PROSTVAC V/F + GM-CSF, where PROSTVAC V is given SC at 2x10^8 Inf.U/0.5mL (Day 1) and PROSTVAC F is given SC at 1x10^9 Inf.U/0.5mL (Weeks 3, 5, 9, 13, 17, 21). GM-CSF is given SC at 100ug (on days of PROSTVAC injection and three subsequent days).
Placebo PROSTVAC V/F + Placebo GM-CSF, where Placebo PROSTVAC V/F is an empty fowlpox vector (Day 1, Weeks 3, 5, 9, 13, 17, 21). Placebo GM-CSF was saline for injection (on days of PROSTVAC injection and three subsequent days).
Overall Number of Participants Analyzed 432 432 433
Median (95% Confidence Interval)
Unit of Measure: Months
34.4
(31.0 to 36.9)
33.2
(30.6 to 37.4)
34.3
(30.7 to 37.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PROSTVAC-V/F-TRICOM + GM-CSF Placebo, Placebo Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments One-sided p-value is from a stratified log-rank test for PROSTVAC-V/F-TRICOM + GM-CSF placebo vs. Placebo Control with Treatment Arm included in model. Stratification is by randomization strata.
Statistical Test of Hypothesis P-Value 0.4742
Comments The overall type-one error probability for the entire trial was designed as a one-sided P=0.025. There were two main overall comparisons, which necessitated a type-one error probability to 0.0125 for each comparison using a Bonferroni correction.
Method Log Rank
Comments The primary analysis method was a stratified log-rank test, and was performed using the ITT Set analyzing data according to the randomized arm.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PROSTVAC-V/F-TRICOM + GM-CSF, Placebo Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments One-sided p-value is from a stratified log-rank test for PROSTVAC-V/F-TRICOM + GM-CSF vs. Placebo Control with Treatment Arm included in model. Stratification is by randomization strata.
Statistical Test of Hypothesis P-Value 0.5885
Comments The overall type-one error probability for the entire trial was designed as a one-sided P=0.025. There were two main overall comparisons, which necessitated a type-one error probability to 0.0125 for each comparison using a Bonferroni correction.
Method Log Rank
Comments The primary analysis method was a stratified log-rank test, and was performed using the ITT Set analyzing data according to the randomized arm.
2.Secondary Outcome
Title Number of Subjects Alive Without Event at 6 Months
Hide Description

A binary assessment that was performed for the 6-months timepoint for the categories of radiographic progression, pain progression, initiation of chemotherapy or death. Subjects without an event prior to 6-months were evaluated at 6-months. Subjects without event by 6-months and were not evaluated at 6-months were assumed to have had an event and analyzed as such.

Progression events were defined as: (1) Two new lesions on bone scan, new metastases on CT scans, or an increased size of nodal lesions per RECIST 1.1. Bone or CT scans occurring prior to calendar month 6 were used to determine radiographic progression. (2) Introduction of scheduled opioid narcotics for cancer-related pain control. (3) Initiation of chemotherapy for prostate cancer was assessed as collected on progression forms as well as in cancer treatment and concomitant medications logs. (4) Death.

Time Frame Randomization through Week 25/End of Treatment visit.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat, including all randomized subjects.
Arm/Group Title PROSTVAC-V/F-TRICOM + GM-CSF Placebo PROSTVAC-V/F-TRICOM + GM-CSF Placebo Control
Hide Arm/Group Description:
PROSTVAC V/F + Placebo GM-CSF, where PROSTVAC V is given SC at 2x10^8 Inf.U/0.5mL (Day 1) and PROSTVAC F is given SC at 1x10^9 Inf.U/0.5mL (Weeks 3, 5, 9, 13, 17, 21). Placebo GM-CSF was saline for injection (on days of PROSTVAC injection and three subsequent days).
PROSTVAC V/F + GM-CSF, where PROSTVAC V is given SC at 2x10^8 Inf.U/0.5mL (Day 1) and PROSTVAC F is given SC at 1x10^9 Inf.U/0.5mL (Weeks 3, 5, 9, 13, 17, 21). GM-CSF is given SC at 100ug (on days of PROSTVAC injection and three subsequent days).
