Trial Outcomes & Findings for Vaccine Therapy With or Without Polysaccharide-K in Patients With Stage IV HER2 Positive Breast Cancer Receiving HER2-Targeted Monoclonal Antibody Therapy (NCT NCT01922921)

NCT ID: NCT01922921

Last Updated: 2023-04-18

Results Overview

Evaluated using physical examinations and clinical labs by type and grade of toxicities noted during treatment, There were graded per Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events 4.0.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

31 participants

Primary outcome timeframe

Up to 4 months

Results posted on

2023-04-18

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I (Placebo) Patients receive HER2 ICD peptide-based vaccine ID once monthly for 3 months, trastuzumab (or trastuzumab and pertuzumab) per standard of care, and placebo PO BID for 4 months. HER-2/neu Intracellular Domain Protein: Given ID Laboratory Biomarker Analysis: Correlative studies Pertuzumab: Given per standard of care Placebo: Given PO Trastuzumab: Given per standard of care	Arm II (Polysaccharide-K) Patients receive HER2 ICD peptide-based vaccine ID and trastuzumab (or trastuzumab and pertuzumab) as in Arm I and polysaccharide-K PO BID for 4 months. HER-2/neu Intracellular Domain Protein: Given ID Laboratory Biomarker Analysis: Correlative studies Pertuzumab: Given per standard of care Polysaccharide-K: Given PO Trastuzumab: Given per standard of care
Overall Study STARTED	16	15
Overall Study COMPLETED	15	14
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vaccine Therapy With or Without Polysaccharide-K in Patients With Stage IV HER2 Positive Breast Cancer Receiving HER2-Targeted Monoclonal Antibody Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Placebo) n=16 Participants Patients receive HER2 ICD peptide-based vaccine ID once monthly for 3 months, trastuzumab (or trastuzumab and pertuzumab) per standard of care, and placebo PO BID for 4 months. HER-2/neu Intracellular Domain Protein: Given ID Laboratory Biomarker Analysis: Correlative studies Pertuzumab: Given per standard of care Placebo: Given PO Trastuzumab: Given per standard of care	Arm II (Polysaccharide-K) n=15 Participants Patients receive HER2 ICD peptide-based vaccine ID and trastuzumab (or trastuzumab and pertuzumab) as in Arm I and polysaccharide-K PO BID for 4 months. HER-2/neu Intracellular Domain Protein: Given ID Laboratory Biomarker Analysis: Correlative studies Pertuzumab: Given per standard of care Polysaccharide-K: Given PO Trastuzumab: Given per standard of care	Total n=31 Participants Total of all reporting groups
Age, Continuous	52 years n=93 Participants	59 years n=4 Participants	52 years n=27 Participants
Sex: Female, Male Female	16 Participants n=93 Participants	15 Participants n=4 Participants	31 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=93 Participants	15 Participants n=4 Participants	31 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) White	14 Participants n=93 Participants	13 Participants n=4 Participants	27 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	16 Participants n=93 Participants	13 Participants n=4 Participants	29 Participants n=27 Participants
Region of Enrollment Italy	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Region of Enrollment Canada	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants

PRIMARY outcome

Timeframe: Up to 4 months

Population: Only 1 patient of the 2 patients listed below had a possibly related event of vomiting.

