Trial Outcomes & Findings for A Study of the Efficacy and Safety of the LEISH-F2 + MPL-SE Vaccine for Treatment of Cutaneous Leishmaniasis (NCT NCT01011309)
NCT ID: NCT01011309
Last Updated: 2013-12-11
Results Overview
Efficacy of immunotherapy with the LEISH-F2 + MPL-SE vaccine was compared to the efficacy of chemotherapy with sodium stibogluconate in the treatment of CL. Efficacy is measured by the date of clinical cure.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
45 participants
Primary outcome timeframe
Day 84
Results posted on
2013-12-11
Participant Flow
Patients with CL were actively recruited from Andean mountain regions endemic for transmission of Leishmania peruviana. Patients were treated in a medical clinic at the Instituto de Medicina Tropical 'Alexander von Humboldt', Universidad Peruana Cayetano Heredia, Lima, Peru.
All eligible patients were randomized to treatment groups. One patient was mistakenly randomized (ineligible) and was not treated.
Participant milestones
| Measure |
Immunotherapy v1.4/1.5
10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 28, and 56.
|
Immunotherapy v1.6
10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 14, and 28.
|
Chemotherapy
Sodium stibogluconate (SSG) given 20 mg/kg/day IV for 20 days.
|
|---|---|---|---|
|
Overall Study
STARTED
|
14
|
10
|
21
|
|
Overall Study
COMPLETED
|
12
|
7
|
16
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
5
|
Reasons for withdrawal
| Measure |
Immunotherapy v1.4/1.5
10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 28, and 56.
|
Immunotherapy v1.6
10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 14, and 28.
|
Chemotherapy
Sodium stibogluconate (SSG) given 20 mg/kg/day IV for 20 days.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
2
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
3
|
Baseline Characteristics
A Study of the Efficacy and Safety of the LEISH-F2 + MPL-SE Vaccine for Treatment of Cutaneous Leishmaniasis
Baseline characteristics by cohort
| Measure |
Immunotherapy v1.4/1.5
n=14 Participants
10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 28, and 56.
|
Immunotherapy v1.6
n=10 Participants
10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 14, and 28.
|
Chemotherapy
n=21 Participants
Sodium stibogluconate (SSG) given 20 mg/kg/day IV for 20 days.
|
Total
n=45 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age Continuous
|
38.3 years
STANDARD_DEVIATION 14.2 • n=5 Participants
|
32.7 years
STANDARD_DEVIATION 6.8 • n=7 Participants
|
40.2 years
STANDARD_DEVIATION 16.0 • n=5 Participants
|
38.0 years
STANDARD_DEVIATION 14.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Region of Enrollment
Peru
|
14 participants
n=5 Participants
|
10 participants
n=7 Participants
|
21 participants
n=5 Participants
|
45 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 84Population: Per-protocol population: All patients who received all three study injections if in the immunotherapy groups or at least 15 injections of SSG if in the chemotherapy group, and completed the Day 56 visit (Immunotherapy v1.6), the Day 84 visit (Immunotherapy v1.4/1.5), or the Day 56 or Day 84 visit (Chemotherapy group).
Efficacy of immunotherapy with the LEISH-F2 + MPL-SE vaccine was compared to the efficacy of chemotherapy with sodium stibogluconate in the treatment of CL. Efficacy is measured by the date of clinical cure.
Outcome measures
| Measure |
Immunotherapy v1.4/1.5
n=12 Participants
10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 28, and 56.
|
Immunotherapy v1.6
n=7 Participants
10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 14, and 28.
|
Chemotherapy
n=16 Participants
Sodium stibogluconate (SSG) given 20 mg/kg/day IV for 20 days.
|
|---|---|---|---|
|
Date of Clinical Cure
Clinical cure by Day 84 without rescue treatment
|
2 participants
|
2 participants
|
15 participants
|
|
Date of Clinical Cure
Clinical cure by Day 84 with rescue treatment
|
10 participants
|
5 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Day 0 through Day 84Population: Safety population: All patients who received at least one study injection.
Safety of immunotherapy with the vaccine was compared to the safety of chemotherapy with sodium stibogluconate. All adverse events are listed regardless of relatedness.
