Trial Outcomes & Findings for A Multiple Antigen Vaccine (STEMVAC) for the Treatment of Patients With Stage IV Non-Small Cell Lung Cancer (NCT NCT05242965)
NCT ID: NCT05242965
Last Updated: 2026-04-03
Results Overview
Immunohistochemical (IHC) staining for CD8+ CD3+ will be performed on the biopsies collected pre-treatment and post 3rd vaccine administration.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
Baseline and after the third vaccine (at approximately 12 weeks)
Results posted on
2026-04-03
Participant Flow
Participant milestones
| Measure |
Arm I (STEMVAC, Sargramostim)
Patients receive STEMVAC ID and sargramostim ID on day 14 (+3 days) of the 21-day maintenance therapy cycle for a series of 3 vaccine doses and a booster vaccine 9 weeks after the third vaccine dose. Patients also undergo CT and biopsy during screening and on the trial, as well as blood sample collection on trial and during follow-up.
CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine: Given ID
Sargramostim: Given ID
Computed Tomography: Undergo CT
Biopsy: Undergo biopsy
Biospecimen Collection: Undergo blood sample collection
|
Arm II (Sargramostim)
Patients receive sargramostim ID on day 14 (+3 days) of the 21-day maintenance therapy cycle for a series of 3 vaccine doses and a booster vaccine 9 weeks after the third vaccine dose. Patients also undergo CT and biopsy during screening and on the trial, as well as blood sample collection on trial and during follow-up.
Sargramostim: Given ID
Computed Tomography: Undergo CT
Biopsy: Undergo biopsy
Biospecimen Collection: Undergo blood sample collection
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
3
|
|
Overall Study
COMPLETED
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Multiple Antigen Vaccine (STEMVAC) for the Treatment of Patients With Stage IV Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Arm I (STEMVAC, Sargramostim)
n=2 Participants
Patients receive STEMVAC ID and sargramostim ID on day 14 (+3 days) of the 21-day maintenance therapy cycle for a series of 3 vaccine doses and a booster vaccine 9 weeks after the third vaccine dose. Patients also undergo CT and biopsy during screening and on the trial, as well as blood sample collection on trial and during follow-up.
CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine: Given ID
Sargramostim: Given ID
Computed Tomography: Undergo CT
Biopsy: Undergo biopsy
Biospecimen Collection: Undergo blood sample collection
|
Arm II (Sargramostim)
n=3 Participants
Patients receive sargramostim ID on day 14 (+3 days) of the 21-day maintenance therapy cycle for a series of 3 vaccine doses and a booster vaccine 9 weeks after the third vaccine dose. Patients also undergo CT and biopsy during screening and on the trial, as well as blood sample collection on trial and during follow-up.
Sargramostim: Given ID
Computed Tomography: Undergo CT
Biopsy: Undergo biopsy
Biospecimen Collection: Undergo blood sample collection
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61 years
n=5 Participants
|
75 years
n=5 Participants
|
66 years
n=10 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
3 participants
n=5 Participants
|
5 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline and after the third vaccine (at approximately 12 weeks)Population: This study ended early due to low accrual. Per the Fred Hutch (FH)/University of Washington (UW) Cancer Consortium Scientific Review Committee Low Accrual Policy, they closed this study to future accrual on July 8, 2025. Due to the early/unexpected closure of this study we only have data on 3 evaluable patients for this endpoint.
Immunohistochemical (IHC) staining for CD8+ CD3+ will be performed on the biopsies collected pre-treatment and post 3rd vaccine administration.
Outcome measures
| Measure |
Arm I (STEMVAC, Sargramostim)
n=1 Participants
Patients receive STEMVAC ID and sargramostim ID on day 14 (+3 days) of the 21-day maintenance therapy cycle for a series of 3 vaccine doses and a booster vaccine 9 weeks after the third vaccine dose. Patients also undergo CT and biopsy during screening and on the trial, as well as blood sample collection on trial and during follow-up.
CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine: Given ID
Sargramostim: Given ID
Computed Tomography: Undergo CT
Biopsy: Undergo biopsy
Biospecimen Collection: Undergo blood sample collection
|
Arm II (Sargramostim)
n=2 Participants
Patients receive sargramostim ID on day 14 (+3 days) of the 21-day maintenance therapy cycle for a series of 3 vaccine doses and a booster vaccine 9 weeks after the third vaccine dose. Patients also undergo CT and biopsy during screening and on the trial, as well as blood sample collection on trial and during follow-up.
