Trial Outcomes & Findings for Donor-Derived Humoral Immunity, Hematopoietic Stem Cell Transplantation, TAR (NCT NCT01611298)
NCT ID: NCT01611298
Last Updated: 2020-04-21
Results Overview
The proportion of participants with antibody recall response along with 95% confidence intervals will be calculated.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
7 participants
Primary outcome timeframe
4 months
Results posted on
2020-04-21
Participant Flow
Participant milestones
| Measure |
Single Arm: Tetanus Toxoid
SCT Donors will receive one dose of tetanus toxoid 0.5mL intramuscularly into deltoid or medial lateral thigh 7-10 days prior to bone marrow or peripheral blood stem cell harvest
Tetanus: Stem cell transplant donors will receive one dose of tetanus toxoid 0.5mL intramuscularly into deltoid or medial lateral thigh 7-10 days prior to bone marrow or peripheral blood stem cell harvest.
Stem cell transplant recipients will receive one dose of tetanus toxoid 0.5mL intramuscularly (or subcutaneously if platelet count less than 50,000/uL) into deltoid or medial lateral thigh 7-10 days prior to stem cell transplant (FIRST dose).
Stem cell transplant recipients will receive a subsequent dose of tetanus toxoid 0.5mL given intramuscularly into deltoid or medial lateral thigh (or given subcutaneously if platelet count is less than 50,000/uL) approximately 3 months following allo stem cell transplant. Patients must meet re-evaluation criteria to receive injection.
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|---|---|
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Overall Study
STARTED
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7
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Overall Study
COMPLETED
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5
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
| Measure |
Single Arm: Tetanus Toxoid
SCT Donors will receive one dose of tetanus toxoid 0.5mL intramuscularly into deltoid or medial lateral thigh 7-10 days prior to bone marrow or peripheral blood stem cell harvest
Tetanus: Stem cell transplant donors will receive one dose of tetanus toxoid 0.5mL intramuscularly into deltoid or medial lateral thigh 7-10 days prior to bone marrow or peripheral blood stem cell harvest.
Stem cell transplant recipients will receive one dose of tetanus toxoid 0.5mL intramuscularly (or subcutaneously if platelet count less than 50,000/uL) into deltoid or medial lateral thigh 7-10 days prior to stem cell transplant (FIRST dose).
Stem cell transplant recipients will receive a subsequent dose of tetanus toxoid 0.5mL given intramuscularly into deltoid or medial lateral thigh (or given subcutaneously if platelet count is less than 50,000/uL) approximately 3 months following allo stem cell transplant. Patients must meet re-evaluation criteria to receive injection.
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|---|---|
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Overall Study
Relapsed
|
2
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Baseline Characteristics
Donor-Derived Humoral Immunity, Hematopoietic Stem Cell Transplantation, TAR
Baseline characteristics by cohort
| Measure |
Single Arm: Tetanus Toxoid
n=7 Participants
SCT Donors will receive one dose of tetanus toxoid 0.5mL intramuscularly into deltoid or medial lateral thigh 7-10 days prior to bone marrow or peripheral blood stem cell harvest
Tetanus: Stem cell transplant donors will receive one dose of tetanus toxoid 0.5mL intramuscularly into deltoid or medial lateral thigh 7-10 days prior to bone marrow or peripheral blood stem cell harvest.
Stem cell transplant recipients will receive one dose of tetanus toxoid 0.5mL intramuscularly (or subcutaneously if platelet count less than 50,000/uL) into deltoid or medial lateral thigh 7-10 days prior to stem cell transplant (FIRST dose).
Stem cell transplant recipients will receive a subsequent dose of tetanus toxoid 0.5mL given intramuscularly into deltoid or medial lateral thigh (or given subcutaneously if platelet count is less than 50,000/uL) approximately 3 months following allo stem cell transplant. Patients must meet re-evaluation criteria to receive injection.
