Trial Outcomes & Findings for Study of a Multi-Antigen Therapeutic Vaccine in Patients With Metastatic Melanoma (NCT NCT00613509)
NCT ID: NCT00613509
Last Updated: 2016-04-14
Results Overview
Number of evaluable study participants who had died or experienced objective disease progression (no clinical objective response to treatment as evaluated by computed tomography \[CT\] scans or physical examination).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
23 participants
Primary outcome timeframe
Day 0 up to 35 weeks post 1st vaccination or treatment
Results posted on
2016-04-14
Participant Flow
Participants were enrolled from 20 May 2008 to 31 March 2009 at 8 medical centers in the US and 3 medical centers in Canada.
A total of 23 participants who met the inclusion and exclusion criteria were enrolled and treated.
Participant milestones
| Measure |
Study Group 1: ALVAC Melanoma Vaccine
Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
|
Study Group 2: Interferon Alpha-2b
Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
|
|---|---|---|
|
Cycle 1
STARTED
|
11
|
12
|
|
Cycle 1
COMPLETED
|
6
|
4
|
|
Cycle 1
NOT COMPLETED
|
5
|
8
|
|
Cycle 2 (Group 2 = Crossover)
STARTED
|
11
|
4
|
|
Cycle 2 (Group 2 = Crossover)
COMPLETED
|
11
|
4
|
|
Cycle 2 (Group 2 = Crossover)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Study Group 1: ALVAC Melanoma Vaccine
Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
|
Study Group 2: Interferon Alpha-2b
Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
|
|---|---|---|
|
Cycle 1
Adverse Event
|
2
|
1
|
|
Cycle 1
Disease Progression
|
2
|
6
|
|
Cycle 1
Unacceptable Toxicity
|
1
|
0
|
|
Cycle 1
Other administrative reason
|
0
|
1
|
Baseline Characteristics
Study of a Multi-Antigen Therapeutic Vaccine in Patients With Metastatic Melanoma
Baseline characteristics by cohort
| Measure |
Study Group 1: ALVAC Melanoma Vaccine
n=11 Participants
Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
|
Study Group 2: Interferon Alpha-2b
n=12 Participants
Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
|
Total
n=23 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
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
52.6 Years
STANDARD_DEVIATION 14.23 • n=5 Participants
|
52.9 Years
STANDARD_DEVIATION 14.34 • n=7 Participants
|
52.8 Years
STANDARD_DEVIATION 14.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
10 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 up to 35 weeks post 1st vaccination or treatmentPopulation: The Progression-Free Survival Time were assessed in the intend-to-treat (ITT) evaluable population.
Number of evaluable study participants who had died or experienced objective disease progression (no clinical objective response to treatment as evaluated by computed tomography \[CT\] scans or physical examination).
Outcome measures
| Measure |
Study Group 1: ALVAC Melanoma Vaccine
n=11 Participants
Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
|
Study Group 2: Interferon Alpha-2b
n=12 Participants
Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
|
|---|---|---|
|
Summary of Disease Progression in Study Participants, Intent-to-treat Population
Progressed or died due to any cause
|
7 Participants
|
6 Participants
|
|
Summary of Disease Progression in Study Participants, Intent-to-treat Population
Did not progress or die due to any cause
|
4 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Day 0 - up to 35 weeks post 1st vaccination or treatmentPopulation: The Progression-Free Survival Time were assessed in the intend-to-treat (ITT) evaluable population.
Progression-Free Survival was assessed by the Response Evaluation Criteria in Solid Tumor criteria from the computed tomography (CT) scans, as per-protocol
Outcome measures
| Measure |
Study Group 1: ALVAC Melanoma Vaccine
n=11 Participants
Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
|
Study Group 2: Interferon Alpha-2b
n=12 Participants
Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
|
|---|---|---|
|
Progression-Free Survival Time by Response Evaluation Criteria in Solid Tumor (RECIST) Criteria in the Intent-to-treat Population
|
15.9 Weeks
Interval 8.0 to
NA: Upper limit not estimated because of insufficient observations above the median
|
8.9 Weeks
Interval 8.3 to
NA: Upper limit not estimated because of insufficient observations above the median
|
SECONDARY outcome
Timeframe: Day 0 to 32 weeks post 1st vaccination or treatmentPopulation: The best overall objective response as number of participants responding was assessed in the intent-to-treat (ITT) evaluable population.
Objective response rate (ORR) is the sum of complete response (CR) and partial response (PR) Complete response = Disappearance of all target lesions. Partial response = At least a 30% decrease in the sum of longest diameter of target lesions, taking as reference the baseline sum longest diameter.