Outcome measures
| Measure |
Immunotherapy v1.4/1.5
n=14 Participants
10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 28, and 56.
|
Immunotherapy v1.6
n=10 Participants
10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 14, and 28.
|
Chemotherapy
n=21 Participants
Sodium stibogluconate (SSG) given 20 mg/kg/day IV for 20 days.
|
|---|---|---|---|
|
Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study.
Injection site pain
|
8 participants
|
10 participants
|
0 participants
|
|
Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study.
Superinfection bacterial
|
4 participants
|
0 participants
|
0 participants
|
|
Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study.
ALT increased
|
8 participants
|
4 participants
|
10 participants
|
|
Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study.
Alkaline phosphatase increased
|
5 participants
|
1 participants
|
1 participants
|
|
Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study.
WBC decreased
|
4 participants
|
1 participants
|
10 participants
|
|
Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study.
Headache
|
3 participants
|
3 participants
|
5 participants
|
|
Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study.
Nausea
|
0 participants
|
0 participants
|
3 participants
|
|
Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study.
Injection site erythema
|
10 participants
|
9 participants
|
0 participants
|
|
Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study.
Injection site induration
|
8 participants
|
10 participants
|
0 participants
|
|
Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study.
Total bilirubin increased
|
4 participants
|
1 participants
|
3 participants
|
|
Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study.
Hemoglobin decreased
|
3 participants
|
0 participants
|
7 participants
|
SECONDARY outcome
Timeframe: Days 0, 56 or 84, and 168Population: Per-protocol population: patients who received all three study injections (immunotherapy groups) or at least 15 SSG injections (chemotherapy group) and completed the Day 84 or Day 56 visit.
Immunogenicity of the vaccine was evaluated by measuring IgG antibody and T-cell responses to the LEISH-F2 protein and soluble Leishmania antigen (SLA). IgG antibodies were measured by ELISA and T-cell cytokine responses (IFN-g and IL-10) were measured by Luminex. Data is presented as median Post:Pre ratios comparing Days 56/84 or 168 to baseline at Day 0.
Outcome measures
| Measure |
Immunotherapy v1.4/1.5
n=12 Participants
10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 28, and 56.
|
Immunotherapy v1.6
n=7 Participants
10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 14, and 28.
|
Chemotherapy
n=16 Participants
Sodium stibogluconate (SSG) given 20 mg/kg/day IV for 20 days.
|
|---|---|---|---|
|
IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10)
IgG antibody to LEISH-F2 - Day 56
|
NA Relative ELISA Units
Immunogenicity not measured at Day 56 in Immunotherapy v1.4/1.5.
|
84.56 Relative ELISA Units
Interval 40.99 to 409.8
|
2.004 Relative ELISA Units
Interval 0.392 to 37.02
|
|
IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10)
IgG antibody to LEISH-F2 - Day 84
|
76.72 Relative ELISA Units
Interval 31.19 to 577.1
|
NA Relative ELISA Units
Immunogenicity not measured at Day 84 in Immunotherapy v1.6.
|
0.662 Relative ELISA Units
Interval 0.176 to 104.3
|
|
IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10)
IgG antibody to LEISH-F2 - Day 168
|
23.93 Relative ELISA Units
Interval 6.74 to 159.6
|
10.26 Relative ELISA Units
Interval 9.11 to 80.75
|
0.74 Relative ELISA Units
Interval 0.24 to 1.29
|
|
IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10)
IgG antibody to SLA - Day 56
|
NA Relative ELISA Units
Immunogenicity not measured at Day 56 in Immunotherapy v1.4/1.5.
|
1.36 Relative ELISA Units
Interval 0.46 to 3.14
|
0.59 Relative ELISA Units
Interval 0.17 to 1.44
|
|
IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10)
IgG antibody to SLA - Day 84
|
1.6 Relative ELISA Units
Interval 0.84 to 4.43
|
NA Relative ELISA Units
Immunogenicity not measured at Day 84 in Immunotherapy v1.6.
|
0.54 Relative ELISA Units
Interval 0.11 to 3.12
|
|
IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10)
IgG antibody to SLA - Day 168
|
0.63 Relative ELISA Units
Interval 0.15 to 2.88
|
0.95 Relative ELISA Units
Interval 0.08 to 1.19
|
0.33 Relative ELISA Units
Interval 0.05 to 0.89
|
|
IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10)
IFN-g response to LEISH-F2 - Day 56
|
NA Relative ELISA Units
Immunogenicity not measured at Day 56 in Immunotherapy v1.4/1.5.