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|---|---|
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Age, Continuous
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7 years
n=5 Participants
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Sex: Female, Male
Female
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2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
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5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=5 Participants
|
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Region of Enrollment
United States
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7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: One participant was off study on day 68 and not included in this analysis.
The proportion of participants with antibody recall response along with 95% confidence intervals will be calculated.
Outcome measures
| Measure |
Single Arm: Tetanus Toxoid
n=6 Participants
SCT Donors will receive one dose of tetanus toxoid 0.5mL intramuscularly into deltoid or medial lateral thigh 7-10 days prior to bone marrow or peripheral blood stem cell harvest
Tetanus: Stem cell transplant donors will receive one dose of tetanus toxoid 0.5mL intramuscularly into deltoid or medial lateral thigh 7-10 days prior to bone marrow or peripheral blood stem cell harvest.
Stem cell transplant recipients will receive one dose of tetanus toxoid 0.5mL intramuscularly (or subcutaneously if platelet count less than 50,000/uL) into deltoid or medial lateral thigh 7-10 days prior to stem cell transplant (FIRST dose).
Stem cell transplant recipients will receive a subsequent dose of tetanus toxoid 0.5mL given intramuscularly into deltoid or medial lateral thigh (or given subcutaneously if platelet count is less than 50,000/uL) approximately 3 months following allo stem cell transplant. Patients must meet re-evaluation criteria to receive injection.
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|---|---|
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Antibody Recall Response Rate
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0.167 proportion of participants
Interval 0.004 to 0.641
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SECONDARY outcome
Timeframe: up to 12 monthsPopulation: One participant was off study on day 68 and not included in this analysis. Six participants included in the analysis had at least one measurement at the follow-up time points. n=the number of participants with measurements for that time point.
Changes from baseline to several time points during follow-up will be calculated.
Outcome measures
| Measure |
Single Arm: Tetanus Toxoid
n=6 Participants
SCT Donors will receive one dose of tetanus toxoid 0.5mL intramuscularly into deltoid or medial lateral thigh 7-10 days prior to bone marrow or peripheral blood stem cell harvest
Tetanus: Stem cell transplant donors will receive one dose of tetanus toxoid 0.5mL intramuscularly into deltoid or medial lateral thigh 7-10 days prior to bone marrow or peripheral blood stem cell harvest.
Stem cell transplant recipients will receive one dose of tetanus toxoid 0.5mL intramuscularly (or subcutaneously if platelet count less than 50,000/uL) into deltoid or medial lateral thigh 7-10 days prior to stem cell transplant (FIRST dose).
Stem cell transplant recipients will receive a subsequent dose of tetanus toxoid 0.5mL given intramuscularly into deltoid or medial lateral thigh (or given subcutaneously if platelet count is less than 50,000/uL) approximately 3 months following allo stem cell transplant. Patients must meet re-evaluation criteria to receive injection.
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|---|---|
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Change in Immunoglobulin Levels
IgM Change at 3 months
|
13.7 MG/DL
Interval 11.9 to 30.5
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Change in Immunoglobulin Levels
IgM Change at 6 months
|
45.0 MG/DL
Interval 21.6 to 148.0
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Change in Immunoglobulin Levels
IgA Change at 3 months
|
-49.9 MG/DL
Interval -68.0 to -31.0
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Change in Immunoglobulin Levels
IgA Change at 6 months
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-1.0 MG/DL
Interval -29.0 to 66.0
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Change in Immunoglobulin Levels
IgA Change at 12 months
|
7.7 MG/DL
Interval -34.0 to 16.0
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Change in Immunoglobulin Levels
IgG Change at 3 months
|
-677.6 MG/DL
Interval -717.0 to -676.1
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Change in Immunoglobulin Levels
IgG Change at 6 months
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-668.2 MG/DL
Interval -678.0 to -369.0
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Change in Immunoglobulin Levels
IgG Change at 12 months
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-683.0 MG/DL
Interval -1182.0 to -659.5
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Change in Immunoglobulin Levels
IgM Change at 12 months
|
75.8 MG/DL
Interval 40.0 to 98.0
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Adverse Events
Single Arm: Tetanus Toxoid
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Single Arm: Tetanus Toxoid
n=7 participants at risk
SCT Donors will receive one dose of tetanus toxoid 0.5mL intramuscularly into deltoid or medial lateral thigh 7-10 days prior to bone marrow or peripheral blood stem cell harvest
Tetanus: Stem cell transplant donors will receive one dose of tetanus toxoid 0.5mL intramuscularly into deltoid or medial lateral thigh 7-10 days prior to bone marrow or peripheral blood stem cell harvest.