Outcome measures

Outcome measures
Measure	Arm I (Placebo) n=16 Participants Patients receive HER2 ICD peptide-based vaccine ID once monthly for 3 months, trastuzumab (or trastuzumab and pertuzumab) per standard of care, and placebo PO BID for 4 months. HER-2/neu Intracellular Domain Protein: Given ID Laboratory Biomarker Analysis: Correlative studies Pertuzumab: Given per standard of care Placebo: Given PO Trastuzumab: Given per standard of care	Arm II (Polysaccharide-K) n=15 Participants Patients receive HER2 ICD peptide-based vaccine ID and trastuzumab (or trastuzumab and pertuzumab) as in Arm I and polysaccharide-K PO BID for 4 months. HER-2/neu Intracellular Domain Protein: Given ID Laboratory Biomarker Analysis: Correlative studies Pertuzumab: Given per standard of care Polysaccharide-K: Given PO Trastuzumab: Given per standard of care	Arm I (Placebo) - CD56bright CD16dim Patients receive HER2 ICD peptide-based vaccine ID once monthly for 3 months, trastuzumab (or trastuzumab and pertuzumab) per standard of care, and placebo PO BID for 4 months. HER-2/neu Intracellular Domain Protein: Given ID Laboratory Biomarker Analysis: Correlative studies Pertuzumab: Given per standard of care Placebo: Given PO Trastuzumab: Given per standard of care	Arm II (Polysaccharide-K) - CD56bright CD16dim Patients receive HER2 ICD peptide-based vaccine ID and trastuzumab (or trastuzumab and pertuzumab) as in Arm I and polysaccharide-K PO BID for 4 months. HER-2/neu Intracellular Domain Protein: Given ID Laboratory Biomarker Analysis: Correlative studies Pertuzumab: Given per standard of care Polysaccharide-K: Given PO Trastuzumab: Given per standard of care
Number of Patients With Grade 3 or Higher Toxicity Per Study Arm.	2 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Up to 16 weeks

Population: Only 9/15 patients were evaluable for this analysis in Arm 1. Only 13/14 patients we evaluable for this analysis in Arm 2.

Augmentation of NK cell activity is defined by a 2-fold increase (at time of maximal change) in NK cell IFN-gamma production and CD107a expression For the results we used CD56 which is the accepted phenotypic marker for natural killer (NK) cells and CD16 which is a receptor on NK cells that facilitates antibody-dependent cellular cytotoxicity (ADCC). CD56dim are typically responsible for cytolytic activity and targets cell killing, whereas, CD56bright are the main source of cytokine production (i.e. IFN-gamma). CD56dim CD16bright NK cells represent at least 90% of all peripheral blood NK cells with a maximum of 10% as CD56bright NK cells We compared the baseline expression of CD56brightCD16dim or CD56dimCD16bright (prior to start of study treatment) to the maximum expression of CD56brightCD16dim or CD56dimCD16bright at 1 of 4 timepoints after the start of the oral administration of study treatment (polysaccharide-K/placebo (either week 4, 8, 12 or 16).

Outcome measures

Outcome measures
Measure	Arm I (Placebo) n=9 Participants Patients receive HER2 ICD peptide-based vaccine ID once monthly for 3 months, trastuzumab (or trastuzumab and pertuzumab) per standard of care, and placebo PO BID for 4 months. HER-2/neu Intracellular Domain Protein: Given ID Laboratory Biomarker Analysis: Correlative studies Pertuzumab: Given per standard of care Placebo: Given PO Trastuzumab: Given per standard of care	Arm II (Polysaccharide-K) n=13 Participants Patients receive HER2 ICD peptide-based vaccine ID and trastuzumab (or trastuzumab and pertuzumab) as in Arm I and polysaccharide-K PO BID for 4 months. HER-2/neu Intracellular Domain Protein: Given ID Laboratory Biomarker Analysis: Correlative studies Pertuzumab: Given per standard of care Polysaccharide-K: Given PO Trastuzumab: Given per standard of care	Arm I (Placebo) - CD56bright CD16dim n=9 Participants Patients receive HER2 ICD peptide-based vaccine ID once monthly for 3 months, trastuzumab (or trastuzumab and pertuzumab) per standard of care, and placebo PO BID for 4 months. HER-2/neu Intracellular Domain Protein: Given ID Laboratory Biomarker Analysis: Correlative studies Pertuzumab: Given per standard of care Placebo: Given PO Trastuzumab: Given per standard of care	Arm II (Polysaccharide-K) - CD56bright CD16dim n=13 Participants Patients receive HER2 ICD peptide-based vaccine ID and trastuzumab (or trastuzumab and pertuzumab) as in Arm I and polysaccharide-K PO BID for 4 months. HER-2/neu Intracellular Domain Protein: Given ID Laboratory Biomarker Analysis: Correlative studies Pertuzumab: Given per standard of care Polysaccharide-K: Given PO Trastuzumab: Given per standard of care
Induction of Interferon (IFN)-Gamma Production and Cluster of Differentiation (CD)107a Expression in NK Cells, Via Flow Cytometry INF gamma+ · >=2 fold increase	4 Participants	9 Participants	4 Participants	7 Participants
Induction of Interferon (IFN)-Gamma Production and Cluster of Differentiation (CD)107a Expression in NK Cells, Via Flow Cytometry INF gamma+ · <2 fold increase	5 Participants	4 Participants	5 Participants	6 Participants
Induction of Interferon (IFN)-Gamma Production and Cluster of Differentiation (CD)107a Expression in NK Cells, Via Flow Cytometry CD107+ · >=2 fold increase	3 Participants	8 Participants	3 Participants	6 Participants
Induction of Interferon (IFN)-Gamma Production and Cluster of Differentiation (CD)107a Expression in NK Cells, Via Flow Cytometry CD107+ · <2 fold increase	6 Participants	5 Participants	6 Participants	7 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 12 months after completion of treatment