Placebo PROSTVAC V/F + Placebo GM-CSF, where Placebo PROSTVAC V/F is an empty fowlpox vector (Day 1, Weeks 3, 5, 9, 13, 17, 21). Placebo GM-CSF was saline for injection (on days of PROSTVAC injection and three subsequent days).
Overall Number of Participants Analyzed 432 432 433
Measure Type: Count of Participants
Unit of Measure: Participants
127
  29.4%
121
  28.0%
131
  30.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PROSTVAC-V/F-TRICOM + GM-CSF Placebo, Placebo Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Odds Ratio and Wald 95% CI estimates are for odds of alive without event for PROSTVAC-V/F-TRICOM + GM-CSF placebo vs. Placebo Control and are from a logistic regression model with Treatment Arm included in model stratified by randomization strata.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.9588
Confidence Interval (2-Sided) 95%
0.7144 to 1.2867
Estimation Comments The Alive Without Event endpoint was analyzed using stratified logistic regression. The 95% CI on the odds ratio estimate was computed as the measure of the magnitude of effect.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PROSTVAC-V/F-TRICOM + GM-CSF, Placebo Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Odds Ratio and Wald 95% CI estimates are for odds of alive without event for PROSTVAC-V/F-TRICOM + GM-CSF vs. Placebo Control and are from a logistic regression model with Treatment Arm included in model stratified by randomization strata.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.8941
Confidence Interval (2-Sided) 95%
0.6647 to 1.2026
Estimation Comments The Alive Without Event endpoint was analyzed using stratified logistic regression. The 95% CI on the odds ratio estimate was computed as the measure of the magnitude of effect.
Time Frame Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study.
Adverse Event Reporting Description An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
 
Arm/Group Title PROSTVAC-V/F-TRICOM + GM-CSF Placebo PROSTVAC-V/F-TRICOM + GM-CSF Placebo Control
Hide Arm/Group Description PROSTVAC V/F + Placebo GM-CSF, where PROSTVAC V is given SC at 2x10^8 Inf.U/0.5mL (Day 1) and PROSTVAC F is given SC at 1x10^9 Inf.U/0.5mL (Weeks 3, 5, 9, 13, 17, 21). Placebo GM-CSF was saline for injection (on days of PROSTVAC injection and three subsequent days). PROSTVAC V/F + GM-CSF, where PROSTVAC V is given SC at 2x10^8 Inf.U/0.5mL (Day 1) and PROSTVAC F is given SC at 1x10^9 Inf.U/0.5mL (Weeks 3, 5, 9, 13, 17, 21). GM-CSF is given SC at 100ug (on days of PROSTVAC injection and three subsequent days). Placebo PROSTVAC V/F + Placebo GM-CSF, where Placebo PROSTVAC V/F is an empty fowlpox vector (Day 1, Weeks 3, 5, 9, 13, 17, 21). Placebo GM-CSF was saline for injection (on days of PROSTVAC injection and three subsequent days).
All-Cause Mortality
