Trial Outcomes & Findings for A Pilot Study of Vaccination With Epitope-Enhanced TARP Peptide and TARP Peptide-Pulsed Dendritic Cells in the Treatment of Stage D0 Prostate Cancer (NCT NCT00972309)
NCT ID: NCT00972309
Last Updated: 2022-10-12
Results Overview
The number of participants in each arm with positive response determined by 3-fold increase over baseline in the number of positive cells by interferon (IFN) gamma enzyme-linked immunosorbent spot (ELISpot) at week 24. Presence of tumor antigen-specific T cells (positive response) mean the vaccine was able to generate immune response (i.e. immunogenicity) which is a good outcome.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
41 participants
Primary outcome timeframe
Week 24
Results posted on
2022-10-12
Participant Flow
Participant milestones
| Measure |
Arm A Montanide ISA 51 VG and Granulocyte-macrophage Colony-stimulating Factor (GM-CSF)
T-cell receptor alternate reading frame protein (TARP) peptide vaccine: Will receive an admixture of the wildtype and epitope enhanced TARP peptides emulsified with Montanide ISA 51 VG and granulocyte-macrophage colony-stimulating factor (GM-CSF). TARP peptide will be administered subcutaneously at weeks 3, 6, 9, 12 and 15 for a total of five vaccinations with a booster dose of vaccine at Weeks 48 and 96.
|
Arm B Autologous Dendritic Cell Vaccine
T-cell receptor alternate reading frame protein (TARP) dendritic cell vaccine: Will receive peptide pulsed dendritic cells administered intradermally in two vaccination sites. TARP pulsed dendritic cells will be administered at weeks 3, 6, 9, 12 and 15 for a total of five vaccinations with a booster dose of vaccine at Weeks 48 and 96.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
|
Overall Study
COMPLETED
|
9
|
7
|
|
Overall Study
NOT COMPLETED
|
12
|
13
|
Reasons for withdrawal
| Measure |
Arm A Montanide ISA 51 VG and Granulocyte-macrophage Colony-stimulating Factor (GM-CSF)
T-cell receptor alternate reading frame protein (TARP) peptide vaccine: Will receive an admixture of the wildtype and epitope enhanced TARP peptides emulsified with Montanide ISA 51 VG and granulocyte-macrophage colony-stimulating factor (GM-CSF). TARP peptide will be administered subcutaneously at weeks 3, 6, 9, 12 and 15 for a total of five vaccinations with a booster dose of vaccine at Weeks 48 and 96.
|
Arm B Autologous Dendritic Cell Vaccine
T-cell receptor alternate reading frame protein (TARP) dendritic cell vaccine: Will receive peptide pulsed dendritic cells administered intradermally in two vaccination sites. TARP pulsed dendritic cells will be administered at weeks 3, 6, 9, 12 and 15 for a total of five vaccinations with a booster dose of vaccine at Weeks 48 and 96.
|
|---|---|---|
|
Overall Study
Switched to alternative treatment
|
0
|
2
|
|
Overall Study
Refused further treatment
|
0
|
1
|
|
Overall Study
Late determination of ineligibility
|
0
|
1
|
|
Overall Study
Second malignancy
|
1
|
1
|
|
Overall Study
Visa issues
|
0
|
1
|
|
Overall Study
Secondary cancer (SCC)
|
0
|
1
|
|
Overall Study
Met off study prostate specific antigen doubling time (PSADT) criteria
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Disease progression on study
|
10
|
4
|
Baseline Characteristics
A Pilot Study of Vaccination With Epitope-Enhanced TARP Peptide and TARP Peptide-Pulsed Dendritic Cells in the Treatment of Stage D0 Prostate Cancer
Baseline characteristics by cohort
| Measure |
Arm A Montanide ISA 51 VG and Granulocyte-macrophage Colony-stimulating Factor (GM-CSF)
n=21 Participants
T-cell receptor alternate reading frame protein (TARP) peptide vaccine: Will receive an admixture of the wildtype and epitope enhanced TARP peptides emulsified with Montanide ISA 51 VG and granulocyte-macrophage colony-stimulating factor (GM-CSF). TARP peptide will be administered subcutaneously at weeks 3, 6, 9, 12 and 15 for a total of five vaccinations with a booster dose of vaccine at Weeks 48 and 96.