|
4.97 Relative ELISA Units
Interval 0.354 to 38.36
|
1.09 Relative ELISA Units
Interval 0.003 to 34.71
|
|
IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10)
IFN-g response to LEISH-F2 - Day 84
|
0.92 Relative ELISA Units
Interval 0.042 to 19.13
|
NA Relative ELISA Units
Immunogenicity not measured at Day 84 in Immunotherapy v1.6.
|
1.333 Relative ELISA Units
Interval 0.073 to 296.8
|
|
IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10)
IFN-g response to LEISH-F2 - Day 168
|
1.00 Relative ELISA Units
Interval 0.04 to 4.76
|
2.06 Relative ELISA Units
Interval 0.41 to 11.3
|
0.82 Relative ELISA Units
Interval 0.15 to 19.6
|
|
IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10)
IFN-g response to SLA - Day 56
|
NA Relative ELISA Units
Immunogenicity not measured at Day 56 in Immunotherapy v1.4/1.5.
|
0.87 Relative ELISA Units
Interval 0.09 to 6.1
|
0.84 Relative ELISA Units
Interval 0.01 to 75.3
|
|
IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10)
IFN-g response to SLA - Day 84
|
0.27 Relative ELISA Units
Interval 0.02 to 39.7
|
NA Relative ELISA Units
Immunogenicity not measured at Day 84 in Immunotherapy v1.6.
|
0.89 Relative ELISA Units
Interval 0.09 to 29.8
|
|
IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10)
IL-10 response to LEISH-F2 - Day 56
|
NA Relative ELISA Units
Immunogenicity not measured at Day 56 in Immunotherapy v1.4/1.5.
|
3.16 Relative ELISA Units
Interval 0.4 to 12.8
|
1.22 Relative ELISA Units
Interval 0.06 to 8.73
|
|
IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10)
IL-10 response to LEISH-F2 - Day 84
|
1.44 Relative ELISA Units
Interval 0.57 to 47.2
|
NA Relative ELISA Units
Immunogenicity not measured at Day 84 in Immunotherapy v1.6.
|
1.17 Relative ELISA Units
Interval 0.06 to 18.9
|
|
IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10)
IL-10 response to SLA - Day 84
|
0.63 Relative ELISA Units
Interval 0.15 to 25.2
|
NA Relative ELISA Units
Immunogenicity not measured at Day 84 in Immunotherapy v1.6.
|
0.92 Relative ELISA Units
Interval 0.04 to 9.85
|
|
IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10)
IL-10 response to SLA - Day 168
|
0.952 Relative ELISA Units
Interval 0.062 to 308.9
|
0.565 Relative ELISA Units
Interval 0.294 to 1.068
|
0.763 Relative ELISA Units
Interval 0.177 to 3.737
|
|
IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10)
IFN-g response to SLA - Day 168
|
0.2 Relative ELISA Units
Interval 0.01 to 76.5
|
0.31 Relative ELISA Units
Interval 0.0 to 2.5
|
0.69 Relative ELISA Units
Interval 0.05 to 3.94
|
|
IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10)
IL-10 response to LEISH-F2 - Day 168
|
2.19 Relative ELISA Units
Interval 0.16 to 27.5
|
0.9 Relative ELISA Units
Interval 0.44 to 3.48
|
1.03 Relative ELISA Units
Interval 0.08 to 4.91
|
|
IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10)
IL-10 response to SLA - Day 56
|
NA Relative ELISA Units
Immunogenicity not measured at Day 56 in Immunotherapy v1.4/1.5.
|
1.02 Relative ELISA Units
Interval 0.64 to 2.68
|
0.69 Relative ELISA Units
Interval 0.03 to 7.44
|
Adverse Events
Immunotherapy v1.4/1.5
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Immunotherapy v1.6
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Chemotherapy
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Immunotherapy v1.4/1.5
n=14 participants at risk
10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 28, and 56.
|
Immunotherapy v1.6
n=10 participants at risk
10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 14, and 28.