PROSTVAC-V/F-TRICOM + GM-CSF Placebo PROSTVAC-V/F-TRICOM + GM-CSF Placebo Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   252/432 (58.33%)      254/432 (58.80%)      248/433 (57.27%)    
Show Serious Adverse Events Hide Serious Adverse Events
PROSTVAC-V/F-TRICOM + GM-CSF Placebo PROSTVAC-V/F-TRICOM + GM-CSF Placebo Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   56/429 (13.05%)      56/429 (13.05%)      53/428 (12.38%)    
Blood and lymphatic system disorders       
Anaemia * 1  1/429 (0.23%)  1 1/429 (0.23%)  1 1/428 (0.23%)  1
Disseminated intravascular coagulation * 1  0/429 (0.00%)  0 1/429 (0.23%)  1 1/428 (0.23%)  1
Febrile neutropenia * 1  1/429 (0.23%)  1 0/429 (0.00%)  0 0/428 (0.00%)  0
Haemolytic uraemic syndrome * 1  0/429 (0.00%)  0 1/429 (0.23%)  1 0/428 (0.00%)  0
Histiocytosis haematophagic * 1  1/429 (0.23%)  1 0/429 (0.00%)  0 0/428 (0.00%)  0
Normochromic normocytic anaemia * 1  0/429 (0.00%)  0 0/429 (0.00%)  0 1/428 (0.23%)  1
Thrombocytopenia * 1  0/429 (0.00%)  0 0/429 (0.00%)  0 1/428 (0.23%)  1
Cardiac disorders       
Acute coronary syndrome * 1  0/429 (0.00%)  0 1/429 (0.23%)  1 1/428 (0.23%)  1
Acute myocardial infarction * 1  0/429 (0.00%)  0 1/429 (0.23%)  1 0/428 (0.00%)  0
Angina pectoris * 1  0/429 (0.00%)  0 0/429 (0.00%)  0 1/428 (0.23%)  1
Arrhythmia supraventricular * 1  0/429 (0.00%)  0 0/429 (0.00%)  0 1/428 (0.23%)  1
Atrial fibrillation * 1  0/429 (0.00%)  0 0/429 (0.00%)  0 3/428 (0.70%)  4
Atrial flutter * 1  1/429 (0.23%)  1 0/429 (0.00%)  0 1/428 (0.23%)  1
Cardiac failure * 1  2/429 (0.47%)  2 1/429 (0.23%)  1 0/428 (0.00%)  0
Mitral valve incompetence * 1  0/429 (0.00%)  0 1/429 (0.23%)  1 0/428 (0.00%)  0
Myocardial infarction * 1  1/429 (0.23%)  1 1/429 (0.23%)  1 0/428 (0.00%)  0
Myocardial ischaemia * 1  1/429 (0.23%)  1 0/429 (0.00%)  0 0/428 (0.00%)  0
Supraventricular tachycardia * 1  0/429 (0.00%)  0 0/429 (0.00%)  0 1/428 (0.23%)  1
Ear and labyrinth disorders       
Vertigo * 1  0/429 (0.00%)  0 1/429 (0.23%)  1 0/428 (0.00%)  0
Eye disorders       
Retinal detachment * 1  1/429 (0.23%)  2 0/429 (0.00%)  0 0/428 (0.00%)  0
Gastrointestinal disorders       
Abdominal pain * 1  0/429 (0.00%)  0 1/429 (0.23%)  1 1/428 (0.23%)  1
Abdominal pain upper * 1  0/429 (0.00%)  0 0/429 (0.00%)  0 1/428 (0.23%)  1
Anal haemorrhage * 1  0/429 (0.00%)  0 0/429 (0.00%)  0 1/428 (0.23%)  1
Constipation * 1  0/429 (0.00%)  0 0/429 (0.00%)  0 1/428 (0.23%)  1
Diarrhoea * 1  0/429 (0.00%)  0 1/429 (0.23%)  1 0/428 (0.00%)  0
Gastritis * 1  0/429 (0.00%)  0 0/429 (0.00%)  0 1/428 (0.23%)  1
Ileus * 1  0/429 (0.00%)  0 0/429 (0.00%)  0 1/428 (0.23%)  1
Ileus paralytic * 1  1/429 (0.23%)  1 0/429 (0.00%)  0 0/428 (0.00%)  0
Inguinal hernia * 1  1/429 (0.23%)  1 0/429 (0.00%)  0 0/428 (0.00%)  0
Inguinal hernia strangulated * 1  1/429 (0.23%)  1 0/429 (0.00%)  0 0/428 (0.00%)  0
Intestinal obstruction * 1  0/429 (0.00%)  0 0/429 (0.00%)  0 1/428 (0.23%)  1