Outcome measures
| Measure |
Study Group 1: ALVAC Melanoma Vaccine
n=11 Participants
Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
|
Study Group 2: Interferon Alpha-2b
n=12 Participants
Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
|
|---|---|---|
|
Best Overall Objective Response as Number of Participants Responding in the Intent-to-treat Population
Participants with measurable disease at baseline
|
11 Particpants
|
11 Particpants
|
|
Best Overall Objective Response as Number of Participants Responding in the Intent-to-treat Population
Complete Response (CR)
|
0 Particpants
|
0 Particpants
|
|
Best Overall Objective Response as Number of Participants Responding in the Intent-to-treat Population
Partial Response (PR)
|
2 Particpants
|
1 Particpants
|
|
Best Overall Objective Response as Number of Participants Responding in the Intent-to-treat Population
Stable Disease (SD)
|
3 Particpants
|
3 Particpants
|
|
Best Overall Objective Response as Number of Participants Responding in the Intent-to-treat Population
Not Evaluable (NE)
|
0 Particpants
|
1 Particpants
|
|
Best Overall Objective Response as Number of Participants Responding in the Intent-to-treat Population
Progression (PD)
|
6 Particpants
|
6 Particpants
|
SECONDARY outcome
Timeframe: Day 0 to 32 weeks post 1st vaccination or treatmentPopulation: The best overall objective response were assessed in the intent-to-treat (ITT) evaluable population.
Objective response rate (ORR) is the sum of complete response (CR) and partial response (PR) Complete response = Disappearance of all target lesions. Partial response = At least a 30% decrease in the sum of longest diameter of target lesions, taking as reference the baseline sum longest diameter.
Outcome measures
| Measure |
Study Group 1: ALVAC Melanoma Vaccine
n=11 Participants
Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
|
Study Group 2: Interferon Alpha-2b
n=12 Participants
Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
|
|---|---|---|
|
Best Overall Objective Response in the Intent-to-treat Population
|
18.2 Percentage of participants
|
9.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 0 to 32 weeks post 1st vaccination or treatmentPopulation: The best overall objective response as mean duration of response were assessed in the intent-to-treat (ITT) evaluable population.
Objective response rate (ORR) is the sum of complete response (CR) and partial response (PR) Complete response = Disappearance of all target lesions. Partial response = At least a 30% decrease in the sum of longest diameter of target lesions, taking as reference the baseline sum longest diameter.
Outcome measures
| Measure |
Study Group 1: ALVAC Melanoma Vaccine
n=11 Participants
Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
|
Study Group 2: Interferon Alpha-2b
n=12 Participants
Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
|
|---|---|---|
|
Best Overall Objective Response as Mean Duration of Response (Weeks) in the Intent-to-treat Population
|
16.3 Weeks
Interval 6.4 to 26.1
|
18.3 Weeks
Interval 18.3 to 18.3
|
SECONDARY outcome
Timeframe: Day 0 to 12 months post last vaccinationPopulation: Safety assessments were conducted in the As-treated safety population.
Common Terminology Criteria for Adverse Events (CTCAE) definitions: Grade 3 is a severe adverse event; Grade 4 is a life-threatening or disabling adverse event.
Outcome measures
| Measure |
Study Group 1: ALVAC Melanoma Vaccine
n=11 Participants
Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
|
Study Group 2: Interferon Alpha-2b
n=12 Participants
Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
|
|---|---|---|
|
Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term
Anemia
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term
Leukocytosis
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term
Abdominal Pain Upper
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term
Axillary Pain
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term
Chest Discomfort
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term
Chest Pain
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term
Inflammation
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term
Pyrexia
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term
Sepsis
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term
Septic Shock
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term
Staphylococcal Bacteremia
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term
Syncope Vasovagal
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term
Polyuria
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term
Alanine Aminotransferase (ALT) Increased
|
0 Participants
|
3 Participants
|
|
Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term
Aspartate Aminotransferase (AST) Increased
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term
Gamma-Glutamyl Transferase (GGT) Increased
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term
Neutrophil Count Decreased
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term
White Blood Cell Count Decreased
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term
Hypernatremia
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term
Hypoalbuminemia
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term
Hypocalcemia
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term
Hyponatremia
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term
Joint Range of Motion Decreased
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term
Metastatic Malignant Melanoma
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term
Brain Edema
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term
Cerebral Hemorrhage
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term
Encephalopathy
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term
Headache
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term
Hemiplegia
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term
Paraesthesia
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term
Peripheral Sensory Neuropathy
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term
Hypotension
|
1 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 to 32 weeks post 1st vaccinationPopulation: Immunologic responses were assessed in the Per-protocol evaluable population.