|
Chemotherapy
n=21 participants at risk
Sodium stibogluconate (SSG) given 20 mg/kg/day IV for 20 days.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Hospitalization due to Antimonial Toxicity
|
0.00%
0/14 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
0.00%
0/10 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
4.8%
1/21 • Number of events 1 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
|
Injury, poisoning and procedural complications
Hospitalization due to Grade 3 Cellulitis
|
7.1%
1/14 • Number of events 1 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
0.00%
0/10 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
0.00%
0/21 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
Other adverse events
| Measure |
Immunotherapy v1.4/1.5
n=14 participants at risk
10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 28, and 56.
|
Immunotherapy v1.6
n=10 participants at risk
10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 14, and 28.
|
Chemotherapy
n=21 participants at risk
Sodium stibogluconate (SSG) given 20 mg/kg/day IV for 20 days.
|
|---|---|---|---|
|
Investigations
ALT increased
|
57.1%
8/14 • Number of events 8 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
30.0%
3/10 • Number of events 3 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
42.9%
9/21 • Number of events 10 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
|
Investigations
Blood alkaline phosphatase increased
|
14.3%
2/14 • Number of events 2 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
0.00%
0/10 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
9.5%
2/21 • Number of events 2 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
|
Investigations
Blood bilirubin increased
|
14.3%
2/14 • Number of events 4 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
10.0%
1/10 • Number of events 1 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
14.3%
3/21 • Number of events 3 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/14 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
0.00%
0/10 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
19.0%
4/21 • Number of events 4 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
|
Investigations
Blood sodium increased
|
0.00%
0/14 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
0.00%
0/10 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
9.5%
2/21 • Number of events 2 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/14 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
10.0%
1/10 • Number of events 1 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
0.00%
0/21 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
|
General disorders
Face oedema
|
7.1%
1/14 • Number of events 1 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
0.00%
0/10 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
0.00%
0/21 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
|
Infections and infestations
Febrile infection
|
0.00%
0/14 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
10.0%
1/10 • Number of events 1 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
0.00%
0/21 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
|
Investigations
Haemoglobin decreased
|
14.3%
2/14 • Number of events 3 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
0.00%
0/10 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
33.3%
7/21 • Number of events 7 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
|
Nervous system disorders
Headache
|
7.1%
1/14 • Number of events 1 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
20.0%
2/10 • Number of events 4 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
23.8%
5/21 • Number of events 5 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/14 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
0.00%
0/10 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
9.5%
2/21 • Number of events 2 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
|
General disorders
Injection site erythema
|
71.4%
10/14 • Number of events 13 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
90.0%
9/10 • Number of events 21 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
—
0/0 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
|
General disorders
Injection site induration
|
57.1%
8/14 • Number of events 9 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
100.0%
10/10 • Number of events 21 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
—
0/0 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
|
General disorders
Injection site pain
|
57.1%
8/14 • Number of events 12 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
100.0%
10/10 • Number of events 25 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
—
0/0 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
|
General disorders
Malaise
|
0.00%
0/14 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
20.0%
2/10 • Number of events 3 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
0.00%
0/21 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/14 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
0.00%
0/10 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
14.3%
3/21 • Number of events 3 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/14 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
10.0%
1/10 • Number of events 1 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
4.8%
1/21 • Number of events 1 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/14 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
0.00%
0/10 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
14.3%
3/21 • Number of events 3 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/14 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
10.0%
1/10 • Number of events 1 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
0.00%
0/21 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
|
Investigations
Platelet count increased
|
0.00%
0/14 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
20.0%
2/10 • Number of events 2 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
0.00%
0/21 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
|
Investigations
Superinfection bacterial
|
7.1%
1/14 • Number of events 1 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
0.00%
0/10 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
0.00%
0/21 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
|
Investigations
WBC decreased
|
14.3%
2/14 • Number of events 2 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
0.00%
0/10 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
47.6%
10/21 • Number of events 10 • Day 0 through Day 336.
All SAEs are listed regardless of relatedness. Other adverse events listed are considered possibly, probably, or definitely related to study vaccination or chemotherapy.
|
Additional Information
Jill Ashman, MSc, Associate Director of Clinical Operations
IDRI
Phone: 206-858-6041
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee IDRI encourages publication in peer-reviewed medical journals and will not unduly withhold permission to publish. However, all proposed publications, papers, abstracts or written materials related to the study or an outline of any oral presentation, shall be submitted to and coordinated by IDRI to assure that no proprietary information is presented and that authorship is fairly represented.
- Publication restrictions are in place
Restriction type: OTHER