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There is no study hypothesis. The purpose of this study is to see if the Pneumococcal conjugate vaccine (PCV13), when administered before and early after an autologous peripheral stem cell transplant will induce an immune response.
This is a pilot study to determine the safety of PCV13 administered to patients with myeloma before and at +7-10 days and +21-24 days after autologous hematopoietic stem cell transplant; and,to quantify the immune response induced by PCV13 vaccination in patients with myeloma when administered before and early after autologous PSCT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PCV 13 | Experimental | Pneumococcal conjugate vaccine (PCV 13), 0.5ml, 3 to 30 days prior to transplant and then again at 7-10 and 21-24 days after transplant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCV 13 | Biological |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Immune Response | Positive response per test category. Post-vaccination result higher than pre-vaccination values for each test category criteria. Additional details are reported under Secondary Outcome Measures. | 30 Days Post Vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| CD4+CTV-IFN-gamma+, Best Response Against Vaccine (CRM 197) | Best CD4+ response against CRM197 at day +30 after transplant, utilizing flow cytometry for interferon-γ (IFN-gamma). Peripheral blood mononuclear cells were stained with cell trace violet (CTV) then incubated with CRM197 or vehicle control. Cells were then harvested and stained for flow cytometry. | 30 Days Post Vaccine |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frederick L Locke, MD | H. Lee Moffitt Cancer Center and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H.Lee Moffitt Cancer Center & Research Institute | Tampa | Florida | 33612 | United States |
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| Label | URL |
|---|---|
| H.Lee Moffitt Cancer Center \& Research Institute | View source |
| Bone Marrow Transplantation advance online publication 12 October 2015; doi: 10.1038/bmt.2015.239 | View source |
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Participants were enrolled at Moffitt Cancer Center between March 2013 and July 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental: PCV 13 | Pneumococcal conjugate vaccine (PCV 13), 0.5ml, 3 to 30 days prior to transplant and then again at 7-10 and 21-24 days after transplant. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental: PCV 13 | Pneumococcal conjugate vaccine (PCV 13), 0.5ml, 3 to 30 days prior to transplant and then again at 7-10 and 21-24 days after transplant. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Immune Response | Positive response per test category. Post-vaccination result higher than pre-vaccination values for each test category criteria. Additional details are reported under Secondary Outcome Measures. | All evaluable participants. | Posted | Number | participants | 30 Days Post Vaccine |
|
|
1 year, 5 months
All participants who received treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental: PCV 13 | Pneumococcal conjugate vaccine (PCV 13), 0.5ml, 3 to 30 days prior to transplant and then again at 7-10 and 21-24 days after transplant. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac disorders - Other, Orthostasis | Cardiac disorders | CTCAE v4.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Frederick Locke, M.D. | H. Lee Moffitt Cancer Center and Research Institute | 813-745-3509 | frederick.locke@moffitt.org |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| C538862 | 13-valent pneumococcal vaccine |
| D000069443 | Heptavalent Pneumococcal Conjugate Vaccine |
| D022242 | Pneumococcal Vaccines |
| ID | Term |
|---|---|
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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| CD8+CTV-IFN-gamma+, Best Response Against Vaccine (CRM 197) | Best CD8+ response against CRM197 at day +30 after transplant, utilizing flow cytometry for interferon-γ (IFN-gamma). Peripheral blood mononuclear cells were stained with cell trace violet then incubated with CRM197 or vehicle control. Cells were then harvested and stained for flow cytometry. Highest percentage increase of CD8 cells from pre-vaccine to Day + 30. | 30 Days Post Vaccine |
| CD8+CD107a+, Best Response Against Vaccine (CRM 197) | Best CD8+ response against CRM197 at day +30 for CD107a. Peripheral Blood Mononuclear Cells (PBMCs) were incubated with CRM197, or control. Cells were harvested and stained for flow cytometry. | 30 Days Post Vaccine |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | CD4+CTV-IFN-gamma+, Best Response Against Vaccine (CRM 197) | Best CD4+ response against CRM197 at day +30 after transplant, utilizing flow cytometry for interferon-γ (IFN-gamma). Peripheral blood mononuclear cells were stained with cell trace violet (CTV) then incubated with CRM197 or vehicle control. Cells were then harvested and stained for flow cytometry. | All evaluable participants. | Posted | Number | percentage of CD4 cells | 30 Days Post Vaccine |
|
|
|
| Secondary | CD8+CTV-IFN-gamma+, Best Response Against Vaccine (CRM 197) | Best CD8+ response against CRM197 at day +30 after transplant, utilizing flow cytometry for interferon-γ (IFN-gamma). Peripheral blood mononuclear cells were stained with cell trace violet then incubated with CRM197 or vehicle control. Cells were then harvested and stained for flow cytometry. Highest percentage increase of CD8 cells from pre-vaccine to Day + 30. | All evaluable participants. | Posted | Number | percentage of CD8 cells | 30 Days Post Vaccine |
|
|
|
| Secondary | CD8+CD107a+, Best Response Against Vaccine (CRM 197) | Best CD8+ response against CRM197 at day +30 for CD107a. Peripheral Blood Mononuclear Cells (PBMCs) were incubated with CRM197, or control. Cells were harvested and stained for flow cytometry. | All evaluable participants. | Posted | Number | percentage of CD8 cells | 30 Days Post Vaccine |
|
|
|
| 3 |
| 7 |
| 7 |
| 7 |
| Sinus bradycardia | Cardiac disorders | CTCAE v4.0 | Systematic Assessment |
|
| Abdminal pain | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE v4.0 | Systematic Assessment |
|
| Lung infection | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE v4.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE v4.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE v4.0 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
|
| Amnesia | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
|
| Fever | General disorders | CTCAE v4.0 | Systematic Assessment |
|
| Injection site reaction | General disorders | CTCAE v4.0 | Systematic Assessment |
|
| Edema limbs | General disorders | CTCAE v4.0 | Systematic Assessment |
|
| Chills | General disorders | CTCAE v4.0 | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE v4.0 | Systematic Assessment |
|
| Flu like symptoms | General disorders | CTCAE v4.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | CTCAE v4.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Gastrointestinal disorders - Other, Heartburn | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Rectal pain | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Papulopustular rash | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
|
| Lung infection | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE v4.0 | Systematic Assessment |
|
| Hallucinations | Psychiatric disorders | CTCAE v4.0 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
|
| Erythema multiforme | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | CTCAE v4.0 | Systematic Assessment |
|
| Hearing impaired | Ear and labyrinth disorders | CTCAE v4.0 | Systematic Assessment |
|
| Middle ear inflammation | Ear and labyrinth disorders | CTCAE v4.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | CTCAE v4.0 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
|
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
|
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Atrial fibriliation | Cardiac disorders | CTCAE v4.0 | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | CTCAE v4.0 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | CTCAE v4.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | CTCAE v4.0 | Systematic Assessment |
|
| Alkaline phosphatase increased | Investigations | CTCAE v4.0 | Systematic Assessment |
|
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| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D045424 |
| Complex Mixtures |
| D017778 | Vaccines, Combined |