|
Arm B Autologous Dendritic Cell Vaccine
n=20 Participants
T-cell receptor alternate reading frame protein (TARP) dendritic cell vaccine: Will receive peptide pulsed dendritic cells administered intradermally in two vaccination sites. TARP pulsed dendritic cells will be administered at weeks 3, 6, 9, 12 and 15 for a total of five vaccinations with a booster dose of vaccine at Weeks 48 and 96.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Continuous
|
63.58 years
STANDARD_DEVIATION 6.84 • n=5 Participants
|
62.67 years
STANDARD_DEVIATION 7.4 • n=7 Participants
|
63.14 years
STANDARD_DEVIATION 7.04 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
20 participants
n=7 Participants
|
41 participants
n=5 Participants
|
|
Baseline Prostate-Specific Antigen (PSA)
|
3.44 ng/mL
n=5 Participants
|
2.74 ng/mL
n=7 Participants
|
3.44 ng/mL
n=5 Participants
|
|
Pre-Treatment Slope Log Prostate-Specific Antigen (PSA)
|
0.087 Slope log
n=5 Participants
|
0.110 Slope log
n=7 Participants
|
0.101 Slope log
n=5 Participants
|
|
Pre-Treatment Prostate-Specific Antigen Doubling Time (PSADT)
|
8.0 Months
n=5 Participants
|
6.3 Months
n=7 Participants
|
6.9 Months
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: 8/21 participants in Arm A and 4/20 participants in Arm B did not have samples available to analyze.
The number of participants in each arm with positive response determined by 3-fold increase over baseline in the number of positive cells by interferon (IFN) gamma enzyme-linked immunosorbent spot (ELISpot) at week 24. Presence of tumor antigen-specific T cells (positive response) mean the vaccine was able to generate immune response (i.e. immunogenicity) which is a good outcome.
Outcome measures
| Measure |
Arm A Montanide ISA 51 VG and Granulocyte-macrophage Colony-stimulating Factor (GM-CSF)
n=13 Participants
T-cell receptor alternate reading frame protein (TARP) peptide vaccine: Will receive an admixture of the wildtype and epitope enhanced TARP peptides emulsified with Montanide ISA 51 VG and granulocyte-macrophage colony-stimulating factor (GM-CSF). TARP peptide will be administered subcutaneously at weeks 3, 6, 9, 12 and 15 for a total of five vaccinations with a booster dose of vaccine at Weeks 48 and 96.
|
Arm B Autologous Dendritic Cell Vaccine
n=16 Participants
T-cell receptor alternate reading frame protein (TARP) dendritic cell vaccine: Will receive peptide pulsed dendritic cells administered intradermally in two vaccination sites. TARP pulsed dendritic cells will be administered at weeks 3, 6, 9, 12 and 15 for a total of five vaccinations with a booster dose of vaccine at Weeks 48 and 96.
|
|---|---|---|
|
Number of Participants With a Positive Immune Response Following Vaccination Determined by Interferon (IFN) Gamma Enzyme-linked Immunosorbent Spot (ELISpot)
|
12 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.Adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life-threatening, and Grade 5 is death related to adverse event.
