Trial Outcomes & Findings for Adjuvant GVAX Vaccine Therapy in Patients With Pancreatic Cancer (NCT NCT00389610)

NCT ID: NCT00389610

Last Updated: 2023-10-26

Results Overview

When calculating the incidences of adverse events, each adverse event (as defined by NCI CTCAE v3) will be counted only once for a given subject.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 56 participants
• Primary outcome timeframe: 14 years
• Results posted on: 2023-10-26

Participant Flow

Participant milestones

Measure	Previously Vaccinated With GVAX Pancreas Vaccine Participants receive booster vaccination every 6 months, given intradermally	GVAX Pancreas Vaccine Naive Participants will receive GVAX pancreas priming vaccinations once every month for a total of 3 months and every 6 months after that, given intradermally.
Overall Study STARTED	11	45
Overall Study COMPLETED	11	23
Overall Study NOT COMPLETED	0	22

Reasons for withdrawal

Measure	Previously Vaccinated With GVAX Pancreas Vaccine Participants receive booster vaccination every 6 months, given intradermally	GVAX Pancreas Vaccine Naive Participants will receive GVAX pancreas priming vaccinations once every month for a total of 3 months and every 6 months after that, given intradermally.
Overall Study Disease Progression	0	19
Overall Study Death	0	1
Overall Study Physician Decision	0	1
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Adjuvant GVAX Vaccine Therapy in Patients With Pancreatic Cancer

Baseline characteristics by cohort

Measure	Previously Vaccinated With GVAX Pancreas Vaccine n=11 Participants Participants receive booster vaccination every 6 months, given intradermally	GVAX Pancreas Vaccine Naive n=45 Participants Participants will receive GVAX pancreas priming vaccinations once every month for a total of 3 months and every 6 months after that, given intradermally.	Total n=56 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	29 Participants n=7 Participants	30 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants	16 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	19 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	26 Participants n=7 Participants	33 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	44 Participants n=7 Participants	54 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	42 Participants n=7 Participants	51 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 14 years

When calculating the incidences of adverse events, each adverse event (as defined by NCI CTCAE v3) will be counted only once for a given subject.

Outcome measures

Measure	Previously Vaccinated With GVAX Pancreas Vaccine n=11 Participants Participants receive booster vaccination every 6 months, given intradermally	GVAX Pancreas Vaccine Naive n=45 Participants Participants will receive GVAX pancreas priming vaccinations once every month for a total of 3 months and every 6 months after that, given intradermally.
Number of Patients Experiencing a Grade 3 or Above Treatment- Related Toxicity	1 Participants	5 Participants

SECONDARY outcome

Timeframe: 16 years

OS will be measured from date of first dose until death or end of follow-up (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve.

Outcome measures

Measure	Previously Vaccinated With GVAX Pancreas Vaccine n=11 Participants Participants receive booster vaccination every 6 months, given intradermally	GVAX Pancreas Vaccine Naive n=45 Participants Participants will receive GVAX pancreas priming vaccinations once every month for a total of 3 months and every 6 months after that, given intradermally.
Overall Survival (OS)	80.5 Months Interval 22.5 to 187.8	30.7 Months Interval 19.3 to 40.7

SECONDARY outcome

Timeframe: 16 years

DFS is defined as the time from the first dose until evidence of disease recurrence or progression confirmed by first scan. DFS will be censored at the date of the last scan for subjects without documentation of disease recurrence or progression at the time of analysis. Estimation based on the Kaplan-Meier curve.

Outcome measures

Measure	Previously Vaccinated With GVAX Pancreas Vaccine n=11 Participants Participants receive booster vaccination every 6 months, given intradermally	GVAX Pancreas Vaccine Naive n=45 Participants Participants will receive GVAX pancreas priming vaccinations once every month for a total of 3 months and every 6 months after that, given intradermally.
Disease-free Survival (DFS)	109.5 Months Interval 5.59 to NA Explanation: Upper bound confidence interval was not reached.	13.7 Months Interval 5.55 to 25.1

Adverse Events

Previously Vaccinated With GVAX Pancreas Vaccine

Serious events: 1 serious events

Other events: 11 other events

Deaths: 10 deaths

GVAX Pancreas Vaccine Naive

Serious events: 0 serious events

Other events: 45 other events

Deaths: 42 deaths

Serious adverse events

Measure	Previously Vaccinated With GVAX Pancreas Vaccine n=11 participants at risk Participants receive booster vaccination every 6 months, given intradermally	GVAX Pancreas Vaccine Naive n=45 participants at risk Participants will receive GVAX pancreas priming vaccinations once every month for a total of 3 months and every 6 months after that, given intradermally.
Nervous system disorders Presyncope	9.1% 1/11 • Number of events 1 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.	0.00% 0/45 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.

