Trial Outcomes & Findings for IGFBP-2 Vaccine and Combination Chemotherapy in Treating Patients With Stage III-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Undergoing Surgery (NCT NCT03029611)

Last Updated: 2022-01-14

Results Overview

The tissue collected at time of cytoreductive surgery, post study treatment, was evaluated by the attending pathologist assigned to look at the tissue for viable tumor cells. The corresponding surgical pathology report was reviewed to evaluate individual pCR (absence of viable tumor cells).

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

11 participants

Primary outcome timeframe

At the time of cytoreductive surgery after receiving study treatment (vaccinations given intradermally approximately two weeks after each combination chemotherapy for 3 doses.)

Results posted on

2022-01-14

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Chemotherapy, IGFBP-2 Vaccine) Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour followed by IGFBP-2 vaccine ID 2 weeks later. Treatment repeats every 3 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. After completion of 3 cycles, patients then undergo cytoreductive surgery. Carboplatin: Given IV Gynecological Surgical Procedure: Undergo cytoreductive surgery Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV pUMVC3-hIGFBP-2 Multi-Epitope Plasmid DNA Vaccine: Given ID
Overall Study STARTED	9
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

IGFBP-2 Vaccine and Combination Chemotherapy in Treating Patients With Stage III-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Undergoing Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Chemotherapy, IGFBP-2 Vaccine) n=9 Participants Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour followed by IGFBP-2 vaccine ID 2 weeks later. Treatment repeats every 3 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. After completion of 3 cycles, patients then undergo cytoreductive surgery. Carboplatin: Given IV Gynecological Surgical Procedure: Undergo cytoreductive surgery Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV pUMVC3-hIGFBP-2 Multi-Epitope Plasmid DNA Vaccine: Given ID
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=99 Participants
Age, Categorical >=65 years	4 Participants n=99 Participants
Age, Continuous	64 years n=99 Participants
Sex: Female, Male Female	9 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	1 Participants n=99 Participants
Race (NIH/OMB) White	7 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	9 participants n=99 Participants

PRIMARY outcome

Timeframe: At the time of cytoreductive surgery after receiving study treatment (vaccinations given intradermally approximately two weeks after each combination chemotherapy for 3 doses.)

Population: Review of the pathology report from cytoreductive surgery.

Outcome measures

Outcome measures
Measure	Treatment (Chemotherapy, IGFBP-2 Vaccine) n=9 Participants Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour followed by IGFBP-2 vaccine ID 2 weeks later. Treatment repeats every 3 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. After completion of 3 cycles, patients then undergo cytoreductive surgery. Carboplatin: Given IV Gynecological Surgical Procedure: Undergo cytoreductive surgery Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV pUMVC3-hIGFBP-2 Multi-Epitope Plasmid DNA Vaccine: Given ID
Rate of Pathologic Complete Response (CR)	0 Participants

SECONDARY outcome

Timeframe: At the time of cytoreductive surgery

Population: Target enrollment was not met. Samples were collected but planned laboratory/statistical analyses were not performed due to termination of study, lack of funding, and insufficient enrollment.

Will be performed and quantitated using published methods and will be correlated with surgical CR by the Man-Whitney U or one-way analysis of variance test depending on the distribution of TIL outcomes.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 months after last vaccine

Will be correlated to tumor burden at definitive surgery.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At the time of cytoreductive surgery after receiving study treatment (vaccinations given intradermally approximately two weeks after each combination chemotherapy for 3 doses.)

Will be assessed by immunohistochemistry (IHC) to determine whether IGFBP-2 vaccination in combination with chemotherapy increases the level of TIL in the tumor. This was done by assessing the level of IGFBP-2 Th1 elicited by study treatment (vaccination concurrent with chemotherapy). we are looking for an increase in TIL.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

Population: Target enrollment was not met. The study was terminated. Planned statistical analysis was not performed due to termination of study, lack of funding, and insufficient enrollment.