Outcome measures
| Measure |
Arm A Montanide ISA 51 VG and Granulocyte-macrophage Colony-stimulating Factor (GM-CSF)
n=21 Participants
T-cell receptor alternate reading frame protein (TARP) peptide vaccine: Will receive an admixture of the wildtype and epitope enhanced TARP peptides emulsified with Montanide ISA 51 VG and granulocyte-macrophage colony-stimulating factor (GM-CSF). TARP peptide will be administered subcutaneously at weeks 3, 6, 9, 12 and 15 for a total of five vaccinations with a booster dose of vaccine at Weeks 48 and 96.
|
Arm B Autologous Dendritic Cell Vaccine
n=20 Participants
T-cell receptor alternate reading frame protein (TARP) dendritic cell vaccine: Will receive peptide pulsed dendritic cells administered intradermally in two vaccination sites. TARP pulsed dendritic cells will be administered at weeks 3, 6, 9, 12 and 15 for a total of five vaccinations with a booster dose of vaccine at Weeks 48 and 96.
|
|---|---|---|
|
Grades 1-5 Adverse Events Possibly, Probably, or Definitely Related to Drug
No Grades 1-5 possibly and probably related to drug
|
0 Adverse Events
|
0 Adverse Events
|
|
Grades 1-5 Adverse Events Possibly, Probably, or Definitely Related to Drug
Grade 1 Injection site reaction/extravasation changes definitely related to drug
|
21 Adverse Events
|
0 Adverse Events
|
|
Grades 1-5 Adverse Events Possibly, Probably, or Definitely Related to Drug
Grade 2 Injection site reaction/extravasation changes definitely related to drug
|
15 Adverse Events
|
0 Adverse Events
|
|
Grades 1-5 Adverse Events Possibly, Probably, or Definitely Related to Drug
No Grades 3-5 definitely related to drug
|
0 Adverse Events
|
0 Adverse Events
|
PRIMARY outcome
Timeframe: Weeks 0, 12, 18 and 24A three-fold increase over baseline in the number of positive cells by tetramer staining OR Interferon (IFN)-gamma enzyme-linked immune absorbent spot (ELISPOT) assay was considered a positive immunological response.
Outcome measures
| Measure |
Arm A Montanide ISA 51 VG and Granulocyte-macrophage Colony-stimulating Factor (GM-CSF)
n=21 Participants
T-cell receptor alternate reading frame protein (TARP) peptide vaccine: Will receive an admixture of the wildtype and epitope enhanced TARP peptides emulsified with Montanide ISA 51 VG and granulocyte-macrophage colony-stimulating factor (GM-CSF). TARP peptide will be administered subcutaneously at weeks 3, 6, 9, 12 and 15 for a total of five vaccinations with a booster dose of vaccine at Weeks 48 and 96.
|
Arm B Autologous Dendritic Cell Vaccine
n=20 Participants
T-cell receptor alternate reading frame protein (TARP) dendritic cell vaccine: Will receive peptide pulsed dendritic cells administered intradermally in two vaccination sites. TARP pulsed dendritic cells will be administered at weeks 3, 6, 9, 12 and 15 for a total of five vaccinations with a booster dose of vaccine at Weeks 48 and 96.
|
|---|---|---|
|
Number of Participants With an Immunological Response of Chromium 51 (51Cr) Release Measured by Tetramer Staining OR Interferon (IFN)-Gamma Enzyme-linked Immune Absorbent Spot (ELISPOT) Assay
Week 12
|
21 Participants
|
14 Participants
|
|
Number of Participants With an Immunological Response of Chromium 51 (51Cr) Release Measured by Tetramer Staining OR Interferon (IFN)-Gamma Enzyme-linked Immune Absorbent Spot (ELISPOT) Assay
Week 24
|
21 Participants
|
13 Participants
|
|
Number of Participants With an Immunological Response of Chromium 51 (51Cr) Release Measured by Tetramer Staining OR Interferon (IFN)-Gamma Enzyme-linked Immune Absorbent Spot (ELISPOT) Assay
Week 0
|
21 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Weeks 12, 24, 36, and 48PSADT response is defined as: a \> 50% increase in calculated PSADT OR a PSADT \> 15 months. Participant's whose PSADT is decreased by \> 50% will be considered PSADT failures. Week 24 PSADT responders will be allowed to receive an additional dose of T-cell receptor alternate reading frame protein (TARP) peptide vaccine at Week 36.
