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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Biological: PCV 13


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PCV 13<br>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 | Biological: PCV 13<br> <br> * Other names: pneumococcal conjugate vaccine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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autologous transplant, multiple myeloma