Trial Outcomes & Findings for Vaccine Therapy in Treating Patients With Stage IV HLA-A2 and HER2 Positive Breast or Ovarian Cancer Receiving Trastuzumab (NCT NCT00194714)

NCT ID: NCT00194714

Last Updated: 2024-06-06

Results Overview

ELIspot: Increased immune response is defined as spots per well (SPW) greater than 2 standard deviations (SD) above baseline value, remained the same if the mean SPW was within 2 SD of the previous value, or decreased if the mean SPW was greater than 2 SD below the previous value. Two SD is equivalent to a P value of .05 in that there is a 95% probability that the values are statistically significant. T is reported as percentage of patients and their corresponding results. HLA-A2 Major Histocompatibility Complex Tetramer Analysis is evaluated using a non-radioactive assay for cell lysis. The HLA-A2 transfected human HER2/neu expressing breast cancer cell line, SKBR3-A2 T cells, expanded after stimulation with immunizing peptide, were added in an effector/target ratio of 40:1. Percent specific lysis was calculated as: (\[experimental release-spontaneous releases of cytotoxic T-lymphocyte cells and target cells\]/\[maximum release-spontaneous release of target cells\])X100.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

22 participants

Primary outcome timeframe

Up to 1.5 years (12 months following the last vaccination)

Results posted on

2024-06-06

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (HER-2/Neu Peptide Vaccine) Patients receive a HER-2/neu (HER2) specific cytotoxic T cell (CTL) generating peptide vaccine ID once per month for 6 months in the absence of disease progression or unacceptable toxicity. The final dose of peptide vaccine delivered is 1.5 mg (500 mcg/each peptide) admixed with 100 mcg GM-CSF as an adjuvant. HER-2/neu Peptide Vaccine: Given ID Laboratory Biomarker Analysis: Correlative studies
Overall Study STARTED	22
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vaccine Therapy in Treating Patients With Stage IV HLA-A2 and HER2 Positive Breast or Ovarian Cancer Receiving Trastuzumab

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (HER-2/Neu Peptide Vaccine) n=21 Participants Patients receive HER-2/neu peptide vaccine ID once per month for 6 months in the absence of disease progression or unacceptable toxicity. HER-2/neu Peptide Vaccine: Given ID Laboratory Biomarker Analysis: Correlative studies
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	49 years n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 1.5 years (12 months following the last vaccination)

Outcome measures

Outcome measures
Measure	Treatment (HER-2/Neu Peptide Vaccine) n=19 Participants Patients receive HER-2/neu peptide vaccine ID once per month for 6 months in the absence of disease progression or unacceptable toxicity. HER-2/neu Peptide Vaccine: Given ID Laboratory Biomarker Analysis: Correlative studies
Immune Response Measured by IFN-gamma Secreting PBMC Precursor Frequency by ELIspot and HLA-A2 Major Histocompatibility Complex Tetramer Analysis HLA-A2 Results · Significantly augmented immune response	14 Participants
Immune Response Measured by IFN-gamma Secreting PBMC Precursor Frequency by ELIspot and HLA-A2 Major Histocompatibility Complex Tetramer Analysis HLA-A2 Results · Did not have augmentation of immune response	4 Participants
Immune Response Measured by IFN-gamma Secreting PBMC Precursor Frequency by ELIspot and HLA-A2 Major Histocompatibility Complex Tetramer Analysis HLA-A2 Results · Decrease in immune response	1 Participants
Immune Response Measured by IFN-gamma Secreting PBMC Precursor Frequency by ELIspot and HLA-A2 Major Histocompatibility Complex Tetramer Analysis ELIspot · Significantly augmented immune response	16 Participants
Immune Response Measured by IFN-gamma Secreting PBMC Precursor Frequency by ELIspot and HLA-A2 Major Histocompatibility Complex Tetramer Analysis ELIspot · Did not have augmentation of immune response	3 Participants
Immune Response Measured by IFN-gamma Secreting PBMC Precursor Frequency by ELIspot and HLA-A2 Major Histocompatibility Complex Tetramer Analysis ELIspot · Decrease in immune response	0 Participants