Outcome measures
| Measure |
Arm A Montanide ISA 51 VG and Granulocyte-macrophage Colony-stimulating Factor (GM-CSF)
n=21 Participants
T-cell receptor alternate reading frame protein (TARP) peptide vaccine: Will receive an admixture of the wildtype and epitope enhanced TARP peptides emulsified with Montanide ISA 51 VG and granulocyte-macrophage colony-stimulating factor (GM-CSF). TARP peptide will be administered subcutaneously at weeks 3, 6, 9, 12 and 15 for a total of five vaccinations with a booster dose of vaccine at Weeks 48 and 96.
|
Arm B Autologous Dendritic Cell Vaccine
n=20 Participants
T-cell receptor alternate reading frame protein (TARP) dendritic cell vaccine: Will receive peptide pulsed dendritic cells administered intradermally in two vaccination sites. TARP pulsed dendritic cells will be administered at weeks 3, 6, 9, 12 and 15 for a total of five vaccinations with a booster dose of vaccine at Weeks 48 and 96.
|
|---|---|---|
|
PSA Doubling Time (PSADT) Response and Failure
Week 36: PSADT is decreased by > 50%
|
0 Participants
|
0 Participants
|
|
PSA Doubling Time (PSADT) Response and Failure
Week 48: PSADT is decreased by > 50%
|
0 Participants
|
0 Participants
|
|
PSA Doubling Time (PSADT) Response and Failure
Week 12: ≥ 50% increase in calculated PSADT OR a PSADT > 15 months
|
12 Participants
|
9 Participants
|
|
PSA Doubling Time (PSADT) Response and Failure
Week 24: ≥ 50% increase in calculated PSADT OR a PSADT > 15 months
|
13 Participants
|
11 Participants
|
|
PSA Doubling Time (PSADT) Response and Failure
Week 36: ≥ 50% increase in calculated PSADT OR a PSADT > 15 months
|
12 Participants
|
10 Participants
|
|
PSA Doubling Time (PSADT) Response and Failure
Week 48: ≥ 50% increase in calculated PSADT OR a PSADT > 15 months
|
9 Participants
|
10 Participants
|
|
PSA Doubling Time (PSADT) Response and Failure
Week 12: PSADT is decreased by > 50%
|
2 Participants
|
0 Participants
|
|
PSA Doubling Time (PSADT) Response and Failure
Week 24: PSADT is decreased by > 50%
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 42-651 days on treatmentPopulation: Data was only available with participants combined for this outcome measure.
Changes in tumor growth rate constants (g) was calculated from fitting the prostate-specific antigen (PSA) curves to an exponential tumor growth model. Comparison of the median growth rate constant to 75th percentile \[upper quartile\]) of the estimated g of individual subjects pre- and post-TARP vaccination. The Tumor Growth Rate Constant was calculated using a regression-growth equation: f(t) = exp(-d x t) + exp(g x t) - 1, where exp is the base of the natural logarithm, e = 2.7182…, and f(t) is the PSA measurement at time t in days, normalized to (divided by) the PSA measurement at day 0, the time at which treatment is commenced. Rate constant d (decay, in days-1) represents the exponential decrease/regression rate constant of the PSA signal during therapy. Rate constant g (growth, also in days-1) represents the exponential growth/re-growth rate constant of the tumor during treatment.
Outcome measures
| Measure |
Arm A Montanide ISA 51 VG and Granulocyte-macrophage Colony-stimulating Factor (GM-CSF)
n=41 Participants
T-cell receptor alternate reading frame protein (TARP) peptide vaccine: Will receive an admixture of the wildtype and epitope enhanced TARP peptides emulsified with Montanide ISA 51 VG and granulocyte-macrophage colony-stimulating factor (GM-CSF). TARP peptide will be administered subcutaneously at weeks 3, 6, 9, 12 and 15 for a total of five vaccinations with a booster dose of vaccine at Weeks 48 and 96.