The vaccine-induced increase of CD8 T-Cell positive response by antigen post-vaccination during the observation period compared to the screening values.
Outcome measures
| Measure |
Study Group 1: ALVAC Melanoma Vaccine
n=9 Participants
Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
|
Study Group 2: Interferon Alpha-2b
n=12 Participants
Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
|
|---|---|---|
|
Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen
Screening: gp100 pool4
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen
Screening: gp100 pool5
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen
7 Weeks post 1st Vaccination: gp100 pool2
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen
7 Weeks post 1st Vaccination: gp100 pool3
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen
Screening: gp100 pool1
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen
Screening: gp100 pool2
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen
Screening: gp100 pool3
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen
Screening: gp100 pool6
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen
Screening: NYESO-1 pool 1
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen
Screening: NYESO-1 pool 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen
Screening: Mart1 pool
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen
Screening: Native 15mer pool
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen
Screening: 9mer pool
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen
7 Weeks post 1st Vaccination: gp100 pool1
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen
7 Weeks post 1st Vaccination: gp100 pool4
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen
7 Weeks post 1st Vaccination: gp100 pool5
|
1 Participants
|
0 Participants
|
|
Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen
7 Weeks post 1st Vaccination: gp100 pool6
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen
7 Weeks post 1st Vaccination: NYESO-1 pool 1
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen
7 Weeks post 1st Vaccination: NYESO-1 pool 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen
7 Weeks post 1st Vaccination: Mart1 pool
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen
7 Weeks post 1st Vaccination: Native 15mer pool
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen
7 Weeks post 1st Vaccination: 9mer pool
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 to 32 weeks post 1st vaccinationPopulation: Immunologic responses were assessed in the Per-protocol evaluable population.
The Vaccine-induced increase of CD4 T-Cell positive response by antigen post-vaccination during the observation period compared to the screening values.
Outcome measures
| Measure |
Study Group 1: ALVAC Melanoma Vaccine
n=9 Participants
Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
|
Study Group 2: Interferon Alpha-2b
n=12 Participants
Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
|
|---|---|---|
|
Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen
Screening: gp100 pool1
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen
Screening: gp100 pool2
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen
Screening: gp100 pool3
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen
Screening: gp100 pool4
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen
Screening: gp100 pool5
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen
Screening: gp100 pool6
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen
Screening: NYESO-1 pool 1
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen
Screening: NYESO-1 pool 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen
Screening: Mart1 pool
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen
Screening: Native 15mer pool
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen
Screening: 9mer pool
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen
7 Weeks post 1st Vaccination: gp100 pool1
|
0 Participants
|
1 Participants
|
|
Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen
7 Weeks post 1st Vaccination: gp100 pool2
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen
7 Weeks post 1st Vaccination: gp100 pool3
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen
7 Weeks post 1st Vaccination: gp100 pool4
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen
7 Weeks post 1st Vaccination: gp100 pool5
|
1 Participants
|
0 Participants
|
|
Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen
7 Weeks post 1st Vaccination: gp100 pool6
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen
7 Weeks post 1st Vaccination: NYESO-1 pool 1
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen
7 Weeks post 1st Vaccination: NYESO-1 pool 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen
7 Weeks post 1st Vaccination: Mart1 pool
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen
7 Weeks post 1st Vaccination: Native 15mer pool
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen
7 Weeks post 1st Vaccination: 9mer pool
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 to 32 weeks post 1st vaccination or treatmentPopulation: Immunologic responses were assessed in the per-protocol evaluable population.
The immunogenicity of the treatment regimens was assessed by regulatory T-cell responses as assessed primarily by the multi-parametric intracellular cytokine staining (ICS) assay.