PRIMARY outcome

Timeframe: Up to 7 months (30 days following the last vaccination)

Population: We recorded a total of 573 individual adverse events from baseline through follow-up evaluation for 21 patients. The data below represents the total number of events by Grade using Common Terminology Criteria for Adverse Events v3.0 (CTCAE)

Descriptive statistics will be used to summarize changes from baseline. At the point the participant signs consent and before they start vaccine we record their existing baseline events (symptoms and diagnoses) and assign a grade to them (see below). Once a participant starts vaccine treatment adverse event AEs were recorded if they are new to the participant or if they increased in severity over their baseline. Grade refers to the severity of the AE. The CTCAE v3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE

Outcome measures

Outcome measures
Measure	Treatment (HER-2/Neu Peptide Vaccine) n=21 Participants Patients receive HER-2/neu peptide vaccine ID once per month for 6 months in the absence of disease progression or unacceptable toxicity. HER-2/neu Peptide Vaccine: Given ID Laboratory Biomarker Analysis: Correlative studies
Number of Adverse Events Graded Using National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 Grade 1	508 adverse events
Number of Adverse Events Graded Using National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 Grade 2	60 adverse events
Number of Adverse Events Graded Using National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 Grade 3	4 adverse events
Number of Adverse Events Graded Using National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 Grade 4	1 adverse events

SECONDARY outcome

Timeframe: Up to 5 years

Population: These are interim results: We are still monitoring overall survival.

Survival for the Stage IV breast cancer patients will be compared to historical control.

Outcome measures

Outcome measures
Measure	Treatment (HER-2/Neu Peptide Vaccine) n=21 Participants Patients receive HER-2/neu peptide vaccine ID once per month for 6 months in the absence of disease progression or unacceptable toxicity. HER-2/neu Peptide Vaccine: Given ID Laboratory Biomarker Analysis: Correlative studies
Overall Survival Alive	10 Participants
Overall Survival Deceased	11 Participants

Adverse Events

Treatment (HER-2/Neu Peptide Vaccine)

Serious events: 3 serious events

Other events: 21 other events

Deaths: 11 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (HER-2/Neu Peptide Vaccine) n=21 participants at risk Patients receive HER-2/neu peptide vaccine ID once per month for 6 months in the absence of disease progression or unacceptable toxicity. HER-2/neu Peptide Vaccine: Given ID Laboratory Biomarker Analysis: Correlative studies
Nervous system disorders CNS Cerebrovascular Ischema	4.8% 1/21 • Number of events 1 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Cardiac disorders Cardiac Arrhythmia	4.8% 1/21 • Number of events 1 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Skin and subcutaneous tissue disorders Ulceration	4.8% 1/21 • Number of events 1 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.