|
Arm B Autologous Dendritic Cell Vaccine
T-cell receptor alternate reading frame protein (TARP) dendritic cell vaccine: Will receive peptide pulsed dendritic cells administered intradermally in two vaccination sites. TARP pulsed dendritic cells will be administered at weeks 3, 6, 9, 12 and 15 for a total of five vaccinations with a booster dose of vaccine at Weeks 48 and 96.
|
|---|---|---|
|
Change in Tumor Growth Rate Constant: Pre-versus Post T-cell Receptor Alternate Reading Frame Protein (TARP) Vaccination
Pre-vaccine
|
0.0042 g = Days^(-1)
|
—
|
|
Change in Tumor Growth Rate Constant: Pre-versus Post T-cell Receptor Alternate Reading Frame Protein (TARP) Vaccination
Post-vaccine
|
0.0021 g = Days^(-1)
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). 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.
Outcome measures
| Measure |
Arm A Montanide ISA 51 VG and Granulocyte-macrophage Colony-stimulating Factor (GM-CSF)
n=21 Participants
T-cell receptor alternate reading frame protein (TARP) peptide vaccine: Will receive an admixture of the wildtype and epitope enhanced TARP peptides emulsified with Montanide ISA 51 VG and granulocyte-macrophage colony-stimulating factor (GM-CSF). TARP peptide will be administered subcutaneously at weeks 3, 6, 9, 12 and 15 for a total of five vaccinations with a booster dose of vaccine at Weeks 48 and 96.
|
Arm B Autologous Dendritic Cell Vaccine
n=20 Participants
T-cell receptor alternate reading frame protein (TARP) dendritic cell vaccine: Will receive peptide pulsed dendritic cells administered intradermally in two vaccination sites. TARP pulsed dendritic cells will be administered at weeks 3, 6, 9, 12 and 15 for a total of five vaccinations with a booster dose of vaccine at Weeks 48 and 96.
|
|---|---|---|
|
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
21 Participants
|
19 Participants
|
Adverse Events
Arm A Montanide ISA 51 VG and Granulocyte-macrophage Colony-stimulating Factor (GM-CSF)
Serious events: 2 serious events
Other events: 21 other events
Deaths: 0 deaths
Arm B Autologous Dendritic Cell Vaccine
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A Montanide ISA 51 VG and Granulocyte-macrophage Colony-stimulating Factor (GM-CSF)
n=21 participants at risk
T-cell receptor alternate reading frame protein (TARP) peptide vaccine: Will receive an admixture of the wildtype and epitope enhanced TARP peptides emulsified with Montanide ISA 51 VG and granulocyte-macrophage colony-stimulating factor (GM-CSF). TARP peptide will be administered subcutaneously at weeks 3, 6, 9, 12 and 15 for a total of five vaccinations with a booster dose of vaccine at Weeks 48 and 96.
|
Arm B Autologous Dendritic Cell Vaccine
n=20 participants at risk
T-cell receptor alternate reading frame protein (TARP) peptide vaccine: Will receive an admixture of the wildtype and epitope enhanced TARP peptides emulsified with Montanide ISA 51 VG and granulocyte-macrophage colony-stimulating factor (GM-CSF). TARP peptide will be administered subcutaneously at weeks 3, 6, 9, 12 and 15 for a total of five vaccinations with a booster dose of vaccine at Weeks 48 and 96.
|
|---|---|---|
|
Renal and urinary disorders
Obstruction, Genitourinary: Ureter
|
4.8%
1/21 • Number of events 1 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
0.00%
0/20 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
General disorders
Pain: Chest/Thorax Not Otherwise Specifed (NOS)
|
4.8%
1/21 • Number of events 1 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
0.00%
0/20 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
Other adverse events
| Measure |
Arm A Montanide ISA 51 VG and Granulocyte-macrophage Colony-stimulating Factor (GM-CSF)
n=21 participants at risk
T-cell receptor alternate reading frame protein (TARP) peptide vaccine: Will receive an admixture of the wildtype and epitope enhanced TARP peptides emulsified with Montanide ISA 51 VG and granulocyte-macrophage colony-stimulating factor (GM-CSF). TARP peptide will be administered subcutaneously at weeks 3, 6, 9, 12 and 15 for a total of five vaccinations with a booster dose of vaccine at Weeks 48 and 96.