IFN-γ ELISPOT assay will be used to evaluate T cell precursor frequency to specific breast tumor antigens. A positive immune response will be defined as a post-vaccination T cell precursor frequency \>1:20,000 antigen-specific PBMCs. In patients with a baseline precursor frequency \>1:20,000, a positive post-vaccination immune response will be defined as a 2-fold increase in antigen-specific PBMC. PBMC will be cryopreserved and subsequently be thawed at time of analysis.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 24 hours after completion of treatment

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 12 months after completion of treatment

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 3 years

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 3 years

Outcome measures

Outcome data not reported

Adverse Events

Arm I (Placebo)

Serious events: 0 serious events

Other events: 16 other events

Deaths: 1 deaths

Arm II (Polysaccharide-K)

Serious events: 0 serious events

Other events: 15 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Director of Clinical Operations

University of Washington

Phone: 2066162305

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Other adverse events
Measure	Arm I (Placebo) n=16 participants at risk Patients receive HER2 ICD peptide-based vaccine ID once monthly for 3 months, trastuzumab (or trastuzumab and pertuzumab) per standard of care, and placebo PO BID for 4 months. HER-2/neu Intracellular Domain Protein: Given ID Laboratory Biomarker Analysis: Correlative studies Pertuzumab: Given per standard of care Placebo: Given PO Trastuzumab: Given per standard of care	Arm II (Polysaccharide-K) n=15 participants at risk Patients receive HER2 ICD peptide-based vaccine ID and trastuzumab (or trastuzumab and pertuzumab) as in Arm I and polysaccharide-K PO BID for 4 months. HER-2/neu Intracellular Domain Protein: Given ID Laboratory Biomarker Analysis: Correlative studies Pertuzumab: Given per standard of care Polysaccharide-K: Given PO Trastuzumab: Given per standard of care
Investigations Lymphocyte count decreased	37.5% 6/16 • Number of events 7 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.	26.7% 4/15 • Number of events 5 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.
Investigations White blood cell decreased	18.8% 3/16 • Number of events 4 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.	20.0% 3/15 • Number of events 3 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.
Investigations Platelet count decreased	25.0% 4/16 • Number of events 5 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.	0.00% 0/15 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.
Investigations Neutrophil count decreased	6.2% 1/16 • Number of events 1 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.	6.7% 1/15 • Number of events 1 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.
Investigations Alanine aminotransferase increased	12.5% 2/16 • Number of events 2 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.	0.00% 0/15 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.
Respiratory, thoracic and mediastinal disorders Cough	6.2% 1/16 • Number of events 1 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.	13.3% 2/15 • Number of events 2 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.
Respiratory, thoracic and mediastinal disorders Dyspnea	6.2% 1/16 • Number of events 1 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.	6.7% 1/15 • Number of events 1 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.
Respiratory, thoracic and mediastinal disorders Other - rhinorrhea	6.2% 1/16 • Number of events 1 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.	0.00% 0/15 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.
Blood and lymphatic system disorders Anemia	25.0% 4/16 • Number of events 4 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.	40.0% 6/15 • Number of events 7 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.
Musculoskeletal and connective tissue disorders Arthralgia	6.2% 1/16 • Number of events 1 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.	0.00% 0/15 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.
Musculoskeletal and connective tissue disorders Pain in extremity	6.2% 1/16 • Number of events 1 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.	0.00% 0/15 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.
Infections and infestations Sinusitis	6.2% 1/16 • Number of events 1 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.	0.00% 0/15 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.
Infections and infestations Upper respiratory infection	12.5% 2/16 • Number of events 2 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.	13.3% 2/15 • Number of events 2 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.
Infections and infestations Other - pneumonia	6.2% 1/16 • Number of events 2 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.	0.00% 0/15 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.
Nervous system disorders Cognitive disturbance	6.2% 1/16 • Number of events 2 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.	0.00% 0/15 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.
Nervous system disorders Dizziness	6.2% 1/16 • Number of events 1 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.	0.00% 0/15 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.
