Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

All Drugs and Chemicals

Vaccines

Heptavalent Pneumococcal Conjugate Vaccine

Immunologic Factors

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

PCV 13

Frederick L Locke, MD

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.

Exploration of Immune Response to Early PCV13 Vaccination in Conjunction With Autologous Transplant

Exploration of Immune Response to Pneumococcal Conjugate Vaccine (PCV13) Administered Before and Early After Autologous Peripheral Stem Cell Transplant (Auto-PSCT) in Patients With Multiple Myeloma

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.

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.

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.

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.

H. Lee Moffitt Cancer Center and Research Institute

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.

Experimental: PCV 13

Age, Categorical

Age, Continuous

Gender

United States

Region of Enrollment

Frederick Locke, M.D.

CD4+CTV-IFN-gamma+,

CD8+CTV-IFN-gamma+,

CD8+CD107a+

Number of Participants With Immune Response

Highest % of CD4 cells Pre-vaccine

Best Response % of CD4 cells Day +30

CD4+CTV-IFN-gamma+, Best Response Against Vaccine (CRM 197)

Highest % of CD8 cells Pre-vaccine

Best Response % of CD8 cells Day +30

CD8+CTV-IFN-gamma+, Best Response Against Vaccine (CRM 197)

CD8+CD107a+, Best Response Against Vaccine (CRM 197)

Overall Study

Spots Global Cancer Trial Database for Exploration of Immune Response to Early PCV13 Vaccination in Conjunction With Autologous Transplant

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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