|
Arm B Autologous Dendritic Cell Vaccine
n=20 participants at risk
T-cell receptor alternate reading frame protein (TARP) peptide vaccine: Will receive an admixture of the wildtype and epitope enhanced TARP peptides emulsified with Montanide ISA 51 VG and granulocyte-macrophage colony-stimulating factor (GM-CSF). TARP peptide will be administered subcutaneously at weeks 3, 6, 9, 12 and 15 for a total of five vaccinations with a booster dose of vaccine at Weeks 48 and 96.
|
|---|---|---|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
9.5%
2/21 • Number of events 3 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
5.0%
1/20 • Number of events 1 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
4.8%
1/21 • Number of events 1 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
5.0%
1/20 • Number of events 1 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
4.8%
1/21 • Number of events 1 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
5.0%
1/20 • Number of events 1 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
Metabolism and nutrition disorders
Bicarbonate, serum-low
|
4.8%
1/21 • Number of events 1 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
0.00%
0/20 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
4.8%
1/21 • Number of events 1 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
5.0%
1/20 • Number of events 1 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
Skin and subcutaneous tissue disorders
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
4.8%
1/21 • Number of events 1 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
0.00%
0/20 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
Metabolism and nutrition disorders
CPK (creatine phosphokinase)
|
0.00%
0/21 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
10.0%
2/20 • Number of events 2 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/21 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
5.0%
1/20 • Number of events 1 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Denuded flaky area on the tip of penis)
|
4.8%
1/21 • Number of events 1 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
0.00%
0/20 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Dermatitis-like rash)
|
4.8%
1/21 • Number of events 1 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
0.00%
0/20 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
Gastrointestinal disorders
Diarrhea
|
14.3%
3/21 • Number of events 3 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
0.00%
0/20 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
4.8%
1/21 • Number of events 1 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
0.00%
0/20 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
Blood and lymphatic system disorders
Edema: limb
|
9.5%
2/21 • Number of events 3 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
5.0%
1/20 • Number of events 1 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
General disorders
Flu-like syndrome
|
0.00%
0/21 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
5.0%
1/20 • Number of events 1 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Cold sores)
|
0.00%
0/21 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
5.0%
1/20 • Number of events 3 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (melena)
|
4.8%
1/21 • Number of events 1 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
0.00%
0/20 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
4.8%
1/21 • Number of events 1 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
0.00%
0/20 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
Metabolism and nutrition disorders
Hemoglobinuria
|
4.8%
1/21 • Number of events 1 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
0.00%
0/20 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
Gastrointestinal disorders
Hemorrhage, gastrointestinal (GI)::Rectum
|
4.8%
1/21 • Number of events 1 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
0.00%
0/20 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
Gastrointestinal disorders
Hemorrhage, GI::Varices (rectal)
|
4.8%
1/21 • Number of events 1 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
0.00%
0/20 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/21 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
5.0%
1/20 • Number of events 1 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
Renal and urinary disorders
Incontinence, urinary
|
4.8%
1/21 • Number of events 1 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
0.00%
0/20 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
Infections and infestations
Infection - Other (Upper airway infection)
|
4.8%
1/21 • Number of events 2 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
0.00%
0/20 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
Infections and infestations
Infection with normal absolute neutrophil count (ANC) or Grade 1 or 2 neutrophils::Upper airway NOS
|
4.8%
1/21 • Number of events 1 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
0.00%
0/20 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
Infections and infestations
Infection with unknown ANC::Bladder (urinary)
|
0.00%
0/21 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
5.0%
1/20 • Number of events 1 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
Infections and infestations
Infection with unknown ANC::Colon
|
4.8%
1/21 • Number of events 1 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
0.00%
0/20 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
Infections and infestations
Infection with unknown ANC::Eye NOS
|
0.00%
0/21 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
5.0%
1/20 • Number of events 1 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
Infections and infestations
Infection with unknown ANC::Upper airway NOS
