Exploration of Immune Response to Early PCV13 Vaccination in Conjunction With Autologous Transplant (PCV13)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01852591|
Recruitment Status : Completed
First Posted : May 13, 2013
Results First Posted : April 4, 2016
Last Update Posted : February 2, 2017
- Study Details
- Tabular View
- Study Results
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Biological: PCV 13||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||October 2016|
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
Biological: PCV 13
- Number of Participants With Immune Response [ Time Frame: 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.
- CD4+CTV-IFN-gamma+, Best Response Against Vaccine (CRM 197) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Patients with confirmed multiple myeloma
- Eligible for treatment with high dose melphalan based regimen and autologous peripheral stem cell transplant
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01852591
|United States, Florida|
|H.Lee Moffitt Cancer Center & Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Frederick L Locke, MD||H. Lee Moffitt Cancer Center and Research Institute|
|Responsible Party:||H. Lee Moffitt Cancer Center and Research Institute|
|Other Study ID Numbers:||
|First Posted:||May 13, 2013 Key Record Dates|
|Results First Posted:||April 4, 2016|
|Last Update Posted:||February 2, 2017|
|Last Verified:||December 2016|
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Blood Protein Disorders
Immune System Diseases
Heptavalent Pneumococcal Conjugate Vaccine
Physiological Effects of Drugs