Will be compared between the treatment arms. Large differences in PFS if observed between the treatment groups will be noted and described. Will be plotted by Kaplan-Meier curve, and compared to the survival data reported by Vergote et al which reported median PFS of 12 months and median OS of 30 months for patients treated with neoadjuvant chemotherapy by a log-rank test.

Outcome measures

Outcome measures
Measure	Treatment (Chemotherapy, IGFBP-2 Vaccine) n=9 Participants Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour followed by IGFBP-2 vaccine ID 2 weeks later. Treatment repeats every 3 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. After completion of 3 cycles, patients then undergo cytoreductive surgery. Carboplatin: Given IV Gynecological Surgical Procedure: Undergo cytoreductive surgery Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV pUMVC3-hIGFBP-2 Multi-Epitope Plasmid DNA Vaccine: Given ID
Overall Survival (OS) Alive	6 Participants
Overall Survival (OS) Deceased - passed away after they left the study	3 Participants

SECONDARY outcome

Timeframe: Up to 12 months

Population: Target enrollment was not met. The study was terminated. Planned statistical analysis was not performed due to termination of study, lack of funding, and insufficient enrollment.

Large differences in PFS if observed between the treatment groups will be noted and described. Will be plotted by Kaplan-Meier curve, and compared to the survival data reported by Vergote et al which reported median PFS of 12 months and median overall survival (OS) of 30 months for patients treated with neoadjuvant chemotherapy by a log-rank test.

Outcome measures

Outcome measures
Measure	Treatment (Chemotherapy, IGFBP-2 Vaccine) n=9 Participants Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour followed by IGFBP-2 vaccine ID 2 weeks later. Treatment repeats every 3 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. After completion of 3 cycles, patients then undergo cytoreductive surgery. Carboplatin: Given IV Gynecological Surgical Procedure: Undergo cytoreductive surgery Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV pUMVC3-hIGFBP-2 Multi-Epitope Plasmid DNA Vaccine: Given ID
Progression Free Survival (PFS) PFS	2 Participants
Progression Free Survival (PFS) Recurrence	2 Participants
Progression Free Survival (PFS) Deceased - passed away after they left the study	3 Participants
Progression Free Survival (PFS) Status unchanged	2 Participants

SECONDARY outcome

Timeframe: At the time of cytoreductive surgery

Population: Target enrollment was not met. The study was terminated. Planned statistical analysis was not performed due to termination of study, lack of funding, and insufficient enrollment.

Will be correlated to level of IGFBP-2 Th1 cells.

Outcome measures

Outcome measures
Measure	Treatment (Chemotherapy, IGFBP-2 Vaccine) n=9 Participants Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour followed by IGFBP-2 vaccine ID 2 weeks later. Treatment repeats every 3 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. After completion of 3 cycles, patients then undergo cytoreductive surgery. Carboplatin: Given IV Gynecological Surgical Procedure: Undergo cytoreductive surgery Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV pUMVC3-hIGFBP-2 Multi-Epitope Plasmid DNA Vaccine: Given ID
Tumor Burden Debulking surgery	7 Participants
Tumor Burden Not evaluable	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: At the time of cytoreductive surgery

Will use the LASSO regularized regression method to generate preliminary data for a predictive signature. Will correlate mutational profiles with primary platinum sensitive, resistance and refractory outcomes, leveraging the Cancer Genome Atlas data publicly available, to determine differences induced by vaccination.

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Chemotherapy, IGFBP-2 Vaccine)