|
4.8%
1/21 • Number of events 1 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
5.0%
1/20 • Number of events 1 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
Infections and infestations
Infection with unknown ANC::Urinary tract NOS
|
9.5%
2/21 • Number of events 2 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
0.00%
0/20 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
Skin and subcutaneous tissue disorders
Injection site reaction/extravasation changes
|
100.0%
21/21 • Number of events 394 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
95.0%
19/20 • Number of events 190 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
General disorders
Insomnia
|
4.8%
1/21 • Number of events 1 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
0.00%
0/20 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
Blood and lymphatic system disorders
Leukocytes (total white blood cell (WBC)
|
9.5%
2/21 • Number of events 3 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
5.0%
1/20 • Number of events 2 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
14.3%
3/21 • Number of events 5 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
35.0%
7/20 • Number of events 9 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
4.8%
1/21 • Number of events 1 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
0.00%
0/20 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/21 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
5.0%
1/20 • Number of events 1 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/21 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
5.0%
1/20 • Number of events 1 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
Nervous system disorders
Neuropathy: sensory
|
0.00%
0/21 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
5.0%
1/20 • Number of events 1 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/absolute granulocyte (AGC)
|
9.5%
2/21 • Number of events 3 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
5.0%
1/20 • Number of events 2 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
Eye disorders
Ocular/Visual - Other (Chalazion)
|
4.8%
1/21 • Number of events 1 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
0.00%
0/20 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
Musculoskeletal and connective tissue disorders
Pain - Other (Arthritis pain)
|
0.00%
0/21 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
5.0%
1/20 • Number of events 1 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
Musculoskeletal and connective tissue disorders
Pain::Abdomen NOS
|
4.8%
1/21 • Number of events 1 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
0.00%
0/20 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
Musculoskeletal and connective tissue disorders
Pain::Back
|
23.8%
5/21 • Number of events 5 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
15.0%
3/20 • Number of events 3 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
Musculoskeletal and connective tissue disorders
Pain::Extremity-limb
|
4.8%
1/21 • Number of events 1 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
0.00%
0/20 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
Musculoskeletal and connective tissue disorders
Pain::Joint
|
0.00%
0/21 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
5.0%
1/20 • Number of events 1 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
Musculoskeletal and connective tissue disorders
Pain::Neck
|
4.8%
1/21 • Number of events 1 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
0.00%
0/20 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
28.6%
6/21 • Number of events 14 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
25.0%
5/20 • Number of events 7 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
Blood and lymphatic system disorders
Platelets
|
4.8%
1/21 • Number of events 1 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
5.0%
1/20 • Number of events 1 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
9.5%
2/21 • Number of events 2 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
0.00%
0/20 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
Metabolism and nutrition disorders
Proteinuria
|
4.8%
1/21 • Number of events 2 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
0.00%
0/20 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
Metabolism and nutrition disorders
Sodium, serum-high (hypernatremia)
|
9.5%
2/21 • Number of events 2 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
5.0%
1/20 • Number of events 1 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
Nervous system disorders
Tremor
|
0.00%
0/21 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
5.0%
1/20 • Number of events 1 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
0.00%
0/21 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
10.0%
2/20 • Number of events 2 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
Eye disorders
Vision-blurred vision
|
4.8%
1/21 • Number of events 1 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
0.00%
0/20 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
Eye disorders
Vision-flashing lights/floaters
|
0.00%
0/21 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
5.0%
1/20 • Number of events 1 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/21 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
5.0%
1/20 • Number of events 1 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
|
General disorders
Weight loss
|
4.8%
1/21 • Number of events 2 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
0.00%
0/20 • From date treatment consent signed and continuously through 30 days after last vaccination, approximately 59 months and 16 days for Arm A and 58 months and 24 days for Arm B.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place