Stem cell transplant recipients will receive one dose of tetanus toxoid 0.5mL intramuscularly (or subcutaneously if platelet count less than 50,000/uL) into deltoid or medial lateral thigh 7-10 days prior to stem cell transplant (FIRST dose).
Stem cell transplant recipients will receive a subsequent dose of tetanus toxoid 0.5mL given intramuscularly into deltoid or medial lateral thigh (or given subcutaneously if platelet count is less than 50,000/uL) approximately 3 months following allo stem cell transplant. Patients must meet re-evaluation criteria to receive injection.
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|---|---|
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Gastrointestinal disorders
Diarrhea
|
14.3%
1/7 • Number of events 1 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
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Blood and lymphatic system disorders
Febrile neutropenia
|
14.3%
1/7 • Number of events 1 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
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Infections and infestations
Infection - Other: Gastrointestinal Abdomen
|
14.3%
1/7 • Number of events 1 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
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Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • Number of events 1 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
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Other adverse events
| Measure |
Single Arm: Tetanus Toxoid
n=7 participants at risk
SCT Donors will receive one dose of tetanus toxoid 0.5mL intramuscularly into deltoid or medial lateral thigh 7-10 days prior to bone marrow or peripheral blood stem cell harvest
Tetanus: Stem cell transplant donors will receive one dose of tetanus toxoid 0.5mL intramuscularly into deltoid or medial lateral thigh 7-10 days prior to bone marrow or peripheral blood stem cell harvest.
Stem cell transplant recipients will receive one dose of tetanus toxoid 0.5mL intramuscularly (or subcutaneously if platelet count less than 50,000/uL) into deltoid or medial lateral thigh 7-10 days prior to stem cell transplant (FIRST dose).
Stem cell transplant recipients will receive a subsequent dose of tetanus toxoid 0.5mL given intramuscularly into deltoid or medial lateral thigh (or given subcutaneously if platelet count is less than 50,000/uL) approximately 3 months following allo stem cell transplant. Patients must meet re-evaluation criteria to receive injection.