Serious events: 0 serious events

Other events: 9 other events

Deaths: 3 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment (Chemotherapy, IGFBP-2 Vaccine) n=9 participants at risk Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour followed by IGFBP-2 vaccine ID 2 weeks later. Treatment repeats every 3 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. After completion of 3 cycles, patients then undergo cytoreductive surgery. Carboplatin: Given IV Gynecological Surgical Procedure: Undergo cytoreductive surgery Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV pUMVC3-hIGFBP-2 Multi-Epitope Plasmid DNA Vaccine: Given ID
Investigations White blood cell decreased	11.1% 1/9 • Number of events 1 • The Adverse Events were collected after first vaccination and through to 6 months post vaccination. We used CTCAE v4.0 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 Platelet count decreased	11.1% 1/9 • Number of events 1 • The Adverse Events were collected after first vaccination and through to 6 months post vaccination. We used CTCAE v4.0 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 Weight loss	22.2% 2/9 • Number of events 2 • The Adverse Events were collected after first vaccination and through to 6 months post vaccination. We used CTCAE v4.0 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 increased	11.1% 1/9 • Number of events 1 • The Adverse Events were collected after first vaccination and through to 6 months post vaccination. We used CTCAE v4.0 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	11.1% 1/9 • Number of events 1 • The Adverse Events were collected after first vaccination and through to 6 months post vaccination. We used CTCAE v4.0 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 Pleural effusion	22.2% 2/9 • Number of events 2 • The Adverse Events were collected after first vaccination and through to 6 months post vaccination. We used CTCAE v4.0 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 Anemia	55.6% 5/9 • Number of events 6 • The Adverse Events were collected after first vaccination and through to 6 months post vaccination. We used CTCAE v4.0 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	33.3% 3/9 • Number of events 4 • The Adverse Events were collected after first vaccination and through to 6 months post vaccination. We used CTCAE v4.0 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	22.2% 2/9 • Number of events 2 • The Adverse Events were collected after first vaccination and through to 6 months post vaccination. We used CTCAE v4.0 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 Bone pain	11.1% 1/9 • Number of events 1 • The Adverse Events were collected after first vaccination and through to 6 months post vaccination. We used CTCAE v4.0 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 Other - leg weakness	11.1% 1/9 • Number of events 1 • The Adverse Events were collected after first vaccination and through to 6 months post vaccination. We used CTCAE v4.0 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 Other - "pulled muscle" in left upper quadrant	11.1% 1/9 • Number of events 1 • The Adverse Events were collected after first vaccination and through to 6 months post vaccination. We used CTCAE v4.0 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 Urinary tract infection	22.2% 2/9 • Number of events 2 • The Adverse Events were collected after first vaccination and through to 6 months post vaccination. We used CTCAE v4.0 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 Other Infection	11.1% 1/9 • Number of events 1 • The Adverse Events were collected after first vaccination and through to 6 months post vaccination. We used CTCAE v4.0 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 Wound infection	11.1% 1/9 • Number of events 1 • The Adverse Events were collected after first vaccination and through to 6 months post vaccination. We used CTCAE v4.0 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 Palpitations	22.2% 2/9 • Number of events 2 • The Adverse Events were collected after first vaccination and through to 6 months post vaccination. We used CTCAE v4.0 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 Cognitive disturbance	11.1% 1/9 • Number of events 1 • The Adverse Events were collected after first vaccination and through to 6 months post vaccination. We used CTCAE v4.0 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	11.1% 1/9 • Number of events 1 • The Adverse Events were collected after first vaccination and through to 6 months post vaccination. We used CTCAE v4.0 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 Headache	33.3% 3/9 • Number of events 3 • The Adverse Events were collected after first vaccination and through to 6 months post vaccination. We used CTCAE v4.0 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 Peripheral sensory neuropathy	55.6% 5/9 • Number of events 5 • The Adverse Events were collected after first vaccination and through to 6 months post vaccination. We used CTCAE v4.0 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	11.1% 1/9 • Number of events 1 • The Adverse Events were collected after first vaccination and through to 6 months post vaccination. We used CTCAE v4.0 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	22.2% 2/9 • Number of events 3 • The Adverse Events were collected after first vaccination and through to 6 months post vaccination. We used CTCAE v4.0 