Large intestinal obstruction * 1  1/429 (0.23%)  1 0/429 (0.00%)  0 0/428 (0.00%)  0
Nausea * 1  0/429 (0.00%)  0 1/429 (0.23%)  1 2/428 (0.47%)  2
Oesophageal varices haemorrhage * 1  0/429 (0.00%)  0 1/429 (0.23%)  1 0/428 (0.00%)  0
Proctitis * 1  0/429 (0.00%)  0 0/429 (0.00%)  0 1/428 (0.23%)  1
Vomiting * 1  2/429 (0.47%)  2 0/429 (0.00%)  0 0/428 (0.00%)  0
General disorders       
Death * 1  0/429 (0.00%)  0 0/429 (0.00%)  0 1/428 (0.23%)  1
General physical health deterioration * 1  1/429 (0.23%)  1 0/429 (0.00%)  0 0/428 (0.00%)  0
Non-cardiac chest pain * 1  0/429 (0.00%)  0 0/429 (0.00%)  0 1/428 (0.23%)  1
Pain * 1  0/429 (0.00%)  0 2/429 (0.47%)  2 0/428 (0.00%)  0
Pyrexia * 1  1/429 (0.23%)  1 0/429 (0.00%)  0 1/428 (0.23%)  1
Hepatobiliary disorders       
Cholelithiasis * 1  1/429 (0.23%)  1 0/429 (0.00%)  0 1/428 (0.23%)  1
Infections and infestations       
Appendiceal abscess * 1  0/429 (0.00%)  0 1/429 (0.23%)  1 0/428 (0.00%)  0
Bacterial infection * 1  0/429 (0.00%)  0 0/429 (0.00%)  0 1/428 (0.23%)  1
Bronchopneumonia * 1  1/429 (0.23%)  1 0/429 (0.00%)  0 0/428 (0.00%)  0
Catheter site infection * 1  0/429 (0.00%)  0 0/429 (0.00%)  0 1/428 (0.23%)  1
Cellulitis * 1  0/429 (0.00%)  0 1/429 (0.23%)  1 0/428 (0.00%)  0
Gastroenteritis * 1  0/429 (0.00%)  0 0/429 (0.00%)  0 1/428 (0.23%)  1
Gastroenteritis viral * 1  1/429 (0.23%)  1 0/429 (0.00%)  0 0/428 (0.00%)  0
Lobar pneumonia * 1  0/429 (0.00%)  0 0/429 (0.00%)  0 1/428 (0.23%)  1
Oral candidiasis * 1  0/429 (0.00%)  0 1/429 (0.23%)  1 0/428 (0.00%)  0
Perinephric abscess * 1  0/429 (0.00%)  0 0/429 (0.00%)  0 1/428 (0.23%)  1
Pneumonia * 1  1/429 (0.23%)  1 2/429 (0.47%)  2 1/428 (0.23%)  1
Pyelonephritis * 1  1/429 (0.23%)  1 1/429 (0.23%)  1 0/428 (0.00%)  0
Sepsis * 1  1/429 (0.23%)  1 1/429 (0.23%)  1 0/428 (0.00%)  0
Spinal cord infection * 1  0/429 (0.00%)  0 2/429 (0.47%)  2 0/428 (0.00%)  0
Staphylococcal sepsis * 1  0/429 (0.00%)  0 0/429 (0.00%)  0 1/428 (0.23%)  1
Urinary tract infection * 1  1/429 (0.23%)  1 3/429 (0.70%)  3 1/428 (0.23%)  1
Urosepsis * 1  2/429 (0.47%)  3 0/429 (0.00%)  0 2/428 (0.47%)  2
Viral infection * 1  0/429 (0.00%)  0 1/429 (0.23%)  1 1/428 (0.23%)  1
Injury, poisoning and procedural complications       
Brain herniation * 1  0/429 (0.00%)  0 0/429 (0.00%)  0 1/428 (0.23%)  1
Cervical vertebral fracture * 1  0/429 (0.00%)  0 1/429 (0.23%)  1 0/428 (0.00%)  0
Cystitis radiation * 1  1/429 (0.23%)  1 0/429 (0.00%)  0 0/428 (0.00%)  0
Fall * 1  0/429 (0.00%)  0 1/429 (0.23%)  1 0/428 (0.00%)  0
Gun shot wound * 1  1/429 (0.23%)  1 0/429 (0.00%)  0 0/428 (0.00%)  0
Hepatic haematoma * 1  0/429 (0.00%)  0 1/429 (0.23%)  1 0/428 (0.00%)  0
Humerus fracture * 1  0/429 (0.00%)  0 1/429 (0.23%)  1 0/428 (0.00%)  0
Post procedural haematuria * 1  0/429 (0.00%)  0 0/429 (0.00%)  0 1/428 (0.23%)  1
