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

Not Applicable

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Patients with confirmed multiple myeloma
Eligible for treatment with high dose melphalan based regimen and autologous peripheral stem cell transplant

Exclusion Criteria

Pregnant or lactating woman, as evaluated by serum testing within 24 hours of administration of the first vaccine
HIV infection confirmed by nucleic acid testing (NAT), as evaluated during pre transplant testing
Common variable immunodeficiency or other inherited systemic immunodeficiency syndrome
Active central nervous system (CNS) malignancy
Prior malignancy within 5 years of enrollment excluding non-melanoma skin cancer or cervical carcinoma after curative resection, not requiring chemotherapy.
History of severe allergy (e.g., anaphylaxis) to any component of pneumococcal conjugate vaccine 7 (PCV7), PCV13, or any diphtheria-toxoid containing vaccine.
Inclusion on a separate trial in which patients may be randomized or otherwise started on maintenance chemotherapies within the first 3 months of autologous transplantation
Patients with significant psychiatric illness likely to affect compliance, as determined by the treating physician
Active or uncontrolled infection
Diffusing lung capacity oxygenation (DLCO) <50 %
Left ventricular ejection fraction (LVEF) <40%
Bilirubin >2

Arm && Interventions

Group	Intervention	Description
PCV 13	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

Primary Outcome Measures

Name	Time	Method
Number of Participants With Immune Response	30 Days Post Vaccine	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.

Secondary Outcome Measures

Name	Time	Method
CD4+CTV-IFN-gamma+, Best Response Against Vaccine (CRM 197)	30 Days Post Vaccine	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.
CD8+CTV-IFN-gamma+, Best Response Against Vaccine (CRM 197)	30 Days Post Vaccine	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.
CD8+CD107a+, Best Response Against Vaccine (CRM 197)	30 Days Post Vaccine	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.