Other adverse events

Other adverse events
Measure	Treatment (HER-2/Neu Peptide Vaccine) n=21 participants at risk Patients receive HER-2/neu peptide vaccine ID once per month for 6 months in the absence of disease progression or unacceptable toxicity. HER-2/neu Peptide Vaccine: Given ID Laboratory Biomarker Analysis: Correlative studies
Respiratory, thoracic and mediastinal disorders Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)	4.8% 1/21 • Number of events 2 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Investigations Lymphopenia	47.6% 10/21 • Number of events 33 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Investigations Anemia	42.9% 9/21 • Number of events 11 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Investigations Platelets low	14.3% 3/21 • Number of events 6 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Investigations Leukopenia	47.6% 10/21 • Number of events 29 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Investigations Leukocytosis	4.8% 1/21 • Number of events 1 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Investigations Eosinophilia	4.8% 1/21 • Number of events 1 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Investigations Neutrophils/granulocytes (ANC/AGC)	33.3% 7/21 • Number of events 9 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Cardiac disorders Palpatations	28.6% 6/21 • Number of events 9 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Cardiac disorders Supraventricular and nodal arrhythmia	4.8% 1/21 • Number of events 1 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Vascular disorders Hypertension	19.0% 4/21 • Number of events 5 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Cardiac disorders Left ventricular systolic dysfunction	14.3% 3/21 • Number of events 3 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Cardiac disorders Chest tightness	4.8% 1/21 • Number of events 1 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
General disorders Fever	19.0% 4/21 • Number of events 4 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
General disorders Rigors/Chills	57.1% 12/21 • Number of events 20 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
General disorders Fatigue	95.2% 20/21 • Number of events 43 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
General disorders Sweating	4.8% 1/21 • Number of events 1 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
General disorders Weepiness	4.8% 1/21 • Number of events 1 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Skin and subcutaneous tissue disorders Dry skin	9.5% 2/21 • Number of events 2 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
General disorders Injection Site Reaction	95.2% 20/21 • Number of events 68 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Vascular disorders Flushing	4.8% 1/21 • Number of events 1 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Injury, poisoning and procedural complications Bruising	4.8% 1/21 • Number of events 1 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Skin and subcutaneous tissue disorders Pruritis/Itching	57.1% 12/21 • Number of events 22 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Skin and subcutaneous tissue disorders Rash/desquamation	28.6% 6/21 • Number of events 8 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Skin and subcutaneous tissue disorders Rash/acneiiform	19.0% 4/21 • Number of events 7 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Skin and subcutaneous tissue disorders Urticaria (hives, welts, wheals)	19.0% 4/21 • Number of events 5 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Skin and subcutaneous tissue disorders Nail changes	9.5% 2/21 • Number of events 2 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Skin and subcutaneous tissue disorders Alopecia	14.3% 3/21 • Number of events 5 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Skin and subcutaneous tissue disorders Ulceration	4.8% 1/21 • Number of events 1 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Skin and subcutaneous tissue disorders Skin breakdown/decubitus ulcer	4.8% 1/21 • Number of events 1 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Skin and subcutaneous tissue disorders Hypopigmentation	4.8% 1/21 • Number of events 1 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Vascular disorders Hot flashes	9.5% 2/21 • Number of events 2 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Gastrointestinal disorders Diarrhea	52.4% 11/21 • Number of events 17 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Gastrointestinal disorders Nausea	57.1% 12/21 • Number of events 22 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Gastrointestinal disorders Vomiting	23.8% 5/21 • Number of events 5 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Gastrointestinal disorders Constipation	19.0% 4/21 • Number of events 4 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Gastrointestinal disorders Mucositis/stomatisis (functional/symptomatic)	4.8% 1/21 • Number of events 1 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Gastrointestinal disorders Blood in stool	4.8% 1/21 • Number of events 2 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Gastrointestinal disorders Hemorrhage, GU	4.8% 1/21 • Number of events 1 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Infections and infestations Infection with normal ANC or GRA1 or 2 neutrophils	47.6% 10/21 • Number of events 11 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Infections and infestations Infection without neutrophils	4.8% 1/21 • Number of events 1 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
General disorders Edema:limb	38.1% 8/21 • Number of events 16 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