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	22.2% 2/9 • Number of events 3 • The Adverse Events were collected after first vaccination and through to 6 months post vaccination. We used CTCAE v4.0 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	44.4% 4/9 • Number of events 5 • The Adverse Events were collected after first vaccination and through to 6 months post vaccination. We used CTCAE v4.0 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 Abdominal distension	11.1% 1/9 • Number of events 1 • The Adverse Events were collected after first vaccination and through to 6 months post vaccination. We used CTCAE v4.0 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 Abdominal pain	11.1% 1/9 • Number of events 1 • The Adverse Events were collected after first vaccination and through to 6 months post vaccination. We used CTCAE v4.0 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 Ascites	11.1% 1/9 • Number of events 1 • The Adverse Events were collected after first vaccination and through to 6 months post vaccination. We used CTCAE v4.0 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 acneiform	11.1% 1/9 • Number of events 1 • The Adverse Events were collected after first vaccination and through to 6 months post vaccination. We used CTCAE v4.0 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 maculo-papular	22.2% 2/9 • Number of events 2 • The Adverse Events were collected after first vaccination and through to 6 months post vaccination. We used CTCAE v4.0 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	100.0% 9/9 • Number of events 12 • The Adverse Events were collected after first vaccination and through to 6 months post vaccination. We used CTCAE v4.0 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	22.2% 2/9 • Number of events 3 • The Adverse Events were collected after first vaccination and through to 6 months post vaccination. We used CTCAE v4.0 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 limbs	11.1% 1/9 • Number of events 1 • The Adverse Events were collected after first vaccination and through to 6 months post vaccination. We used CTCAE v4.0 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 Non-cardiac chest pain	11.1% 1/9 • Number of events 1 • The Adverse Events were collected after first vaccination and through to 6 months post vaccination. We used CTCAE v4.0 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 Pain	55.6% 5/9 • Number of events 6 • The Adverse Events were collected after first vaccination and through to 6 months post vaccination. We used CTCAE v4.0 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	44.4% 4/9 • Number of events 4 • The Adverse Events were collected after first vaccination and through to 6 months post vaccination. We used CTCAE v4.0 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	22.2% 2/9 • Number of events 2 • The Adverse Events were collected after first vaccination and through to 6 months post vaccination. We used CTCAE v4.0 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 Hypotension	11.1% 1/9 • Number of events 1 • The Adverse Events were collected after first vaccination and through to 6 months post vaccination. We used CTCAE v4.0 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	22.2% 2/9 • Number of events 2 • The Adverse Events were collected after first vaccination and through to 6 months post vaccination. We used CTCAE v4.0 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	22.2% 2/9 • Number of events 2 • The Adverse Events were collected after first vaccination and through to 6 months post vaccination. We used CTCAE v4.0 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 Cystitis noninfective	11.1% 1/9 • Number of events 1 • The Adverse Events were collected after first vaccination and through to 6 months post vaccination. We used CTCAE v4.0 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 Hematuria	11.1% 1/9 • Number of events 1 • The Adverse Events were collected after first vaccination and through to 6 months post vaccination. We used CTCAE v4.0 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 Acute kidney injury	11.1% 1/9 • Number of events 1 • The Adverse Events were collected after first vaccination and through to 6 months post vaccination. We used CTCAE v4.0 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 Other - paracentisis	44.4% 4/9 • Number of events 4 • The Adverse Events were collected after first vaccination and through to 6 months post vaccination. We used CTCAE v4.0 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 Other - IVC filter placed due to clots	11.1% 1/9 • Number of events 1 • The Adverse Events were collected after first vaccination and through to 6 months post vaccination. We used CTCAE v4.0 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 Other - thoracentesis x 2 due to pleural effusion. Hospitalized	11.1% 1/9 • Number of events 1 • The Adverse Events were collected after first vaccination and through to 6 months post vaccination. We used CTCAE v4.0 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 Other - ex-lap, RSO, omentectomy, appendectomy, tumor debulking	11.1% 1/9 • Number of events 1 • The Adverse Events were collected after first vaccination and through to 6 months post vaccination. We used CTCAE v4.0 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

UWashington (University of Washington)

Phone: 206-616-2305

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place