Other adverse events

Measure	Previously Vaccinated With GVAX Pancreas Vaccine n=11 participants at risk Participants receive booster vaccination every 6 months, given intradermally	GVAX Pancreas Vaccine Naive n=45 participants at risk Participants will receive GVAX pancreas priming vaccinations once every month for a total of 3 months and every 6 months after that, given intradermally.
Blood and lymphatic system disorders Lymphadenopathy	9.1% 1/11 • Number of events 1 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.	6.7% 3/45 • Number of events 4 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.
Gastrointestinal disorders Nausea	0.00% 0/11 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.	6.7% 3/45 • Number of events 3 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.
Gastrointestinal disorders Diarrhea	9.1% 1/11 • Number of events 1 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.	4.4% 2/45 • Number of events 2 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.
General disorders Chills	36.4% 4/11 • Number of events 7 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.	13.3% 6/45 • Number of events 6 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.
General disorders Fatigue	18.2% 2/11 • Number of events 3 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.	22.2% 10/45 • Number of events 14 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.
General disorders Fever	9.1% 1/11 • Number of events 1 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.	13.3% 6/45 • Number of events 16 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.
General disorders Flu-Like symptoms	81.8% 9/11 • Number of events 23 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.	51.1% 23/45 • Number of events 62 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.
General disorders Malaise	0.00% 0/11 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.	8.9% 4/45 • Number of events 4 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.
Investigations White blood cell count elevated	9.1% 1/11 • Number of events 1 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.	6.7% 3/45 • Number of events 4 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.
Investigations Eosinophil count elevated	9.1% 1/11 • Number of events 1 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.	35.6% 16/45 • Number of events 16 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.
Metabolism and nutrition disorders Anorexia	18.2% 2/11 • Number of events 2 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.	15.6% 7/45 • Number of events 7 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.
Musculoskeletal and connective tissue disorders Arthralgia	9.1% 1/11 • Number of events 1 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.	11.1% 5/45 • Number of events 6 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.
Musculoskeletal and connective tissue disorders Myalgia	36.4% 4/11 • Number of events 4 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.	17.8% 8/45 • Number of events 8 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.
Musculoskeletal and connective tissue disorders Weakness	9.1% 1/11 • Number of events 1 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.	6.7% 3/45 • Number of events 3 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.
Nervous system disorders Headache	9.1% 1/11 • Number of events 1 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.	8.9% 4/45 • Number of events 4 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.
Respiratory, thoracic and mediastinal disorders Nasal congestion	9.1% 1/11 • Number of events 1 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.	8.9% 4/45 • Number of events 4 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.
Skin and subcutaneous tissue disorders Blisters	27.3% 3/11 • Number of events 8 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.	17.8% 8/45 • Number of events 13 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.
Skin and subcutaneous tissue disorders Dry skin	9.1% 1/11 • Number of events 1 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.	6.7% 3/45 • Number of events 3 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.
Skin and subcutaneous tissue disorders Pruritus	36.4% 4/11 • Number of events 5 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.	4.4% 2/45 • Number of events 2 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.
Skin and subcutaneous tissue disorders Rash	9.1% 1/11 • Number of events 1 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.	6.7% 3/45 • Number of events 5 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.
Skin and subcutaneous tissue disorders Urticaria	36.4% 4/11 • Number of events 10 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.	22.2% 10/45 • Number of events 17 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.
Skin and subcutaneous tissue disorders Bruising (vaccination site)	9.1% 1/11 • Number of events 1 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.	4.4% 2/45 • Number of events 2 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.
Skin and subcutaneous tissue disorders Erythema (vaccination site)	100.0% 11/11 • Number of events 64 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.	100.0% 45/45 • Number of events 250 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.
Skin and subcutaneous tissue disorders Vaccine Flares (vaccination site)	36.4% 4/11 • Number of events 18 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.	28.9% 13/45 • Number of events 38 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.
Skin and subcutaneous tissue disorders Induration (vaccination site)	100.0% 11/11 • Number of events 64 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.	100.0% 45/45 • Number of events 247 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.
Skin and subcutaneous tissue disorders Skin hyperpigmentation (vaccination site)	9.1% 1/11 • Number of events 1 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.	8.9% 4/45 • Number of events 7 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.
Skin and subcutaneous tissue disorders Tenderness (vaccination site)	81.8% 9/11 • Number of events 56 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.	75.6% 34/45 • Number of events 146 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.
Skin and subcutaneous tissue disorders Pruritus (vaccination site)	100.0% 11/11 • Number of events 53 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.	82.2% 37/45 • Number of events 191 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.
Skin and subcutaneous tissue disorders Warmth (vaccination site)	90.9% 10/11 • Number of events 42 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.	77.8% 35/45 • Number of events 87 • 16 years This study used the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for adverse event reporting. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events. Adverse events were assessed for up to 14 years. All-Cause Mortality was assessed for up to 16 years.

Additional Information

Daniel Laheru, MD

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Phone: 410-955-8974

Email: laherda@jhmi.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place