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.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
8
H.Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
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.
Time frame: 30 Days Post Vaccine
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.
Time frame: 30 Days Post Vaccine
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.
Time frame: 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.
Time frame: 30 Days Post Vaccine
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