Sargramostim: Given ID
Computed Tomography: Undergo CT
Biopsy: Undergo biopsy
Biospecimen Collection: Undergo blood sample collection
|
|---|---|---|
|
CD8 is Reported as a Fraction of CD3+ Tumor Infiltrating Lymphocytes (TIL) in 4 High-power Field (HPF)
Baseline % of CD8+ of CD3+ TIL
|
32 percentage of CD8+ of CD3+ TIL
Interval 32.0 to 32.0
|
32 percentage of CD8+ of CD3+ TIL
Interval 14.0 to 51.0
|
|
CD8 is Reported as a Fraction of CD3+ Tumor Infiltrating Lymphocytes (TIL) in 4 High-power Field (HPF)
Post Vaccine % of CD8+ of CD3+ TIL
|
49 percentage of CD8+ of CD3+ TIL
Interval 49.0 to 49.0
|
41 percentage of CD8+ of CD3+ TIL
Interval 26.0 to 56.0
|
PRIMARY outcome
Timeframe: Up to 20 weeksWill be evaluated using the modified National Cancer Institute (NCI) toxicity criteria. Toxicity evaluation will be based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Outcome measures
| Measure |
Arm I (STEMVAC, Sargramostim)
n=2 Participants
Patients receive STEMVAC ID and sargramostim ID on day 14 (+3 days) of the 21-day maintenance therapy cycle for a series of 3 vaccine doses and a booster vaccine 9 weeks after the third vaccine dose. Patients also undergo CT and biopsy during screening and on the trial, as well as blood sample collection on trial and during follow-up.
CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine: Given ID
Sargramostim: Given ID
Computed Tomography: Undergo CT
Biopsy: Undergo biopsy
Biospecimen Collection: Undergo blood sample collection
|
Arm II (Sargramostim)
n=3 Participants
Patients receive sargramostim ID on day 14 (+3 days) of the 21-day maintenance therapy cycle for a series of 3 vaccine doses and a booster vaccine 9 weeks after the third vaccine dose. Patients also undergo CT and biopsy during screening and on the trial, as well as blood sample collection on trial and during follow-up.
Sargramostim: Given ID
Computed Tomography: Undergo CT
Biopsy: Undergo biopsy
Biospecimen Collection: Undergo blood sample collection
|
|---|---|---|
|
Number of Participants With Recorded Adverse Event(s)
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 1 yearWill measure the magnitude of the Th1 STEMVAC specific immune response using IFN-gamma enzyme-linked immunosorbent spot (ELISPOT). T-test among the 2 groups (vaccine and adjuvant alone) will be conducted to evaluate immune response if skewness is not observed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 yearWill evaluate if vaccine induced T-cells traffic to tumor and eliminate cancer cells which have undergone epithelial to mesenchymal transformation (EMT). Will assess TCR-beta (TCRb) gene usage in both T-cell lines expanded from peripheral blood and in the tumor biopsy, and the expression of EMT related genes in the tumor after vaccination with STMEVAC+GM-CSF or GM-CSF alone. Shannon diversity index will be summarized and the Clopper-Pearson confidence interval will be computed for the rate of T-cell trafficking among the 10 patients subject to TCRb sequencing.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 month after the 3rd vaccine (Up to 6 months)Will evaluate potential clinical response approximately one month after the 3rd vaccine using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. An informal comparison will be conducted to compare the ORR between the two arms, with the Fisher exact test to account for small sample size.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsKaplan-Meier estimates of the survival function with 95% confidence intervals (CIs) at specific time points (using Greenwood's formula for the standard error) will be computed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsKaplan-Meier estimates of the survival function with 95% CIs at specific time points (using Greenwood's formula for the standard error) will be computed. Comparisons of OS in the two arms will be conducted by the log-rank test.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 yearTwo-sample T-tests or the Wilcoxon test will be utilized to compare the absolute change of T-cell activation markers and the Type I immune cells from baseline based on the normality of the data.
Outcome measures
Outcome data not reported
Adverse Events
Arm I (STEMVAC, Sargramostim)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Arm II (Sargramostim)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm I (STEMVAC, Sargramostim)
n=2 participants at risk
Patients receive STEMVAC ID and sargramostim ID on day 14 (+3 days) of the 21-day maintenance therapy cycle for a series of 3 vaccine doses and a booster vaccine 9 weeks after the third vaccine dose. Patients also undergo CT and biopsy during screening and on the trial, as well as blood sample collection on trial and during follow-up.
CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine: Given ID
Sargramostim: Given ID
Computed Tomography: Undergo CT
Biopsy: Undergo biopsy
Biospecimen Collection: Undergo blood sample collection
|
Arm II (Sargramostim)
n=3 participants at risk
Patients receive sargramostim ID on day 14 (+3 days) of the 21-day maintenance therapy cycle for a series of 3 vaccine doses and a booster vaccine 9 weeks after the third vaccine dose. Patients also undergo CT and biopsy during screening and on the trial, as well as blood sample collection on trial and during follow-up.