Outcome measures
| Measure |
Study Group 1: ALVAC Melanoma Vaccine
n=9 Participants
Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
|
Study Group 2: Interferon Alpha-2b
n=12 Participants
Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
|
|---|---|---|
|
Summary of Cellular Immune Response to the Vaccination or Treatment (Percent Regulatory T-Cells Responses)
Screening
|
2.7 Percent Cell Count
Standard Deviation 1.02
|
3.4 Percent Cell Count
Standard Deviation 1.24
|
|
Summary of Cellular Immune Response to the Vaccination or Treatment (Percent Regulatory T-Cells Responses)
Cycle 1 Week 1
|
3.3 Percent Cell Count
Standard Deviation 1.42
|
2.3 Percent Cell Count
Standard Deviation 0.65
|
|
Summary of Cellular Immune Response to the Vaccination or Treatment (Percent Regulatory T-Cells Responses)
Cycle 1 Week 7
|
2.9 Percent Cell Count
Standard Deviation 0.83
|
3.1 Percent Cell Count
Standard Deviation 1.13
|
|
Summary of Cellular Immune Response to the Vaccination or Treatment (Percent Regulatory T-Cells Responses)
Cycle 2 Week 23
|
3.3 Percent Cell Count
Standard Deviation 0.90
|
3.8 Percent Cell Count
Standard Deviation 0.51
|
|
Summary of Cellular Immune Response to the Vaccination or Treatment (Percent Regulatory T-Cells Responses)
Cycle 2 Week 32
|
4.0 Percent Cell Count
Standard Deviation 0.48
|
2.6 Percent Cell Count
Standard Deviation 0.07
|
Adverse Events
Study Group 1: ALVAC Melanoma Vaccine
Serious events: 5 serious events
Other events: 5 other events
Deaths: 0 deaths
Study Group 2: Interferon Alpha-2b
Serious events: 5 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Study Group 1: ALVAC Melanoma Vaccine
n=11 participants at risk
Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
|
Study Group 2: Interferon Alpha-2b
n=12 participants at risk
Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal Perforation
|
0.00%
0/11 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
8.3%
1/12 • Number of events 1 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
|
General disorders
Disease Progression
|
18.2%
2/11 • Number of events 2 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
16.7%
2/12 • Number of events 2 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
|
General disorders
Chest Pain
|
9.1%
1/11 • Number of events 1 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
8.3%
1/12 • Number of events 1 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
|
Infections and infestations
Sepsis
|
9.1%
1/11 • Number of events 1 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
|
Infections and infestations
Septic Shock
|
0.00%
0/11 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
8.3%
1/12 • Number of events 1 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/11 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
8.3%
1/12 • Number of events 1 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Malignant Melanoma
|
18.2%
2/11 • Number of events 2 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
Other adverse events
| Measure |
Study Group 1: ALVAC Melanoma Vaccine
n=11 participants at risk
Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
|
Study Group 2: Interferon Alpha-2b
n=12 participants at risk
Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/11 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
8.3%
1/12 • Number of events 1 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
9.1%
1/11 • Number of events 1 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
9.1%
1/11 • Number of events 2 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
|
General disorders
Axillary Pain
|
9.1%
1/11 • Number of events 2 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
|
General disorders
Chest Discomfort
|
9.1%
1/11 • Number of events 1 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
|
General disorders
Inflammation
|
9.1%
1/11 • Number of events 1 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
|
General disorders
Pyrexia
|
0.00%
0/11 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
8.3%
1/12 • Number of events 1 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
|
Investigations
ALT Increased
|
0.00%
0/11 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
25.0%
3/12 • Number of events 3 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
|
Investigations
AST Increased
|
0.00%
0/11 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
8.3%
1/12 • Number of events 1 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
|
Investigations
GGT Increased
|
9.1%
1/11 • Number of events 1 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
8.3%
1/12 • Number of events 1 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
|
Investigations
Neutrophil Count Decreased
|
9.1%
1/11 • Number of events 3 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
|
Investigations
White Blood Cell Count Decreased
|
9.1%
1/11 • Number of events 3 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
|
Infections and infestations
Staphylococcal Bacteremia
|
0.00%
0/11 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
8.3%
1/12 • Number of events 1 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
9.1%
1/11 • Number of events 1 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/11 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
8.3%
1/12 • Number of events 1 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/11 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
8.3%
1/12 • Number of events 1 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/11 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
8.3%
1/12 • Number of events 1 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Joint Range of Motion Decreased
|
9.1%
1/11 • Number of events 1 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
|
Nervous system disorders
Brain Edema
|
9.1%
1/11 • Number of events 1 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
|
Nervous system disorders
Cerebral Hemorrhage
|
9.1%
1/11 • Number of events 1 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
|
Nervous system disorders
Encephalopathy
|
9.1%
1/11 • Number of events 1 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
|
Nervous system disorders
Headache
|
9.1%
1/11 • Number of events 1 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
|
Nervous system disorders
Hemiplegia
|
9.1%
1/11 • Number of events 1 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/11 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
8.3%
1/12 • Number of events 1 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
0.00%
0/11 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
8.3%
1/12 • Number of events 1 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
|
Nervous system disorders
Syncope Vasovagal
|
0.00%
0/11 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
8.3%
1/12 • Number of events 1 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
|
Renal and urinary disorders
Polyuria
|
9.1%
1/11 • Number of events 1 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
|
Vascular disorders
Hypotension
|
9.1%
1/11 • Number of events 1 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
|
Additional Information
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