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|---|---|
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Renal and urinary disorders
Pain - Bladder
|
28.6%
2/7 • Number of events 2 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
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Musculoskeletal and connective tissue disorders
Pain - Bone
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28.6%
2/7 • Number of events 2 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
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Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
28.6%
2/7 • Number of events 2 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Nervous system disorders
Pain - Head/headache
|
14.3%
1/7 • Number of events 1 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
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Musculoskeletal and connective tissue disorders
Pain - Joint
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14.3%
1/7 • Number of events 1 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
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Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
42.9%
3/7 • Number of events 11 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
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Investigations
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
85.7%
6/7 • Number of events 22 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
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|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
100.0%
7/7 • Number of events 21 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
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Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
42.9%
3/7 • Number of events 3 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Metabolism and nutrition disorders
Bicarbonate, serum-low
|
57.1%
4/7 • Number of events 11 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
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Investigations
Bilirubin (hyperbilirubinemia)
|
28.6%
2/7 • Number of events 2 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
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|
Skin and subcutaneous tissue disorders
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
14.3%
1/7 • Number of events 1 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
28.6%
2/7 • Number of events 2 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
71.4%
5/7 • Number of events 22 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Gastrointestinal disorders
Constipation
|
14.3%
1/7 • Number of events 1 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
42.9%
3/7 • Number of events 4 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Infections and infestations
Mucosal infection
|
14.3%
1/7 • Number of events 1 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Gastrointestinal disorders
Diarrhea
|
42.9%
3/7 • Number of events 7 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
14.3%
1/7 • Number of events 1 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
14.3%
1/7 • Number of events 1 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
14.3%
1/7 • Number of events 1 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
General disorders
Fatigue (lethargy, malaise, asthenia)
|
14.3%
1/7 • Number of events 1 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Blood and lymphatic system disorders
Febrile neutropenia(fever of unknown origin wo clinically or microbiologically documented infection)
|
28.6%
2/7 • Number of events 2 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
42.9%
3/7 • Number of events 5 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Investigations
GGT (gamma-Glutamyl transpeptidase)
|
42.9%
3/7 • Number of events 8 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
28.6%
2/7 • Number of events 7 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
14.3%
1/7 • Number of events 3 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Renal and urinary disorders
Hemorrhage, GU - Urinary NOS
|
14.3%
1/7 • Number of events 2 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
42.9%
3/7 • Number of events 3 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Infections and infestations
Infection(documented clinically or microbiologically) with Grade 3 or 4 neutrophils-Bladder(urinary)
|
14.3%
1/7 • Number of events 1 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Infections and infestations
Infection - Other: Mucosa
|
14.3%
1/7 • Number of events 3 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Upper airway NOS
|
14.3%
1/7 • Number of events 1 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Investigations
Lipase
|
14.3%
1/7 • Number of events 1 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
71.4%
5/7 • Number of events 21 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Oral cavity
|
14.3%
1/7 • Number of events 4 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Gastrointestinal disorders
Nausea
|
57.1%
4/7 • Number of events 10 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Investigations
PTT (Partial Thromboplastin Time)
|
14.3%
1/7 • Number of events 1 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
28.6%
2/7 • Number of events 4 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
14.3%
1/7 • Number of events 2 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Nervous system disorders
Pain - Other: Headache
|
14.3%
1/7 • Number of events 3 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Gastrointestinal disorders
Pain - Other: Oral Cavity
|
14.3%
1/7 • Number of events 1 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
General disorders
Pain - Pain NOS
|
14.3%
1/7 • Number of events 1 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Reproductive system and breast disorders
Pain - Vagina
|
14.3%
1/7 • Number of events 1 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Psychiatric disorders
Personality/behavioral
|
14.3%
1/7 • Number of events 1 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
28.6%
2/7 • Number of events 2 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
42.9%
3/7 • Number of events 4 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
42.9%
3/7 • Number of events 8 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Renal and urinary disorders
Proteinuria
|
14.3%
1/7 • Number of events 2 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Infections and infestations
Pulmonary/Upper Respiratory - Other: Rhinorrhea
|
14.3%
1/7 • Number of events 2 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other: Wheezing
|
14.3%
1/7 • Number of events 1 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
57.1%
4/7 • Number of events 6 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
General disorders
Rigors/chills
|
28.6%
2/7 • Number of events 2 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Reproductive system and breast disorders
Sexual/Reproductive Function - Other: Menstrual cramps
|
14.3%
1/7 • Number of events 1 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
100.0%
7/7 • Number of events 15 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia - Sinus arrhythmia
|
14.3%
1/7 • Number of events 1 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Nervous system disorders
Tremor
|
14.3%
1/7 • Number of events 1 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Metabolism and nutrition disorders
Triglyceride, serum-high (hypertriglyceridemia)
|
28.6%
2/7 • Number of events 2 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Gastrointestinal disorders
Vomiting
|
57.1%
4/7 • Number of events 14 • Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place