Sargramostim: Given ID
Computed Tomography: Undergo CT
Biopsy: Undergo biopsy
Biospecimen Collection: Undergo blood sample collection
|
|---|---|---|
|
Investigations
Neutrophil count decreased
|
50.0%
1/2 • Number of events 1 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
0.00%
0/3 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
|
Investigations
Creatinine increased
|
50.0%
1/2 • Number of events 1 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
0.00%
0/3 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.0%
1/2 • Number of events 1 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
66.7%
2/3 • Number of events 2 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
50.0%
1/2 • Number of events 1 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
0.00%
0/3 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
|
Eye disorders
Blurred Vision
|
50.0%
1/2 • Number of events 2 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
0.00%
0/3 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
|
Eye disorders
Dry Eye
|
50.0%
1/2 • Number of events 1 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
0.00%
0/3 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
|
Eye disorders
Watering Eyes
|
50.0%
1/2 • Number of events 1 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
0.00%
0/3 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
|
Infections and infestations
Upper Respiratory Infection
|
50.0%
1/2 • Number of events 1 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
33.3%
1/3 • Number of events 1 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
|
Nervous system disorders
Headache
|
50.0%
1/2 • Number of events 2 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
0.00%
0/3 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
|
Nervous system disorders
Accidental Opioid Overdose
|
50.0%
1/2 • Number of events 1 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
0.00%
0/3 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
1/2 • Number of events 1 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
0.00%
0/3 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
1/2 • Number of events 1 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
0.00%
0/3 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
|
Gastrointestinal disorders
Abdominal Pain
|
50.0%
1/2 • Number of events 1 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
0.00%
0/3 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
|
General disorders
Flu Like Symptoms
|
50.0%
1/2 • Number of events 1 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
0.00%
0/3 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
|
General disorders
Pain
|
50.0%
1/2 • Number of events 1 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
33.3%
1/3 • Number of events 1 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
|
General disorders
Injection Site Reaction
|
100.0%
2/2 • Number of events 2 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
0.00%
0/3 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
|
Injury, poisoning and procedural complications
Minor Contusion, Left Forehead
|
50.0%
1/2 • Number of events 1 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
0.00%
0/3 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
50.0%
1/2 • Number of events 1 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
33.3%
1/3 • Number of events 1 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
|
Psychiatric disorders
Insomnia
|
50.0%
1/2 • Number of events 1 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
0.00%
0/3 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
|
Ear and labyrinth disorders
Tinnitus
|
50.0%
1/2 • Number of events 1 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
0.00%
0/3 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis After Lung Biopsy
|
0.00%
0/2 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
33.3%
1/3 • Number of events 1 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/2 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
66.7%
2/3 • Number of events 2 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
|
Musculoskeletal and connective tissue disorders
T-10 Spine Tingling with Numbness
|
0.00%
0/2 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
33.3%
1/3 • Number of events 1 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
|
Musculoskeletal and connective tissue disorders
Muscle Cramping, Bilateral Legs
|
0.00%
0/2 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
33.3%
1/3 • Number of events 1 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
|
Respiratory, thoracic and mediastinal disorders
Tinea Pedis
|
0.00%
0/2 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
33.3%
1/3 • Number of events 1 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
|
Infections and infestations
Skin Infection
|
0.00%
0/2 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
33.3%
1/3 • Number of events 1 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/2 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
33.3%
1/3 • Number of events 1 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
33.3%
1/3 • Number of events 1 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
0.00%
0/2 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
33.3%
1/3 • Number of events 2 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/2 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
33.3%
1/3 • Number of events 1 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/2 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
33.3%
1/3 • Number of events 1 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
|
Vascular disorders
Hypotension
|
0.00%
0/2 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
33.3%
1/3 • Number of events 1 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/2 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
33.3%
1/3 • Number of events 2 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/2 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
33.3%
1/3 • Number of events 1 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/2 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
33.3%
1/3 • Number of events 1 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/2 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
33.3%
1/3 • Number of events 1 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.00%
0/2 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
33.3%
1/3 • Number of events 1 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
|
Renal and urinary disorders
Decrease Sensation with Urination
|
0.00%
0/2 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
33.3%
1/3 • Number of events 1 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
|
Renal and urinary disorders
Urinary Urgency
|
0.00%
0/2 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
33.3%
1/3 • Number of events 1 • Systemic adverse events (AE) will be recorded from the time of confirmed eligibility through End of Treatment (up to 20 weeks). Patients are monitored for the development of vaccine toxicities with clinical lab results and physical exams. Clinically significant AEs are graded on a scale of 1-5. We will record AEs reported to us by the patient, caregivers, and clinical support staff. All-cause mortality will be assessed up to 5 years. Serious and other AEs were assessed up to 20 weeks.
Toxicity evaluation will be graded on a scale of 1-5 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The attribution is assigned as to its relation to the vaccine on a scale of not related to definitely related.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place