Nervous system disorders Headache	6.2% 1/16 • Number of events 1 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.	46.7% 7/15 • Number of events 9 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.
Nervous system disorders Paresthesia	6.2% 1/16 • Number of events 1 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.	0.00% 0/15 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.
Nervous system disorders Dysesthesia	6.2% 1/16 • Number of events 1 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.	0.00% 0/15 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.
Gastrointestinal disorders Diarrhea	18.8% 3/16 • Number of events 4 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.	40.0% 6/15 • Number of events 8 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.
Gastrointestinal disorders Nausea	18.8% 3/16 • Number of events 5 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.	0.00% 0/15 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.
Gastrointestinal disorders Vomiting	12.5% 2/16 • Number of events 4 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.	0.00% 0/15 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.
Gastrointestinal disorders Constipation	12.5% 2/16 • Number of events 2 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.	6.7% 1/15 • Number of events 1 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.
Gastrointestinal disorders Bloating	6.2% 1/16 • Number of events 1 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.	0.00% 0/15 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.
Gastrointestinal disorders Abdominal pain	12.5% 2/16 • Number of events 2 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.	0.00% 0/15 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.
Gastrointestinal disorders Other - minor acid reflux after drinking tea for half hour or so	6.2% 1/16 • Number of events 1 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.	0.00% 0/15 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.
Gastrointestinal disorders Dry mouth	6.2% 1/16 • Number of events 1 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.	0.00% 0/15 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.
Gastrointestinal disorders Flatulence	12.5% 2/16 • Number of events 3 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.	0.00% 0/15 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.
Skin and subcutaneous tissue disorders Rash acneiform	6.2% 1/16 • Number of events 1 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.	0.00% 0/15 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.
Skin and subcutaneous tissue disorders Rash maculo-papular	12.5% 2/16 • Number of events 2 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.	6.7% 1/15 • Number of events 2 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.
Skin and subcutaneous tissue disorders Other - acne/rash	6.2% 1/16 • Number of events 1 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.	0.00% 0/15 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.
General disorders Fatigue	31.2% 5/16 • Number of events 6 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.	13.3% 2/15 • Number of events 2 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.
General disorders Flu like symptoms	43.8% 7/16 • Number of events 8 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.	46.7% 7/15 • Number of events 12 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.
General disorders Non-cardiac chest pain	12.5% 2/16 • Number of events 2 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.	0.00% 0/15 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.
General disorders Pain	6.2% 1/16 • Number of events 1 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.	6.7% 1/15 • Number of events 1 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.
General disorders Injection site reaction	87.5% 14/16 • Number of events 29 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.	86.7% 13/15 • Number of events 26 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.
General disorders Gait disturbance	6.2% 1/16 • Number of events 1 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.	0.00% 0/15 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.
Vascular disorders Hot flashes	6.2% 1/16 • Number of events 1 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.	6.7% 1/15 • Number of events 2 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.
Vascular disorders Other - head sweats-daily	6.2% 1/16 • Number of events 1 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.	0.00% 0/15 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.
Metabolism and nutrition disorders Hypocalcemia	31.2% 5/16 • Number of events 5 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.	6.7% 1/15 • Number of events 1 • Clinical and/or chemical parameters for all study patients will be evaluated for potential toxicity at baseline, before each vaccine, and 1 month after the third vaccine (total of 4 months evaluation). Toxicity grading will be evaluated per CTEP CTCAE 4.0 and monitoring of AEs will be done per FDA and NCI guidelines. AEs will be tabulated per CTCAE 4.0 system organ class and descriptive statistics will be used to summarize toxicity profiles for the PSK and placebo groups.