Radiation oesophagitis * 1  1/429 (0.23%)  1 1/429 (0.23%)  1 0/428 (0.00%)  0
Spinal cord injury * 1  1/429 (0.23%)  1 0/429 (0.00%)  0 1/428 (0.23%)  1
Sternal fracture * 1  1/429 (0.23%)  1 0/429 (0.00%)  0 0/428 (0.00%)  0
Toxicity to various agents * 1  0/429 (0.00%)  0 1/429 (0.23%)  1 0/428 (0.00%)  0
Upper limb fracture * 1  0/429 (0.00%)  0 1/429 (0.23%)  1 0/428 (0.00%)  0
Vascular bypass dysfunction * 1  0/429 (0.00%)  0 1/429 (0.23%)  1 0/428 (0.00%)  0
Investigations       
Blood creatinine increased * 1  0/429 (0.00%)  0 0/429 (0.00%)  0 1/428 (0.23%)  1
Troponin increased * 1  1/429 (0.23%)  1 0/429 (0.00%)  0 0/428 (0.00%)  0
Metabolism and nutrition disorders       
Cell death * 1  1/429 (0.23%)  1 0/429 (0.00%)  0 0/428 (0.00%)  0
Dehydration * 1  0/429 (0.00%)  0 1/429 (0.23%)  1 1/428 (0.23%)  1
Diabetes mellitus * 1  1/429 (0.23%)  1 0/429 (0.00%)  0 0/428 (0.00%)  0
Gout * 1  0/429 (0.00%)  0 1/429 (0.23%)  1 0/428 (0.00%)  0
Hyponatraemia * 1  0/429 (0.00%)  0 1/429 (0.23%)  1 0/428 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Back pain * 1  0/429 (0.00%)  0 0/429 (0.00%)  0 1/428 (0.23%)  1
Bone pain * 1  1/429 (0.23%)  1 1/429 (0.23%)  1 0/428 (0.00%)  0
Pathological fracture * 1  0/429 (0.00%)  0 1/429 (0.23%)  1 2/428 (0.47%)  2
Rhabdomyolysis * 1  0/429 (0.00%)  0 1/429 (0.23%)  1 0/428 (0.00%)  0
Spinal osteoarthritis * 1  1/429 (0.23%)  1 0/429 (0.00%)  0 0/428 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Carcinoma in situ of skin * 1  1/429 (0.23%)  1 0/429 (0.00%)  0 0/428 (0.00%)  0
Colon cancer * 1  0/429 (0.00%)  0 1/429 (0.23%)  1 0/428 (0.00%)  0
Lung neoplasm malignant * 1  0/429 (0.00%)  0 1/429 (0.23%)  1 1/428 (0.23%)  1
Metastases to central nervous system * 1  1/429 (0.23%)  1 1/429 (0.23%)  1 1/428 (0.23%)  1
Metastases to meninges * 1  0/429 (0.00%)  0 1/429 (0.23%)  1 0/428 (0.00%)  0
Metastatic pain * 1  0/429 (0.00%)  0 1/429 (0.23%)  1 2/428 (0.47%)  2
Neuroendocrine carcinoma of the skin * 1  0/429 (0.00%)  0 0/429 (0.00%)  0 1/428 (0.23%)  1
Renal cell carcinoma * 1  1/429 (0.23%)  1 0/429 (0.00%)  0 0/428 (0.00%)  0
Squamous cell carcinoma of skin * 1  0/429 (0.00%)  0 1/429 (0.23%)  1 0/428 (0.00%)  0
Tumour pain * 1  0/429 (0.00%)  0 0/429 (0.00%)  0 1/428 (0.23%)  1
Nervous system disorders       
Carotid artery stenosis * 1  1/429 (0.23%)  1 0/429 (0.00%)  0 0/428 (0.00%)  0
Cerebral haematoma * 1  1/429 (0.23%)  1 0/429 (0.00%)  0 0/428 (0.00%)  0
Cerebral haemorrhage * 1  0/429 (0.00%)  0 1/429 (0.23%)  1 1/428 (0.23%)  1
Cerebrovascular accident * 1  1/429 (0.23%)  1 2/429 (0.47%)  2 1/428 (0.23%)  2
Cervical cord compression * 1  1/429 (0.23%)  1 0/429 (0.00%)  0 0/428 (0.00%)  0
Ischaemic stroke * 1  1/429 (0.23%)  1 2/429 (0.47%)  2 0/428 (0.00%)  0
Nerve compression * 1  1/429 (0.23%)  1 0/429 (0.00%)  0 0/428 (0.00%)  0
Peripheral motor neuropathy * 1  0/429 (0.00%)  0 1/429 (0.23%)  1 0/428 (0.00%)  0