General disorders Edema: Head and neck	4.8% 1/21 • Number of events 1 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Reproductive system and breast disorders Swelling left breast	4.8% 1/21 • Number of events 1 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Blood and lymphatic system disorders Lymphnode pain	4.8% 1/21 • Number of events 1 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Investigations aspartate aminotransferase (AST)/SGOT	9.5% 2/21 • Number of events 6 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Metabolism and nutrition disorders Hypokalemia	9.5% 2/21 • Number of events 6 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Metabolism and nutrition disorders Hyponatremia	9.5% 2/21 • Number of events 2 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Metabolism and nutrition disorders Alanine aminotransferase increased (ALT)/SGPT	9.5% 2/21 • Number of events 6 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Metabolism and nutrition disorders Hyperglycemia	9.5% 2/21 • Number of events 2 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Investigations Creatinine	14.3% 3/21 • Number of events 8 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Metabolism and nutrition disorders Hypoalbuminemia	4.8% 1/21 • Number of events 3 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Musculoskeletal and connective tissue disorders Tendonitis	4.8% 1/21 • Number of events 1 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Nervous system disorders Dizziness	38.1% 8/21 • Number of events 11 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Psychiatric disorders Confusion	4.8% 1/21 • Number of events 1 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Nervous system disorders Neuropathy: sensory	14.3% 3/21 • Number of events 4 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Nervous system disorders Neuropathy: motor	9.5% 2/21 • Number of events 3 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Nervous system disorders Syncope	4.8% 1/21 • Number of events 1 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Nervous system disorders Pain - Headache	66.7% 14/21 • Number of events 42 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Gastrointestinal disorders Pain - Abdomen NOS	19.0% 4/21 • Number of events 7 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Musculoskeletal and connective tissue disorders Pain - Leg cramps	4.8% 1/21 • Number of events 2 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Musculoskeletal and connective tissue disorders Pain - Back	19.0% 4/21 • Number of events 7 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Musculoskeletal and connective tissue disorders Pain - Arlthralgia	23.8% 5/21 • Number of events 6 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Musculoskeletal and connective tissue disorders Pain - Neck	4.8% 1/21 • Number of events 1 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Musculoskeletal and connective tissue disorders Pain - Chest Wall	4.8% 1/21 • Number of events 1 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Musculoskeletal and connective tissue disorders Pain - Rib	4.8% 1/21 • Number of events 1 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Musculoskeletal and connective tissue disorders Pain - Bone	9.5% 2/21 • Number of events 2 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Musculoskeletal and connective tissue disorders Pain - Injection site	14.3% 3/21 • Number of events 3 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Reproductive system and breast disorders Pain - Breast	4.8% 1/21 • Number of events 1 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Respiratory, thoracic and mediastinal disorders Pain - Lung	4.8% 1/21 • Number of events 3 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Blood and lymphatic system disorders Pain - Lymphnode	9.5% 2/21 • Number of events 4 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Musculoskeletal and connective tissue disorders Myalgia	61.9% 13/21 • Number of events 43 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Respiratory, thoracic and mediastinal disorders Pain - Pleuritic	4.8% 1/21 • Number of events 1 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	14.3% 3/21 • Number of events 6 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Respiratory, thoracic and mediastinal disorders Bronchospasm, wheezing	4.8% 1/21 • Number of events 2 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Surgical and medical procedures Hemorrhage/Bleeding associated with surgery, intra-operative or postoperative	4.8% 1/21 • Number of events 1 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Renal and urinary disorders Urine leukocytes	4.8% 1/21 • Number of events 2 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
General disorders Flu-like syndrome	33.3% 7/21 • Number of events 10 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Eye disorders Vision - blurred	4.8% 1/21 • Number of events 1 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Cardiac disorders Hypotension	4.8% 1/21 • Number of events 1 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Infections and infestations Infection Other - PAC infection	4.8% 1/21 • Number of events 1 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Infections and infestations Infection Other - Cold	4.8% 1/21 • Number of events 1 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Metabolism and nutrition disorders Hypocalcemia	4.8% 1/21 • Number of events 1 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Musculoskeletal and connective tissue disorders Pain - Extremity Limb	4.8% 1/21 • Number of events 1 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Musculoskeletal and connective tissue disorders Arthralgia	4.8% 1/21 • Number of events 1 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Eye disorders Dry Eye Syndrome	4.8% 1/21 • Number of events 1 • Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease. We used CTCAE v3.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.

Additional Information

Director of Clinical Operations

University of Washington - Cancer Vaccine Institute

Phone: 2062459258

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place