Presyncope * 1  1/429 (0.23%)  1 0/429 (0.00%)  0 0/428 (0.00%)  0
Radiculopathy * 1  0/429 (0.00%)  0 1/429 (0.23%)  1 0/428 (0.00%)  0
Spinal cord compression * 1  1/429 (0.23%)  1 4/429 (0.93%)  4 2/428 (0.47%)  2
Syncope * 1  1/429 (0.23%)  1 0/429 (0.00%)  0 2/428 (0.47%)  2
Transient ischaemic attack * 1  1/429 (0.23%)  1 0/429 (0.00%)  0 0/428 (0.00%)  0
Psychiatric disorders       
Confusional state * 1  0/429 (0.00%)  0 1/429 (0.23%)  1 0/428 (0.00%)  0
Delirium * 1  0/429 (0.00%)  0 0/429 (0.00%)  0 1/428 (0.23%)  1
Renal and urinary disorders       
Acute kidney injury * 1  1/429 (0.23%)  1 1/429 (0.23%)  1 1/428 (0.23%)  1
Dysuria * 1  1/429 (0.23%)  1 0/429 (0.00%)  0 0/428 (0.00%)  0
Haematuria * 1  2/429 (0.47%)  4 7/429 (1.63%)  8 4/428 (0.93%)  4
Hydronephrosis * 1  5/429 (1.17%)  5 1/429 (0.23%)  1 2/428 (0.47%)  2
Obstructive uropathy * 1  0/429 (0.00%)  0 0/429 (0.00%)  0 1/428 (0.23%)  1
Pyelocaliectasis * 1  0/429 (0.00%)  0 1/429 (0.23%)  1 0/428 (0.00%)  0
Renal failure * 1  2/429 (0.47%)  3 0/429 (0.00%)  0 0/428 (0.00%)  0
Ureteric obstruction * 1  0/429 (0.00%)  0 0/429 (0.00%)  0 1/428 (0.23%)  1
Urethral stenosis * 1  0/429 (0.00%)  0 1/429 (0.23%)  1 2/428 (0.47%)  2
Urinary bladder haemorrhage * 1  1/429 (0.23%)  1 0/429 (0.00%)  0 0/428 (0.00%)  0
Urinary retention * 1  6/429 (1.40%)  6 4/429 (0.93%)  4 1/428 (0.23%)  1
Urinary tract obstruction * 1  1/429 (0.23%)  1 2/429 (0.47%)  2 0/428 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Acute respiratory failure * 1  0/429 (0.00%)  0 1/429 (0.23%)  1 0/428 (0.00%)  0
Bronchiectasis * 1  0/429 (0.00%)  0 0/429 (0.00%)  0 1/428 (0.23%)  1
Pleural effusion * 1  0/429 (0.00%)  0 1/429 (0.23%)  1 0/428 (0.00%)  0
Pulmonary embolism * 1  5/429 (1.17%)  5 1/429 (0.23%)  1 0/428 (0.00%)  0
Pulmonary oedema * 1  0/429 (0.00%)  0 0/429 (0.00%)  0 1/428 (0.23%)  1
Vascular disorders       
Aortic aneurysm * 1  0/429 (0.00%)  0 1/429 (0.23%)  1 0/428 (0.00%)  0
Aortic stenosis * 1  1/429 (0.23%)  1 0/429 (0.00%)  0 1/428 (0.23%)  1
Intermittent claudication * 1  0/429 (0.00%)  0 0/429 (0.00%)  0 1/428 (0.23%)  1
Lymphoedema * 1  0/429 (0.00%)  0 1/429 (0.23%)  1 0/428 (0.00%)  0
Vascular compression * 1  1/429 (0.23%)  1 0/429 (0.00%)  0 0/428 (0.00%)  0
Venous thrombosis limb * 1  0/429 (0.00%)  0 0/429 (0.00%)  0 1/428 (0.23%)  1
1
Term from vocabulary, MedDRA (18.0)
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PROSTVAC-V/F-TRICOM + GM-CSF Placebo PROSTVAC-V/F-TRICOM + GM-CSF Placebo Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   351/429 (81.82%)      367/429 (85.55%)      346/428 (80.84%)    
Gastrointestinal disorders       
Constipation * 1  39/429 (9.09%)  44 26/429 (6.06%)  29 28/428 (6.54%)  31
Diarrhoea * 1  38/429 (8.86%)  41 28/429 (6.53%)  31 21/428 (4.91%)  22
Nausea * 1  51/429 (11.89%)  65 51/429 (11.89%)  62 36/428 (8.41%)  41
General disorders       
Asthenia * 1  32/429 (7.46%)  46 37/429 (8.62%)  50 49/428 (11.45%)  52
Chills * 1  34/429 (7.93%)  50 44/429 (10.26%)  60 35/428 (8.18%)  42
Fatigue * 1  94/429 (21.91%)  117 105/429 (24.48%)  149 91/428 (21.26%)  116
Influenza like illness * 1  44/429 (10.26%)  68 55/429 (12.82%)  86 36/428 (8.41%)  63
Injection site erythema * 1  201/429 (46.85%)  594 256/429 (59.67%)  765 200/428 (46.73%)  626
Injection site induration * 1  46/429 (10.72%)  98 67/429 (15.62%)  140 58/428 (13.55%)  128
Injection site oedema * 1  22/429 (5.13%)  41 23/429 (5.36%)  47 19/428 (4.44%)  45
Injection site pain * 1  109/429 (25.41%)  252 128/429 (29.84%)  247 119/428 (27.80%)  247
Injection site pruritus * 1  77/429 (17.95%)  145 109/429 (25.41%)  235 57/428 (13.32%)  124
Injection site swelling * 1  73/429 (17.02%)  187 101/429 (23.54%)  247 67/428 (15.65%)  183
Injection site warmth * 1  15/429 (3.50%)  31 28/429 (6.53%)  55 21/428 (4.91%)  38
Oedema peripheral * 1  21/429 (4.90%)  22 24/429 (5.59%)  24 12/428 (2.80%)  12
Pyrexia * 1  37/429 (8.62%)  50 91/429 (21.21%)  142 53/428 (12.38%)  63
Infections and infestations       
Urinary tract infection * 1  23/429 (5.36%)  28 17/429 (3.96%)  22 22/428 (5.14%)  28
Metabolism and nutrition disorders       
Decreased appetite * 1  39/429 (9.09%)  43 25/429 (5.83%)  29 31/428 (7.24%)  33
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  49/429 (11.42%)  70 50/429 (11.66%)  69 55/428 (12.85%)  71
Back pain * 1  62/429 (14.45%)  70 43/429 (10.02%)  46 48/428 (11.21%)  55
Musculoskeletal pain * 1  15/429 (3.50%)  15 28/429 (6.53%)  33 21/428 (4.91%)  27
Myalgia * 1  36/429 (8.39%)  46 35/429 (8.16%)  47 43/428 (10.05%)  61
Pain in extremity * 1  28/429 (6.53%)  34 28/429 (6.53%)  28 23/428 (5.37%)  26
Nervous system disorders       
Dizziness * 1  18/429 (4.20%)  20 17/429 (3.96%)  19 22/428 (5.14%)  25
Headache * 1  32/429 (7.46%)  67 43/429 (10.02%)  61 36/428 (8.41%)  45
Respiratory, thoracic and mediastinal disorders       
Cough * 1  25/429 (5.83%)  26 20/429 (4.66%)  24 15/428 (3.50%)  16
Vascular disorders       
Hot flush * 1  23/429 (5.36%)  24 20/429 (4.66%)  21 12/428 (2.80%)  15
Hypertension * 1  28/429 (6.53%)  33 23/429 (5.36%)  26 22/428 (5.14%)  25
1
Term from vocabulary, MedDRA (18.0)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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: Program Lead, Clinical Operations
Organization: Bavarian Nordic A/S
Phone: + 45 3326 ext 8383
EMail: info@bavarian-nordic.com
Layout table for additonal information
Responsible Party: Bavarian Nordic
ClinicalTrials.gov Identifier: NCT01322490     History of Changes
Other Study ID Numbers: BNIT-PRV-301
First Submitted: March 23, 2011
First Posted: March 24, 2011
Results First Submitted: July 16, 2019
Results First Posted: August 8, 2019
Last Update Posted: September 4, 2019